[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: These were: age of 2;0–5;11 years at ascer-tainment; clinical diagnosis of autistic disorder by theassessing professional; fulfilling full diagnostic cri-teria for classical autism on the ADI. (All but 4 casesalso showed full diagnostic algorithm criteria on theADOS and these 4 cases were just 1 point below cut-off, see Table 1.)
Excluded criteria: Exclusion criteria were: severe globaldevelopmental delay; severe environmental depriva-tion in infancy; 1st language other than English;diagnosed hearing impairment; diagnosed visualimpairment; known chronic psychiatric or physicalillness in parents; no evidence of any desire tointeract with adult.
Intervention Characteristics
Intervention
Control
Funktionsniveau, klinikerbedømt, Vineland, higher better
Kernesymptomer autisme, klinikerbedømt, ADI- RSI, lower better
Sponsorship source: Shirley foundation.
Country: UK
Authors name: Catherine Aldred
Institution: Human Communication and Deafness Group, University of Manchester, UK
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: a) presence of PDD (autism, PDD-NOS, Asperger’s disorder)established by DSM-IV-TR clinical criteria1 and corroborated by the Autism DiagnosticInterview-Revised (ADI-R);36 (b) age 4 to 13 years inclusive; (c) ≥ 18 on the Irritabilitysubscale of the parent-rated ABC; 37,38 (d) CGI—Severity score ≥ 4; (e) medication free fortwo weeks for most psychotropic drugs, and for four weeks for fluoxetine and/or depotneuroleptics; (f) IQ ≥ 35 or mental age ≥ 18 months as assessed by Stanford Binet, LeiterInternational Performance Scale, or Mullen Scales of Development; and (g) if takinganticonvulsant, seizure-free for ≥ six months and with stable dose for four weeks.
Excluded criteria: Exclusion criteria included (a) positive Beta HCG pregnancy test for girls; (b) prior adequate trial ofrisperidone; (c) other PDD (i.e., Rett’s disorder, Childhood Disintegrative Disorder); (d)lifetime diagnosis of schizophrenia, other psychotic disorder, bipolar disorder, or currentdiagnosis of major depression, obsessive compulsive disorder, or substance abuse; (e)significant medical condition (e.g., heart, liver, renal, pulmonary disease), unstable seizuredisorder, or significant abnormality on routine laboratory tests
Pretreatment: Most clinical characteristics, including the HSQ, were similar across treatment groups. However,ABC Stereotypic Behavior, Vineland scores, IQ, and use of anticonvulsant medication weredifferent across treatment groups. The MED group had lower functional skills and was morelikely to be treated with anticonvulsants.
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., HSQ-total, lower is better
Antal bivirkninger, beskrives narrativt
Sponsorship source: Financial Disclosures by Site: O.S.U. Dr. Aman: Bristol-Meyers Squibb, consultant, research grant; Johnson & Johnson, consultant,research grant; Forest, consultant, research grant. Dr. Arnold: Abbott, consultant; Eli Lilly, research grant; CureMark, research grant;Neuropharm, research grant, consultant; Novartis, consultant, research grant, speaker’s bureau; Noven, research grant; Organon,consultant; Shire, consultant, research grant, speaker’s bureau; Sigma Tau, consultant, research grant; Targacept, research grant.Indiana University. Dr. McDougle: Bristol-Myers Squibb, consultant, research grant, speaker’s bureau. Dr. Stigler: Bristol-MyersSquibb Co., research grant, Janssen, research grant. Yale. Dr. Scahill: Supernus, consultant; Neuropharm, consultant; Janssen,consultant; Bristol-Myers Squibb, consultant; Shire, consultant. Univ. Pittsburgh. Dr. Handen: Bristol-Myers Squibb, research grant;Neuropharm, research grant; Forest, consultant. NIMH: Dr. Wagner held stock in Johnson & Johnson in an amount deemed bygovernment-wide regulations not to create a conflict of interest, and has since divested. All other authors: No disclosures
Country: US
Comments: Trial Registration: NCT00080145
Authors name: Michael G. Aman
Institution: The Nisonger Center UCEDD, Ohio State University
Email: aman.1@osu.edu
Address: The Nisonger Center UCEDD, Ohio State University, 1581 Dodd Drive, Columbus, OH43210-1296
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria for the child participants included:(a) being between 1.5 and 4.5 years of age (18–56 months) at intake, (b) exceeding autism classification cut-off scores based onAutism Diagnostic Observation Schedule, Second Edition (ADOS-2;Lord et al., 2012), and (c) meeting DSM-5 ASD diagnostic criteriabased on expert clinical judgement by a licensed clinical psychologist. Inclusion criteria for parents included willingness to (a)complete two-day intake and post assessment batteries, (b) participate in a weekly two-hour parent education session, and (c) be athome for up to eight hours a week of clinician-delivered intervention. Participants in this study were recruited from online adver-tisements, community referrals, and internal referrals.
Pretreatment: There were no significant differences between groups on demographicvariables of age, sex, or race. There were no significant differences between groups on baseline measures of child social respon-siveness, NTW, NDW, or MLU-w (p > .05).
Intervention Characteristics
Intervention
Control
Sponsorship source: This study was funded by Autism Speaks (Grant ID20131198), United States
Country: US
Setting:
Comments:
Authors name: Amy C. Barrett
Institution: Koegel Autism Center, Department of Counseling, Clinical, and School Psychology, Gervitz Graduate School of Education, University of California,
Email: amybarret414@gmail.com
Address: Koegel Autism Center, Department of Counseling, Clinical, and School Psychology, Gervitz Graduate School of Education, University of California,Santa Barbara, Santa Barbara, CA, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants had to have moderate or greater behav-ioral problems as measured by a pretreatment score of 15 orgreater on the parent-rated Aberrant Behavior Checklist–Irritability subscale (ABC-I) (reviewed by a research coordi-nator and tallied by computer)17and a rating of moderate orhigher (≥4) on the Clinical Global Impression–Severity(CGI-S) by an independent evaluator. Children receiving stable medication or remedial orbehavioral interventions were eligible if there were noplanned changes in existing interventions for the duration ofthe trial.
Excluded criteria: Children with receptive language less than 18months on the Mullen Receptive Language scale, notenrolled in a school program, or living in a household with-out an English-speaking caregiver were excluded. Otherexclusion criteria were aDSM-IV-TRdiagnosis of Rett disor-der or childhood disintegrative disorder, presence of a knownserious medical condition in the child that would interferewith participation, or current psychiatric disorder requiringalternative treatment. Concomitant psychiatric disorderswere assessed by clinical interview aided by the parent-ratedEarly Child Symptom Inventory.18Children whose parentsparticipated in a structured parent training program in thepast 2 years were also excluded.
