[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Overall
Included criteria: Inclusion criteria were:(1) confirmed ADHD diagnosis, (2) enrollment in grades 2 through 5, and (3) IQ ≥ 85.
Excluded criteria: Exclusion criteria were: (1) severe comorbid disorder (ODD, ASD, or depression), (2) history ofseizures, (3) IQ ≤ 85, (4) disability that would affect ability to use a computer, (5) illnesses thatrequired immediate treatment.
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, forældrebedømt, mean SD, EoT
Sponsorship source: This work received no external funding
Country: Iran
Authors name: Morteza Nazifi
Institution: Department of Psychology, University of Bojnord
Email: Nazifi90@yahoo.com
Address: Department of Psychology, University of Bojnord, Bojnord, 9453155111, Iran.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Overall
Included criteria: Patient recruitment was carried out from cases that con-sulted at the Child and Adolescent Psychiatric Unit from the University Hospital Mútua Terrassa from June 2010 to March 2012. A total of 66 outpatients participated in the study. All were diagnosed of combined-type ADHD accord-ing to the DSM-IV-TR criteria. Comorbidity with other disruptive behaviour disorders was accepted (i.e. opposi-tional defiant disorder or conduct disorder) according to the DSM-IV-TR criteria. All diagnoses were confirmed using the semi-structured Kiddie-Schedule for Affective Disorders and Schizophrenia, Present and Lifetime Ver-sion (K-SADS-PL) [37] interview that was administered to participants’ parents. Other inclusion criteria included age between 7 and 12years; T scores on the Conners ADHD index for parents and teachers >70 at the time of diagnosis; no previous psychological or pharmacological treatment for ADHD; and access to a personal computer with Internet connection
Excluded criteria: Exclusion criteria included IQ80; comor-bidity with autism spectrum disorder, psychosis, affective or anxiety disorder, consumption of toxic substances, or learning disorder; history of traumatic brain injury in the last 2years; and perceptual-motor alterations that would preclude the use of a computer. Participants whose educa-tional or socio-economic context would make it unlikely for families to comply with the study requirements and fol-low the treatment procedure (subjects whose families did not speak Spanish or were monitored by social services due to suspected abuse/neglect) were also excluded from the study. Furthermore, children who participated in fewer than 20 training sessions were excluded from the posterior data analysis, as were those who initiated other pharmacological or psychological treatments during study participation
Pretreatment: None
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, forældrebedømt, mean SD, EoT
ADHD kernesymptomer, lærerbedømt, mean SD, EoT
Adfærdsforstyrrelser, forældrebedømt, mean SD, EoT
Adfærdsforstyrrrelser, lærerbedømt, mean SD, EoT
Sponsorship source: This study has received financial support through the Award 22è PREMI FER-RAN SALSAS I ROIG—Salut Mental i Comunitat granted by the City Council of Rubi (Spain) in 2010.
Country: Spain
Setting: Home
Authors name: Aitana Bigorra
Institution: Programa de Doctorat de Psiquiatria, Universitat Autònoma de Barcelona, Barcelona, Spain
Email: abigorra@mutuaterrassa.es
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Participants who fulfilled the fol-lowing criteria were included: (1) a clinical diagnosis ofhyperkinetic disorder (F90.0, corresponding to ADHD com-bined type) (47); (2) age between 14–17 years; and (3) IQ>80.
Excluded criteria: The exclusion criteria were: (1) pharmacological treat-ment other than methylphenidate, dexamphetamine, and/oratomoxetine; (2) comorbid conduct disorder, autism spec-trum disorders, or major depression; (3) history of headtrauma or verified neurological disease; (4) motor or percep-tual disabilities which prevented the use of a computer; (5)medical illness that required treatment; and (6) no access toa computer and internet at home.
Pretreatment: RVP probability of hit (attention)
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, forældrebedømt, mean SD, EoT
ADHD kernesymptomer, lærerbedømt, mean SD, EoT
Sponsorship source: This trial has been supported by a grant from the Region of SouthernDenmark Psychiatry Research foundation (nr. 7/6/2010).
Country: Denmark
Setting: Psychiatry, University
Comments:
Authors name: Aida Bikic
Institution: Department for Child and Adolescent Psychiatry
Email: aida.bikic@rsyd.dk
Address: Kresten Phillipsens Vej 15, 6200 Aabenraa, Denmark
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Overall
Included criteria: Inclusion criteriaincluded: 1) children between the ages of 7–11 years; 2) a diagnosis of ADHD throughconsensus diagnosis based on parent and teacher ratings on the Disruptive BehaviorDisorder Rating Scales (DBD; Pelham, Gnangy, Greenslade, Milich, 1992) andimpairment using the Impairment Rating Scale (Fabiano et al., 2006); and a semi-structuredinterview with the parent using the Kiddie-SADS (Kaufman et al., 1997); 3) fluency inEnglish (parent and child), and; 4) internet access at home.
