[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention1: NFPP
WL
Overall
Included criteria: Participants were 3.0-to 4.11-year-old boys and girls attending a preschool, daycare or nursery school at least 2 and-a-half days a week. Inclusion required that the primary caretaker be fluent in English and that the child have an IQ ≥ 70 on the Wechsler Preschool Primary Scale of Intelligence, 3rd edition (WPPSI-III; Wechsler, 2002); elevated scores above age and gender norms on the DSM-IV Total, DSMIV Hyperactive/Impulsive, or DSM-IV Inattentive subscales on both the Revised Conners Teacher (CTRS-R) (T-score ≥ 65) and Parent (CPRS-R) Rating Scales (T-score ≥ 60), (Conners, Sitarenios, Parker, & Epstein, 1998a,b); a Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; American Psychiatric Association, 1994) diagnosis of ADHD (any type) on the Diagnostic Interview Schedule for ChildrenParent Report Version 4, (Shaffer, Fisher, & Lucas, 1998),modified Young Child Version (DISC-IV-YC) (Lucas, Fisher, & Luby, 1998), confirmed by clinical evaluation conducted by apsychologist with child and parent; standard score ≥ 7 on the Concepts and Following Directions subscale of the ClinicalEvaluation of Language Fundamentals (CELF-2, Semel, Wiig, & Secord, 2004).Recruitment relied on referrals from preschools, daycares, nursery schools, community resources (clinics, physicians, and agencies), parent mailings, newspaper ads, and website postings.
Excluded criteria: Reasons for exclusion included current medication or behavioral treatment for ADHD; a diagnosis of pervasive developmental disorder, psychosis, or post-traumatic stress disorder; history of sexual or physical abuse; or any other psychiatric or medical condition judged to contraindicate participation. Children with common mental health diagnoses were not excluded
Pretreatment:
Intervention Characteristics
Intervention1: NFPP
WL
ADHD kernesymptomer kliniker/observatør (lower better)
ADHD kernesymptomer, forældrebedømt (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (Lower better)
Skadevirkninger
Sponsorship source: This research was supported by National Institute of Mental Health Grant 5R01MH074556 to H.B.A.
Country: USA
Setting: clinic
Comments:
Authors name: Howard B Abikoff
Institution: The Child Study Center at NYU Langone Medical Center
Email: howard.abikoff@nyumc.org
Address: One Park Avenue, New York, NY 10016, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Triple-P
WL
Included criteria: Inclusion criteria were the following: (a) children aged 5–10years; (b) children were diagnosed to have ADHD upon medicaldiagnosis according to theDSM-IV-TR; (c) children scored at orabove an estimated IQ of 80 on the Test of Nonverbal Intelli-gence, which is a language-free intelligence test measuringabstract problem-solving ability (Test Of Nonverbal Intelligence,Third Edition; Brown, Sherbenou, & Johnsen, 1997); (d)parents were Chinese Cantonese speaking; (e) parents were themain caregivers of the child; (f) parents were living with theirchild; (g) parents did not have intellectual impairment or psy-chosis; and (h) parents did not receive formal behavioural treat-ment in the past
Excluded criteria: NS
Pretreatment:
Intervention Characteristics
Triple-P
WL
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: NS
Country: Hong Kong
Setting: Clinic
Comments:
Authors name: Alma Au
Institution: Department of Applied Social Sciences, The Hong Kong Polytechnic University,
Email: Correspondence email: kammy-km.lau@polyu.edu.h
Address: Kam-Mei Lau, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Enhanced Behavioral Family Intervention (EBFI)
WL
Intervention 2:
Included criteria: (a) the target child was aged between 36 and 48 months;(b) mothers rated their child’s behavior as being in the elevated range on the Eyberg Child Behavior Inventory (ECBI; Intensity score ≥ 127 or Problem score ≥ 11; Eyberg & Ross, 1978); (c) the child showed no evidence of developmental disorder (e.g., language disorder, autism) or significant health impairment; (d) the child was not currently having regular contact with another professional or agency or taking medication for behavioral problems; and(e) the parents were not currently receiving therapy for psychological problems, were not intellectually disabled, and reported they were able to read the newspaper without assistance.
Excluded criteria:
Pretreatment:
Intervention Characteristics
Enhanced Behavioral Family Intervention (EBFI)
WL
Intervention 2:
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: The study is supported by grants from Queensland Healthand the National Health and Medical Research Council(941044, 971099
Country: Australia
Setting: clinic
Comments: The Triple P project is an ongoing study conducted at the School of Psychology, The University of Queensland
Authors name: William Bor
Institution: South Brisbane Child and Youth Mental Health Service, Brisbane, Australia.
Email: e-mail: matts@psy.uq.edu.au
Address: Address all correspondence to Matthew R. Sanders, PhD, Parenting and Family Support Centre, School of Psychology, University of Queensland, Brisbane QLD 4072, Australia; e-mail:
NKR01 ADHD børn og unge on 27/10/2020 20:44
Select
OBS diagnose
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
TASH + TAU
TAU
Included criteria: Participants were parents, mostly mothers, of school-aged children with ADHD. Parents were eligible for the study if their child was aged 6–12 years, attending school, had been diagnosed with ADHD by a pediatrician or child psychiatrist, was on methylphenidate with a stable dose for at least the previous 2 months, and no change of medication or dose was planned.Ref fig 1
Excluded criteria: NS
Pretreatment: In the intention-to-treat sample, no significant group differences between the EG and CG regarding demographic characteristics, functional impairment, and symptoms were seen at baseline
Intervention Characteristics
TASH + TAU (RCC)
TAU
Funktionsniveau hos barnet/den unge, forældrerapporteret (WFIRS-P total) (lower better)
ADHD kernesymptomer, forældrebedømt FBB-ADHS total symptom score (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: The study was supported by a grant from ShirePharmaceuticals Development Ltd. (unrestricted grant).