Pretreatment: The study groups appeared similar at baseline except for maternal college education
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældre bedømt, CGI, much improved or very much improved
Bivirkninger, antal, beskrives narrativt
Adfærdsvanskeligheder, forældre rap., HSQ-total, lower is better
Sponsorship source: unding/Support:This work was funded by theNational Institute of Mental Health by grants to YaleUniversity/Emory University (MH081148; principalinvestigator: Dr Scahill), the University of Pittsburgh(MH080965; principal investigator: Dr Johnson),Ohio State University (MH081105; principalinvestigator: Dr Lecavalier), Indiana University(MH081221; principal investigator: Dr Swiezy), andthe University of Rochester (MH080906; principalinvestigator: Dr Smith). The project described inthis publication also was supported by MH079130(principal investigator: Dr Sukhodolsky); aUniversity of Rochester Clinical and TranslationalScholar Award (CTSA) (UL1 TR000042) from theNational Center for Advancing TranslationalSciences of the National Institutes of Health (NIH);a CTSA (UL1 RR024139) and grant from theNational Center for Research Resources (NCRR)(5KL2RR024138), a component of the NIH; and theNIH Roadmap for Medical Research. This work wassupported in part by a Public Health Service grant(UL1 RR025008) from the CTSA program of theNIH NCRR at Emory University School of Medicineand also supported by the Marcus Foundation,Joseph B. Whitehead Foundation, Children’sHealthcare o
Country: US
Comments: NTC012334414
Authors name: Lawrence Scahil
Institution: Marcus AutismCenter, Children’s Healthcare ofAtlanta and Emory University Schoolof Medicine
Email: Lawrence.Scahil@emory.edu
Address: Marcus AutismCenter, Children’s Healthcare ofAtlanta and Emory University Schoolof Medicine, 1920 Briarcliff NE,Atlanta, GA 30329
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligi-bility was based on elevated scores on key assessmentssupported by expert clinician impression regarding ASDsymptoms, no more than half-time childcare, between 36and 42 weeks’ gestation, birthweight>2,500g, andabsence of identifiable neurological, genetic, or severe sen-sory or motor conditions.
Pretreatment: No significant associations emergedbetween treatment allocation and sex (P5.08), ethnic-ity (P5.64), caregiver education (P5.70), sibling status(P5.38), recruitment source (P5.70) or ASD diagnosisat intake (P5.71). No group differences emerged formean age, ADOS-2, MSEL, PLS-4, or VABS scores atintake (allP’s>.16; see Table 2); nor for the BL video-coded measures (allP’s>.25).
Intervention Characteristics
Intervention
Control
Funktionsniveau, Vineland II, lower is better
Kernesymptomer, kliniker bedømt, ADOS-2 CSS, lower is better
Forældretrivsel, PSI eller parent stress subscale, lower is better
Sponsorship source: This research was funded by Autism Speaks Canada, theSinneave Family Foundation, and the Craig Foundation,with support from the Joan and Jack Craig Chair inAutism Research (SEB and IMS) and the Stollery Child-ren’s Hospital Foundation Chair in Autism Research (LZ).IMS and LZ contributed equally to this work.
Country: Canada
Authors name: Jessica A. Brian
Institution: Autism Research Centre, Bloorview Research Institute/University of Toronto, Toronto, ON
Email: jbrian@hollandbloor-view.ca
Address: 50 Kilgour Rd. Toronto, ON M4G 1R8, Canada.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Children who met criteria for autism spectrum disorders (ASD)
Excluded criteria: Families of children who did not obtain a predetermined ‘at-risk’ score on the STAT and/or did not meet symptom criteria for an ASD based on expert clinical impression were excluded (n = 32). One child was excluded after the in-person evaluation because of a late disclosure of a Fragile X diagnosis and two families whose children met enrollment criteria were not randomized and did not participate due to family choice
Intervention Characteristics
Intervention
Control
Sprog (Ekspressivt), Mullen, higher better, FU
Sprog (forståelse), Mullen, higher better, FU
Kommunikation, PIA-CV nonverbal communication*, lower better
Funktionsniveau, klinikerbedømt, Vineland, higher better
Kernesymptomer autisme, klinikerbedømt, ADOS, lower better
Sponsorship source: This research was supported by a grant from Autism Speaks and the Marino Autism Research Institute
Country: USA
Authors name: Alice S. Carter
Institution: University of Massachusetts
Email: alice.carter@umb.edu.
Address: Department of Psychology, 100 Morrissey Boulevard, Boston, MA 02125, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældre bedømt, Vineland II (VABS), lower is better
Bivirkninger
Kernesymptomer, klinikerbedømt, ADOS-2 CSS, lower is better
Sponsorship source: This study was supported by NationalInstitute of Mental Health grantU54MH066399 (to Dr Dawson)
Country: US
Comments: This trial has been registered at www.clinicaltrials.gov(identifier NCT00090415)
Authors name: Geraldine Dawson
Institution: AutismSpeaks; DepartmentofPsychiatry, UniversityofNorthCarolina, ChapelHill, NorthCarolina; DepartmentofPsychology,
Email: gdawson@autismspeaks.org
Address: 4120 Bioinformatics Building, University of NorthCarolina, Chapel Hill, North Carolina
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Children meeting ICD-10 criteria for childhood autism using the CHAT screening tool
Excluded criteria: Children with severe general development delay
Intervention Characteristics
Intervention
Control
Kernesymptomer autisme, klinikerbedømt, ADI- RSI, lower better
Forældretrivsel (PSI), lower is better
Sponsorship source: A Medical Research Council Project Grant and a grant from the Special Trustees of Guy’s Hospital to SBC, AC and GB supported this research.
Country: UK
Authors name: Auriol Drew
Institution: Newcomen Centre,Guy’s HospitalLondon,UK
Email: t.charman@ich.ucl.ac.uk
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Children 2 to 5 years old with ASD and significant language delay.
Excluded criteria: Children were excluded if they had.1 hour of weekly individual speech therapy,.15 hours of weekly 1:1ABA treatment, or unstable interventions 1 month before baseline or anticipated treatment changes during the trial.Other severe psychiatric disorders, genetic abnormality, an active medical problem, a primary language other than English, living >50 miles away
Intervention Characteristics
Intervention
Control
Funktionsniveau, klinikerbedømt, CGI-Severity, Lower better
Kernesymptomer autisme, forældrerapporteret (SRS), SRS, lower better
Sponsorship source: : Supported by a grant from the National Institute on Deafness and Other Communication Disorders (DC01368902; principal investigator: Dr Hardan). Dr. Abrams received additional support from a National Institute of Mental Health K01 Mentored Research Scientist Development Award (MH102428). Data management was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health through grant UL1 TR001085. Funded by the National Institutes of Health (NIH).
Country: USA
Authors name: Grace W. Gengoux
Institution: a Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California
Study design: RCT
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants were 30 families with children ages 3 years, 0months to 7 years, 11 months with a previous diagnosis ofan ASD from a healthcare professional. To participate inthe study, children had to demonstrate cognitive function-ing at the 2-year-old level or higher and speak a minimumof three words or word approximations. Children withdual diagnoses of ASD and intellectual disability werenot excluded. To ensure they would have thecapacity to learn treatment skills, they had to attain a stan-dard score of 75 or higher on a cognitive screening measureor have completed at least 2 years of college.
Excluded criteria: Exclusioncriteria for this study included change in behavioralmedication type or dosage during the month precedingthe start of treatment or any time during study involve-ment. Children receiving additional behavioral treatments(e.g., ABA Discrete Trial Training) were excluded.
Intervention Characteristics
Intervention
Control
Kernesymptomer, forældrebedømt, SRS-2, lower is better
Adfærdsvanskeligheder, forældre rap., ECBI - intensity, lower is better
Forældretrivsel, PSI/parent stress subscale, lower is better
Sponsorship source: Research was supported by grants from the Universityof Florida’s Center for Pediatric Psychology and FamilyStudies.
Country: US
Authors name: Nicole C. Ginn
Institution: TEACCHAutism Program, University of North Carolina
Email: nicole_ginn@med.unc.edu
Address: University of North Carolina, Campus Box 7180,Chapel Hill, NC 2799-7180
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Families with a child aged 2 years to 4 years and 11 months, and meeting criteria for core autism according to the international standard diagnostic tests (social and communication domains of the ADOS-G,11 and two of three domains of the Autism Diagnostic Interview Revised [ADI-R] algorithm19) were included in the study.