Excluded criteria: Children were excluded if 1) there was evidence of a pervasive developmental disorder based on previous diagnosis and/or elevated sores on the Child Autism Rating Scale (Schopler, Reichler, Renner, 1988) rated by the evaluator at intake, or psychosis; 2) the child or parent presented withemergency psychiatric needs that required immediate services (e.g., suicidal or homicidalintent), and; 3) if the child had an estimated Full Scale IQ below 80 based on two subtests ofthe Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler et al. 1999).
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, forældrebedømt, mean SD, EoT
ADHD kernesymptomer, lærerbedømt, mean SD, EoT
Sponsorship source: Funding for this project was provided through Award Number R34MH088845 from the National Institute ofMental Health.
Country: USA
Setting:
Comments:
Authors name: Anil Chacko
Institution: Queens College, City University of New York
Email: chacko@qc.cuny.edu
Address: 65-30 Kissena Blvd., Flushing NY 11367
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Overall
Included criteria: Eligibility criteria.Eligible participants were all children aged 8 to 12 years with (a) aprior DSM-IV-TR [52] diagnosis of ADHD combined-type and absence of any autism spectrum disorder according to a child psychologist or psychiatrist, (b) a score within the clinicalrange (95thto 100thpercentile) on the ADHD scales of both the parent and teacher version ofthe Disruptive Behavior Disorder Rating Scale (DBDRS [53]; Dutch translation: [54]), (c)meeting criteria for ADHD combined-type on the ADHD section of the Diagnostic InterviewSchedule for Children, parent version (PDISC-IV [55]). The PDISC-IV is a structured diagnos-tic interview based on the DSM-IV, with adequate psychometric properties, (d) absence of conduct disorder (CD) based on the CD sections of the PDISC-IV, (e) an IQ score80 establishedby the short version of the Dutch Wechsler Intelligence Scale for Children (WISC-III; [56]).Two subtests, Vocabulary and Block Design, were administered to estimate Full Scale IQ(FSIQ). This composite score has satisfactory reliability and correlates highly with FSIQ [57],(f) absence of any neurological disorder, sensory (color blindness, vision) or motor impairmentas stated by the parents, (g) not taking any medication other than Methylphenidate or Dextro-amphetamine. Participants discontinued their Methylphenidate at least 24 hours before eachtest-session, allowing a complete wash-out [58]. Participants taking Dextroamphetamine dis-continued medication 48 hours before each test-session [59], finally, (h) parents had to agreeto keep the dose of ADHD medication stable between the intake and the 3-months follow-upsession, and had to consent not to initiate or participate in other psychosocial treatments.
Excluded criteria: not reported
Pretreatment: None
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, forældrebedømt, mean SD, EoT
ADHD kernesymptomer, lærerbedømt, mean SD, EoT
Livskvalitet
Adfærdsforstyrrelser, forældrebedømt, mean SD, EoT
Adfærdsforstyrrrelser, lærerbedømt, mean SD, EoT
Sponsorship source: Funding:The authors have no support or funding toreport.
Country: Netherlands
Setting: mental-healthcare centers/home-based
Comments:
Authors name: Sebastiaan Dovis
Institution: 1Department of Developmental Psychology, University of Amsterdam, Amsterdam, The Netherlands,2Addiction, Development, and Psychopathology (Adapt) Lab, Department of Psychology, University ofAmsterdam, Amsterdam, The Netherlands,3Cognitive Science Center A
Email: S.Dovis@uva.nl
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: All participant were diagnosed with AD/HD of the combined type by a psychologist in accordance to DSM-IV
Excluded criteria: Participants with clinical significant comorbid disorder were excluded. Participants were excluded if they were known to suffer from epileptic seizures, serious head-injuries, periods of unconciousness or co-morbid learning, behavioral and psychiatric disorders
Intervention Characteristics
Intervention 1
Control
ADHD core symptom, parent rating SE
Sponsorship source: The research was supported by a small internal grant from the university of Wollongong.