Country: Germany
Setting: clinic
Comments:
Authors name: Christina Dose
Institution: Department for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of theUniversity of Cologne, Cologne
Email: Correspondence: manfred.doepfner@uk-koeln.de
Address: Correspondence: Manfred Doepfner, Department for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Cologne, Robert-Koch-Str. 10, 50931 Cologne, Germany;
Christina Mohr Jensen on 28/10/2020 00:35
Det er lidt en outlier ift. design men pt. taget med videre
ITT analysis
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Behavioral Parent Treatment Group Home (BPTH@HOME)
Care as usual
Online BPT
Overall
Included criteria: Children eligible for inclusion were between the ages of 3 years 0 months (3;0) and 5 years11 months (5;11); enrolled in a preschool or day care settingat least 2 days a week unless otherwise unable to enroll(e.g., behavioral problems, lack of services for unrelateddisability); and have no diagnoses of autism spectrum dis-order (ASD), pervasive developmental disorder, intellectualdisability, neurological damage, or significant motor or phy-sical impairments. In addition, parents had to have an elec-tronic device with Internet access and be willing to attendF2F meetings or complete online sessions. Children musthave metDiagnostic and Statistical Manual of MentalDisorders(5th ed.;DSM-5; American PsychiatricAssociation,2013) criteria for one of the three presentationsof ADHD based on graduate research assistant–adminis-tered clinical interview and parent behavior ratings includ-ing parent report of elevated levels of impairment at home(i.e., score greater than 90th percentile on one or moreConners Early Childhood Rating Scale subscales relevantto ADHD).
Excluded criteria: Children who obtained a Differential Ability Scale globalcognitive ability score lower than 80 were excluded
Pretreatment: There were no significantbetween-group differences in demographic and diagnostic char-acteristics or cognitive ability prior to treatment
Intervention Characteristics
Behavioral Parent Treatment Group Home (BPTH@HOME)
Care as usual
Online BPT
ADHD kernesymptomer, forældrebedømt (ADHD-RS) (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: The research reported here was supported by the Institute ofEducation Sciences, U.S. Department of Education, throughGrant R324A120284 to Lehigh University
Country: California, USA
Setting:
Comments: ADHD pre-Kindergartners (PEAK)
Authors name: George J. DuPaul
Institution: Departmentof Education and Human Services, Lehigh University, 111 Research Drive,Bethlehem, PA 18015
Email: E-mail:gjd3@lehigh.edu
Address: 111 Research Drive, Bethlehem, PA 18015
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Behavioral Parent Treatment Group Home (BPTG@HOME)
Overall
Included criteria: Participants were 53 parents with a 3- to 4-year-old child (M = 4.0 years) with elevated and impairing levels of ADHD symptoms. Mothers had a mean age of 35.4 years (SD = 4.87), and the 43 fathers who contributed study data had a mean age of 38.8 years (SD = 6.65). A third of all families had an annual income below NZ$75,000 (approxi-mately US$50,000), another third more than NZ$100,000 (approximately US$67,000), and just over half of the moth-ers had a university degree (55.7%). Seventeen families had a parent with clinically elevated levels of ADHD symp-toms. The majority of the children were male (71.7%) and of New Zealand European ethnicity (79.2%).Recruitment took place throughout New Zealand, between January 2013 and August 2014, through commu-nity outreach in early childhood education centers, child care centers, organizations that work with young families, and media outlets. After initial contact, parents completed a 45-min telephone screening interview to inform parents and assess eligibility. Families were included if their child met the cutoff criteria on the Werry–Weiss–Peters (WWP) activity rating scale (≥14; Routh, 1978) and the Parental Account of Child Symptoms (PACS; ≥16; Taylor, Sandberg, Thorley, & Giles, 1991), and if their child was perceived to have impaired functioning due to hyperac-tive/inattentive behaviors
Excluded criteria: Reasons for exclusion included being below the cutoff score for ADHD symptoms (n = 22), no perceived impairment in functioning (n = 13), child outside the age range (n = 9), parent or child already receiving sup-port for parenting and/or child behavior (n = 9), no interest in participating (n = 9), presence of a developmental disor-der (n = 4), lack of time (n = 4), no Internet access (n = 2), and interested in face-to-face support only (n = 2). Another 13 families failed to complete T1 assessment, leaving 53 participants in the study (see Figure 1)
Pretreatment:
Intervention Characteristics
Intervention1: Behavioral Parent Treatment Group Home (BPTG@HOME)
Kontrol 1: Care as usual
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
ADHD kernesymptomer, forældrebedømt, min 3 mdr FU (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (min 3 mdr FU) (lower better)
Sponsorship source: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by grants from the New Zealand Federation of Graduate Women and the University of Auckland
Country: New Zealand
Setting:
Comments:
Authors name: Nike Franke
Institution: Faculty of Education and Social Work, The University of Auckland
Email: n.franke@auckland.ac.nz
Address: Private Bag 92601, Symonds St., Auckland 1150, New Zealand
Christina Mohr Jensen on 28/10/2020 17:19
Select
Der er blot to tlf. opkald til støtte - er det mon nok? Jeg har lukket med for nu, men det bør diskuteres hvad omfang af terapeutstøtte til e-programmer bør være
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Parenting Your Hyperactive Preschooler (PYHP)
Overall
Included criteria: (a) Behavior Assessment System for Children 2–Parent Report Scale (BASC 2-PRS; Reynolds & Kamphaus, 2004) hyperactivity scores of 65 or higher, or (b) at least six hyperactive/impulsive symptoms based on the Diagnostic Interview Schedule of Children, Fourth Edition (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, & Schwab-Stone, 2000).
Excluded criteria: Children who showed evidence of mental retardation, autism, Asperger's syndrome, or cerebral palsy were excluded.
Pretreatment:
Intervention Characteristics
Parenting Your Hyperactive Preschooler (PYHP)
WL
ADHD kernesymptomer, forældrebedømt (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: NS
Country: USA
Setting: Clinic
Comments:
Authors name: Sharonne D herbert
Institution: University of Massachusetts Amherst
Email: eharvey@psych.umass.edu
Address: Address correspondence to Elizabeth Harvey, Ph.D., Department of Psychology, Tobin Hall, 135 Hicks Way, University of Massachusetts, Amherst, MA 01003; USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
New Forest Parent Training Programme (NFPP)
Overall
Included criteria: Inclusion criteria were: age between 3-7 years; clinical ADHD diagnosis supportedbythe Development and Well-Being Assessment (DAWBA)29; Danish as a first language spoken athome.
Excluded criteria: Exclusion criteria were: Intellectual disabilities (IQ < 70); autism spectrum disorder diagnosis; in receipt of pharmacological or psychosocial treatment for ADHD. Severe parental psychiatric disorder (i.e. untreated psychosis, bipolar or severe depressive disorder); severe social adversity inthe home (i.e. active child protection involvement).
