ADHDNCT03502239
Cognitive Rehabilitation (Mega Team) and Its Effects on Emotional and Behavioral Regulation in ADHD, ASD, and CHD
A study testing Mega Team - video game in people with ADHD and ASD, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Children with disorders that impact neurodevelopment often have difficulties with executive functions and regulating emotions. Cognitive-based video game training has been shown to improve outcomes, however, this training has been expensive, has required professional supervision, and has been investigated only within… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, ASD, CHD - Congenital Heart Disease
- What is being tested?
- Mega Team - video game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2018to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sub-Study 1 Inclusion Criteria
- Must be 6-12 years of age
- Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent.
- Diagnosed with ADHD based upon DSM 5 criteria by a referring clinician confirmed by semi structured interview with the parents using PICS, including information from parent and teacher ratings of an established measure of ADHD symptoms.
- Does not have a diagnosis of ASD or CHD [in this case, individuals can be enrolled into Study 2 (ASD) or Study 3 (CHD)].
- Have reliable access to the internet
Show all 17Show fewer
- Sub-Study 2 inclusion criteria
- Must be 6-12 years of age
- Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
- Meets clinical diagnosis of ASD by referral services (Holland Bloorview, CAMH) supported by ADOS.
- Have reliable access to the internet
- Sub-Study 3 inclusion criteria
- Must be 6-12 years of age
- Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
- Must have a diagnosis of Transposition of the Great Arteries (TGA) or Hypoplastic left heart syndrome
- Must have received cardiac surgery before 6 weeks of age.
- Have reliable access to the internet
Who cannot join
- Sub-Study 1 Exclusion Criteria
- Younger than 6 years or older than 12
- IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
- Does not meet consensus diagnosis of DSM 5 criteria for ADHD based on a semi structured interview with the parents using PICS-6, including information from parent and teacher ratings of an established measure of ADHD symptoms.
- Has a diagnosis of ASD or CHD [in this case, individuals can be enrolled into Study 2 (ASD) or Study 3 (CHD)].
- Sub-Study 2 exclusion criteria
Show all 14Show fewer
- Younger than 6 years or older than 12
- IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
- Does not meet confirmed diagnosis of ASD based on ADOS
- Sub-Study 3 exclusion criteria
- Younger than 6 years or older than 12
- IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
- Does not have a diagnosis of Transposition of the Great Arteries (TGA) or Hypoplastic left heart syndrome
- Did not receive cardiac surgery before 6 weeks of age.
Trial locations and contacts
1 site in 1 country.
About this study
Children with disorders that impact neurodevelopment often have difficulties with executive functions and regulating emotions. Cognitive-based video game training has been shown to improve outcomes, however, this training has been expensive, has required professional supervision, and has been investigated only within a narrow group of children. The Mega Team study will test the effects of a highly engaging, take-home video game-based intervention designed to improve executive functioning in children with various brain-based developmental disorders.
Read the detailed description
The target population for this study will be children between the ages of 6-12 with a diagnosis of ADHD, ASD or CHD. Potential subjects for this study will be recruited from the clinical teams within SickKids and partnering institutions (e.g., CAMH and Holland Bloorview). Participants will be identified by a psychiatrist, psychologist or specialist physician as meeting diagnostic criteria for one of the three disorders; 1) ADHD, 2) ASD, 3) CHD. Families of children who have expressed interested in this study will be contacted by research staff to discuss the study in more detail and will coordinate the logistics of an initial consent and enrollment appointment. Parent(s)/guardian(s) of participants will be required to consent and children will be required to assent to take in this study.
This protocol is divided into 3 studies: sub-study 1 (ADHD), sub-study 2 (ASD) and sub-study 3 (CHD) each consisting of a pre-post treatment design with 6 month follow-up. Each sub-study includes an active treatment and wait -list arm. Please see study visit schedule (pg. 11) for time-line of events and measures by participant at each time point. Participants will be tested at SickKids at pre-treatment, post-treatment and follow-up. Participants will train at home with weekly calls from research staff. Assessors at all clinic visits will be blind to treatment status. All pre, post and following-up clinic assessments will be conducted off stimulant medication with a washout period of 48 hours.