Excluded criteria: We excluded children with a twin with autism; a non-verbal age equivalent to 12 months or younger on the Mullen Early Learning Scales;20 epilepsy requiring medication; severe hearing or visual impairment in a parent or the child; or a parent with a severe psychiatric disorder requiring treatment.
Intervention Characteristics
Intervention
Control
Kernesymptomer, klinikerbedømt, ADOS total score, lower is better
Sponsorship source: UK Medical Research Council, and UK Department for Children, Schools and Families
Country: UK
Authors name: Prof Jonathan Green
Institution: Psychiatry Research Group
Email: jonathan.green@manchester.ac.uk
Address: Room 4.319, University Place, Oxford Road, Manchester M13 9PL, UK
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants included children: (a) 2–6 years old (b) diagnosed with autism based on DSM-IV-TR criteria, Autism Diagnostic Interview-Revised (ADI-R) Autism Diagnostic Observation Schedule (ADOS), and expert clinical judgment (c) communication delayed on Preschool Language Scale (PLS-4)(d) able to vocalize with intent when prompted by a clinician during the screening visit(e) with stable concomitant interventions (e.g. ABA, special education, medications, biomedical treatments) for 1 month prior to participation with no planned changes(f) with at least one parent available to consistently participate
Excluded criteria: (a) participation in more than 60 min weekly of individual speech therapy (b) comorbid severe psychiatric disorder (c) genetic abnormality(d) active medical problems
Intervention Characteristics
Intervention
Control
Kernesymptomer autisme, forældrerapporteret, SRS, lower better
Funktionsniveau, klinikerbedømt, CGI-Severity, lower=better
Bivirkninger, antal personer
Sponsorship source: Autism Speaks Treat-ment Grant (#5773; PI: Hardan). Data management was sup-ported by the National Center for Research Resourcesand the National Center for Advancing TranslationalSciences, National Institutes of Health, through grantUL1 RR025744
Country: USA
Authors name: Antonio Y. Hardan
Institution: Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligibility required: an ASD diagnosis, a score ≥15 on the Irritability subscale of the Aberrant Behavior Checklist (described below), and a CGI Severity (CGI-S) score ≥4. Additional interventions and medications were required to be stable for 6 weeks, with no planned changes for the course of the study.
Excluded criteria: Children with serious medical conditions or another psychiatric disorder in need of treatment, receptive language skills ≤18 months (as determined by standardized cognitive and developmen-tal assessments), or those with current or past treatment in structured PT for disruptive behavior were excluded.
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., ABC -irritability subscale, lower is better
Forældretrivsel, PSI/parent stress subscale, lower is better
Sponsorship source: This work was funded by the National Institute of Men-tal Health by the following grants: Yale University/Emory University MH081148 (principal investigator: L. Scahill); University of Pitts-burgh/University of Florida MH080965 (principal investigator: C. Johnson); Ohio State University MH081105 (principal investigator: L. Lecavalier); Indiana University MH081221 (principal investigator: N. Swiezy); University of Rochester MH080906 (principal investigator: T. Smith). Additional support was provided by MH079130 (princi-pal investigator: D Sukhodolsky), the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Numbers UL1 TR000454 (Emory University), UL1 TR000042 (Uni-versity of Rochester), UL1 RR024139 (Yale University) and the Mar-cus Foundation. We thank the families who participated in this study
Country: US
Authors name: Suzannah Iadarola
Institution: University of Rochester Medical Center, Rochester, NY, USA and Department of Pediatrics, University of Rochester Medical Center
Email: suzannah_iadarola@urmc.rochester.edu
Address: Department of Pediatrics, University of Rochester Medical Center, 601 Elmwood Avenue, Box 671, Rochester, NY 14642, USA
Study design: RCT
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Children were eligible ifthey had adiagnosis of pervasive developmental disorder or authmnewlymadebya developmental pediatrician usingDSMIDRcriteria
Excluded criteria: Children were excluded if they bad any of tbefoliowing: an age 24 mont or over72 months atthe time of diagnosis; residenceof more than 60miles outside the city of Winnipeg; existing attendance atdaycareorscbool atthe time of diagnosis; or tbe presence of a severephysicaJdisabilitythatwouJdprecludecompletionofdevelopmentaltestitems
Intervention Characteristics
Intervention
Control
Kernesymptomer, forældrebedømt, ABC total parent version, lower is better
Kernesymptomer, klinikerbedømt, ABC total, lower is better
Forældretrivsel, SACL, lower is better
Sponsorship source: Thisresearch was suppcsu:d byGrant#6f/J7-1649-62 from thc NationalHealth Research and Development Program(NHRDP).
Country: Canada
Authors name: Leslie L.Jocelyn
Institution: Child Development Clinic
Address: Children's Hospital, 840Sberbrook Street..WiMipeg, Manitoba R3A1S1, Canada
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusionarycriteria included that the child was younger than36 months, met criteria for autism following DSM-IVcriteria by an independent clinician, and did not haveadditional syndromes.
Excluded criteria: No exclusions were made based upon gender, ethnicity ordevelopmental age.
Intervention Characteristics
Intervention
Control
Sponsorship source: This study was supported by NIMH grantMH064927 awarded to Connie Kasari.
Country: US
Comments: Clinical Trials #: NCT00065910
Authors name: C. Kasari
Institution: Division of Psychological Studies in Education, University of California Los Angeles
Email: kasari@gseis.ucla.edu
Address: University ofCalifornia Los Angeles, 3132 Moore Hall, UCLA, Los Angeles,CA 90095, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants were eligible to participate if they: (a) had a child between the ages of 3 and 12 years with a DSM-IV/5 diagnosis of autism (APA 2013), as verified with the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) by the research team and with no other primary sensory deficit such as deafness or blindness; (b) had a child eligible for special education ser-vices under the category of autism; (c) nominated a target problem behavior; (d) agreed to be randomly assigned to a condition; (d) agreed to be audiotaped; (e) agreed to commit to activities related to condition assignment (e.g., time for consultation, completion of forms, being observed); and (f) had no plans to move for the duration of the study.
Excluded criteria: Ineligi-ble families were those who: (a) had another child already in the study or (b) were not comfortable with the assess-ments or intervention conducted in English.
Pretreatment: The results from these analyses highlight the statistical similarity across the conditions with respect to child age, gender, race/ethnicity, concurrent services received, household income, mother and father’s educa-tion, and child ADOS-2 and Vineland standard scores. It is important to note that although some differences were found between conditions with respect to two concurrent services received during the study (i.e., speech and behavior therapy), these differences should be interpreted with caution given the large family of significance tests conducted on selected demographic and baseline variables. In this sample, problem behaviors ranged from tantrums involving aggressive behav-iors (51%), Stereotypy (17%), noncompliance and escape behaviors (13%) each and inappropriate initiations (6%)
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., ECBI - intensity, lower is better
Forældretrivsel, PSI/parent stress subscale, lower is better
Sponsorship source: our funding source (The University of Louisville and Uni-versity of Kentucky Collaborative Research initiative
Country: US
Authors name: Grace M. Kuravackel
Institution: Department of Pediatrics, University of Louisville School of Medicine
Email: g0math01@luisville.edu
Address: Department of Pediatrics, University of Louisville School of Medicine, 1405 East Burnett Avenue, Louisville, KY 40292, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: ll participants had an ASD diagnosis based upon the Autism Diagnostic Interview–Revised (Rutter, Le Couteur & Lord 2003) and expert clinical evaluation that included interview, observation, and DSM-IV-TR checklist (APA 2000). ASD included Autistic Disorder (n = 57, 44.5% of sample), Pervasive Developmental Disorder Not Otherwise Specified (n = 50, 39.1% of sample), and Asperger’s Disorder (n= 21, 16.4% of sample). Participants had to exhibit problematic overactivity and/or inattention at both home and school, defined as mean item score ≥ 1.5 on both the parent- and teacher-completed SNAP-IV as well as CGI-Severity score ≥ 4.