Pretreatment:
Intervention Characteristics
New Forest Parent Training Programme (NFPP)
TAU
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
ADHD kernesymptomer, forældrebedømt, min 3 mdr FU (lower better)
Forældrestress (PSI) (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (min 3 mdr FU) (lower better)
Livskvalitet hos barnet (PedsQL) (higher better)
Sponsorship source: This study was supported by research grants from TrygFonden and Helse- fonden, Denmark, and was supported by the Central and Capital Regions of Denmark.
Country: Denmark
Setting: Clinic
Comments:
Authors name: Anne-Mette Lange
Institution: Aarhus University Hospital, Research Department, Center for Child and Adolescent Psychiatry.Skovagervej 28240 RisskovDenmark
Email: annelang@rm.dk
Address: Skovagervej 2, 8240 Risskov, Denmark
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
IYPT (Webster-Stratton, 2007) group-based intervention
Intervention 1
Kontrol 1
Included criteria: Participants were included in the trial if: (a) the person wasthe primary caregiver of the child; (b) the child was aged 3–7 years;1(c) the primary refer-ral reason related to persistent hyperactivity, inattention and/or impulsive behaviours; (d)the child scored above the cut-off(>17) on the screening measure, the Werry–Weiss–Peters Activity Rating Scale (WWPARS; Werry,1968); (e) the child was not receivingany ADHD medication prior to, or for the duration of, the research; and (f) the parentor child had not previously attended any IY programmes.
Excluded criteria:
Pretreatment: No significant differences between groups
Intervention Characteristics
Intervention 1
Kontrol 1
ADHD kernesymptomer, forældrebedømt (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: The Incredible Years Ireland Study was funded by Archways with support from The AtlanticPhilanthropies.
Country: Ireland
Setting:
Comments:
Authors name: Yvonne Leckey
Institution: Department of Psychology, Maynooth University, Maynooth, Ireland
Email: yvonne.leckey@mu.ie
Address: Maynooth University, Maynooth, Ireland
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Behavioral Parent Treatment Group Home (BPTG@HOME)
Care as usual
Included criteria: The sample consisted of 32 families. Children met the following criteria: were 4–6years of age attending a preschool program, parents reported hyperactivity and be-havior problems; had an ADHD diagnosis, combined or hyperactive-impulsive (HIT)type, according to theNIMH Diagnostic Interview Schedule for Children IVFParentVersion (NIMH-DISC IV, 1997); had an IQ80 on the Peabody Picture VocabularyTest (PPVT); showed no evidence of significant sensory, language, neurological, orpervasive developmental difficulties; their mothers were Puerto Rican and lived with their children; were not receiving treatment with stimulant or other psychotropicmedication; and their parents agreed not to participate in any other form of childpsychotherapy and/or pharmacotherapy until completion of study participation. Otherinclusion criteria included: absence of domestic violence, severe major depression,substance abuse, psychopathology, or severe mental retardation in participatingparents. None of the parents were excluded for any of these criteria. All parents wereoriented on other treatment options and informed of their right to leave the treatmentat any time. Their primary language was Spanish
Excluded criteria: This study targeted the combined (CT) and HIT types of ADHD and excluded the predominantly inattentive type (IT) for three reasons.
Intervention Characteristics
Behavioral Parent Treatment Group Home (BPTG@HOME)
Care as usual
ADHD kernesymptomer, forældrebedømt (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: This research was supported by NIH Research Grant 5R24-MH-49368-12 funded by the National Instituteof Mental Health and by the Division of Mental Disorders, Behavioral Research & Aids to Guillermo Bernal.
Country: Puerto Rico
Setting:
Comments:
Authors name: Maribel Matos, Ph.D
Institution: Department of Psychology, University Center for Psychological Services and Research, Universityof Puerto Rico, Rio Piedras, Puerto Rico, PO Box 23174, San Juan, PR 00931-3174.
Email: m-matos@uprrp.edu
Address: Rio Piedras, Puerto Rico, PO Box 23174, San Juan, PR 00931-3174
Christina Mohr Jensen on 30/10/2020 17:53
Select
Jeg kan simpelthen ikke greje hvad jeg skal gøre med de her PCIT studier - jeg synes jo ikke det sådan rammer helt spot on - medtaget for nu og så må vi diskutere det
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention1: Behavioral Parent Treatment Group Home (BPTG@HOME)
Kontrol 1: Care as usual
Kontrol 2
Intervention 2:
Overall
Included criteria: Children had to meet the following inclusion criteria: (1) at time of referral a diagnosis of ADHD (all comorbid disorders allowed) as obtained from medical records (based on clinical interviews with the parents and teacher); (2) a Global Assessment of Functioning score of <55, according to the DSM-IV-TR; (3) current Eyberg Child Behavior Inventory (ECBI) ratings in the clinical range (i.e., intensity scale >131 and problem scale>3); (4) a full scale, verbal, and performance IQ >70 as established within the previous 2 years (in 94.5% of the cases based on Wechsler Intelligence Scale for Children-III-NL);(5) had previously been offered and/or received routine treatments including ADHD medication and/or clinic-based behavioral parent training; (6) attending primary school and aged 6–13 at time of inclusion in the trial.
Excluded criteria: Children were excluded from the study if (1) they had a medical condition that prohibited participation in the study; (2) their parents were unable to understand or follow instructions, e.g., due to intellectual disability of the parents; (3) their family had received home-based treatment in the previous year
Pretreatment: Table 3 shows basic demographic features (child’s age, total IQ, and educational level of the primary caregiver), treat-ment characteristics (duration of treatment and number of sessions), and change of extra care during trial (medication and other care) of the three study arms. There were no sig-nificant differences between BPTG@HOME and the other study arms on the baseline ratings of the outcome measures. In addition, there were no differences in medication use dur-ing treatment between the three study arms and in extra care received at T1, T2, and T3. However, the care-as-usual treat-ment lasted significantly longer than BPTG@HOME and consisted of significantly more sessions, and the BPTG@HOME condition had younger children (see Table 3
Intervention Characteristics
Intervention1: Behavioral Parent Treatment Group Home (BPTG@HOME)
Kontrol 1: Care as usual
ADHD kernesymptomer, forældrebedømt (lower better)
ADHD kernesymptomer, forældrebedømt, min 3 mdr FU (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (min 3 mdr FU) (lower better)
Sponsorship source: This study has been financially supported by the Netherlands Organization for Health Research and Development (ZonMw, nr 15700.3010).