Country: Australia
Setting:
Comments:
Authors name: Stuart J. Johnstone
Institution: Brain and behaviour Research Institute and School of Psychology
Email: sjohnsto@uow.edu.au
Address: Wollongong, NSW 2522, Australia
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: All participants were required to be free of hearing or vision problems, have not previously experienced epileptic seizures, serious head injuries or periods of unconsciousness and show a normal-range IQ and spelling ability. AD/HD participants required a professional diagnosis of AD/HD (any subtype)
Excluded criteria: Participants were excluded if they previously have shown evidence of psychiatric, behavioural or learning problems, as reported by their parents.
Pretreatment: Of the 60 children included, 8 were not on any medication, 26 were taking Concerta, 21 taking Ritalin, 3 taking dexamphetamine and 3 taking Strattera
Intervention Characteristics
Intervention 1
Intervention 2
Control
ADHD core symptoms, parent rating, SD
Sponsorship source: The research was supported in part by NeuroCog soluations Pty Ltd (Australia)
Country: Australia
Setting: not stated
Comments: none
Authors name: Stuart J. Johnstone
Institution: School of Psychology, University of Wollongong
Email: sjohnsto@uow.edu.au
Address: Wollongog, NSW 2522, Australia
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: 1) diagnosis of ADHD of either combined or predominantly inattentive subtype 2) age between 7 and 12 years 3) access to a personal computer with an internet connection at home or in school
Excluded criteria: 1) being treated with stimulants, atomoxetine, neuroleptic or any other psychoactive drug 2) fulfilling criteria for diagnosis of clinical significant oppositional defiant disorder, autistic syndrome, Aspergers syndrome or depression 3) history of seizures during the past 2 years 4) IQ 80 5) motor or perceptial handikap that would prevent the usage of a computer program 6) educational level and socioeconomic situation that made it unlikely that the familiy would be able to follow the treatment procedure and study requirements 7) medial illness requiring immediate treatment
Pretreatment: No differences
Intervention Characteristics
Intervention 1
Control
ADHD core symptom, parent rating, SD
ADHD core symptom, teacher rating, SD
Sponsorship source: Drs. Forssberg and Klingberg and Ms Westerberg own stock in Cogmed. Ms. Olesen had a consultancy agreement with Cogmed.
Country: Sweden
Setting: Personal computer in home or school
Comments:
Authors name: Torkel Klingberg
Institution: Unit of Neuropediatrics, Department of Women and Children´s Health, Astrid Lindgren´s Children´s hospital
Email: torkel.klingberg@kbh.ki.se
Address: Unit of Neuropediatrics, Department of Women and Children's Health, Astrid Lindgren's Children's Hospital, Q2:07, Karolinska Institute, 171 76 Stockholm, Sweden
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: All whom had been identified by their teacher as having attention difficulties. Children scoring at least 1.0 standard deviations above the sample mean (measured on the Inattentive Scale of the CTRS-R:L) were potentially eligable for the study. For students whom second language were english, wher included if their non-verbal IQ score exceeded 70.
Excluded criteria: Students were excluded if their T-score on the Inattentive Scale was below 60. Student with full scale IQ scores below 70 were excldued due to the likelihood of them becoming frustrated by the training.
Pretreatment: Nothing mentioned
Intervention Characteristics
Intervention 1
Intervention 2
Control
ADHD core symptom, teacher rating, OR
Sponsorship source: This study was supported by Grant R305H050036 from the department of education
Country: USA
Setting: 5 public schools in the southeastern USA
Comments:
Authors name: David L. Rabiner
Institution: Center for Child and Family Policy/Dept. of Psychology Neuroscience, Duke University, Durham, USA
Email: drabiner@duke.edu
Address: Duke university, Durham, NC 27708, USA
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: Participants were diagnosed by a qualified psychiatrist, neurologist or psychologisk according to DSM-IV criteria. Written parental consent was a prerequisite for participation in the study.
Excluded criteria: Not reported
Pretreatment: There was no significant difference between ages and intellegence between the two groups
Intervention Characteristics
Intervention 1
Control
ADHD core symptom, parent rating SEM
Sponsorship source:
Country: UK
Setting:
Comments:
Authors name: Lilach Shalev
Institution: Behavioral brain sciences center, school of psychology
Email: 1.shalev.1@bham.ac.uk
Address: University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: Children were eligible if they had a diagnosis of ADHD confirmed by their psychian and sufficient english ability to complete assessments and intervention protocols. Both boys and girls were eligible, regardless of their subtype of ADHD or medication use.