Stratification: Participants may be taking medications at the time of the study (stimulants and non-stimulants including SSRI or antipsychotic medications). Families will be asked to be stabilized on their current dose of medication for at least for a month before commencing the study and to maintain the same medication and dosage during the 5 week study. If a change in the type of medication or dosage takes place during the study it will be recorded. Due to the established impact of stimulant medications on EF 20 21 this class of medication will be used as part of the randomization process to attain equal proportions of participants using stimulant medications in the Mega Team and TAU groups. As some medication use is anticipated in all disorder groups the same randomization approach will be used in all three studies.
Sample Size: The sample size for sub-study 1 (ADHD) will be 220 participants with 110 randomized into each group from initial estimated recruitment pool of 250. The sample size will provide 80% power to declare statistical significance if the true difference between treatment groups is 0.43 standard deviations or greater, using a two-sided, 5% level test of hypothesis, Bonferroni corrected for three comparisons. A pilot study of Mega Team is currently underway (Dr. Crosbie PI, a registered clinical trial) and results from that pilot will provide final estimates of the standard deviations before commencement of the current study. The planned sample for each of sub-study 2 (ASD) and sub-study 3 (CHD) will be 120 (60 per arm) given the novelty of investigating cognitive rehabilitation targeting EFs in these populations. Information from sub-study 1, which will happen first, and the results from the Mega Team pilot study, will allow adjustment in sample size of sub-study 2 and sub-study 3. All aspects of enrollment, randomization, and attrition will be monitored and documents using CONSORT flow diagram22.
Randomization: Participants within each sub-study who have consented/ assented to the study and meet all inclusion criterion will be randomized to either Mega Team or TAU waitlist stratified by medication status (yes or no)) using random block sizes. Randomization will be carried out using RedCAP23.
Blinding: Assessors at all clinic visits will be blind to treatment status. Participants and parents will be asked not to make mention of their treatment status during visits. They will be reminded of this regularly. Assessors will indicate their blinded status at the end of all visits. Parents and children will be asked not to inform teachers of the treatment status. At the time of questionnaire completion, teachers will be asked if they are aware of the treatment status of the child.
Intervention Conditions:
Mega Team Training Sessions: Mega Team is highly engaging video game based cognitive intervention that trains multiple executive functions: response inhibition, verbal working memory and visual working memory in the context of a single game with increasing difficulty based on the individual performance. Children in the treatment group will train at home on their own tablet or on a study tablet provided to the family (if needed). They will be instructed to practice Mega Team for 15 minutes a day, approximately 5 days a week for a targeted minimum of 21 sessions and a maximum of 25 sessions. The minimum value of 21 sessions has been selected based on findings of prior research. Majority of studies using other models of intervention have been able to capture significant training-induced improvements after 21 sessions 24-26. The maximum training of 25 sessions has been set to control for variability within and between our groups. Performance on Mega Team will automatically upload to a secure portal hosted by eHave for monitoring of enrolment, adherence and for data analyses. Scoring algorithms will track how often and how long the participants trained on Mega Team as well as their performance. Weekly calls from research staff will provide motivation and address barriers to game play.
TAU waiting list Control: Children in the control group will not be provided with any overt intervention but continue with treatment recommendations as provided by their clinical care team. They will be asked to complete a video game usage log weekly to record the type and duration of their regular video game playing, and will receive weekly calls from research staff, as will participants assigned to Mega Team. Participants on in the TAU group will be given access to the game at the completion of the 6 month follow-up visit.
- Conditions
- ADHD, ASD, CHD - Congenital Heart Disease
- Being tested
- Mega Team - video game
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mega Team - video gameOther
Also called Mega Team
Subjects randomly assigned to the treatment group will be instructed to practice Mega Team for 15 minutes a day, 5 days a week for a minimum of 21 days and a maximum of 25 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects randomly assigned to this arm will train on the Mega Team video game. Receives: Other: Mega Team - video game |
| Control- wait list group | No intervention | Subjects randomly assigned to this arm will be the wait-list group. They are allowed to play the video games that they usually play. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Response Inhibition
Inhibitory control will be measured using the Stop Signal Task (SST). The SST measures the ability to cancel an already initiated motor response. The primary outcome measure will be the participants' average stop signal reaction time (SSRT).
