[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Inclusion criteria required that children have a diagnosis of AS or High Functioning Autism (HFA) as confirmed by a pediatrician as well as meeting criteria on the Asperger Syndrome Diagnostic Interview (ASDI;Gillberg,Rastam,&Wentz,2001). Children with Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) were also accepted for this study. In addition, the children needed to achieve an IQ score of 79 or higher on the Wechsler Abbreviated Scale of Intelligence (WASI) to ensure that they would be able to grasp the content of the program.
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SCPQ, 9 items, higher better, range ikke oplyst
Angst, SCAS, lower better, 39 items, 0-3 pr item.
Sponsorship source:
Country: Australia
Setting: Recruited from primary schools in the Brisbane and greater Brisbane area in Australia. Participants were also referred by clinics that specialize in AS and ASD.
Authors name: Kate Sofronoff
Institution: School of Psychology, University of Queensland
Email: kate@psy.uq.edu.au
Address: University of Queensland
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: (1) ASD diagnosis according to the Autism Diagnostic Observation Schedule-Generic (ADOS-G; Lord et al. 2000), which veri-fied previous clinical diagnosis by licensed psychologists unassociated with the current study; (2) no comorbid diag-nosis (e.g., ADHD, language disorder, sensory or motor dis-abilities); and (3) IQ>70 according to the Mullen Scales of Early Learning (Mullen 1997) to denote sufficiently high cognitive and language abilities to participate in the inter-vention. To be noted, we defined our participants with ASD as high-functioning based on their IQ level beyond intellec-tual disability.
Intervention Characteristics
Intervention
Control
Funktionsniveau, klinikerbedømt, VABS composite (therapist ratings)
Sponsorship source: This research was partially supported by the Association of Children at Risk given to the first author.
Country: Israel
Setting: Trained on-site therapists in the special education preschool led the manualized intervention over a 6-month period in three 45-min sessions per week held in a quiet separate room.
Authors name: Nirit Bauminger-Zviely
Institution: School of Education, Bar-Ilan University
Email: nirit.bauminger@biu.ac.il
Address: 529002 Ramat Gan, Israel
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: AS diagnosis confirmed by a pediatrician, achievement of a WISC-III pro-rated IQ score of 85 or above, and child aged 7½–11 years at the time of the intake assessment;
Excluded criteria: No information
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SSQ(forældrebedømt) , 30 items, higher better, range 0-60
Sponsorship source: No info
Country: Australia
Authors name: Renae Beaumont
Institution: The University of Queensland, Australia
Email: kate@psy.uq.edu.au
Address: School of Psychology, University of Queensland, Brisbane, Australia
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: ASD according to the DSM-IV-TR , based on multiple assessments by psychologists and psychiatrists working independently of this study;Verbal IQ score within the normal range or above (>70), based on the Peabody Picture Vocabulary Test – III-NL
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SSQ(forældrebedømt) , 30 items, higher better, range 0-60
Sponsorship source: The study is funded by Fonds Psychische Gezondheid, (project number 2009 6442)
Country: Netherlands
Setting: Participants were recruited from an academic center for child and adolescent psychiatry in Amsterdam.
Authors name: Sander Begeer
Institution: Developmental Psychology, VU University Amsterdam
Email: S.Begeer@vu.nl
Address: Sander Begeer, Developmental Psychology, VU University Amsterdam, Van der Boechorststraat 1,1081BT Amsterdam, The Netherlands.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Overall
Included criteria: Children (7–12 years) and adolescents (13– 17 years) with a clinical consensus International Classification of Diseases–10th Revision (ICD-10) diagnosis of autism, atypical autism, Asperger syndrome, or pervasive developmental disorder not otherwise specified;Full Scale IQs > 70 according to the Wechsler Intelligence Scale for Children
Excluded criteria: Clinically assessed self-injury, an ICD-10 diagnosis of conduct disorder, antisocial or borderline personality disorder, any psychotic disorder that would interfere with participation or require alternative treatment, and insufficient Swedish languagecapacities
Pretreatment:
Intervention Characteristics
Intervention 1
Kontrol 1
Funktionsniveau, klinikerbedømt, CGI-Severity, change score
Funktionsniveau, forældrebedømt, ABAS -II, parent, changescore
Bivirkninger
Forældretrivsel, Perceived Stress Scale (PSS), change score
Sponsorship source: Funded by the Stockholm County Council, Karolinska Institutet, the Swedish Research Council, the Foundation Sunnerdahls Disability, Majblomman
Country: Sweden
Setting:
Comments:
Authors name: Nora Choque Olsson
Institution: Center of NeurodevelopmentalDisorders (KIND), Neuropsychiatry Unit, Karolinska Institutet, Stockholm
Email: sven.bolte@ki.se
Address: Sven Bolte, PhD, Center of Neurodevelopmental Disorders (KIND), Child and Adolescent Psychiatry Research Center, Karolinska Institutet and Stockholm County Council, Gavlegatan 22B, S-11330 Stockholm, Sweden
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: (1) clinical DSM-IV-TR ASD diagnosis [Autistic disorder, Asperger’s disorder, or Pervasive Developmental Disorder-Not Otherwise Specifed (PDD-NOS)], based on thorough diagnostic procedures (developmental history, current problems, child observation, and information from school) in expert teams including at least a child psychologist and a child psychiatrist; (2) the child’s clinician indicated SST as frst appropriate treatment; (3) parents and child were motivated for SST, as established during a meeting with the clinician, parents and child; (4) preferably IQ ≥ 80. Children with IQs slightly below 80 were included when therapists established they could follow an SST; (5) being in the last two and half years of primary education; (6) no physical condition afecting participation; (7) the child could travel to the child mental health center for training.
Excluded criteria:
Pretreatment:
Intervention Characteristics
Intervention
Control
Sociale færdigheder, Vineland Socialization
Sponsorship source: Author AdB received the grant that funded this study (the Netherlands Organization for Health Research and Development; ZonMw, nr 157003005
Country: The Netherlands
Authors name: Vera Dekker
Institution: Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Email: Annelies de Bildt: a.de.bildt@accare.nl
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: 1. The child satisfied ADOS-G and ADI-R criteria for anAutism Spectrum Disorder (see below). 2. The child was currently attending a 2nd through 5thgrade regular classroom for most of the school daywithout a ‘‘shadow’’ or other closely supervising adult.The age range was selected based in part uponprevious clinical experience. Children who wereyounger than second graders were too overwhelmedby the didactic presentations to benefit. The localschool systems usually grouped children past 5th gradein middle school. In contrast to elementary schoolwhere usually one teacher saw a child throughout theday, middle schoolers were taught by several teachers.The range of grades was therefore restricted toelementary school since collection of outcome datafrom multiple teachers would pose logistic difficulties.The presence of a ‘‘shadow’’ or closely supervisingadult might impact upon the treatment fidelity, sincethese adults would not be under the supervision of thepresent investigators and may introduce unknownadditional intervention components for individualchildren in the study.3. The child was not currently prescribed any psychotro-pic medication. A previous study (Frankel and Myatt2007) suggested that psychotropic medication maymitigate the effects of treatment.4. The child’s Verbal IQ was greater than 60. Thisinsured sufficient verbal ability so that the childrencould comfortably interact with other children in theclasses.5. The child was able to switch topics in a conversationwhen the other person was interested in talking aboutsomething else. Since the first modules taught childrento select friends based upon common interests, thiscriterion ensured that the child had sufficient skill todetermine another child’s areas of interest. In essencethis briefly assessed the child’s capacity for jointattention and basic social reciprocity, which indicatedreadiness for the intervention. 6. The child had adequate knowledge of rules in playingat least two common age-appropriate board games(e.g., checkers, chess, etc.). Since it was hypothesizedthat common interests and activities were fundamentalto forming friendships, this criterion ensured that thechild had sufficient play repertoire to engage withother children on play dates. CFT does not devote timeto teach the rules of common games but helps parentsintervene when their child doesn’t abide by rules.7. The child had knowledge of rules to play commonschool yard games (e.g., handball, kickball, foursquare, tetherball, jump rope, etc.). The rationale forthis criterion was the same as criterion #6.8. Absence of a thought disorder9. The child was free of clinical seizure disorder, grossneurologic disease, or other medical disorder (e.g.,moderately impaired hearing, or severe uncorrectablevisual impairment). Criteria 5–8 were established during a child mentalstatus exam
Pretreatment: "No baseline scores were significantly different between groups (p’s[.13)."