Excluded criteria: Children were excluded if they had a coexsisting diagnosis of conduct disorder, pervasive developmental disorder or other serious mental illness (eg. psychosis)
Pretreatment: There were no statistically significant preinterventions differences in demographic characteristics across the three groups.
Intervention Characteristics
Intervention 1
Intervention 2
Control
ADHD core symptom, parent rating, SD
ADHD core symptom, teacher rating, SD
Sponsorship source: The study was supported by grants from the Deborah Munroe Noonan Memorial Research Fund and the Newton Schools Foundation
Country: USA
Setting: Hospital/Middle school
Comments:
Authors name: Naomi J. Steiner
Institution: Floating Hospital for Children, Boston, MA, USA
Email: nsteiner@tuftsmedicalcenter.org
Address: Floating Hospital for Children 800, washington street #334, Boston MA 02111, USA
Conference Publication
Wrong outcomes
Conference Publication
Conference Publication
Wrong comparator
Adult population
Conference Publication
Meta-analysis of the already selected studies
Wrong comparator
Conference Publication
Adult population
Wrong comparator
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comments: In Appendix S1: Used online randomization software, to produce random sets of numbers in the four matched subgroups. The subgroups were formed before randomization.
Quote: Participants were enrolled in the study and were randomly assigned to one of the intervention groups by a member of the research team, using a computer-generated sequence. The study group allocation was blinded to chil- dren, their family, their teachers and the professionals who performed the cognitive assessments. In addition, participants, families and teachers were unaware of the difference between the experimental and the control training (i.e. the automatic adjustment of difficulty). The double-blind condition was maintained in all evaluations conducted through- out the study.
Quote: A clinician, unrelated to the trial and blinded to baseline data and participant ID, performed the randomization by selecting the numbers assigned to each participant from an envelope.
Quote: Participants were randomly assigned to treatment condition (CWMT Active= 44; CWMT Placebo= 41; see Figure 1 for CONSORT diagram) by a senior research staff (blind to participant profile) based on a random permutation calculator (http:// www.webcalculator.co.uk/statistics/rpermute3.htm).
Quote: "If inclusion criteria were met, parent and child were invited to the pre-test session and the startup session, and were independently allocated to one of the three treatment conditions using the process of randomization by minimization [82] on the basis of age, gender, IQ, medication-use (yes/no), and parent- and teacher-rated inattention and hyperactivity/impulsivity symptoms (using the 6-months DBDRS)."
Comment: Random allocation was handled by SR (Steven Roodenrys)
Participants were randomly assigned to one of the three conditions. It is unclear how this was done
Comment: A randomized blinded list of numbers associated with the CDs containing the treatment or comparison program was sent out to each clinical center. Randomization was done with blocks of four
Randomization was done within school to ensure a balanced representation of students
Comment: The participants were randomly assigned to either the experimental group or the control group. Not clear how this is done.
Using a computer-generated random digit generator the remaining 41 participants were randomly assigned to one of the two interventions or the waiting list
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: In Appendix S1: Used online randomization software, to produce random sets of numbers in the four matched subgroups. The subgroups were formed before randomization.
Quote: "Participants were enrolled in the study and were randomly assigned to one of the intervention groups by a member of the research team, using a computer-generated sequence."
Quote: "CANTAB. A clinician, unrelated to the trial and blinded to baseline data and participant ID, performed the randomization by selecting the numbers assigned to each participant from an envelope."
Quote: "Participants were randomly assigned to treatment condition (CWMT Active= 44; CWMT Placebo= 41; see Figure 1 for CONSORT diagram) by a senior research staff (blind to participant profile) based on a random permutation calculator (http:// www.webcalculator.co.uk/statistics/rpermute3.htm)."
Quote: "Once a research assistant completed a startup session with a particular family, he/she could not test or have further contact with that family or the teacher (to preserve blinding). During the 5-week, home-based training, a coach (a research assistant blind to the treatment condition) made weekly calls (of about 15 minutes; using a standardized telephone protocol) to the participating families to monitor progress, motivation and compli- ance, and to solve technical and game-related problems. Parents and children were explicitly instructed not to discuss the content of the training tasks with the coach. If a coach did receive information revealing the treatment condition, he/she was replaced and could no longer have contact with the family or the teacher."
Judgement Comment: Random allocation was handled by SR, with all the other researchers, the participants and their parents being blinded.Unclear how this is done unclear if SR could foresee allocation?
Judgement Comment: Nothing stated
Judgement Comment: The CDs were distributed by the testing psychologists to the children in the order they entered the study at each site. Thus the physician, psychologist, parent and child were all blind to child status group until after the follow-up assessment.