Excluded criteria: We excluded children with significant psychiatric disorders other than ASD, ADHD, and DBD, medical conditions, or abnormalities on routine laboratory tests and ECG.
Intervention Characteristics
Intervention
Control
Forældretrivsel, PSI/parent stress subscale, lower is better
Sponsorship source: Dr. Aman has received research contracts, consulted with, served on advisory boards, or done investigator training for AMO Pharma, CogState, Inc.; Confluence Pharmaceutica; CogState Clinical Trials, Ltd.; Coronado Biosciences; Forest Research; Hoffman-La Roche; Johnson & Johnson, Lumos Pharma, MedAvante, Inc.; Novartis; Ovid Therapeutics, ProPhase LLC; and Supernus Pharmaceuticals. Dr. Handen has received research support from Lilly, Roche, Curemark, Autism Speaks, NIMH, and NIA. Dr. Arnold has received research funding from Curemark, Forest, Lilly, Neuropharm, Novartis, Noven, Shire, Supernus, Roche, YoungLiving, NIH and Autism Speaks. He has consulted with Gowlings, Neuropharm, Organon, Pfizer, Sigma Tau, Shire, Tris Pharma, and Waypoint. He has been on advisory boards for Arbor, Ironshore, Novartis, Noven, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, and received travel support from Noven. Dr. Hollway has received research funding from Forest Research Institute, Sunovion Pharmaceuticals, Supernus Pharmaceuticals, Young Living, F. Hoffman-La Roche AG, and Autism Speaks. Drs. Lecavalier, Pan, Smith, Tumuluru, and Silverman, have no conflicts of interest to report.HHS
Country: US
Comments: ClinicalTrials.gov Title: Atomoxetine, Placebo and Parent Management Training in Autism (Strattera) ClinicalTrials.gov Identifier: NCT00844753
Authors name: Luc Lecavalier
Institution: Nisonger Center and Department of Psychology
Email: Luc.Lecavalier@Osumc.edu
Address: Ohio State University; 371D McCampbell Hall, 1581 Dodd Dr. Columbus, Oh 43210
Study design: RCT
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: The children whose diagnoses were confirmed by a developmental pedia-trician and met clinical criteria for autistic disorders according to the Diag-nostic and Statistical Manual of Mental Disorders(DSM-IV; American PsychiatricAssociation, 1994) were invited to participate in the study, if they were 2–6years of age.
Excluded criteria: The children were excluded if a) they had any additionalmedical diagnosis (e.g. genetic syndromes, diagnosed hearing impairment,diagnosed visual impairment or seizures); b) they were geographically in-accessible for follow-up visits; or c) their parents were not literate or hadknown chronic psychiatric or physical illness
Pretreatment: here was no statistical differ-ence in the other baseline parameters of either group including average ageof the children at entry, level of development and symptom severity.
Intervention Characteristics
Intervention
Control
Kernesymptomer, forældrebedømt, CARS total score, change, higher is better
Sponsorship source: NA
Country: Thailand
Authors name: KINGKAEW PAJAREYA
Institution: Department of Rehabilitation Medicine, Srisanwan Building, Faculty of Medicine, SirirajHospital, Mahidol University, Bangkok,Thailan
Email: sikpj@mahidol.ac.th
Address: Department of Rehabilitation Medicine, Srisanwan Building, Faculty of Medicine, SirirajHospital, Mahidol University, Bangkok,Thailan
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria for children included: having an independent clinical diagnosis of autistic disorder by a physician based on theDSM-IV-TR(AmericanPsychiatricAssociation,2000), having scores on the Autism Diagnostic Observation Schedule(ADOS;Lordetal.,1989)or Autism Diagnostic Interview–Revised (ADI-R;Lord,Rutter,&LeCouteur,1994) that meet classification for ASD, and being unable to perform 80% of items on the Early Learning Measure (ELM;Smith,Buch,etal.,2000) pretest. The ELM pretest was used to identify children who had difficulty with important early learning skills such as verbal and non-verbal communication and imitation.
Excluded criteria: children who demonstrated significant motoror sensory impairments, or who had a sibling already involved in the study (inordertopreventthesamefamiliesfromreportingfordifferentparticipants) were excluded
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældre bedømt, Vineland II (VABS), lower is better
Forældretrivsel, PSOC higher is better, change
Sponsorship source: Funding provided by the Ontario Mental Health Foundation
Country: Canada
Authors name: J.Reitzel
Institution: McMasterUniversity,Hamilton,ON,Canada
Email: reitzel@hhsc.ca
Address: 555 SanatoriumRoad,Hamilton, ON, Canada L9C0C4.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Scores above the designated cut-off levels on the Autism Diagnostic Observation Scale;Absence of joint attention during interaction with parents based on direct observation;Chronological age below 30 months at the onset of intervention
Excluded criteria: Confounding diagnosis (e.g.,failure to thrive, premature birth >6 weeks, or other developmental disabilities such as Down syndrome)
Intervention Characteristics
Intervention
Control
Funktionsniveau, klinikerbedømt, VABS communication, højere bedre
Sponsorship source: Grant from Autism Speaks, 1735
Country: USA
Authors name: Hannah H. Schertz
Institution: Department of Curriculum & Instruction, Indiana University
Email: hschertz@indiana.edu
Address: 201 N Rose Ave., Bloomington, IN 47405, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Scores above the designated cut-off levels on the Toddler Module of the Autism Diagnostic Observation Scale-II;no more than three instances of responding to or initiating joint attention during a 10 min play session with parents in their home; chronological age below 30 months at evaluation
Excluded criteria: Confounding condition (e.g., failure to thrive, premature birth >6 weeks, or other developmental disabilities such as Down syndrome)
Intervention Characteristics
Intervention
Control
Sponsorship source: Institute for Education Sciences, U.S. Department of Education R324A120291
Country: USA
Authors name: Hannah H. Schertz
Institution: Department of Curriculum & Instruction, Indiana University
Email: hschertz@indiana.edu
Address: 201 N Rose Ave., Bloomington, IN 47405, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Families were eligible to participate if (1) the child was 6years or younger when entering the study, (2) the child had previously been diagnosed withAutism Spectrum Disorder, (3) the child showed limited or no use of spoken language(generally fewer than 25 words and no phrases based on parent report), (4) the child’smother was fluent in English and willing/available to participate in all assessment andtreatment sessions, and (5) the family lived within a reasonable travel distance from theresearch lab (generally less than 90 minutes)
Excluded criteria:
Pretreatment:
Intervention Characteristics
Intervention
Control
Sponsorship source: Preparation of this article was supported by CPEA Grant HD35470 from the National Institute of Child Health andHuman Development, the M.I.N.D. Institute Research Program, and a PSC-CUNY grant.