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SSRS, 55 items, beskrives narrativt
Sponsorship source: This research was supported by NIH ResearchGrant U54 MH68172 funded by the National Institute of MentalHealth, NICHD, NIDCD and NINDS, Marian Sigman, STAARTCenter Program Principal Investigator and Fred Frankel, ProjectPrincipal Investigator.
Country: USA
Authors name: Fred Frankel
Institution: UCLA Semel Institute For Neuroscience and Human Behavior
Email: ffrankel@mednet.ucla.edu
Address: 300 UCLA Medical Plaza, Los Angeles, CA 90095, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: 8–20-year-old patients with an ICD-10 diagnosis of autistic disorder, Asperger Syndrome, or atypical autism
Excluded criteria: full scale IQ < 70;schizophrenia, bipolar disorder, social phobia, obsessive compulsive disorder, major depressive disorder with suicidal ideation or any personality disorder as well as aggressive behaviour or any severe neurological or medical condition interfering withgroup therapy; In-patient treatment, and group-based social skills training during the last 6 months prior to the study
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SRS total, change score
Bivirkninger
Sponsorship source: German Research Foundation DFG (grant FR2069/2-1 to C.M.F.)
Country: Germany
Authors name: Christine M. Freitag
Institution: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt
Email: C.Freitag@em.uni-frank furt.de
Address: Goethe University, Deutschordenstraße 50, 60528 Frankfurt am Main, Germany
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Children aged five to six years (one year before enter-ing elementary school) whose diagnoses were autismspectrum disorders confirmed by child psychiatrists(International Statistical Classification of Diseases andRelated Health Problems (ICD-10): F84.0), normalintelligence (IQ≥75), and moderate severity of autismcharacteristics (CARS-TV≥25) were included in thestudy.
Excluded criteria: Exclusion criteria were as follows: 1) Children with severe psychiatric comorbidities (e.g., obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder); 2) Mothers with mental illness with amajor obstacle in daily life (e.g., schizophrenia, severe depression, or drug or alcohol dependency)
Pretreatment: Demographic features were slightly different between the groups, including age, sex, DQ score, diagnosis,CARS score, SQ score, and background of family education and socio-economic status
Intervention Characteristics
Intervention
Control
IRS, higher better
PSI, lower better
Sponsorship source: This study was funded by a grant from the Meiji Yasuda Mental HealthFoundation in 2011. The foundation had no role in data collection, analysis or interpretation of the study. We declare that we have no conflicts of interest.
Country: Japan
Setting: Participants were recruited by mail and telephone from a group including all children and their families who were assessed at a Japanese medical center that special-izes in autism and who were eligible according to theinclusion criteria below
Authors name: Kayoko Ichikawa
Institution: Department of Health Informatics, Kyoto University School of Public Health
Email: nakayama.takeo.4a@kyoto-u.ac.jp
Address: Department of Health Informatics, Kyoto University School of Public Health ,Yoshida-Konoe, Sakyo, Kyoto 606-8501, Japan
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Children and adolescents (7–17 years) with a diagnosis of ASD (F84.0, F84.1, F84.5, or F84.9) according to the International Classification of Diseases;Previously established diagnosis of ADHD (F90.0 or F90.8), anxiety disorder (F40, F41 or F43), or depression (F32 or F33);IQ>70 determined through the Wechsler Intelligence Scale for Children.
Excluded criteria: History of clinically assessed self-injury, conduct disorder (F91), hyperkinetic conduct disorder (F90.1), antisocial personality disorder (F60.2), borderline personality disorder (F60.3), any form of schizophrenia or related psychotic disorder (F20–F29) that would interfere with participation or require alternative treatment, and insufficient Swedish language capacities.
Pretreatment:
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældrebedømt, CGI-severity
Bivirkninger
Sponsorship source: Stockholm County Council, Majblomman, Foundation Sunnerdahls Disability, the Pediatric Research Foundation at Astrid Lindgren Children’s Hospital and the Swedish Research Council
Country: Sweden
Setting:
Comments:
Authors name: Ulf Jonsson
Institution: Pediatric Neuropsychiatry Unit, Department of Women’s and Children’s Health, Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND), Karolinska Institutet
Email: Sven Bölte: sven.bolte@ki.se
Address: Pediatric Neuropsychiatry Unit, Department of Women’s and Children’s Health, Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND), Karolinska Institutet, Gävlegatan 22B, SE-11330 Stockholm, Sweden
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Inclusion for enrollment in PEERS and this study included meeting several criteria. First, the adolescent had to clearly state interest in participating in the group via administration of a PEERS-specific mental status checklist (Laugeson and Frankel 2010). Second, the teen and his or her parent(s) needed to be willing to attend PEERS regularly, with a maximum of two absences allowed. In addition, the child needed to obtain a verbal and full scale IQ score on the Kaufman Brief Intelligence Test-Second Edition (Kaufman and Kaufman 2004) of greater than or equal to 70. Further, teens needed to be between the ages of 11 and16years old at the time of their intake, and be enrolled in either middle school or high school. Finally, the child had to meet criteria for a diagnosis of either Autism or Autism Spectrum Disorder on the Autism Diagnostic Observation Schedule-General (ADOS-G; Lord et al. 2002), Module 4.
Pretreatment: Parents in the final sample ranged from 32 to 56years of age with an average of 46.3years of age; teens ranged from 11 to 16years of age with an average of 13.8years of age at the time of intake. There were no significant differences on parent age or teen age between the experimental and waitlist groups. In addition, no significant differences between groups were found for teen intellectual functioning (as measured on the KBIT-2) or ASD symptom severity (as measured on the ADOS-G, Module 4)
Intervention Characteristics
Intervention
Control
Forældretrivsel, SIPA
Sponsorship source: This research was part of a doctoral dissertation and was supported by grants from the Organization for Autism Research (OAR) as well as the Marquette University Forward Thinking Program.
Country: USA
Setting: Families were recruited for participation in PEERS through local ASD support, service, and diagnostic agencies, advertisements in the local Autism Society newsletter, and through word of mouth from families with previous participation
Comments:
Authors name: Jeffrey S. Karst
Institution: Department of Psychology, Marquette University
Email: jeffrey.karst@marquette.edu
Address: Department of Psychology, Marquette University, Children’s Hospital of Wisconsin, Milwaukee, WI
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: 3 or 4 years of age and had received a clinical diagnosis of autism
Excluded criteria: had seizures, were 5 years of age or older;had additional medical diagnoses (e.g., genetic syndromes);were geographically inaccessible for follow-up visits (e.g., international families);did not plan to stay in the EIP for at least 4 weeks
Intervention Characteristics
Intervention
Control
Sponsorship source: NIH grant HD035470 and the CPEA network
Country: USA
Authors name: Connie Kasari
Institution: UCLA
Email: Kasari@gseis.ucla.edu
Address: 3132 Moore Hall, UCLA, Los Angeles, CA 90095, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Children between the ages of 8–11 years, with a Full Scale IQ score C 70, were included if they had a clinical diagnosis of PDD, and if they met criteria for a PDD on the Autism Diagnostic Observation Schedule algorithm score, the Social Communication Questionnaire score and the Pervasive Developmental Disorders Behavior Inventory
Excluded criteria: Children scoring higher than 18 on the irritability scale of the ABC or scoring in the clinically significant range on any CSI scalewere excluded
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SCI prosocial index, higher better
Funktionsniveau, klinikerbedømt, CGI-improvement, responder vs nonresponder
Sponsorship source: Organization for Autism Research; Beatrice Renfield- Yale School of Nursing Clinical Initiatives Fund; Research Units on Pediatric Psychopharmacology, National Institute of Mental Health.