Judgement Comment: Randomization was done within school to ensure a balanced representation of students
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: In Appendix S1: The study was not double-blinded, as clinicians were aware of group assignments. Participants, also, were aware that there were three types of treatments in the current study: two types of cognitive training, and stimulant medication intervention.
Quote: "The study group allocation was blinded to children, their family, their teachers and the professionals who performed the cognitive assessments. In addition, participants, families and teachers were unaware of the difference between the experimental and the control training (i.e. the automatic adjustment of difficulty). The double-blind con- dition was maintained in all evaluations conducted through- out the study."
No comments
Quote: "subtests range from .74–.81. Procedure <b>At study intake, parents and children were informed of randomization to one of two computerized programs to target working memory. No information was provided to the parents, children, or teachers regarding the relative benefits of the two programs. As such, these individuals were blind to study group assignment."
Quote: "This was a multicenter (14 sites), double-blind, placebo-controlled, multi-arm parallel-group study conducted in the Netherlands"
Judgement Comment: See prior comment - blinding was kept throughout, and it is plausible that parents and teachers would not know which group was active or placebo.
Judgement Comment: Random allocation was handled by SR, with all the other researchers, the participants and their parents being blinded "... with all other researchers, the participants and their parents being blind to condition membership"
Judgement Comment: Participants and their parents were given a full explanation of the procedure and understood that they may be allocated to a waitlist condition with an opportunity to participate in training after the waitlist period.Nothing was mentioned as to how blinding was obtained.
Judgement Comment: The CDs were distributed by the testing psychologists to the children in the order they entered the study at each site. Thus the physician, psychologist, parent and child were all blind to child status group until after the follow-up assessment
Judgement Comment: Teachers were initiallyblind to students´ condition, but some undoubtedly became aware of who received intervention.
Judgement Comment: Participants were randomly assigned to either the experimental group or the control group, and the group identity was known neither to participants nor to their parents.Unclear if personnel was blinded.
Judgement Comment: Insufficient information on blinding
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: In Appendix S1: The study was not double-blinded, as clinicians were aware of group assignments.
Quote: "The study group allocation was blinded to children, their family, their teachers and the professionals who performed the cognitive assessments. In addition, participants, families and teachers were unaware of the difference between the experimental and the control training (i.e. the automatic adjustment of difficulty). The double-blind condition was maintained in all evaluations conducted throughout the study."
Quote: "This was a randomized, double-blinded trial."
Judgement Comment: Teachers will most likely not know if adolescents are in the active or sham group - may be unbiased
Quote: "All assessments were conducted by research staff who were blind to participant treatment randomization."
Quote: "This was a multicenter (14 sites), double-blind, placebo-controlled, multi-arm parallel-group study conducted in the Netherlands"
Judgement Comment: Random allocation was handled by SR, with all the other researchers, the participants and their parents being blinded "... with all other researchers, the participants and their parents being blind to condition membership"
Judgement Comment: Participants and their parents were given a full explanation of the procedure and understood that they may be allocated to a waitlist condition with an opportunity to participate in training after the waitlist period. Nothing was mentioned as to how blinding was obtained.
Judgement Comment: The CDs were distributed by the testing psychologists to the children in the order they entered the study at each site. Thus the physician, psychologist, parent and child were all blind to child status group until after the follow-up assessment
Judgement Comment: Randomization was done within school to ensure a balanced representation of students. Parents of students randomized to the control condition were offered the opportunity to have their child receive the intervention of their choice the following year. Teachers were initially blind to students condition but some undoubtedly became aware of who received intervention.
Judgement Comment: Insufficcient information of the blinding of outcome assessors
Judgement Comment: Insufficient information on blinding of outcome assessors.
Attrition bias due to amount, nature or handling of incomplete outcome data
Comments: No missing outcome data at EoT
Quote: No significant differences were found between the experimental and control groups with respect to the proportion of dropouts during any study period (Fisher’s exact test: from T0 to T1: χ 2 = 3.65, df = 1, p = 0.08; from T1 to T2: χ 2 = 0.18, df = 1, p = 0.51; from T0 to T2: χ 2 = 2.41, df = 1, p = 0.12). The last participant excluded from the data analysis after participation in the study was excluded due to a diagnosis of pervasive developmental disorder not otherwise specified. Missing values refer to questionnaires that were not completed (T0: 1 WFIRS-P, 1 SDQ-teacher; T1: 1 BRIEF-teacher; T2: 1 BRIEF-parent, 1 SDQ-parent, 4</b> BRIEF-teacher, 2 Conners-teacher, 5 TRF).