Country: US
Authors name: Michael Siller
Institution: Department of Psychiatry, University of California and Psychology Department, Hunter College of the City University of New York
Email: msiller@hunter.cuny.edu
Address: TTN: Michael Siller, Hunter College - CUNY, Psychology Dept., RM 611 HN, 695 Park Ave, New York, NY10065-5024
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: ll participants met criteria for Autistic Disorder, AS or PDDNOS according to DSM-IV-TR (American Psychiatric Association 2000); ASD or autism according to ADOS-G (Lord et al. 2000); and autistic disorder according to the Autism Diagnostic Interview-Revised.All participants also had to either demonstrate clinically significant externalizing behavior measured by the Behavior Assessment System for Children (BASC) or exceed the cut-off on the Intensity Scale of the Eyberg Child Behavior Inventory.
Excluded criteria: Children were excluded if they had a Full Scale IQ score of <70 on the Wechsler Abbreviated Scales of Intelligence for Children (WASI; Wechsler 1999) and did not possess enough receptive and expressive language to participate in this language-intensive intervention.
Pretreatment: There were no statistically significant differences between the groups on age, IQ, or level of symptoms.
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., ECBI - intensity, lower is better
Forældretrivsel, PSI/parent stress subscale, lower is better, skal beskrives narrativt
Sponsorship source: This study was supported by a Children’s Miracle Network Grant from the U.C. Davis Medical Center to Drs. Solomon and Goodlin-Jones.
Country: US
Authors name: Marjorie Solomon
Institution: Department of Psychiatry & Behavioral Sciences, University of California, M.I.N.D. Institute, Sacramento, CA, USA
Address: Davis, 2825 50th Street, Sacramento, CA 95817, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were age 3.0 to 5.11 years (actual 2 yr 8 mo–5 yr 11 mo) at the time of intervention and previous clinicaldiagnosis of autism spectrum disorder (ASD) according to DSM-427 criteria (i.e., autism vs PDD NOS) and meeting criteria for autism or ASD on the Autism Diagnostic Observation Schedule (ADOS) and Social Communication Questionnaire (SCQ).
Excluded criteria: diagnosis of Asperger syndrome, genetic disorders, severe medical conditions, a parent with severe psychiatric disorder or cognitive impairment, and/or families in which English was not the primary language. The Peabody Picture Vocabulary Test—Fourth Edition 39 was used to screen parents for cognitive functioning that would permit understanding of the intervention processes with a minimum requirement of sixth-grade vocabulary.
Intervention Characteristics
Intervention
Control
Kernesymptomer autisme, forældrerapporteret, SCQ, lower better
Forældretrivsel (PSI), lower is better
Sponsorship source: National Institute of Mental Health (NIMH) and Small Business Innovation Research (SBIR) grant (grant# 2 R44 MH078431-02A1)
Country: USA
Authors name: Richard Solomon
Institution: Ann Arbor Center for Developmental and Behavioral Pediatrics, Ann Arbor, MI
Email: dr.ricksol@comcast.net
Address: 2930 Parkridge Dr, Ann Arbor, MI 48103
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria:
Excluded criteria: Exclusion criteria were the children diagnosed with a PDD of the Asperger’s disor-der type and the not otherwise specified (PDD-NOS) type (APA, 1994), the parents who had insufficient English lan-guage skills to participate and those children who were undergoing intensive applied behaviour analysis (ABA) programme (Lovaas, 1987)
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældrebedømt, VABS daily living, higher is better
Kernesymptomer, forældrebedømt, CARS total score, change, higher is better
Sponsorship source: This research was supported by NH&MRC of Australia Project Grant (124303).
Country: Australien
Authors name: Bruce Tonge
Institution: School of Psychology and Psychiatry, Faculty of Medicine, Nursing and Health Sciences, Monash University
Email: Email: bruce.tonge@monash.edu
Address: Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168, Australia.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: children with a clinical suspicion of ASD
Excluded criteria: Out of the 70 children, 36 were excluded from the study, 29 chil-dren did not meet DSM-IV TR diagnostic criteria for autistic disorder or were below the autism spectrum cut-off on the ADI-R and ADOS-G; 7 children were excluded for epilepsy.
Pretreatment: No evidence of baseline significant differences was found between the CPMT group and the ACG
Intervention Characteristics
Intervention
Control
Kernesymptomer, kliniker bedømt, ADOS-2 CSS, lower is better
Adfærdsvanskeligheder, forældre rap., CBCL-EXT
Forældretrivsel, parent stress subscale, lower is better
Authors name: Stefano Vicari
Institution: Department of Neuroscience, IRCCS Children’s Hospital Bambino Gesù
Email: giovanni.valeri@opbg.net
Address: Department of Neuroscience, IRCCS Children’s Hospital Bambino Gesù, Piazza Sant’ Onofrio, 4 00165 Rome, Italy
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusionary criteria consisted of: (a) an age between 1.5 and 4.5 years (18–56 months) at intake, (b) an autism classification based on cut-off scores of the Autism Diagnostic Observation Schedule, Second Edi-tion (ADOS-2; Lord et al. 2000; Luyster et al. 2009), and (c) an ASD diagnosis based on DSM-5 diagnostic criteria (APA 2013) and expert clinical judgement by a licensed clinical psychologist.
Excluded criteria: Children with comorbid medical or psychiatric conditions were excluded from participation.
Pretreatment: There were no significant between-group differ-ences on the demographic variables of age, sex, or racial category. While there were no significant between-group dif-ferences on the ADOS-2, Mullen, PLS-5, PPVT-4, or EVT-2 (p>.05), there was a significant difference in pre-trial Vineland-II ABC Standard Scores, with Treatment Group partici-pants having higher scores than Waitlist Group participants, M=12.56, 95% CI [5.15, 19.98], t(21)=3.52, p=.002.
Intervention Characteristics
Intervention
Control
Funktionsniveau, Vineland II, lower is better
Kernesymptomer, kliniker bedømt, ADOS-2 CSS, lower is better
Sponsorship source: This study was funded by Autism Speaks
Country: US
Authors name: Ty W. Vernon
Institution: University of California Santa Barbara, Santa Barbara, CA, USA
Email: tyvernon@ucsb.edu
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Allchildrenincludedinthis study had a primarydiagnosis of an Autism Spectrum Disorder (i.e. a PervasiveDevelopmental Disorder) from a paediatrician. For themajority of participating families, the parents reported theirchild’s diagnosis as“Autism Spectrum Disorder”or“Asperger Syndrome”. In addition, for the majority ofparticipating families the parents reported that their childwas verbal. A semi-structured diagnostic interview wasdeveloped specifically for this study based upon DSM-IVcriteria for Autistic Disorder and Pervasive DevelopmentalDisorder Not Otherwise Specified and Gillberg’s criteria(Gillberg2002) for Asperger syndrome (AppendixB). Thisinterview was used to verify an ASD diagnosis.
Excluded criteria:
Pretreatment: No significant differences in demographics were foundat pre-intervention between the treatment and the wait-list groups. o significant pre-treatment differences betweenthe treatment and the control group were found in parentreported child behaviour, F (3,55)=1.11, ns or in dysfunc-tional parenting styles, parenting satisfaction and parentalefficacy, F (5, 53)=0.19, ns.
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., ECBI - intensity, lower is better
Forældretrivsel, Being a parent satisfaction scale, higher better
Sponsorship source: The study was supported by a small grant fromthe School of Psychology, The University of Queensland.