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Change in Working Memory
Verbal and Spatial N-back (1, 2 conditions) will be used to assess central executive working memory. The N-Back task requires on-line monitoring, updating, and manipulation of information and measures key processes within working memory. In the N-Back task, the participant is required to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously, where n is a pre-specified integer, usually 0, 1, or 2. The current study will use letters (verbal) and spatial location (spatial) paradigms. Visual and spatial working memory span will be assessed using the Spatial Span subtest and the Digit Span item from the WISC-IV Integrated. The primary outcome measure will be the overall score.
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Secondary outcomes (4)
Planning and Organization
The Tower Test from the Delis-Kaplan Executive Function System (D-KEFS;28 is a test of planning and problem solving abilities. Participants are asked to construct towers of discs on a set of pegs corresponding to a model. Raw scores reflect the participant's ability to use the fewest possible moves to achieve the tower depicted in the model.
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Everyday functioning and impairment
Parent and teacher rating of behaviours and impairments associated with executive functions will be assessed using The Behavior Rating Inventory of Executive Function (BRIEF;29). This is a 86 item questionnaires with solid psychometric properties (ref) with correlations with other measures of emotional and behavioral functioning29.
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Inattentive and Hyperactivity Behaviour rated by parent and teacher
Items associated with inattentiveness and hyperactivity from the SNAP IV will be used to estimate behavioural symptoms associated with ADHD. The SNAP-IV (SNAP-IV; Swanson IV, 2003) is an 18-item scale that includes the DSM-IV criteria for ADHD with items 1-9 representing the inattentive subset of symptoms and items 10-18 representing the Hyperactivity/Impulsivity subset.
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Academic accuracy and efficiency
Academic efficiency and accuracy will be assessed using the fluency measures from the Woodcock Johnson III30 test of achievement. The fluency tasks measure the accuracy of completing academic tasks within a time limit. Reading, math and writing fluency subtests will be included.
Measured: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start26 May 2018
- Primary completion10 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Child-Bright Network, Ehave, The Governors of the University of Alberta
- Responsible party
- Principal investigator, Jennifer Crosbie, The Hospital for Sick Children
- Investigators
- Jennifer Crosbie, Ph.D., C.Psych., Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502239
- Sponsor's protocol ID
- 1000057380
- Status last verified
- May 2025
- First submitted
- 12 Mar 2018
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data will be shared with our sponsor/funders - ChildBright Network and eHave.
Publications
Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641McAuley T, Crosbie J, Charach A, Schachar R. The persistence of cognitive deficits in remitted and unremitted ADHD: a case for the state-independence of response inhibition. J Child Psychol Psychiatry. 2014 Mar;55(3):292-300. doi: 10.1111/jcpp.12160. Epub 2013 Nov 22.
PubMed 24261515Lawson RA, Papadakis AA, Higginson CI, Barnett JE, Wills MC, Strang JF, Wallace GL, Kenworthy L. Everyday executive function impairments predict comorbid psychopathology in autism spectrum and attention deficit hyperactivity disorders. Neuropsychology. 2015 May;29(3):445-53. doi: 10.1037/neu0000145. Epub 2014 Oct 13.
PubMed 25313979Morris MC, Evans LD, Rao U, Garber J. Executive function moderates the relation between coping and depressive symptoms. Anxiety Stress Coping. 2015;28(1):31-49. doi: 10.1080/10615806.2014.925545. Epub 2014 Jun 17.
PubMed 24866556Vinogradov S, Fisher M, de Villers-Sidani E. Cognitive training for impaired neural systems in neuropsychiatric illness. Neuropsychopharmacology. 2012 Jan;37(1):43-76. doi: 10.1038/npp.2011.251. Epub 2011 Nov 2.
PubMed 22048465Cortese S, Ferrin M, Brandeis D, Buitelaar J, Daley D, Dittmann RW, Holtmann M, Santosh P, Stevenson J, Stringaris A, Zuddas A, Sonuga-Barke EJ; European ADHD Guidelines Group (EAGG). Cognitive training for attention-deficit/hyperactivity disorder: meta-analysis of clinical and neuropsychological outcomes from randomized controlled trials. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):164-74. doi: 10.1016/j.jaac.2014.12.010. Epub 2014 Dec 29.
PubMed 25721181Beck SJ, Hanson CA, Puffenberger SS, Benninger KL, Benninger WB. A controlled trial of working memory training for children and adolescents with ADHD. J Clin Child Adolesc Psychol. 2010;39(6):825-36. doi: 10.1080/15374416.2010.517162.