Country: USA
Authors name: Kathleen Koenig
Institution: Yale Child Study Center, Yale School of Medicine
Email: kathy.koenig@yale.edu
Address: P.O. Box 207900, New Haven, CT 06520-7900, USA
For more info; Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria for teens were: (a) chronological age was between 13 and 17 years; (b) social problems as reported by the parent; (c) a previous diagnosis of either high functioning Autism, Asperger’s Disorder, or Pervasive Developmental Disorder—NOS; (d) English fluency of the teen; (e) having a parent or family member who was a fluent English speaker and who was willing to participate in the study; (f) a verbal IQ of 70 or above on the K-BIT-2; (g) no history of major mental illness, such as bipolar disorder, schizo-phrenia, or psychosis; and (h) absence of hearing, visual, orphysical impairments which precluded teen from participating in outdoor sports activities
Intervention Characteristics
Intervention
Control
Sociale færdigheder, Social skills rating scale ,parent rated, 38 items, higher better
Livskvalitet (venskab)
Sponsorship source: NIH Training Grant #T32-MH17140, Andrew Leuchter, Principal Investigator. The writing of this paper was partially supported by NIMH Grant #1U54MH068172, Fred Frankel, Project Principal Investigator
Country: USA
Authors name: Elizabeth A. Laugeson
Institution: UCLA Semel Institute for Neuroscience and Human Behavior
Email: elaugeson@mednet.ucla.edu
Address: 760 Westwood Plaza, Ste. 48-243B, Los Angeles, CA 90024, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: A written diagnosis of a HFASD, Wechsler Intelligence Scale for Children-4th Edition;short-form IQ>70;WISC-IV Verbal Comprehension Index (VCI) or Perceptual Reasoning Index (PRI) > 80;Anexpressive or receptive language score > 80 on a short-form of the Comprehensive Assessment of Spoken Language
Excluded criteria:
Pretreatment:
Intervention Characteristics
Intervention
Control
Sociale færdigheder, BASC-2-PRS Social skill scale, higher better
Sponsorship source:
Country: USA
Authors name: Christopher Lopata
Institution: Department of Counseling, School and Educational Psychology
Email: lopatac@canisius.edu
Address: University at Buffalo, State University of New York, Buffalo, NY, 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 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
Included criteria: (a) chronological age between 11 and 16 years; (b) social problems as reported by the parent; (c) English fluency for the adolescent;(d) parent or family member was a fluent English speaker and was willing to participate in the study; (e) no history of adolescent major mental illness, such as bipolar disorder, schizophrenia, or psychosis; (f) no history of hearing, visual, or physical impairments which precluded the adolescent from participating in PEERS activities; (g) a previous and current diagnosis of either HFA, AS, or Pervasive Developmental Disorder—NOS, with current as assessed via the Autism Diagnostic Observation Schedule;(h) a adolescent verbal IQ of 70 or above assessed via the Kaufman Brief Intelligence Test-Second Edition
Intervention Characteristics
Intervention
Control
Sociale færdigheder, Social skills rating scale ,parent rated, 38 items, higher better
Livskvalitet (venskab)
Sponsorship source: Research Development Grant;Regular Research Grant from Marquette University;Grant from the Autism Society of Southeastern Wisconsin
Country: USA
Authors name: Kirsten A. Schohl
Institution: Department of Psychology, Marquette University
Email: kirsten.schohl@mu.edu
Address: PO Box 1881, Milwaukee, WI 53201-1881, USA
For more info; Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Age 3.0 to 5.11 years (actual 2 yr 8 mo–5 yr 11 mo) at the time of intervention;Previous clinical diagnosis of autism spectrum disorder (ASD) according to DSM-427 criteria (i.e., autism vs PDD NOS);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;Parent with severe psychiatric disorder or cognitive impairment;Families in which English was not the primary language
Pretreatment:
Intervention Characteristics
Intervention
Control
PSI, PSI, lower 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
Email: dr.ricksol@ comcast.net
Address: Ann Arbor Center for Developmental and Behavioral Pediatrics, 2930 Parkridge Dr, Ann Arbor, MI 48103
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were as follows: 8- to 11-year-old children with a diagnosis of ASD and a verbal IQ score of > 70. Diagnosis was established using DSM-IV24 criteria (clinical interview), Autism Diagnostic Observation Schedule (ADOS, Module 3)25, and the Autism Diagnostic Interview-Revised (ADI-R)26. A clinical history, diagnostic testing, and standardized IQ tests were undertaken at screening.
Excluded criteria: Exclusion criteria were as follows: initiation of new psychiatric medication within 30 days prior to screening, known gross structural abnormalities in the brain, active seizure disorder, and aggression towards others. Of 87 families who signed consent, 18 did not get randomized for the following reasons: failure to meet study inclusion criteria, group scheduling conflicts, or inability to complete the first fMRI scan.
Pretreatment: (Table 1) No baseline group differences.
Intervention Characteristics
Intervention
Control
Sociale færdigheder
Sponsorship source: The authors acknowledge Autism Speaks, the National Institute of Mental Health (NIMH, R21MH089236-01), the Brain and Behavior Research Foundation, and the Seaver Foundation for their support.Disclosure: Dr. Soorya has received research funding from Autism Speaks, the Brain and Behavior Research Foundation, and the Brinson Foundation. She has served as a consultant to University of North Carolina-Chapel Hill, the Mount Sinai School of Medicine, and Coronado Biosciences. She has received royalties from Hogrefe Publishing. Dr. Weinger has received research funding from Autism Speaks. Dr. Gorenstein has received funding from the UJA Federation of New York. Dr. Halpern has received funding from the UJA Federation of New York. Dr. Kolevzon has received research funding from the National Institutes of Health, Autism Science Foundation, Seaver Foundation, Hoffman-La Roche, Neuren Pharmaceuticals, and Synapdx. Dr. Buxbaum has received research funding from NIMH, the National Institute on Aging, and Sage Bionetworks. He has served as an advisory board member for the Brain and Behavior Research Foundation, the Hussman Foundation, the Phelan-McDermid Syndrome Foundation, and the Autism Science Foundation. He is an editor for Molecular Autism and receives royalties from the Biomed Central Publishing Group. He is also an editor for Elsevier, The Neuroscience of Autism Spectrum Disorders, and Oxford University Press, Neurobiology of Mental Illness. He retains intellectual property rights for IGF1 in Shank3 IP, PTSD Risk Assessment, and Autism Genetics/Treatment. Dr. Wang has received research funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Mr. Beck and Ms. Soffes report no biomedical financial interests or potential conflicts of interest
Country: USA
Setting: Potential participants were recruited from community agencies, local practitioners, and advertisements.