Country: Australia
Authors name: Koa Whittingham
Institution: SandersSchool of Psychology, The University of Queensland
Email: kate@psy.uq.edu.au
Address: St Lucia,Brisbane, QLD 4072, Australia
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants were the primary caregivers of a child aged3–8 years either with a recent diagnosis of ASD or with astrongly suspected diagnosis (based on information froma clinician within the service). The primary caregiver hadto have a good understanding of English.
Excluded criteria: Attending another parenting programduring the intervention phase of the research; (b) familyin crisis (e.g., child at risk of residential placement);(c) child in foster care without a long-term plan for thatplacement; (d) child on the child protection register; or(e) refusal to give consent to take part in the research.There were no exclusion criteria based on co-occurringintellectual disability.
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældre rap., CBCL-EXT
Forældretrivsel, PSI eller parent stress subscale, lower is better
Sponsorship source: This research was funded by Autistica (Grant No. 7240).
Country: UK
Setting: real world setting
Authors name: Margiad E. Williams
Institution: Centre for Evidence Based Early Intervention
Email: margliad.williams@bangor.ac.uk
Address: Centre for Evidence Based Early Intervention, Nantlle Building, Normal Site, BangorUniversity, Bangor LL57 2PZ
Study design: Randomized controlled trial
Study grouping: Crossover
Baseline Characteristics
Intervention
Control
Overall
Included criteria: eventeenchildren with autism, aged 17–36 months, who werereferred to the DKCAC for developmental assessment,were recruited to participate in the study. These childrenwere diagnosed as ASD by developmental paediatriciansusing Diagnostic and Statistical Manual of Mental Disor-ders IV (American Psychiatric Association2000), AutismDiagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS)(Lord et al.2002). The severity of autism was assessedwith Childhood Autism Rating Scale (CARS) (Schopleret al.1998). There were no co-morbid neurological orpsychiatric disorders and none had received any commu-nication or social skills training.
Excluded criteria:
Pretreatment: Posthoc analysisindicated that the two groups were comparable in chrono-logical and mental age as measured by the Griffiths MentalDevelopmental Scales (GMDS) (Griffiths1996), andseverity of ASD as measured by CARS
Intervention Characteristics
Intervention
Control
Forældretrivsel, parent distress subscale, beskrives narrativt
Country: China
Authors name: Virginia C. N. Wong
Institution: Division of Child Neurology/Developmental Paediatrics/Neurohabilitation, Department of Paediatrics and AdolescentMedicine, The University of Hong Kong
Email: vcnwong@hku.hk
Address: The University of Hong Kong, Pokfulam Road,Hong Kong, China
Wrong indication
Wrong comparator
Wrong study design
Wrong comparator
Wrong study design
Wrong study design
Wrong language
Wrong patient population
Wrong study design
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Randomization broken
Wrong study design
Wrong dose
Wrong study design
Wrong study design
Wrong comparator
Wrong patient population
Wrong patient population
Wrong dose
Wrong dose
Wrong study design
Wrong study design
Wrong comparator
Wrong patient population
Wrong dose
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "participating in the project. Randomisation <b>Randomisation into treatment and control groups was undertaken by an independent statistician after com- pletion of baseline assessment. The randomisation was stratified throughout for chronological age and severity of baseline autistic behaviours, since these variables might have predicted response to treatment.</b> Four subgroups were thus generated"
Judgement Comment: Insufficient information on sequence generation
Quote: "2:1 randomization to COMB and MED, respectively. The 2:1 randomization was adopted to enhance recruitment on the assumption that most families would prefer combined treatment. Due to chance, the actual ratio obtained was nearly 3:2."
Judgement Comment: It is stated that its randomaised but there is no information on method used for randomisation
Quote: "This pilot study utilized a randomized controlled trial (RCT) design. Following the initial assessment, participants were age- matched and randomly assigned to either the PRISM treatment condition (TR) or treatment-as-usual waitlist (WL) condition."
Quote: "After intake, participants were randomly assigned to either the treatment or waitlist condition by a chance procedure (i.e. coin flip)."
Judgement Comment: participants were randomly assigned
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "This study used a randomized waitlist-control design. Following intake assessment, families were randomized into either Treatment (T; Social ABCs) or Control (C; treatment-as- usual) conditions. To equalize group sizes and prevent cohort effects, randomization was conducted in blocks of 4 (2T and 2C). We used four of six possible blocks (T-T-C-C and C-C-T-T were eliminated to avoid having four consecutive participants assigned to the same con- dition). A statistician external to the study generated separate randomly determined block orders, with ran- domization up to 60, per site."
Judgement Comment: Randomized waitlist-control design
Quote: "‘partial’ intent to treat analyses. <b>Families were randomized within each site using software that utilized a random number generator to assign children to the intervention or control group.</b> The software weighted the probability"
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "Allocation to the Parent training or Local services only groups was made from a random numbers table."
Quote: "medical history to confirm eligibility. <b>Eligible children were stratified on the basis of sex and were randomly assigned (1:1) to the treatment (PRT-P) or control (DTG) group via electronic generation of random numbers (www.randomizer. org) by a senior investigator not involved in the trial.</b> All measures were collected at"
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "Randomiza- tion was done using a coin flip (www.random.org) by a senior investigator not involved in the clinical assessment or treat- ment. Sequence generation was done by the project coordina- tor who was not involved in the clinical ratings. After randomization, the senior investigator informed the coordina- tor about the group assignment."
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: Likely random. "As participants were determined eligible, they were randomly assigned in a 1:1 allocation to either the JAML intervention or services-as-usual (which we label as “control”) condition."
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "related autism categories (autism vs autism spectrum), and child’s gender."
Quote: "Randomization was computer-generated and occurred within sites using a matched pair design with primary blocking variables of age (younger than 4.49 yr vs 4.5 yr or older), ADOS-"
Quote: "A randomised group comparison design"
Quote: "Intervention sub- jects were randomly allocated by computer to"
Quote: "The study design is a rater-blinded RCT of two parallel groups: CPMT group (LPI plus CPMT) and ACG (only LPI)."
Quote: "families were randomly assigned to a CPMT group or to an ACG, stratified according to child’s age and cognitive/developmental functioning."
Quote: "registered at hospital office and <b>independent statistician assigned identification number to each family. Children were randomly assigned to either the CPMT group or to the ACG, stratified by age (2–4.5 years; 4.6–6.11 years) and cognitive level.</b> The statistician informed the trial"
Judgement Comment: No information on method used for randomisation
Quote: "A randomized clinical trial design was used as the meth- odological framework for this pilot investigation. Random assignment with stratification by age was conducted."
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "were randomly allocated, using random permuted blocks, to either the intervention (IY- ASLD) or wait-list, treatment as usual control condition in a 1:1 ratio. Randomization was undertaken by an inde- pendent statistician in the North Wales Organization for Randomized Trials in Health and Social Care (NWORTH), who informed the trial administrator who subsequently informed the sites. Randomization was stratified by site, child age (3–5 years or 6–8 years), and child gender."
Judgement Comment: randomly allocated, using random permuted blocks
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: No information on method used for concealing allocation
Judgement Comment: No information on method used to conceal allocation
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "A statistician external to the study generated separate randomly determined block orders,"
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "Sequence generation was done by the project coordina- tor who was not involved in the clinical ratings. After randomization, the senior investigator informed the coordina- tor about the group assignment."
Judgement Comment: Insufficient information on allocation concealment
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: No information in method used for concealing allocation
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "Deidentified demographic and diagnostic data for enrolled families were sent to the MSU research team for randomization"
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: No information on method used for concealing allocation
Quote: "Treatment allocation was determined at the start of the study and revealed to coor- dinators, research assistants, and families only after complet- ing the baseline assessment."