Quote: The participant who dropped out of the trial was excluded from the statistical analysis.
Quote: "An Intent-To-Treat (ITT) approach was used to compare treatment effects of the two treatment conditions. Mixed effects regression was used"
Comment: Missing outcome data was balanced across intervention groups
Comment: 20 were randomly allocated - and 18 completed training" "4 removed from low intensity and three in high.. " - No itt. Unclear how many was withdrawn from the analysis
Comment: Only data was obtained from the children completing the 25 sessions. 151 completed the initial training sessions with 23 participants not completing more than 15 of the requested 25 trials.
Comment: Only children from the intervention group withdrew: two because of computer problems and one because of social problems.
Comment: Twenty students were excluded from further participation because their T-score on the DSM-IV inattentive scale was below 60. Analysis accounted for missing data (assuming missing at random)
Comment: Insufficient information
Comment: imbalance in numbers and reason for missing data across intervention groups (figure 1)
Reporting bias due to selective outcome reporting
Quote: "registered in ClinicalTrials.gov (Identifier: NCT01675804;"
Quote: "This study is registered as ISRCTN00767728 (www.controlled-trials. com)."
Judgement Comment: Retrospectively registered in clinical trials- selective outcome reporting unclear
Judgement Comment: No reference to study protocol.
Quote: "http://clinicaltrials.gov/ct2/show/NCT01137318)."
Quote: "This was a multicenter (14 sites), double-blind, placebo-controlled, multi-arm parallel-group study conducted in the Netherlands (trial register: http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=2728; registry name: improving executive functioning in children with ADHD: training executive functions within the context of a computer game; registry number: NTR2728). No important changes to methods were made after trial commencement (the trial started April 2011 and ended January 2013). The protocol for this trial and CONSORT check- list are available as S1 Protocol and S1 CONSORT Checklist.."
Judgement Comment: The research protocol was approved by ethics committee.
No comments
Judgement Comment: No reference to protocol. Do not refer to non-compliers analysis in statistical methods. Method description on collecting information on adverse events was not described.
Judgement Comment: No reference to protocol.cannot find the statistical method description (analysis of missing data described in result section).
Judgement Comment: No reference to study protocol.Statistical methods incoorporated in results section.
Judgement Comment: There were 3 participants in the neurofeedback group and 2 in the SCF group who where excluded. Not explained why. No reference to study protocol, but include expected outcomes.
Bias due to problems not covered elsewhere in the table
Quote: "This work received no external funding. All authors have sub- stantially contributed to this research. The authors have declared that they have no competing or potential conflicts of interest."
Quote: "Acknowledgments Maribel Ahuir, Llanos Artigao, Clara Barba, Andrea Bracho, Bernat Carreras, Noemi Carrillo, Marta Doñate, Cristina Enero, Alejandra Escura, Adrian Gaitan, Javi Sanchez, Pablo Vidal-Ribas, Maria Teresa Ordeig, Sylva-Astrik Torossian. This study has received financial support through the Award 22è PREMI FER- RAN SALSAS I ROIG—Salut Mental i Comunitat granted by the City Council of Rubi (Spain) in 2010."
Quote: "Disclosure statement Torben Østergaard Christensen holds the license for the Danish version of Scientific Brain Training (SBT), now referred to as Happy Neuron Pro. The other authors report no conflicts of interest. Funding This trial has been supported by a grant from the Region of Southern Denmark Psychiatry Research foundation (nr. 7/6/2010)."
Quote: "Funding for this project was provided through Award Number R34MH088845 from the National Institute of Mental Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health."
Quote: "Funding: The authors have no support or funding to report. Competing Interests: P.J.M.P. is member of Stichting Gaming & Training, a nonprofit organization that facilitates the development and implementation of ‘‘Braingame Brian.’’; S.v.d.O. has been a paid consultant for Janssen Pharmaceuticals with regard to ‘‘Healseeker,’’ a serious game for cognitive function"
No comments
No comments
Judgement Comment: Conflict of interest described.Funding source not described.
Judgement Comment: The role of the funding source has not been stated.Potential conflict of interest has not been described.The study seems otherwise free of other sources of bias.
Judgement Comment: Appears to be free of other sources of bias.No reference to conflict of interest and funding source.
Judgement Comment: No reporting on conflict of interest or role of funding source, but appears free of other sources of bias.