Comments: Protocol: NCT01190917
Authors name: Latha V. Soorya
Institution: Department of Psychiatry, Rush University Medical Center
Email: latha_soorya@rush.edu
Address: Department of Psychiatry, Rush University Medical Center, 2150 West Harrison Street, Chicago, IL 60612;
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Prior clinical diagnosis of a HFASD (i.e., Asperger’s, autism, or pervasive developmental disorder-not otherwise specified [PDDNOS]);Wechsler Intelligence Scale for Children-4th Edition Short-form IQ > 70 (and Verbal Comprehension Index or Perceptual Reasoning Index score ≥ 80);Expressive or receptive language score ≥ 80 on a short-form of the Comprehensive Assessment of Spoken Language ;A score meeting ASD criteria on the ADI-R
Intervention Characteristics
Intervention
Control
Sociale færdigheder, BASC-2-PRS Social skill scale, higher better
Sponsorship source: Grant from the John R. Oishei Foundation
Country: USA
Authors name: MARCUS L. THOMEER
Institution: Institute for Autism Research, Canisius College
Email: thomeerm@canisius.edu
Address: Science Hall 1016D, 2001 Main Street, Buffalo, NY 14208
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Participants werescreened by agency sta using the same diagnostic criteria and cognitive andlanguage inclusion parameters used in the prior replication RCT (Thomeer et al.,2012), except the community agency did not require diagnostic conrmation usingthe Autism Diagnostic Interview–Revised (Rutter, LeCouteur, & Lord, 2003). Instead,diagnostic status was conrmed using the Social Communication Questionnaire(SCQ; Rutter, Bailey, & Lord, 2003). Due to resource limitations, screening proceduresin a Phase 4 community trial are likely to be less rigorous than Phase 3 RCTs (Smith etal., 2007). Eligibility criteria were a prior clinical diagnosis of ASD (or autism,Asperger’s, or Pervasive Developmental Disorder Not Otherwise Specied), WechslerIntelligence Scale for Children–Fourth Edition (WISC-IV; Wechsler, 2003) short-form IQhigher than 70 (and Verbal Comprehension Index or Perceptual Reasoning Indexscore ≥ 80), and Receptive or Expressive language score of 80 or higher on a shortform of the Comprehensive Assessment of Spoken Language (CASL; CarrowWoolfolk, 1999). The WISC-IV short-form consisted of the Block Design, Similarities,Vocabulary, and Matrix Reasoning subtests and the CASL short-form consisted of theAntonyms, Synonyms, Syntax Construction, and Paragraph Comprehension subtests
Pretreatment: Demographic data were examined for cross-condition comparability. Resultsindicated no signicant between-condition dierences on average child age,t(55) = −1.89, p = .063; parent education, t(55) = 1.01, p = .319; WISC-IV short-form IQ,t(55) = −0.65, p = .516; WISC-IV Verbal Comprehension Index, t(55) = −1.16, p = .253;WISC-IV Perceptual Reasoning Index, t(55) = −0.37, p = .713; CASL Expressive,t(55) = 0.22, p = .828; CASL Receptive, t(55) = 0.16, p = .870; or SCQ, t(55) = −1.46,p = .150. Fisher’s Exact Test two-tailed p values for gender (.470) and ethnicity (.730)were also nonsignicant.
Intervention Characteristics
Intervention
Control
Sociale færdigheder, BASC-2-PRS Social skill scale
Sponsorship source: The research reported in this article was supported by a grant from the Peter and ElizabethC. Tower Foundation. Findings and conclusions are those of the authors and do notnecessarily reect the views of the funding agency.
Country: USA
Authors name: Marcus L. Thomeer
Institution: Institute for Autism Research, Canisius College
Email: thomeerm@canisius.edu
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: The participants of the project were adolescents (ages 12–17 at the start of the study) with a confirmed diagnosis of ASD. Individuals were required to have a verbal IQ over 70 and communicate using fluent, full sentence phrases.
Excluded criteria: Four recruited individuals were excluded for either (a) not having an ASD diagnosis (3 individuals) or (b) not meeting language and verbal IQ requirements (1 indi-vidual), resulting in 40 program participants.
Pretreatment: Groups had significantly different baseline SSIS teen scores (p=0.034).
Intervention Characteristics
Intervention
Control
Sociale færdigheder, Parent SSIS
Sponsorship source: Funding for this research project was provided by the Organi-zation for Autism Research
Country: USA
Setting: Recruitment occurred in two separate yearly cycles using targeted online research advertisements, correspond-ence with local junior high and high school staff, univer-sity autism center website listings, and email notifica-tions.
Comments:
Authors name: Ty W. Vernon
Institution: Koegel Autism Center, Department of Counseling, Clinical, and School Psychology
Email: tyvernon@ucsb.edu
Address: Clinical, and School Psychology, Gevirtz Graduate School of Education, University of California Santa Barbara, Santa Barbara, CA 93106-9490, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Parents provided their child’s diagnosticassessment report and all of the 42 male and 7 femaleparticipants had received a previous diagnosis within theautism spectrum (HFASD, Asperger Syndrome, PDD-NOS), determined by a clinical psychologist, psychiatristor developmental pediatrician. Although only 63 % of thechildren (n=31) had been diagnosed within 3 years of thestudy, (mean age of diagnosis was 6:4), current autisticsymptoms were confirmed by three further measures: theSocial Responsiveness Scale—Second Edition (SRS-2);the Autism Quotient (AQ); and the subscales of theVineland Adaptive Behavior Scales—Second Edition(VABS-II). Communicative abilities were measured usingthe communication subscale of the VABS-II.In addition to the 49 participants, two children wereoriginally tested but were not included in this study. Thesetwo children began the S.S.ToM intervention and withdrewafter only two sessions; in each case the child became in-creasingly resistant to parental encouragement to attendsessions. Two other children participated in interventiongroups however their data was not included in the studydue to low scores on either the Autism Quotient (AQ-Child) or the Social Responsiveness Scale (SRS-2).Based on an initial assessment, children were includedin the study if they had the following: an interest in playingwith peers of a similar age as reported by the parent andthen confirmed during an initial interview; the ability toengage in age-appropriate levels of verbal communication;and a parent or guardian who was fluent in English andwilling to participate in the study.
Excluded criteria: Exclusionary criteriawere: an intellectual disability, significant adaptive com-munication challenges (VABS-II communicationscore\60), the child’s need for a teacher’s aide for theentire school day to ensure safety and manage behavior; anobvious lack of interest in developing friendships withpeers; the inability to participate in a two-way conversa-tion, and hearing or visual impairments that were seriousenough to preclude participation in group instruction andgame play
Pretreatment: No differences at baseline
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SRS–social communication subscale change score - higher better
Sponsorship source: NI
Country: Canada
Setting: All participants were recruited through community-based organizations that offer services for populations withautism, as well as through publicly-funded schools. Studyparticipants joined during one of two phases. During thefirst phase, which was part of an ongoing service of CFTsocial skills training for the ASD community, families wererecruited for CFT training.
Authors name: Cynthia Waugh
Institution: Ontario Institute for Studies in Education, University ofToronto
Email: cynthia.waugh@mail.utoronto.ca
Address: 252 Bloor Street West, 9th floor, Toronto,ON M5S 1V6, Canada
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: To be eligible for the study, participants had to bebetween the ages of 12 and 17 years, have an ASD diagnosis supported by the ADOS (Lordet al., 2002) and ADI-R (Lord et al., 1994), and meet diagnostic criteria for at least one offour anxiety disorders, SoP, GAD, SP, or SAD, as determined by the ADIS-C/P (Table 1).Youth also had to have a current verbal IQ of 70 or above and no previous diagnosis ofintellectual disability. Concomitant psychiatric medication was permitted if the dose wasstable for at least four weeks with no planned changes for the duration of the randomizedtrial.
Excluded criteria: Adolescents with a primary (i.e., most severe or impairing) diagnosis of Obsessive-Compulsive Disorder (OCD), Panic Disorder (PD), Panic Disorder with Agoraphobia (PD/Ag), or Agoraphobia without Panic Disorder (Ag-PD) were excluded. Some of thesedisorders require more specialized types of CBT (e.g., exposure with response preventionfor OCD), and little is known about the presentation or treatment of others (e.g., Ag-PD) inASD. However, several participants had multiple anxiety disorders (e.g., SoP and OCD)(Table 1). Adolescents with serious behavioral problems (e.g., frequent tantrums oraggression) were also excluded. All potential participants who were excluded were providedwith referrals
Intervention Characteristics
Intervention
Control
Sociale færdigheder, SRS total, 65 item, 1-4, parent rated, lower better.
Funktionsniveau, klinikerbedømt, CGI-improvement, responder vs nonresponder
Bivirkninger
Angst, PARS, 0-30, lower better
Sponsorship source: This project was supported by a grant from the National Institute of Mental Health [1K01MH079945-01; PI: S. W.White]
Country: USA
Setting: Participants were recruited primarily through a university-affiliated clinic specializing in thetreatment of ASD. In addition, area clinicians, clinics, schools, and media advertisementswere used as referral sources.