Quote: "The statistician informed the trial office and clinical teams of allocation."
Judgement Comment: No information on method used for concealing allocation
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "All data assessors were masked to group allocation."
Quote: "were masked to group allocation. <b>Partici- pants were informed of their allocation by letter.</b> Procedures The IY-ASLD parent program"
Quote: "Randomization was undertaken by an inde- pendent statistician in the North Wales Organization for Randomized Trials in Health and Social Care (NWORTH), who informed the trial administrator who subsequently informed the sites."
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Blinding of treatment personnel and participants were not feasible and is likely to influence outcomes
Judgement Comment: Not possible to blind participants or personnel
Judgement Comment: Not possible to blind participants are personnel
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "Control families were informed that they could receive the Social ABCs"
Quote: "Control families were informed that they could receive the Social ABCs"
Judgement Comment: Control families were informed that they could receive the Social ABCs after 6 month.Coaches could not be blinded
Judgement Comment: Blinding of participants and personnel not feasible, and is likely to influence outcome reporting
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: Blinding not feasible and is likely to influence outcomes of interest
Judgement Comment: Blinding of participants and personnel are not feasible and is likely to influence outcome
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: Blinding of participants and personnel not feasible, and is likely to influence outcome
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: Not feasible to blind participants and personnel
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: Blinding of participants and personnel are not feasible, and is likely to influence outcome reporting
Judgement Comment: Not possible to blind participants or personnel
Quote: "Families and therapists could not be blinded to treatment allocation."
Judgement Comment: Not possible to blind
Judgement Comment: Not possible to blind participants or personnel
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: Not possible to blind participants or personnel
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "The assessment team consisted of an educational psychologist and educational audiologist who were experienced in assessing children with autism and were blind to the subjects’ group status."
Quote: "The researchers were blind to case-control status. Parents were told not to disclose their treatment status during assessment. In order that the treated children’s experience of the treatment room did not influence the assessments or betray itself to the researchers, all fol- low-up assessments were conducted in a different room to the intervention. Parents travelled to the centre for assessment using a different route and entrance. Repeat ADOS assessments were alternated between the researchers to avoid sequential interviewing of the same child."
Quote: "ratio obtained was nearly 3:2. <b>Each subject was followed by two clinicians: a treating clinician who monitored medication dose and AEs, but was otherwise blind through Week 8, and an independent evaluator who was blind to treatment assignment</b> Page 3 J Am Acad"
Quote: "ratio obtained was nearly 3:2. <b>Each subject was followed by two clinicians: a treating clinician who monitored medication dose and AEs, but was otherwise blind through Week 8, and an independent evaluator who was blind to treatment assignment</b> Page 3 J Am Acad"
Judgement Comment: It is stated that the evaluator is blind, but some of the outcomes, eg. vineland is parent-reported
Quote: "Raters were masked to the participants’ diagnosis, treatment condition, timepoint of the observation, and study hypotheses."
Quote: "Parent-child play interaction videos were behaviorally coded using Noldus Observer software (Noldus Information Technology, 2010) by two trained research assistants. Raters were masked to the participants’ diagnosis, treatment condition, timepoint of the observation, and study hypotheses."
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "used the Parenting Stress Index [PSI-Short Form; Abidin, 1995] at intake and F-Up. This 36-item scale has acceptable test–retest reliability (range: 0.68–0.85) and good internal consistency for Total Stress"
Judgement Comment: Video coders were blind to group allocation. Otherwise self-reported.
Judgement Comment: Blinding of outcome assesors not feasible, and is likely to influence outcome reporting
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: Blinding not feasible and is likely to influence outcomes of interest
Quote: "communicate as much as possible. <b>Consistent with previous research, 6,7 raters blind to group assignment tallied the child’s total functional verbal utterances and also specified utterance type (ie, unintelligible, imitative, verbally prompted, nonverbally prompted, or spontaneous).</b> Multiple-word utterances were scored as"
Quote: "set of raters trained independently. <b>Ratings were completed by raters blind to group assignment and time point.</b> Agreement was 87%, and k"
Judgement Comment: For the chosen outcomes the raters were blind to allocation group
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "All raters were blind to group assignment and treatment phase."
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: "To assessintervention outcomes, the PJAM parent–child interactionassessment was re-administered and videos were viewed andcoded by trained assessors who were naïve to time point andtreatment conditions.""All observational coding took place at acentral observational coding laboratory at the Indiana site.Coders, who were blind to group assignment, recordedwhether any of the noted behaviors occurred in each 10-sinterval."" Instructions were given by assessors who were naïve to treatment assignment.""All assessment activities were conducted in familyhomes by research assistants who were trained on assessment procedures prior to enrolling families in the study."
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "All interactional observation measures were video-recorded in the home, then scored by raters blinded to group, and time assign- ment. Each"
Quote: "evaluators were blinded as to intervention status."
Quote: "These meas- ures were completed by a clinician blind to the results of the pretreatment assessments and to treatment group mem- bership."
Quote: "The clinicians conducting the follow-up assessments were blind to the results of the pretreatment assessments and group membership and were specifically instructed not to discuss group membership with the parents. However, it is possible that a parent might have disclosed group membership at this time, and therefore, the blind can only be regarded as partial."
Judgement Comment: some outcomes are self-reported by parents
Quote: "Assessors and supervising research staff were independent from therapists and were unaware of treatment allocation and method of randomization."
Judgement Comment: Vineland is parent reported.
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: Some outcomes, e.g. vineland, are parent reported
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Participants dropped out before treatment were replaced and ITT analyses were made
Judgement Comment: Unclear if all participated in analysis
Judgement Comment: Fairly low attrition rates. Intervention group 4/16, control 1/12, but Different reason for dropout. 4 with missind data in the intervention and 3 in the control group.
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "To reduce Type II error risk, we adopted an a priori modified intent-to-treat approach wherein partici- pants enrolled for at least 4 weeks were included in analyses. This resulted in imputed data, using the “last observation carried forward” approach [White, Horton, Carpenter, & Pocock, 2011], for video data for four par- ticipants (2T, 2C; 3 for week 24 only) and for five cases for the primary standardized assessments (those above and one other who completed training but did not complete follow-up [F-Up] assessment; 3T and 2C)."
Judgement Comment: Low attrition rates in both groups and not related to intervention. Intervention: 2/31, control: 2/32
Quote: "at the time of assignment. <b>All participants with pre-treatment data and data from at least one of the follow-up periods were included in analyses, irrespective of HMTW treatment attendance. However, we use the term ‘partial’ intent to treat because ‘full’ intent to treat requires imputation of all missing data. We elected not to carry forward values from earlier periods to later periods when participants</b> Carter et al. Page 3"
Judgement Comment: No ITT on missing data, but the distribution of missing data in the treatment group (10%) compared to the control group (14%), did not differ substantielly.
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "Parental stress: Parental Stress Inventory (PSI) [1]. Some questionnaire data were missing. The"
Judgement Comment: Missing data was low and similar between groups
Judgement Comment: Unbalance in drop out rate between groups and there are no informtaion on how missing data was handled
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: Attrition was overall low and similar between groups
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: "Of the 73 assigned to treatment, 64 remained for postassessment and 55 for 6-month follow-up assessment. For the 71 assigned to the control condition, 67 remained for post-assessment and 59 for follow-up.""This study employed a randomized controlled, intent to treattrial design." "Multiple imputation via the EM algorithm (see, for example,Enders 2010; Schafer and Graham 2002) was used to replacemissing data. Twenty-five datasets with imputed data wereestimated. We then replicated the analysis models on thesedata and combined the results using SAS “proc mi analyze”(SAS 9.4, SAS Institute 2014). Results for ITT models wereconfirmed."