Country: The Netherlands
Setting: clinic
Comments: -
Authors name: Ellen Nobel
Institution: Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen,
Email: e.nobel@me.com
Address: Hanzeplein 1 XA10, NL-9713 GZ Groningen, The Netherlands
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Parent-Focused Treatment (PFT)
Care as usual
Included criteria: Inclusion criteria specified a primary DSM-IV diagnosis of ADHD-I (confirmed by the KSADS-PL; see below), IQ > 80 (confirmed with the Wechsler Intelligence Scale for Children, version IV [WISC-IV, Wechsler, 2003]), living with at least one parent for the past year, child age between 7-11 years (and grades 2-5), attending school full time in a regular classroom, ability to participate in our groups on the days scheduled, school proximity within 45 minutes of study site to allow for the clinician to conduct school meetings, and teacher consent to participate in a school-based treatment
Excluded criteria: Families of children who were taking non-stimulant psychoactive medication were excluded because of difficulty withholding medication to confirm ADHD-I symptoms, as were cases planning to initiate or change medication treatment (stimulant or otherwise) in the near term. Children with significant developmental disorders (e.g., pervasive developmental disorder) or neurological illnesses were also excluded
Pretreatment: Only medication status at randomization differed across the treatment groups (p = .035), with significantly more CLAS children reporting medication use (9.5%) than PFT (1.4%), but not compared to TAU (2.0%).
Intervention Characteristics
Parent Focused Treatment (PFT)
Care as usual
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
Funktionsniveau hos barnet/den unge, forældrerapporteret (CGAS) (higher better)
Sponsorship source: This research was supported by a grant from the National Institute of Mental Health MH077671.
Country: US
Setting: Clinic
Comments:
Authors name: Linda J. Pfiffner
Institution: Department of Psychiatry
Email: lindap@lppi.ucsf.edu
Address: 401 Parnassus Ave., Box 0984, University of California, San Francisco, San Francisco, CA 94143
Henning Keinke Andersen on 12/11/2020 02:29
Værdier er angivet som Mean (SE)!!
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Well Parent Japan (NFPP)
WL
Included criteria: Fluency in Japanese language and parenting a child, aged 6–12 years, demonstrating 6 or more definite symptoms of inattention and/or hyperactivity/impulsivity on the parent completed SNAP
Excluded criteria: Self-reported psychiatric symptomatology in the mother or other personal issues for which a group programme would be counter-indicated (e.g., delusions or paranoia, no parents were excluded); current or recent, i.e., within two months of screening, participation in another parenting programme; and the presence of moderate to severe Diagnostic and Statistical Manual ofMental Disorders (5th ed., DSM-5, APA 2013) symptoms of Autism Spectrum Disorder (ASD) in the target child, i.e., endorsement of symptoms equivalent to Level 3 on the GARS-3
Pretreatment:
Intervention Characteristics
Well Parent Japan (NFPP)
WL
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: This work was supported by a KAKENHI (Grants-in-Aid forScientific Research) from the Japan Society for the Promotion ofScience to S.S. and internal subsidy funding from the OkinawaInstitute of Science and Technology Graduate University (OIST),Okinawa, Japan
Country: Japan
Setting: Clinic
Comments:
Authors name: Shizuka Shimabukuro
Institution: Human Developmental Neurobiology Research Unit, Okinawa Institute of Science and Technology Graduate University, 1919-1 Tancha, Onna-son, Okinawa 904-0495, Japan
Email: tripp@oist.jp
Address: Human Developmental Neurobiology Research Unit, Okinawa Institute of Science and Technology Graduate University, 1919-1Tancha, Onna-son, Okinawa 904-0495, Japan
Christina Mohr Jensen on 28/10/2020 17:35
Select
Kriterierne for ADHD er lidt løse, men da der er nogle kulturelle hensyn kan den måske alligevel overvejes - der er min 6 symp påAI/HI
NKR01 ADHD børn og unge on 05/11/2020 18:11
Included
Allerede inkluderet
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
New Forest Parenting Programme (NFPP)
Overall
Included criteria: Seventy-eight 3-year-old children (48 boys) entered the trial. Theywere identified at their 3-year developmental check from a populationof 3,051 children born between January 1992 and September 1993.There was an initial screening stage, and all children who scored morethan 20 on the Werry-Weiss-Peters Activity Scale (Routh, 1978) (n=286) were included in an initial sample. Only those children who metclinically validated cutoffs on the Parental Account of ChildhoodSymptoms (PACS) (Taylor et al., 1991) ADHD/Hyperkinesis scaleand whose parents reported that their condition was associated withimpairment significant enough to warrant clinical intervention (n=78) were included in the trial.
Excluded criteria: Children were excluded from the trial if their parents had a serious mental illness, they had a serious learning disability, or they had a previous diagnosis for an unrelated mental health condition.
Pretreatment:
Intervention Characteristics
New Forest Parenting Programme (NFPP)
WL
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) (higher better)
Oplevet forældrekompetence, Parenting Sense of Competence Scale (PSOC) - self efficacy subscale (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
ADHD kernesymptomer, forældrebedømt, min 3 mdr FU (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (min 3 mdr FU) (lower better)
Sponsorship source: This research was supported by a grant from the NHS R&D Committee
Country: UK
Setting: Clinic
Comments:
Authors name: EDMUND J.S. SONUGA-BARKE
Institution: Centre for Research into Psychological Development, Department of Psychology, University of Southampton, England
Email: NS
Address: Dr. Sonuga-Barke, Professor of Psychology, Department of Psychology, University of Southampton, SO17 1BJ England.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
NEW FOREST PARENTING PROGRAMME (NFPP)
TAU
Included criteria: Children were included if: (i) they were between 2 years 9 months and 4 years 6 months old; (ii) had a parent/caregiver aged 18 years or over; (iii) screened positive for ADHD symptoms (score≥ 20) on the WerryWeiss-Peters Activity Rating Scale (WWP) and; (iv) were given an ADHD research diagnosis of any sub-type based on the parent DISC-IV-ADHD Scale
Excluded criteria: Excluded if they had (i) a full clinical diagnosis of autismspectrum disorder; (ii) were severely delayed developmentally (18 months or more behind their chronologicalage on the Parent Involvement Project (PIP) Developmental Scales [20]; (iii) had a main caregiver with a seriousmental illness (e.g., psychosis). They were also excludedfor practical reasons including: (iv) if children were inshort- to medium-term foster care placements; (v) on theChild Protection Register or (vi) when their main carerhad insufcient English language
Pretreatment:
Intervention Characteristics
NEW FOREST PARENTING PROGRAMME (NFPP)
TAU
ADHD kernesymptomer, forældrebedømt (lower better)
ADHD kernesymptomer, forældrebedømt, min 3 mdr FU (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: This was an independent study funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0108-10061 to Solent NHS Trust who were the grant holders and hosted the trial).