PubMed 21058129Dahlin, K. I. E. Effects of working memory training on reading in children with special needs. Read. Writ. 24, 479-491 (2011)
Holmes J, Gathercole SE, Dunning DL. Adaptive training leads to sustained enhancement of poor working memory in children. Dev Sci. 2009 Jul;12(4):F9-15. doi: 10.1111/j.1467-7687.2009.00848.x.
PubMed 19635074Johnstone SJ, Roodenrys S, Blackman R, Johnston E, Loveday K, Mantz S, Barratt MF. Neurocognitive training for children with and without AD/HD. Atten Defic Hyperact Disord. 2012 Mar;4(1):11-23. doi: 10.1007/s12402-011-0069-8. Epub 2011 Dec 20.
PubMed 22179720Alloway, T. Can interactive working memory training improving learning? J. Interact. Learn. Res. 23, 197-207 (2012)
Shalev L, Tsal Y, Mevorach C. Computerized progressive attentional training (CPAT) program: effective direct intervention for children with ADHD. Child Neuropsychol. 2007 Jul;13(4):382-8. doi: 10.1080/09297040600770787.
PubMed 17564853Van der Molen MJ, Van Luit JE, Van der Molen MW, Jongmans MJ. Everyday memory and working memory in adolescents with mild intellectual disability. Am J Intellect Dev Disabil. 2010 May;115(3):207-17. doi: 10.1352/1944-7558-115.3.207.
PubMed 20441391Craig F, Margari F, Legrottaglie AR, Palumbi R, de Giambattista C, Margari L. A review of executive function deficits in autism spectrum disorder and attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2016 May 12;12:1191-202. doi: 10.2147/NDT.S104620. eCollection 2016.
PubMed 27274255Willcutt EG, Doyle AE, Nigg JT, Faraone SV, Pennington BF. Validity of the executive function theory of attention-deficit/hyperactivity disorder: a meta-analytic review. Biol Psychiatry. 2005 Jun 1;57(11):1336-46. doi: 10.1016/j.biopsych.2005.02.006.
PubMed 15950006
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation (Mega Team) and Its Effects on Emotional and Behavioral Regulation in ADHD, ASD, and CHD
- ClinicalTrials.gov ID
- NCT03502239
- Acronym / sponsor ID
- 1000057380
- Conditions
- ADHD, ASD, CHD - Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Child-Bright Network, Ehave, The Governors of the University of Alberta
- Study start
- 26 May 2018 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with disorders that impact neurodevelopment often have difficulties with executive functions and regulating emotions. Cognitive-based video game training has been shown to improve outcomes, however, this training has been expensive, has required professional supervision, and has been investigated only within a narrow group of children. The Mega Team study will test the effects of a highly engaging, take-home video game-based intervention designed to improve executive functioning in children with various brain-based developmental disorders.
Detailed description
The target population for this study will be children between the ages of 6-12 with a diagnosis of ADHD, ASD or CHD. Potential subjects for this study will be recruited from the clinical teams within SickKids and partnering institutions (e.g., CAMH and Holland Bloorview). Participants will be identified by a psychiatrist, psychologist or specialist physician as meeting diagnostic criteria for one of the three disorders; 1) ADHD, 2) ASD, 3) CHD. Families of children who have expressed interested in this study will be contacted by research staff to discuss the study in more detail and will coordinate the logistics of an initial consent and enrollment appointment. Parent(s)/guardian(s) of participants will be required to consent and children will be required to assent to take in this study.
This protocol is divided into 3 studies: sub-study 1 (ADHD), sub-study 2 (ASD) and sub-study 3 (CHD) each consisting of a pre-post treatment design with 6 month follow-up. Each sub-study includes an active treatment and wait -list arm. Please see study visit schedule (pg. 11) for time-line of events and measures by participant at each time point. Participants will be tested at SickKids at pre-treatment, post-treatment and follow-up. Participants will train at home with weekly calls from research staff. Assessors at all clinic visits will be blind to treatment status. All pre, post and following-up clinic assessments will be conducted off stimulant medication with a washout period of 48 hours.