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "meet fidelity criteria. Statistical Analysis <b>Apart from the Mullen and MCDI-WS, missing data were missing completely at random (Little’s MCAR test x 2 [42, N 5 112] 5 50.16, p 5 .181). Data were imputed forward for using the last observation carried forward method at the scale level. Although multiple imputation procedures are promising, 49 the field has not advanced to provide methods for addressing repeated measures ANOVA analysis, 50 as used in this article. A common alternative has been the use of last observation car- ried. 51,52 Analyses used an intent-to-treat approach, which included all cases randomized to PLAY and CS groups including those that did not complete the in- tervention. Exceptions were the video-based MBRS, CBRS, and FEAS, which were rated only for cases that completed the intervention. To test for the effect of treatment group on ADOS classification, an ordered logistic regression was conducted predicting ADOS di- agnosis at Time 2 controlling for initial diagnosis, child age, and site. Ordered logistic regressions were con- ducted for the PSI and CES-D binomial classifications at Time 2 controlling for site, child age and Time 1 clas- sification on the measure. For all other outcomes, re- peated measures univariate or multivariate analyses of covariance (analysis of covariance and MANCOVAs) were conducted on sets of variables with treatment group as a between-group variable. When MANCOVAs were significant, follow-up univariate analyses were conducted to identify the direction of the differences. RESULTS Dosage</b> PLAY families participated in an"
Judgement Comment: Low attrition. Reasons not likely to affect outcomes
Quote: "Results are presented for the children of parents in the PEBM treatment (n = 35), PEAC treatment (n = 33) and control group (n = 35). Two PEAC group parents did not complete the parent training because work commitments involved moving interstate. Two low-functioning children in the PEAC group did not complete testing on the PEP-R and RDLS due to inattention and distressed behaviour."
Quote: "control group or treatment groups. <b>Following this allocation of regions, treatment participants (rural (n = 35) and metropolitan (n = 35)) were randomly allocated to either the PEBM or PEAC interventions. The control group (n = 35) comprised 17 rural children and 18 metropolitan children. Results are presented for the children of parents in the PEBM treatment (n = 35), PEAC treatment (n = 33) and control group (n = 35). Two PEAC group parents did not complete the parent training because work commitments involved moving interstate. Two low-functioning children in the PEAC group did not complete testing on the PEP-R and RDLS due to inattention and distressed behaviour.</b> The diagnosis was made by"
Judgement Comment: No dropout in PEBM and control group
Judgement Comment: All randomized participants were included in analysis
Judgement Comment: Attrition rates high in the intervention group: Intervention 4/16, control 1/12
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: Low attrition rates. 4/29 in intervention group and 1/29 in control group. 28/25 had data on child behaviour. 28/23 had information on PSI
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reporting bias due to selective outcome reporting
Judgement Comment: There is no reference to study protocol, but the study appears to report on all outcomes of interest
Quote: "Trial Registration: NCT00080145"
Judgement Comment: Report on relevant outcomes
Quote: "In addition to a priori hypotheses examining pre-to-post changes in treatment and waitlist groups, we also conducted exploratory post-hoc analyses with a subgroup of minimally verbal children in the pilot trial."
Judgement Comment: No reference to study protocol.
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "http//ClinicalTrials.gov identifier: NCT02428452."
Judgement Comment: Several extra outcomes reported not included in protocol (NCT02428452)
Judgement Comment: No reference to study protocol, but the study appears to report on different timepoints -depending on outcomes of interest
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: No reference to study protocol, but appears to report on all outcomes of interest
Quote: "in the clinical trials database <b>(clinicaltrials.gov; identifier NCT02037022).</b> The full protocol is available"
Judgement Comment: In protocol it is stated that outcom measures should be done at 6, 12 and 24 weeks. Only 24 weeks is reported
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Quote: "(clinical trial NCT01881750; http://www.clinicaltrials.gov)."
Judgement Comment: The study protocol and reporting does not match in relation to secondary outcomes, as not all were reported on.
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: No reference to study protocol, and do not report on outcomes of interest
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "Clinical Trials Registry number: NCT01768806."
Judgement Comment: Several outcomes in study was not reported in protocol
Judgement Comment: Not reffering to a protocol but report on releavnt outcomes
Judgement Comment: Not reffering to a protocol og pre-registration however report on relevant outcomes
Judgement Comment: No reference to study protocol, but No reason to suspect selective outcome reporting
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "(preregistered: http://www.isrctn.com; ISRCTN57070414)."
Judgement Comment: Several of the outcomes on study protocol are not reported. Time points doenn't match either. Maybe this doesn't matter much when it is a pilot study ISRCTN57070414
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study appears to be free from other sources of bias
Quote: "Washington University School of Medicine. <b>This work was funded by National Institute of Mental Health by the following RUPP grants: O.S.U., U10MH66768; Indiana University, U10MH66766; and Yale, U10MH66764. Johnson & Johnson Pharmaceutical Research & Development provided active risperidone for the study.</b> Page 10 J Am Acad"
Judgement Comment: The study seems free of other sources of bias
Quote: "This study was funded by Autism Speaks (Grant ID20131198), United States. The funding source had no involvement in study design; the collection, analysis, or interpretation of data; the writing of the report; and the decision to submit the article for pub- lication."
Judgement Comment: No other sources of bias found
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: The study seems free of other sources of bias.
Judgement Comment: The study appears to be free from other sources of bias
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Judgement Comment: The study appears to be free from other sources of bias
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Postorino, Valentina; Sharp, William G.; McCracken, Courtney E.; Bearss, Karen; Burrell, T. L.; Evans, A. N.; Scahill, Lawrence
A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum DisorderClinical child and family psychology review 2017;20(4):391-402
Reference: Murza, Kimberly A.; Schwartz, Jamie B.; HahsVaughn, Debbie L.; Nye, Chad. Joint attention interventions for children with autism spectrum disorder: A systematic review and meta-analysis.International Journal of Language & Communication Disorders 2016;51(3):236-251
Judgement Comment: No reasons to suspect other sources of bias.
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Judgement Comment: The study appears to be free from other sources of bias
Quote: "of this early intervention. Funding <b>This research was supported by NH&MRC of Australia Project Grant (124303).</b> References American Psychiatric Association (1994)"
Judgement Comment: No other sources of bias found
Quote: "On behalf of all authors, the corresponding author states that there is no conflict of interest."
Judgement Comment: The study seems free of other biases
Quote: "All authors declare that they have no conflicts of interest."
Judgement Comment: No other sources of bias
Reference:
Tarver, Joanne; Palmer, Melanie; Webb, Sophie; Scott, Stephen; Slonims, Vicky; Simonoff, Emily; Charman, Tony
Child and parent outcomes following parent interventions for child emotional and behavioral problems in autism spectrum disorders: A systematic review and meta-analysisAutism : the international journal of research and practice 2019;23(7):1630-1644
Quote: "Judy Hutchings reports personal fees for the delivery of leadership training for Incredible Years. The remaining authors have declared that they have no competing or potential conflicts of interest."
Judgement Comment: The study seems free of other sources of bias
Reference:
Oono, Inalegwu P.; Honey, Emma J.; McConachie, Helen. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). The Cochrane database of systematic reviews 2013;(4):CD009774