Country: UK
Setting: Clinic
Comments:
Authors name: Edmund J. S. Sonuga‑Barke
Institution: Academic Unit of Psychology, University of Southampton, Southampton SO17 IBJ, UK
Email: edmund.sonuga-barke@kcl.ac.uk
Address: Edmund J. S. Sonuga-Barke edmund.sonuga-barke@kcl.ac.uk
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
NFPP
TAU
Overall
Included criteria: Inclusion into the trial was a score of 16 or over on the PACS ADHD symptom scale. Nine children did not meet clinical criteria according to the PACS interview. Because of limited resources IQ was not assessed during the trial.
Excluded criteria: Families were excluded from the trial if they had previously or were currently attending the local child and adolescent services, if the mother was known to have a severe mental illness or if the child had a pervasive developmental disorder, severe receptive language impairment, neurological disorder or was on the social services register for a current history of child sexual or physical abuse
Pretreatment:
Intervention Characteristics
NFPP
TAU
ADHD kernesymptomer, forældrebedømt (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (min 3 mdr FU) (lower better)
Sponsorship source: The project was funded by The Island of Guernsey Research Fund through Wessex Medical Trust HOPE to MT, ES-B, LP, PT
Country: UK
Setting: clinic
Comments:
Authors name: Margart J.J. Thompson
Institution: Child and Adolescent Mental Health Service, Southampton City PCT, Southampton, UK
Email: mt1@soton.ac.uk; ejb3@soton.ac.uk
Address: School of Psychology, Institute for Disorders of Impulse and Attention, University of Southampton, Southampton SO17 1BJ, UK
Henning Keinke Andersen on 11/11/2020 01:49
Included
Intervention 1: NFPP
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
BPT+RCC
RCC alone
Overall
Included criteria: Eligibility was determined by the following criteria: meetDSM-IVcriteria for ADHD; IQ >80 (Full Scale IQ of the WISC-III-R,for children under the age of 6 years; the Full Scale IQ of theWPPSI-R); age between 4 and 12 years; and both parents (ifpresent) were willing to participate in the BPT program.
Excluded criteria: NS
Pretreatment: OBS group differences for ADHD at baseline ( CPRS ADHD INDEX!) samt på PSI (Parental Stress)
Intervention Characteristics
BPT+RCC
RCC alone
ADHD kernesymptomer, forældrebedømt (lower better)
Forældrestress (lower better)
Adfærdsvanskeligheder, forældrebedømt (ECBI, CBCL) (Lower better)
Sponsorship source: The study has been supported by the University Medical Center Groningen
Country: The Netherlands
Setting: clinic
Comments: The study support is not necessarily financially
Authors name: Barbara J. van den Hoofdakker,
Institution: Department of Psychiatry, University Medical Center Groningen, University of Groningen, The Netherland
Email: b.van.den.hoofdakker@accare.nl.
Address: Barbara J. van den Hoofdakker, University Center of Child and Adolescent Psychiatry, P.O. Box 660, 9700 AR Groningen, TheNetherlands
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Tripple P
WL
Included criteria: NS
Excluded criteria: NS
Pretreatment: NS
Intervention Characteristics
Triple P
WL
Funktionsniveau hos barnet/den unge, forældrerapporteret (CGAS) (higher better)
ADHD kernesymptomer, forældrebedømt (lower better)
Sponsorship source:
Country:
Setting:
Comments:
Authors name: Öztürk Yusuf
Institution:
Email: yusuf26es@hotmail.com
Address:
Population is children aged 7-12 years og age with ADHD and receiving methylphenidate medication for at least 2 months.
No baseline information provided to determine comparability between IV and WL group
Wrong intervention
Wrong comparator
Wrong patient population
Wrong study design
Wrong study design
Wrong study design
Wrong patient population
Wrong intervention
Wrong intervention
Study protocol without data
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong intervention
Wrong study design
Wrong study design
Wrong study design
Wrong patient population
Wrong study design
Wrong indication
Conference abstract
Conference abstract
Wrong study design
Wrong intervention
Wrong study design
Wrong patient population
Wrong study design
Wrong study design
Wrong study design
Wrong patient population
Wrong indication
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong patient population
Wrong patient population
Wrong study design
Wrong intervention
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
The randomization was stratified by age (3 or 4 years old) and gender. Block randomization to the three treatment conditions (NFPP, HNC, WL) was in a ratio (2:2:1) and was carried out in blocks of random sizes (5 or 10). The randomization assignment was computer generated and automatically linked to a subject when the subject’s data for eligibility were entered into the database and it was established that s/he met the study entry criteria. The randomization sequence was generated by the research organization responsible for data management.
They completed pre-intervention assessment and gave written informed consent prior to being randomly allo- cated into either the intervention group (Triple P) or control group. There were eight and nine participants in the interven- tion and control groups, respectively. The randomisation was conducted by a research assistant who was not involved in this project.
Method not described. Participants in this study were 87 families that had previously been randomly assigned to one of three treatment groups, EBFI, SBFI, or a WL control group
Participating families were randomly assigned to either an enhancement group (EG; n = 51) or a CG (n = 52; see Figure 1). The randomization process was carried out using computerized block-randomization (blocks of four families)
Sequence generation not described in details
Quote: "After eligibility was determined and parent written consent was obtained, families were randomly assigned to participate in the F2F program (n = 16), participate in the online program (n = 15), or be placed in the WLC group (n = 16) to receive the online program at the conclusion of 15 weeks, after posttreatment assessment phase."
Quote: "After T1 assessment, families were randomly allocated to the intervention or delayed intervention group." Sequence generation not described in details
After the pretest session, children were randomly assigned to one of two groups (PT and WL). Each child was matched with another child based on gender and hyperactivity severity. The second author used an online random number generator to assign one member of the pair to the PT group. If there were an odd number of children, a trio was formed, and 2 of the 3 children were randomly assigned to the PT group.