Stratification: Participants may be taking medications at the time of the study (stimulants and non-stimulants including SSRI or antipsychotic medications). Families will be asked to be stabilized on their current dose of medication for at least for a month before commencing the study and to maintain the same medication and dosage during the 5 week study. If a change in the type of medication or dosage takes place during the study it will be recorded. Due to the established impact of stimulant medications on EF 20 21 this class of medication will be used as part of the randomization process to attain equal proportions of participants using stimulant medications in the Mega Team and TAU groups. As some medication use is anticipated in all disorder groups the same randomization approach will be used in all three studies.
Sample Size: The sample size for sub-study 1 (ADHD) will be 220 participants with 110 randomized into each group from initial estimated recruitment pool of 250. The sample size will provide 80% power to declare statistical significance if the true difference between treatment groups is 0.43 standard deviations or greater, using a two-sided, 5% level test of hypothesis, Bonferroni corrected for three comparisons. A pilot study of Mega Team is currently underway (Dr. Crosbie PI, a registered clinical trial) and results from that pilot will provide final estimates of the standard deviations before commencement of the current study. The planned sample for each of sub-study 2 (ASD) and sub-study 3 (CHD) will be 120 (60 per arm) given the novelty of investigating cognitive rehabilitation targeting EFs in these populations. Information from sub-study 1, which will happen first, and the results from the Mega Team pilot study, will allow adjustment in sample size of sub-study 2 and sub-study 3. All aspects of enrollment, randomization, and attrition will be monitored and documents using CONSORT flow diagram22.
Randomization: Participants within each sub-study who have consented/ assented to the study and meet all inclusion criterion will be randomized to either Mega Team or TAU waitlist stratified by medication status (yes or no)) using random block sizes. Randomization will be carried out using RedCAP23.
Blinding: Assessors at all clinic visits will be blind to treatment status. Participants and parents will be asked not to make mention of their treatment status during visits. They will be reminded of this regularly. Assessors will indicate their blinded status at the end of all visits. Parents and children will be asked not to inform teachers of the treatment status. At the time of questionnaire completion, teachers will be asked if they are aware of the treatment status of the child.
Intervention Conditions:
Mega Team Training Sessions: Mega Team is highly engaging video game based cognitive intervention that trains multiple executive functions: response inhibition, verbal working memory and visual working memory in the context of a single game with increasing difficulty based on the individual performance. Children in the treatment group will train at home on their own tablet or on a study tablet provided to the family (if needed). They will be instructed to practice Mega Team for 15 minutes a day, approximately 5 days a week for a targeted minimum of 21 sessions and a maximum of 25 sessions. The minimum value of 21 sessions has been selected based on findings of prior research. Majority of studies using other models of intervention have been able to capture significant training-induced improvements after 21 sessions 24-26. The maximum training of 25 sessions has been set to control for variability within and between our groups. Performance on Mega Team will automatically upload to a secure portal hosted by eHave for monitoring of enrolment, adherence and for data analyses. Scoring algorithms will track how often and how long the participants trained on Mega Team as well as their performance. Weekly calls from research staff will provide motivation and address barriers to game play.
TAU waiting list Control: Children in the control group will not be provided with any overt intervention but continue with treatment recommendations as provided by their clinical care team. They will be asked to complete a video game usage log weekly to record the type and duration of their regular video game playing, and will receive weekly calls from research staff, as will participants assigned to Mega Team. Participants on in the TAU group will be given access to the game at the completion of the 6 month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Mega Team - video gameSubjects randomly assigned to this arm will train on the Mega Team video game. |
| Control- wait list group | No intervention | –Subjects randomly assigned to this arm will be the wait-list group. They are allowed to play the video games that they usually play. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Sub-Study 1 Inclusion Criteria
- Sub-Study 2 inclusion criteria
- Sub-Study 3 inclusion criteria
Key exclusion criteria (14 listed)
- Sub-Study 1 Exclusion Criteria
- Sub-Study 2 exclusion criteria
- Sub-Study 3 exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mega Team - video gameAlso: Mega TeamSubjects randomly assigned to the treatment group will be instructed to practice Mega Team for 15 minutes a day, 5 days a week for a minimum of 21 days and a maximum of 25 days. | Other | Treatment group |
Primary outcome
Change in Response Inhibition
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Inhibitory control will be measured using the Stop Signal Task (SST). The SST measures the ability to cancel an already initiated motor response. The primary outcome measure will be the participants' average stop signal reaction time (SSRT).