Authors name: Susan W. White
Institution: Department of Psychology, Virginia Polytechnic Institute and State University, Virginia Tech
Email: sww@vt.edu
Address: 109 Williams Hall (0436), Blacksburg, VA 24060
Study design: Randomized controlled trial
Study grouping: Crossover
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria for adolescentsincluded: (a) between 12 and 18 years of age, (b) currentlyenrolled in school between sixth grade of elementaryschool to third grade of high school, (c) experiencingsocial difficulties as recognized by parents, (d) previouslydiagnosed with ASD by a reliable mental health professional, or strongly suspected to have ASD at thetime of referral by a trained professional, (e) verballyfluent with a verbal intelligence quotient (IQ)≥65according to a standardized intelligence test, (f) substan-tially motivated to participate in treatment, (g) no historyof major mental illness (e.g. schizophrenia, bipolar disor-der, severe major depressive disorder with significant sui-cidal ideation, or other types of psychotic disorders), (h)no current problems with aggressive behavior or severeoppositional tendency, (i) no hearing, visual, or physicaldisabilities that would prevent participation in outdoorsports activities, and (j) the absence of other clinicallysignificant physical or neurological illnesses that wouldinhibit participation in treatment.
Pretreatment: Page 9: "Independent samplest-test revealed no significant differences in age, IQ, years of parental education, socioeconomic status (SES), ASD symptom severity, or baseline social skills profile between the TG and CG participants (p’s>0.05)."
Intervention Characteristics
Intervention
Control
Adfærdsvanskeligheder, forældrerapporteret, K-CBCL total, lower better
Angst, STAI-S, lower better
PSI, BDI, 0-3, lower better (gennemsnit af mor og far)
Sponsorship source: This work was supported by a research grant (number 02–2011-047) from Seoul National University Bundang Hospital andKorea Healthcare Technology R&D Project (A120029)from the Ministry of Health and Welfare, Republic ofKorea. Dr. Elizabeth Laugeson receives royalties fromRoutledge for sales of the PEERS®Treatment Manual. Dr.Hee Jeong Yoo receives royalties from Hakjisa for sales ofthe Korean versions of Autism Diagnostic ObservationScale and Social Communication Questionnaire.
Country: South Korea
Setting: Study participants were enrolled from child and adoles-cent psychiatric clinics at Seoul National University Hos-pital, Gil Hospital, Kyung Hee University Medical Center,and from advertisements mailed to child psychiatrists inthe Korean Academy of Child and Adolescent Psychiatry,and parents of offspring with ASD who participate ina support grou
Authors name: Elizabeth A. Laugeson
Institution: Semel Institute for Neuroscience and Human Behavior, University of California
Email: elaugeson@mednet.ucla.edu
Address: Semel Institute for Neuroscience and Human Behavior, University of California, LosAngeles, 760 Westwood Plaza, Ste. 48-243B, Los Angeles, CA 90024
Wrong study design
in german
Wrong study design
Wrong study design
Wrong study design
Wrong intervention
Wrong study design
Wrong study design
Wrong study design
Wrong study design
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Wrong study design
in german
Adult population
Wrong study design
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Wrong intervention
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Adult population
Adult population
no full text
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong intervention
Allerede inkluderet
Wrong study design
Wrong intervention
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "The blocks of four were created as screening interviews were completed and children were determined eligible. The families in each block of four were determined by the order in which they had completed the assessment session."
Judgement Comment: No information on the method used for randomisation
Quote: "personnel, parents, and children. Randomization <b>Using a randomized block design, the 23 participating spe- cial education preschools were randomly assigned to the four study groups (CONVERSE, INTERACT, PLAY, or WAIT) along the two recruitment years, including a divi- sion between three geographical regions in proportion to the number of children with ASD and special education preschools recruited per region.</b> Thus, all four study groups"
Judgement Comment: No information on method used for randomisation
Quote: "Participants were randomly assigned to the JDTP (n = 26) and wait-list control (n = 23) conditions."
Quote: "Chi- square analyses indicated no significant differences between the groups in the proportion of males (n = 23 treatment group; n = 21 wait-list control group) and females (n = 3 treatment group; n = 2 wait-list control group), v 2 < 1."
Judgement Comment: Unclear sequence generation however, likely random.
Quote: "The treatment group included a similar number of girls (n 5 4, 9%) compared with the control group (n 5 3, 6%; ns.)."
Quote: "An independent researcher randomized the participating children to treatment or waiting list conditions using a digital ran- dom number generator."
Quote: "The coordinating center randomly assigned eligible participants to SSGT or standard care using block randomization in a 1:1 ratio applying computer-generated random numbers (random.org) stratified within site and age group."
Quote: "Randomization was done in blocks of five groups per stratum, based on setting, using a computer-generated list of treatment allocations,"
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Quote: "This randomized, multicentre-controlled phase-III trial"
Quote: "An internet-based, GCP-compliant randomization system (http://randomizer.at) was used. Stratified randomization was done for eight or ten individuals per centre at one time in a 1:1 allocation ratio, resulting in equally sized groups of 4-5 individuals per condition."
Quote: "computer-generated allocation schedule based on the following three variables based on the minimization method of balancing three variables: Sex, autism severity (CARS score ≤30 or CARS score >30), and social competence (SQ score ≤100 or SQ score >100). Program providers were unaware of the allocation sequences."
Quote: "The randomization was performed by a senior researcher using computer-generated random numbers (http://www. rando m.org) stratified by age groups (children aged 7–12 and adolescents aged 13–17). Participants in each group were randomly assigned to the experimental or control group using block randomization in a 1:1 ratio."
Quote: "at the time of intake. <b>There were no significant differences on parent age or teen age between the experimental and waitlist groups. In addition, no significant differences between groups were found for teen intellectual functioning (as measured on the KBIT-2) or ASD symptom severity (as measured on the ADOS-G, Module 4).</b> For additional demographic information, please"
Quote: "11 Randomization and Inclusion Criteria <b>Following initial enrollment in PEERS via the phone screener, families were randomly assigned to either the “experimental” or “control” group</b> (see Fig. 1 for CONSORT"
Quote: "10 adolescents per group), and <b>was done by alternating assignment per subject number. The only contingency to random assignment was that no PEERS group could contain only one child of either gender.</b> Inclusion for enrollment in PEERS"
Quote: "Children were random- ized to group, and as expected, none of the char- acteristics were significantly different between groups (p values ranged from .31 to .84)."
Quote: "In the current study, we employed a randomized control design in which two different intervention groups were contrasted with a control group."
Judgement Comment: LIkely random generation however, unclear method
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: " Randomization wascomputer-generated and occurred within sites usinga matched pair design with primary blocking variables ofage (younger than 4.49 yr vs 4.5 yr or older), ADOS related autism categories (autism vs autism spectrum),and child’s gender. Each group was allocated 64 families.PLAY and CS groups did not differ significantly on anydemographic or outcome variables. "
Quote: "2) facilitated play (control condition). <b>Participants were recruited in seven phases between January 2008 and March 2012. Allocation to conditions was determined by computer- generated randomization in blocks of 10–12 for each recruitment phase.</b> Assessments were conducted at baseline"
Quote: "on demographic and outcome variables. <b>There were no significant differences between treatment groups on outcome variables or moderators at baseline.</b> Ethnicity data from caregiver reports"
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "were unable to be replaced. <b>The 57 eligible children were randomly assigned to one of the two study conditions ( n = 28 treatment or n = 29 waitlist control) using an online random number generator.</b> Allocation to treatment condition was"
Quote: "intervention, follow-up, and data analyses). <b>Demographic data were examined for cross-condition comparability. Results indicated no signi cant between-condition di erences on average child age, t (55) = −1.89, p = .063; parent education, t (55) = 1.01, p = .319; WISC-IV short-form IQ, t (55) = −0.65, p = .516; WISC-IV Verbal Comprehension Index, t (55) = −1.16, p = .253; WISC-IV Perceptual Reasoning Index, t (55) = −0.37, p = .713; CASL Expressive, t (55) = 0.22, p = .828; CASL Receptive, t (55) = 0.16, p = .870; or SCQ, t (55) = −1.46, p = .150. Fisher’s Exact Test two-tailed p values for gender (.470) and ethnicity (.730) were also nonsigni cant.</b> Measures According to Koenig, De"
Quote: "All participants were ran- domly assigned to a treatment group or waitlist control group."