Participants were randomly assigned (1:1) to NFPP and TAU following T1 assessment.Randomization was conducted in blocks of four or six and in 12 strata defined by center, genderand age (3-5 and 6-7 year) using a web-based and logged randomization service within Trialpartner Participants were randomly assigned (1:1) to NFPP and TAU following T1 assessment.Randomization was conducted in blocks of four or six and in 12 strata defined by center, genderand age (3-5 and 6-7 year) using a web-based and logged randomization service within Trialpartner
Randomisation was carried out on a 2:1 basis by an independent statistician using a computer-generated random number sequence. This allowed for the inclusion of a larger interventiongroup (i.e. PT + CT or PT), which is ethically desirable in evaluations within a communitysetting, whilst also ensuring that fewer people were placed on a waiting list. The unit ofrandomisation was the parent–child dyad and participants were block randomised byarea to ensure that parents attended the programme in their locality.
Quote: "Of these, 32 cases were randomized to either PCIT (n Œ 20) or the WL (n Œ 12) conditions."
Quote: "Following this module, recruited families were organized in six groups of five. In each of these groups, three families were randomly assigned to the PCIT and two to the WL group. The last group only had two families that were randomly assigned to the PCIT."
Quote: "After the pretreatment assessment, each family participated in a two-session psy- choeducational module about ADHD and its relationship with behavior problems, associated difficulties, risks and protective factors, possible etiologies, and treatment options. Following this module, recruited families were organized in six groups of five. In each of these groups, three families were randomly assigned to the PCIT and two to the WL group. The last group only had two families that were randomly assigned to the PCIT. Because of the pilot nature of this study, we opted for a randomization allocation of 3:2 because of budget and ethical considerations."
Computergenerated randomization
Quote: "Children were randomized to CLAS (36 at site 1 and 38 at site 2), PFT (36 at site 1 and 38 at site 2), or TAU (24 at site 1 and 27 at site 2)."
Judgement Comment: Insufficient information - 'Children were randomized to CLAS' p 6 Sequence generation not described
Quote: "they were randomized to immediate treatment or waitlist control groups by the first author using a simple random number generator."
Not sufficient information. The present trial used a randomized, controlled design. Children who met the inclusion criteria were randomly assigned to either PT (n = 30), PC&S (n = 28), or a waiting-list control group (WLC; n = 20).
Quote: "After all baseline (T1) measures were completed, participants were block randomised into study arms by the Southampton Clinical Trials Unit using the TENALEA [see www. tenalea.com] system [3 (NFPP): 3 (IY): 1 (TAU) ratio] to ensure power for the comparison of the two treatment arms. Stratification was by site and tranche."
Participants were randomized (using random number tables) to receive either the revised NFPP (N = 21) or TAU (N = 20) condition.
Quote: "Sixty children who met the inclusion criteria for the trial were randomized using the online Random Sequence Generator (www.random.org on 01.06.2013)."
Subjects were randomly assigned (randomized block design) to one of two treatment arms: 5 months of BPT (12 sessions in group format) plus uncontrolled RCC provided by a child and adolescent psychiatrist (n = 47) or 5 months of uncontrolled RCC alone (n = 47).
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Block randomization to the three treatment conditions (NFPP, HNC, WL) was in a ratio (2:2:1) and was carried out in blocks of random sizes (5 or 10). The randomization assignment was computer generated and automatically linked to a subject when the subject’s data for eligibilitywere entered into the database and it was established that s/he met the study entry criteria.
No information on allocation concealment
No information provided
No information provided
No information provided
No information provided
No information provided
Research assistants were masked to treatment allocation and located separately to avoid contamination
An administrator subsequently informed participants of their treatment allocation. While the administratorwas also a researcher on the study, all other researchers were unaware of group allocation and parents were asked not to inform researchers at follow-up assessment as to their allocated group to minimise potential basis (where possible).
No information provided
Containing a letter stating either the randomization outcome active home treatment (but not which treatment) or waiting list. Parents who were randomized to our home-based parent training or to the care-as-usual treatment were not explicitly informed about the nature of the allocated home-based treatment. Furthermore, no information about the differences between the treatments was publicized on a website and the thera- pists who performed the care-as-usual treatment were not informed about the content of the other home-based treat- ment. Moreover, when parents had questions about the randomization and the other treatment, all therapists were instructed not to answer the question, but to refer to the research team. The flow of subjects from initial recruitment through the final analysis is presented in Fig. 1. Table 1 contains child and family characteristics.
No information provided to determine allocation concealment
No information provided
No information provided
Parents and therapists were not blinded to treatment allocation. However, to protect blinding for all other members of the team including statisticians and researchers collecting and coding direct observations, only site PIs and designated administrative staff liaised with the trials unit and participants, with regard to allocation. Families were informed of the need to maintain blindness. This meant that researchers who collected outcome measures at T2 and T3 (see below) were, as far as possible, blind to treatment allocation. Teachers were also potentially blind to allocation. The coding of the observation data (which was videoed) was done by a researcher who had not met the family and was unaware of the group allocation.
No allocation concealment procedures reported
No information provided
No information on allocation concealment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
No blinding possible for this kind of intervention
Insufficient information on blinding of participants and personnel
No blinding possible
Blinding not possible
No blinding possible
Not possible to blind intervention group and personnel
No blinding possible
Trial participants could not be masked. Parents were asked not to reveal treatment status of their children to teachers
Participants were aware of allocation. However, all other researchers were unaware of group allocation
Not possible to blind intervention group
No blinding possible
Not possible to blind participants
Personnel are not blinded and not possible to blind intervention group. Four treatment groups were run by the same two female therapists, native Japanese speakers with graduate degrees in psychology. The principal therapist completed the standard NFPP training programme in English in the UK. During the course of the RCT she participated in regular supervision with two of the NFPP developers. The second therapist was trained and supervised by the principal therapist.
Insufficient information, but IVs PT/PCS are described so blinding of both participants and personal seems not possible
Parents and therapists were not blinded to treatment allocation
Every effort was made to keep the assessing psychologist blind to the treatment status of the children. The therapists and the families were told not to discuss their treatment status with the psychologist. The psychologist was not aware of the therapy content delivered to the families and worked in a different part of the building from the therapists. The videos were coded after collection at a later time. The psychologist collecting the data coded it from only T1 sessions, T2 and T3 sessions were recorded by independent observers. Measures of interrater reliability were calculated on the basis of 31% of tapes across all time points by two independent raters blind to treatment status.
Not possible to blind
Participants and those delivering intervention cannot be blinded.
Detection bias due to knowledge of the allocated interventions by outcome assessors
High for parents as blinding is not possible
Insufficient information on blinding of outcome assessors
No blinding possible
Blinding not possible
Self-reported outcomes
Self-reported outcomes
No blinding possible
Self-reported outcomes, blinding not possible
Parent-reported outcomes. Blinding not possible
Self-reported measurements, no blinding possible
Parent reported outcomes. No blinding possible
Self-reported measurements. No blinding possible
Some outcomes are self-reported.