Change in Working Memory
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Verbal and Spatial N-back (1, 2 conditions) will be used to assess central executive working memory. The N-Back task requires on-line monitoring, updating, and manipulation of information and measures key processes within working memory. In the N-Back task, the participant is required to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously, where n is a pre-specified integer, usually 0, 1, or 2. The current study will use letters (verbal) and spatial location (spatial) paradigms. Visual and spatial working memory span will be assessed using the Spatial Span subtest and the Digit Span item from the WISC-IV Integrated. The primary outcome measure will be the overall score.
4 secondary outcomes
Planning and Organization
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Everyday functioning and impairment
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Inattentive and Hyperactivity Behaviour rated by parent and teacher
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Academic accuracy and efficiency
Time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 24261515McAuley T, Crosbie J, Charach A, Schachar R. The persistence of cognitive deficits in remitted and unremitted ADHD: a case for the state-independence of response inhibition. J Child Psychol Psychiatry. 2014 Mar;55(3):292-300. doi: 10.1111/jcpp.12160. Epub 2013 Nov 22.
- Background: PubMed 25313979Lawson RA, Papadakis AA, Higginson CI, Barnett JE, Wills MC, Strang JF, Wallace GL, Kenworthy L. Everyday executive function impairments predict comorbid psychopathology in autism spectrum and attention deficit hyperactivity disorders. Neuropsychology. 2015 May;29(3):445-53. doi: 10.1037/neu0000145. Epub 2014 Oct 13.
- Background: PubMed 24866556Morris MC, Evans LD, Rao U, Garber J. Executive function moderates the relation between coping and depressive symptoms. Anxiety Stress Coping. 2015;28(1):31-49. doi: 10.1080/10615806.2014.925545. Epub 2014 Jun 17.
- Background: PubMed 22048465Vinogradov S, Fisher M, de Villers-Sidani E. Cognitive training for impaired neural systems in neuropsychiatric illness. Neuropsychopharmacology. 2012 Jan;37(1):43-76. doi: 10.1038/npp.2011.251. Epub 2011 Nov 2.
- Background: PubMed 25721181Cortese S, Ferrin M, Brandeis D, Buitelaar J, Daley D, Dittmann RW, Holtmann M, Santosh P, Stevenson J, Stringaris A, Zuddas A, Sonuga-Barke EJ; European ADHD Guidelines Group (EAGG). Cognitive training for attention-deficit/hyperactivity disorder: meta-analysis of clinical and neuropsychological outcomes from randomized controlled trials. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):164-74. doi: 10.1016/j.jaac.2014.12.010. Epub 2014 Dec 29.
- Background: PubMed 21058129Beck SJ, Hanson CA, Puffenberger SS, Benninger KL, Benninger WB. A controlled trial of working memory training for children and adolescents with ADHD. J Clin Child Adolesc Psychol. 2010;39(6):825-36. doi: 10.1080/15374416.2010.517162.
- BackgroundDahlin, K. I. E. Effects of working memory training on reading in children with special needs. Read. Writ. 24, 479-491 (2011)
- Background: PubMed 19635074Holmes J, Gathercole SE, Dunning DL. Adaptive training leads to sustained enhancement of poor working memory in children. Dev Sci. 2009 Jul;12(4):F9-15. doi: 10.1111/j.1467-7687.2009.00848.x.
- Background: PubMed 22179720Johnstone SJ, Roodenrys S, Blackman R, Johnston E, Loveday K, Mantz S, Barratt MF. Neurocognitive training for children with and without AD/HD. Atten Defic Hyperact Disord. 2012 Mar;4(1):11-23. doi: 10.1007/s12402-011-0069-8. Epub 2011 Dec 20.
- BackgroundAlloway, T. Can interactive working memory training improving learning? J. Interact. Learn. Res. 23, 197-207 (2012)
- Background: PubMed 17564853Shalev L, Tsal Y, Mevorach C. Computerized progressive attentional training (CPAT) program: effective direct intervention for children with ADHD. Child Neuropsychol. 2007 Jul;13(4):382-8. doi: 10.1080/09297040600770787.
- Individual participant dataSharing planned: Yes. de-identified data will be shared with our sponsor/funders - ChildBright Network and eHave.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Crosbie, Ph.D., C.Psych. principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mega Team - video game in people with ADHD and ASD, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Response Inhibition (time frame: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502239, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.