Quote: "T tests failed to reach significance for age, grade, KBIT-2 Verbal IQ, parent SSIS, parent SRS-2, and parent/participant SMCS intake scores. There was a significant difference in adolescent participant SSIS total standard scores. Despite randomiza- tion procedures, the treatment group was found to endorse significantly lower adolescent reported SSIS scores at the pre-intervention time point."
Judgement Comment: Unclear randomisation generation (likely random) and baseline imbalance.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "were used as referral sources. <b>After determining eligibility (see later), participants were randomly assigned to receive the 14-week intervention immediately or to a Wait-List (WL) control condition of equal length, after which time they were offered the intervention.</b> White et al. Page 3"
Quote: "Random assignment was done by a person unaffiliated with the study who drew the names from a box."
Quote: "treatment assignment (MASSI or WL). <b>For each wave of 6 subjects, baseline measures were collected over a one-week period. Similarly, outcome measures were collected within five days of the treatment (or waitlist) endpoint. These groups were created sequentially, with no attempt made to affect group composition. As such, each treatment group of four (three with ASD and one non-ASD peer tutor) was fairly heterogeneous (e.g., participants of different ages and gender).</b> Participants Inclusion and exclusion criteria—To"
Quote: "and the PARS = .77. <b>There were no statistically significant differences between groups on any demographic or clinical variables at baseline</b> (see Tables 1 and 2)."
Quote: "The website http://www.random.org was used to randomly assign the eligible teens to the treatment group (TG) or the delayed treatment control group (CG)."
Quote: "as P < 0.05. Results <b>Independent samples t-test revealed no significant differ- ences in age, IQ, years of parental education, socioeco- nomic status (SES), ASD symptom severity, or baseline social skills profile between the TG and CG participants</b> (p’s > 0.05). Baseline characteristics"
Judgement Comment: No baseline imbalances.
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "Random allocation was performed by the first author and parents were informed of their group allocation via telephone."
Judgement Comment: No information on method used for concealing allocation
Judgement Comment: No information on methods to conceal the allocation is provided
Quote: "The randomization outcome was shared with the primary investigator, who informed parents about which arm of the trial they would be in. Baseline assessment took place before ran- dom allocation."
Quote: "and weighted blankets (Table 1). <b>Randomization and Blinding The coordinating center randomly assigned eligible participants to SSGT or standard care using block randomization in a 1:1 ratio applying computer-generated random numbers (random.org) stratified within site and age group.</b> Parents and trainers were aware"
Judgement Comment: No information on method used for concealing allocation
Quote: "research assis- tants, unaware of the randomization algorithm and unable to access the computer-generated list to conceal the sequence of allocation."
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Judgement Comment: Allocation only concealed from Teachers.
Quote: "Program providers were unaware of the allocation sequences."
Quote: "an independent allocation manager ran a computer-generated allocation schedule"
Quote: "Parents and trainers were aware of the treatment conditions, while teachers were blinded to treatment conditions. The latter was ensured by a teacher survey showing no awareness of group allocation beyond chance."
Judgement Comment: No information on method used for concealing allocation
Judgement Comment: No information on the method used to conceal allocation
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: No information on method used for concealing allocation
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: No information on method used for concealing allocation
Judgement Comment: No information on method used for concealing allocation
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "five waves of six adolescents. <b>Once a group of six participants meeting inclusion criteria was assembled, they were asked to return to the clinic for baseline assessment and random assignment. Random assignment was done by a person unaffiliated with the study who drew the names from a box.</b> Once all study measures were"
Judgement Comment: Allocation was likely concealed indtil after baseline measurements
Judgement Comment: No information on method used for concealing allocation
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Not feasible for neither participants nor personnel to be blind to intervention status
Quote: "Trained on-site therapists in the special education preschool led the manualized intervention"
Judgement Comment: Not feasible to blind participants. Unclear if personnel were blinded.
Judgement Comment: Not feasible to blind neither pariticpants nor personnel
Judgement Comment: Not possible to blind neither participants or personnel
Quote: "Parents and trainers were aware of the treatment conditions. Teachers were blinded to treatment conditions; this was ensured by a teacher survey showing no awareness of SSGT participation beyond chance."
Judgement Comment: Not possible to blind participants or personnel
Judgement Comment: Not possible to blind participants or personnel
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Quote: "Patients, families and therapists could not be masked with regard to treatment allocation."
Quote: "intervention allocation could not be masked from the children and their mothers in the program or from the program providers."
Judgement Comment: Blinding not feasible for the participants and their mothers nor the program providers.
Judgement Comment: Not possible to blind participants or personnel. Open label study
Quote: "criteria for enrollment in PEERS. <b>Parents were informed immediately regarding their teen’s eligibility for participation.</b> The teens were then provided"
Quote: "of the PEERS treatment manual. <b>Teen group leaders were assisted by trained undergraduate psychology students, who acted as “coaches” during behavioral rehearsal of skills learned in PEERS and assisted in role-play presentations of rules. Parent sessions were led by advanced graduate students in the Clinical Psychology Doctoral Program, again under the supervision of the trained PEERS provider, who provided weekly hour-long supervision sessions for both graduate students and coaches.</b> The treatment sessions were held"
Judgement Comment: Not feasible to blind participants. NI about blinding of the personnel delivering the intervention.
Quote: "The staff in the Early Intervention Program (EIP) were independent of the research staff, and blind to the hypotheses of the intervention study."
Judgement Comment: Not feasible to blind participants. Likely blinded personnel.
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: Not feasible to blind personnel and participants. "After randomization, 2 families fromthe CS group chose to pay for PLAY services rather thanparticipating in the control group and left the study"
Quote: "Therapists and Treatment Fidelity <b>Intervention groups were led by licensed clinical psychologists with a minimum of three years of experience working with children with ASD. Each group also included two therapy assistants trained in the respective treatment model by lead therapists. Therapists delivered either the CBI or control treatment and were not shared between conditions. In addition, weekly supervision was provided for each treatment team led by the lead therapist. A total of three lead therapists and 16 assistant therapists provided interventions across the seven group cycles.</b> Treatment fidelity ratings were conducted"
Judgement Comment: No possible to blind participants and personnel
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: Not possible to blind participants and personnel
Quote: "One undergraduate was assigned as the designated primary social facilitator for each partici- pant and was responsible for all check-in and check-out ses- sions (described below), along with all progress meetings with that individual. Advanced clinical psychology doctoral students and/or a licensed clinical psychologist jointly con- ducted all training and supervision sessions."
Judgement Comment: NI about blinding of personnel. blinding not feasible for participants.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "the names from a box. <b>Once all study measures were completed at the baseline visit, the subject and family were informed about their treatment assignment (MASSI or WL).</b> For each wave of 6"
Judgement Comment: Not possible to blind participants and personnel
Judgement Comment: Not possible to blind participants and personnel
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "It is important to acknowledge that the majority of the outcomes were evaluated by means of parent-report. The data is thus subjective t and may be open to bias. Parents may have had expectations that their child would improve following the program."
Quote: "All parents were presented with questionnaire packs both before and after the intervention and at three-month follow-up for the intervention condition."
Judgement Comment: Relevant outcomes SCPQ and SCAP are parent reported, and parents were not blinded to allocation.