No blinding possible
Parent reported outcomes - blinding not possible
No blinding of parents possible
Self-reported outcomes
Parent reported outcome measures
Attrition bias due to amount, nature or handling of incomplete outcome data
No serious dropout rates and authors perform ITT analyses
No major dropouts
Drop out rates are 42% (EBFI), 27% (SBFI) og 15% (control, WL). So for IV groups a relative high drop out
Both intention-to-treat and per-protocol analyses were conducted, the intention-to-treat analyses forming the primary analytic approach. The intention-to-treat sample consisted of all families which had been randomized. For" Quote: "Missing values for dosages at postassessment were replaced using the EM procedure with dosages at baseline and available information on dosages at postassessment as predictors (intention-to-treat sample: 17 cases with missing values in the EG and 16 cases with missing values in the CG; per-protocol sample: two cases with missing values in the EG and five cases with missing values in the CG)." Judgement Comment: Missing data have been imputed using appropiate methods.However, there were a higher rate of non-completers in the intervention group (18 versus 11)
Some dropouts in each group, with different reason
At post-intervention (T2), five families did not complete all questionnaires. Of these five families, two could not be contacted, one family was too busy, one mother suffered a prolonged illness, and one family in the delayed intervention group started another parenting program. At 6-month follow-up (T3), another three families failed to complete the questionnaires, two of whom could not be contacted and one family was too busy. They perform ITT analyses
Using an intent-to-treat approach, pretest data were carried forward for missing posttest data, and posttest data were carried backward for missing pretest data. All 17 PT mothers completed posttest measures. One WL mother could not be reached to complete posttest data. One mother who partici- pated in the PT group completed posttest but was missing some pretest measures. Eleven PT mothers and 10 WL mothers had complete audiotape data at posttest (missing data was due to a combination of parents forgetting to complete the recording and technical failure of tapes). One PT mother com- pleted posttest but not pretest taping. Twelve PT fathers completed pretest or posttest measures. Two fathers completed pretest but not posttest, and one father completed posttest but not pretest.
Allocation, drop out and fidelity <b>In total,164 participants were randomized (Fig 1). Outcome measures were completed by mothers (n=139), fathers (n=15) and foster parents/other (n=9). Eighty-eight families were randomized to NFPP, and 83 completed all 8 sessions. (mean no. of hours/family = 12.07). Sessions were attended by both parents (58.8%), mother (29.5%), father (4.5%) (see Table S10, available online). Content fidelity was 95.3% (range: 83-100%). Seventy-six families were randomized to TAU (mean no. hours/family=8.8 hours). Patient records showed that 20 of these families did not receive any treatment between T1 & T3. Forty-six families attended parent groups and 32 families attended individual sessions instead of or in addition to group intervention across</b> the three sites. FIG 1.
Per-protocol analysis was not conducted as only three participants were lost to follow-up, no account of why participants were lost
Of these, 32 cases were randomized to either PCIT (n Œ 20) or the WL (n Œ 12) conditions. Only one case dropped out immediately from the PCIT; 19 families completed posttreatment measures and 17 the follow-up assessment. Nine fathers from the PCIT attended treatment sessions. All mothers from the WL completed the assessment after a 3.5-month waiting period. See Figure 1. No account of why the participant dropped out or why post assessment was not collected for 3 out of 20 participants 1 family started medication in the invention group but were included in analysis.
The Medical Ethical Committee of the University Medical Center in Groningen provided ethical approval for the study (METC nr 2010.289). The trial has been registered at https ://www.trial regis ter.nl: Home-based behavioral treatment for ADHD; NTR3021.
Results <b>1.41% of data were missing at baseline, 3.78% of data were missing at post-treatment, and 7.87% of values were missing at follow-up. Missing values appeared to be related to attrition. Prior to post-assessment, four families discontinued their participation, and prior to follow-up, eight families ended their involvement.</b> Mean scale substitution was used.
Fifty-two mothers met inclusion criteria and agreed to participate in the study. Twenty-eight mothers were ran- domly assigned to the immediate treatment group and 24 to the wait-list control group. All mothers assigned to the treatment group participated in the intervention. In the control group, three mothers withdrew, two after complet- ing the pre-treatment questionnaires (one reported being too busy to participate, the other moved away from the area), another mother participated in the laboratory assessments but did not return the pre-treatment questionnaires and subsequently withdrew from the study. Reason for dropout and numbers are not balanced between groups.
Intention to treat was the basis for the inclusion of cases in the analysis. Attrition was low (seven children withdrew during the trial). Dropout was usually for personal or domestic reasons rather than dissatisfaction with treatment. Children whose parents dropped out were no different from those who remained in the program on any of the T 1 measures. Dropouts were handled in the most statistically conservative manner by replacing their scores at T 2 and T 3 with val- ues representing the poorest outcome for participants in their partic- ular condition. This approach to dropouts avoided overestimating potential effects of therapies on noncompleters while strengthening the study through an intention-to-treat analysis.
ITT analyses - Drop out 1 of 134 reported for intervention group
Ten families did not complete T2 assessments—four in NFPP including two that did not complete the intervention and six TAU families. Nine families did not complete T3 measures—two NFPP and seven TAU families. Two NFFP participants not assessed at T2 were assessed at T3. This meant that T1 to T3 data were unavailable for 11 children (four treatment and seven controls). Table 1 reports the child and parent symptom profiles of those children who remained in the study throughout and those that dropped out or did not have measures at all three time points. Drop outs had more severe ADHD as measured by both clinical interview and parent completed questionnaire. They were similar in other respects. It appears that the dropout families had children with more severe ADHD symptoms, compared to the completing families
7 Dropouts in intervention and 5 in control group. Unbalanced numbers of discontinuation. Drop-out rates 23 og 16 % respectively. No reasons provided.
Only two drop outs, one in each group
Reporting bias due to selective outcome reporting
Trial registry: Home-Based Parent Training in ADHD Preschoolers; Registration ID, ClinicalTrials.gov Identifier: NCT01320098; URL: http://www/clinicaltrials.gov/ct2/show/NCT01320098
No information to determine whether selective outcome reporting
All relevant outcomes apppear reported
The RCT was registered at ClinicalTrials.gov (identifier: NCT01660425; URL: https://clinicaltrials.gov/ct2/show/ NCT01660425) and approved by the Medical Ethical Committee of the University Hospital of Cologne, Germany
No protocol registration, but all relevant outcomes appear reported
Quote: "ACTRN12613000480785)."
Quote: "Ethics approval was obtained, and the trial was registered on the Australian New Zealand Clinical Trials Registry (ANZCTR; registration code: ACTRN12613000480785)."
Judgement Comment: A decrease in hyperactive/ inattentive child behaviour.- Measured by the Conners Early Childhood Behaviour questionnaire (Conners EC-BEH) Inattention/ Hyperactivity subscale, completed by the primary caregiver.Timepoint [1]Pre-intervention, post-intervention and at 6-month follow-up (i.e. 6 months after completion of treatment).Primary outcome [2]A decrease in hyperactive/ inattentive child behaviour.- Measured by the Conners EC-BEH short form Inattention/ Hyperactivity subscale, completed by the secondary caregiver.Timepoint [2]Pre-intervention, post-intervention and at 6-month follow-up (i.e. 6 months after completion of treatment).Secondary outcome [1]Reduction of less optimal parenting practices as measured by the Parenting Scale (PS).Timepoint [1]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [2]Increase in self-reported authoritative parenting as measured by the Parenting Styles and Dimensions Questionnaires (PSDQ) authoritative parenting scale.Timepoint [2]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [3]Increase in parent satisfaction and efficacy. Measured by the Parenting Sense of Competence Scale (PSOC).Timepoint [3]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [4]Decrease in symptoms of depression, anxiety and stress reported by parents. Measured by the Depression Anxiety Stress Scales (DASS-21).Timepoint [4]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [5]A decrease in teacher reported hyperactive/ inattentive child behaviour.- Measured by the Strengths and Difficulties Questionnaire-Hyperactivity scale (SDQ).Timepoint [5]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [6]An improvement in the child's social functioning measured by preschool teacher ratings on the Child Behaviour Scale (CBS).Timepoint [6]Pre-intervention, post-intervention, and at 6-month follow-up.Secondary outcome [7]Client satisfaction as measured by the Client Satisfaction Questionnaire, completed by the primary caregiver.Timepoint [7]6-month follow-up.
Not clear. Pretests indicate that both mothers and fathers are assigned IV and WL, but analyses present data from mothers only
Quote: "3 <b>ClinicalTrial.gov identity no: NCT01684644. A Controlled Study of Parent Training in the Treatment of ADHD in Young Children (D’SNAPP)</b> Introduction Behavioral parent training (PT)"
Quote: "ISRCTN82596506."
Report outcome as presented in protocol
Not referring to a protocol registration, but seems to report on relevant outcomes
Quote: "tains child and family characteristics. <b>The Medical Ethical Committee of the University Medi- cal Center in Groningen provided ethical approval for the study (METC nr 2010.289). The trial has been registered at https ://www.trial regis ter.nl: Home-based behavioral treat- ment for ADHD; NTR3021. Because of the slow recruit- ment, we changed from a single-center to a multi-center</b> studies. Measures The primary outcome"
It is not clear if this is posthoc analyse. Not referring to a protocol.Study refers to a previous study by Pfiffner 2014! Dropouts at baseline: 1,41% However 7.87 % of data values were missing at FU
This study was approved by the Okinawa Institute of Science and Technology (OIST) Graduate University, Japan Human Subjects Research Review Committee. However, no reference to study protocol.
No information to clarify selective outcome reporting. No trial registration, but all relevant outcomes appear to be reported
No protocol but all relevant outcomes appear reported
No trial protocol, but all relevant data seem to be reported
Not referring to a protocol, but report on relevant outcomes
All outcomes prospectively stated have been reported. However, Authors collected data from both parents separately but stated that: "In this study we analyzed the data from the mothers" (p 1266).
Bias due to problems not covered elsewhere in the table
Study seems free of other types of bias
The study appears to be free of other sources of bias
Study seems free of other sources of bias
The study appears to be free of other sources of bias
"Range of intervention targets. FUNDING <b>The research reported here was supported by the Institute of Education Sciences, U.S. Department of Education, through Grant R324A120284 to Lehigh University. The opinions expressed are those of the authors and do not represent views of the Institute or the U.S. Department of Education.</b> REFERENCES Abidin, R. R. (1995)."
The study seems free of other types of bias
The study seems from other sources of bias.
Study seems free of other sources of bias
Study appears to be free of other types of bias
The study seems free of other sources of bias.Note1. One child, aged 2.9 years, was slightly outside of the eligibility criteria but was included in the study.Disclosure Statement No potential conflict of interest was reported by the authors.
Quote: "This research was supported by NIH Research Grant 5R24-MH-49368-12 funded by the National Institute of Mental Health and by the Division of Mental Disorders, Behavioral Research & Aids to Guillermo Bernal. The content is solely the responsibility of the authors and does not represent the official views of the NIMH or the National Institute of Health. The research also received support from the Institutional Funds for Research from the Dean of Graduate Studies and Research at the University of Puerto Rico, Rio Piedras Campus."
The study seems to be free of other types of bias
Judgement Comment: No other apparent bias
This work was supported by the National Institute of Mental Health (grant MH077671; Principal Investigators: Linda J. Pfiffner, contact P.I., and Stephen P. Hinshaw). The study seems free from other sources of bias.
Quote: "K.L. and G.T. have no interests to declare. S.S. has received a speaker fee from Shire. D.D. received fees from Eli Lilly, non-financial support from Eli Lilly, grants from Shire, personal fees from Shire, non-financial support from Shire, fees from Medice, non- financial support from HBPharma and royalties from the sale of the new Forest Parent Training Programme Self Help book. M.T. has received recent funding from Shire, a speaker fee from Jansen-Cilag, fees from training and supervision of the New Forest Parenting Programme and royalties from the sale of the new Forest Parent Training Programme Self Help book. C.L.-B. has received speaker fees from Janssen-Cilag and Shire, fees from training and supervision of the New Forest Parenting Programme and royalties from the sale of the New Forest Parent Training Programme Self Help book." The study appears to be free of other sources of bias
The study appears to be free of other sources of bias
The study appears to be free of other sources of bias
The study appears to be free of other sources of bias
Quote: " <b>Disclosure statement No potential conflict of interest was reported by the authors.</b> ORCID Özyurt Gonka http://orcid.org/0000-0002-0508-0594 Akay"
The study appears to be free from other sources of bias
Study appears to be free from other sources of bias.