Quote: "All assessments were collected both at Time1 (T1—base- line) and Time2 (T2—immediately after 6-month treat- ment) for all four groups including the control group. Tri- angulation of data sources (direct observations, assigned therapist’s ratings, and uninvolved head educator’s ratings) measured the targeted PPSI intervention’s impact."
Judgement Comment: VABS assessed by uninvolved head educators and by the assigned therapists. Unclear blinding. Many of the outcomes are assessed by the therapist not blind to group allocation
Quote: "Pre-treatment assessment measures were re-admin- istered to parents and children at the post-treatment and 6-week follow-up sessions."
Judgement Comment: Though some outcomes was measured by assessor blind to treatment group, the SSQ was assessed by the parents who were not blind to treatment group
Judgement Comment: Due to the nature of the intervention parents were aware of the intervention receipt. Parent reported outcomes. They were not blind to treatment group
Judgement Comment: Many outcomes were rated by parents ho were not blind to group allocation. For outcomes of interest: CGI-S were assessed by blind teachers. ABAS-II and PSS reported by unblinded parents.
Quote: "The first measurement took place before randomization, at later measurements informants or interviewers were not blind to condition."
Quote: "later measurements informants or interviewers were not blind to condition."
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Quote: "Teachers who rated secondary outcome measures were masked and blinded."
Judgement Comment: "Patients, families and therapistscould not be masked with regard to treatment allocation.Teachers who rated secondary outcome measures weremasked and blinded."SRS was parent-rated
Quote: "Two inde- pendent, trained evaluators who were blind to the allo- cation evaluated child-mother interaction in the videos."
Quote: "Children were evaluated both by their mothers and by independent evaluators. The mothers self-reported the condition of their child at baseline and within one month after the end of the intervention"
Quote: "To avoid bias, we standardized measurements for assessment and employed independent evaluators and independent allocation managers who were blinded to allocation. However, intervention allocation could not be masked from the children and their mothers in the program or from the program providers."
Judgement Comment: "our conclusions are mainly based on unblinded parent ratings, and we cannot rule out that their assessments were biased"
Quote: "skills, experiences, and self- perception. <b>Following administration of these questionnaires, teens participated in other components of the broader investigation of PEERS. At the conclusion of the intake process, families were notified of their assignment to either the experimental or waitlist group to ensure that responses were not biased by group assignment.</b> PEERS Intervention Following completion of"
Judgement Comment: "Parents were informed immediately regarding their teen’s eligibility for participation" - Relevant in this regard is the outcome SIPA .
Quote: "independent clinical testers (not asso- ciated with research staff and blind to study purpose and hypotheses) assessed each child."
Quote: "Both structured assessments of joint attention and play skills and mother–child interactions were collected pre and post intervention by independent assessors."
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: Likely all but parent ratings (PSI) were blinded."The ADOS and Mullen were administered in ES offices, and evaluators were blinded as to intervention status.""All interactional observation measures were video-recorded in the home, then scored by raters blinded to group, and time assignment.""Parent-child play with toys in the home wasvideo-recorded for 7.5 minutes at pre- and postassessment and coded by raters blind to group allocation and assessment time."
Quote: "for participants in cycles 4–7. <b>Behavioral outcomes included blinded neuropsychological assessments of social cognition and caregiver reports of social behavior.</b> In addition, a subset of"
Judgement Comment: Neuropsychological assessments were blinded. Caregiver reports and parent ratings were not.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "Pretest child testing and parent ratings were conducted for both groups during the 5 days prior to the initiation of treatment."
Judgement Comment: BASC-2-PRS OUTCOME of interest were assessed by staff clinicians and parents. NI about blinding of staff clinicians (likely not blinded)
Quote: "Correlated measurement error is a serious concern, as parents and adolescents were not blind to group assignment and served as raters in this particular investigation."
Quote: "A number of assessment measures were used to assess base- line functioning and improvement. These instruments were administered prior to starting the START program and after every 5 weeks."
Judgement Comment: SSIS parent is outcome of interest. NI if SSIS were administered before allocation were known.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "Coders made their ratings blind to the therapists’ ratings of fidelity. Adverse events spontaneously reported by parents, adolescent participants, or therapists were logged and reviewed by the first author."
Quote: "living, social activities, and home). <b>The blinded independent evaluators (IEs) interviewed the parent and adolescent together at baseline to assess severity and again at the endpoint (immediately post-treatment) to assess improvement.</b> All IEs were trained to"
Quote: "The PARS was conducted and scored by a trained rater who was blind to treatment assignment."
Judgement Comment: Though some outcomes (e.g CGI) was assesed by raters blind to group allocation, others (eg SRS) are parent rated outcomes
Judgement Comment: Blinding not feasible due to type of intervention and parent-rated outcome.
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Only one particpant in intervention group and none in the control group withdrew from the study before post assessment
Judgement Comment: According to the flowchart there was no attrition in any of the groups
Quote: "inconsistency in teacher ratings. Results <b>Improvement in social functioning made by particip- ants in the treatment and control groups from pre- to post-treatment was evaluated using repeated meas- ures multivariate analyses of variance (MANOVA).</b> Social skills measures: parent report"
Judgement Comment: Ni about attrition or deviations from interventions. Likely per protocol analysis
Judgement Comment: 1 drop out and 20 loss to follow-up (38%) however, appropriate Intention to treat analysis. No appropriate sensitivity analysis (per protocol).
Quote: "total of 22 participants (15%) in the SSGT arm did not complete the training, and 7 (5%) dropped out from stan- dard care (Figure 1). There were no statistically significant differences between completers and noncompleters regarding clinical and demographic characteristics. Parent- rated data were incomplete for a total of 33 participants (22%) posttreatment and 43 participants (29%) at follow-up for SSGT, as well as 17 participants (12%) posttreatment and 40 participants (27%) at follow-up for standard care. Missing data were associated with lower IQ and higher parent-rated SRS at baseline, a pattern that was nearly identical for both groups. Trainer ratings were incomplete for 29 participants (19%) posttreatment and 41 participants (27%) at follow-up for SSGT, as well as 12 participants (8%) posttreatment and 28 participants (19%) at follow-up for standard care. Teacher ratings were incomplete for 77 par- ticipants (51%) posttreatment and 92 participants (61%) at follow-up for SSGT, as well as 63 participants (43%) post- treatment and 87 participants (60%) at follow-up for stan- dard care."
Judgement Comment: Low attrition rates at posttreatment (33/150 in intervention group and 17/146 in control group). Analysis was done according to intention to treat principle
Quote: "Second, we evaluated the effectiveness of the treatment conditions compared to CAU with hier- archical linear modeling using the intent-to-treat princi- ple, including all available data points."
Judgement Comment: Low attrition rates in both groups (2/47 in interventions group and 1/22 in control group)
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Quote: "n = 228 patients were randomized. Due to withdrawal of consent (n = 2) and missing baseline pSRS (n = 17), the ITT analysis comprised 209 patients (see Figure 2; n = 22 to 66 patients per centre)."
Judgement Comment: Intention to treat analyses performed with low attrition (11/112 in intervention group and 6/114 in control group)
Judgement Comment: One participant discontinued intervention. ITT analysis.
Quote: "training and did not provide <b>data posttreatment nor at follow-up. For the par- ent-rated measures complete posttreatment data were avail- able for 17 (74%) participants in the KONTAKT group and 25 (93%) participants in the control group, while complete follow-up data were available for 16 (70%) participants in the KONTAKT group and 23 (85%) participants in the con- trol group. Complete trainer-rated posttreatment assessments were available for 16 (70%) participants in the KONTAKT group and 25 (93%) participants in the control group, while complete follow-up assessments were available for 18 (78%) participants in the KONTAKT group and 26 (96%) partici- pants in the control group. Complete teacher-rated posttreat- ment assessments were available for 9 (39%) participants in the KONTAKT group and 16 (59%) participants in the control group, while complete follow-up assessments were available for 12 (52%) participants in the KONTAKT group and 13 (48%) participants in the control group. Teacher-rated data should be interpreted with caution due to an unsatisfac- tory rate of complete data but are still reported for transpar- ency reasons.</b> Figure 1 shows participant flow"
Judgement Comment: From flow chart: Higher attrition in KONTAKT group at posttreatment (6/24, 25%) compared to SC (2/27, 7,4%). "Primary and secondary analyses were conducted according to intention-to-treat principles including all randomized participants for whom data were available at baseline"
Quote: "statistics, version 19 (IBM 2010). <b>Statistical analyses suggested no significant differences on key demographic variables between parents who completed parenting measures and families who did not complete the intervention, those with missing or incomplete data, or families in which a different parent completed pre- and post-measures.</b> Primary analyses were also conducted"
Judgement Comment: Similar and low attrition rates (7/39 in intervention group and 10/42 in control group)
Quote: "Sixty-five children with autism were randomized to treatment conditions of joint attention, symbolic play or control group. Pre- and post-intervention analyses were conducted on a final sample of 58 children. Seven children (2 in the joint attention group, 1 in the play group, and 4 in the control group) were excluded from analyses because they did not meet ADI-R and ADOS criteria for autism, refused final assessments, or left the program unexpectedly. Thus, the final sample con- sisted of 20 children in the joint attention group, 21 children in the play group and 17 children in the control group."
Judgement Comment: Low attrition rate however, unclear for what reasons individual drop outs from groups and per protocol analysis.
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: <15% drop out in each group. Appropriate analysis. "Apart from the Mullen and MCDI-WS, missing datawere missing completely at random (Little’s MCAR testx2 [42, N 5 112] 5 50.16, p 5 .181). Data were imputedforward for using the last observation carried forwardmethod at the scale level." <15% drop out in each group. Appropriate analysis. "Apart from the Mullen and MCDI-WS, missing datawere missing completely at random (Little’s MCAR testx2 [42, N 5 112] 5 50.16, p 5 .181). Data were imputedforward for using the last observation carried forwardmethod at the scale level."
Judgement Comment: Low attrition rates at EoT (0/35 in the intervetion group and 2/34 in the control group).
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "determined and consent was obtained. <b>All 57 children randomly assigned completed the study and were included in the analyses (see Figure 1 for the progress of participants through the study).</b> A description of the sample"
Quote: "condition participated in external programming. <b>There was no attrition from either the treatment or waitlist control group after allocation to treatment condition.</b> The waitlist control participants received"
Judgement Comment: Figure 1 (flow chart) illustrates no loss to follow up
Quote: "randomized using the same procedures. <b>Of the 20 participants ultimately assigned to the START treatment condition, 4 withdrew from the study prior to the completion of the group. Reasons provided for withdraw- ing from the group included: joining an extracurricular social activity that conflicted with the scheduled group time (2 participants), excessive driving distance to the project location (1 participant), and expressed dissatisfaction with the assigned group’s demographic make-up (1 partici- pant). Specifically, two participants joined highly desired extracurricular activities (a robotics club and the school vol- leyball team, respectively) after completing the first 6–10 sessions of the START program. Another participant’s weekly 2 h round-trip commute was too difficult to sustain. The final participant reported dissatisfaction with the rela- tively younger age range of the remaining participants in her assigned group.</b> One individual from the waitlist"
Judgement Comment: Per protocol analysis. No sensitivity analysis of drop outs. Drop outs in IG related to group allocation. Attrition rates in both groups (4/20 in intervention group and 1/20 in control group)
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Quote: "1 and 2). Feasibility-related outcomes <b>Attrition—Overall, 25 of 30 subjects (83.3%) completed the randomized trial: 13 of 15 (87%) in MASSI and 12 of 15 (80%) in WL (difference not significant).</b> All drop-outs were male. One"
Judgement Comment: 2 and 3 in IG and CG respectively of total 15 in each group were lost to follow-up. ITT analysis conducted.
Quote: "During the 14 weeks of treatment, five partici- pants in the TG and three in the CG withdrew because of the teens’ lack of motivation, family events, entering college, or moving."
Judgement Comment: A total of 8 of 55 participants dropped out during the intervention. No analysis of drop out characteristics. Per protocol analysis.
Reporting bias due to selective outcome reporting
Judgement Comment: No protocol however, thorough reporting of relevant outcomes.
Judgement Comment: No reference to study protocol, but appears to report on outcomes of interest
Judgement Comment: No protocol however, thorough reporting of outcomes.
Quote: "the trial (www.trialregister.nl, trial number 2327) and published before the data collection was fin- ished."
Judgement Comment: Outcomes does not match those in protocol (https://www.trialregister.nl/trial/2203)
Judgement Comment: Reported outcomes matches the study protocol (NCT01854346)
Judgement Comment: Several of the outcomes in study protocol os not reported (https://www.trialregister.nl/trial/2279). Secondary outcome measures: FMSS, RCADS P (t0. t1 and t2), and ADOS (t0, t1 and t2) was pre-specified in protocol however, not reported.
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Quote: "The study protocol was published (Freitag et al., 2013)"
Quote: "The study was registered as an International Standard Randomized-Controlled Trial (ISRCTN94863788)."
Judgement Comment: Several of the secondary outcomes from protocol are not reported (ISRCTN94863788)
Quote: "This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000004560)."
Judgement Comment: Protocol did not specify precise outcome measures.
Judgement Comment: Protocol available and no protocol violations (https://clinicaltrials.gov/ct2/show/NCT01854346)
Judgement Comment: No reference to study protocol. They mention that this is part of a larger RCT, but do not indicate reference
Judgement Comment: No reference to study protocol, and does not report on relevant outcomes
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: Protocol NCT01768806.- Vineland Adaptive Behavior Scale was pre-specified as secondary outcome in protocol however, this is not mentioned nor reported in the article.- PSI, SCQ, FEAS and Mullen developmental quotient was reported in article, but not pre-specified in protocol.
Judgement Comment: Several of the outcomes in study protocol are not reported (NCT01190917)
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: No reference to study protocol, but appears to report outcomes of interest
Judgement Comment: No reference to study protocol, but appears to report on outcomes of interest
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: No reference to study protocol, but appears to report on outcomes of interest
Judgement Comment: No protocol available. Thorough and relevant outcome reporting.
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No other sources of bias found
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No other sources of bias found
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias
Quote: "The participants received a 100 SEK (11 EUR) voucher as an incentive for participating in the trial."
Judgement Comment: No reasons to suspect other sources of bias.
Quote: "families participating in this study. <b>Incentive for participation limited to a small prize (i.e., approximately 25 dollars in value) provided at the end of PEERS for teens who successfully completed the program.</b> The final sample for this"
Judgement Comment: No reasons to suspect other sources of bias. Incentive for teens to participate was however noted.
Judgement Comment: No reasons to suspect other sources of bias.
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference:
Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D.
A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
Reference: Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)The Cochrane database of systematic reviews 2012;(7):CD008511
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: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Reference:
Reichow, Brian; Steiner, Amanda M.; Volkmar, Fred. Cochrane review: social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD)Evidence-based child health : a Cochrane review journal 2013;8(2):266-315
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Reference: Wolstencroft, J.; Robinson, L.; Srinivasan, R.; Kerry, E.; Mandy, W.; Skuse, D. A systematic review of group social skills interventions, and meta-analysis of outcomes, for children with high functioning ASD.Journal of Autism and Developmental Disorders 2018;48(7):2293-2307
Judgement Comment: No other sources of bias was found
Quote: "Dr. Elizabeth Laugeson receives royalties from Routledge for sales of the PEERS ® Treatment Manual. Dr. Hee Jeong Yoo receives royalties from Hakjisa for sales of the Korean versions of Autism Diagnostic Observation Scale and Social Communication Questionnaire."
Judgement Comment: No reasons to suspect other major sources of bias.