Cognitive Rehabilitation (Mega Team) and Its Effects on Emotional and Behavioral Regulation in ADHD, ASD, and CHD

NCT03502239 | Completed

• 1 other identifier: 1000057380
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

ADHD; ASD; CHD - Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)

• Everyday functioning and impairment

  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

  Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)

• Academic accuracy and efficiency

  Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)

Study Arms (2)

Treatment group

EXPERIMENTAL

Subjects randomly assigned to this arm will train on the Mega Team video game.

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.

Interventions

Mega Team - video game OTHER

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.

Also known as: Mega Team

Treatment group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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 \[in this case, individuals can be enrolled into Study 2 (ASD) or Study 3 (CHD)\].
• 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
• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Child-Bright Network: collaborator
• Ehave: collaborator
• The Governors of the University of Alberta: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (30)

• Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

  PMID: 23020641 BACKGROUND

• McAuley 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.

  PMID: 24261515 BACKGROUND

• Lawson 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.

  PMID: 25313979 BACKGROUND

• Morris 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.

  PMID: 24866556 BACKGROUND

• Vinogradov 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.

  PMID: 22048465 BACKGROUND

• Cortese 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.

  PMID: 25721181 BACKGROUND

• Beck 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.

  PMID: 21058129 BACKGROUND

• Dahlin, K. I. E. Effects of working memory training on reading in children with special needs. Read. Writ. 24, 479-491 (2011)

  BACKGROUND

• 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.

  PMID: 19635074 BACKGROUND

• Johnstone 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.

  PMID: 22179720 BACKGROUND

• Alloway, T. Can interactive working memory training improving learning? J. Interact. Learn. Res. 23, 197-207 (2012)

  BACKGROUND

• 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.

  PMID: 17564853 BACKGROUND

• Van 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.

  PMID: 20441391 BACKGROUND

• Craig 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.

  PMID: 27274255 BACKGROUND

• Willcutt 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.

  PMID: 15950006 BACKGROUND

• Calderon J, Bellinger DC. Executive function deficits in congenital heart disease: why is intervention important? Cardiol Young. 2015 Oct;25(7):1238-46. doi: 10.1017/S1047951115001134. Epub 2015 Jun 17.

  PMID: 26082199 BACKGROUND

• Wechsler, D. WASI -II: Wechsler abbreviated scale of intelligence - second edition. J. Psychoeduc. Assess. 31, 337-41 (2013)

  BACKGROUND

• Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.

  PMID: 9204677 BACKGROUND

• Bussing R, Fernandez M, Harwood M, Wei Hou, Garvan CW, Eyberg SM, Swanson JM. Parent and teacher SNAP-IV ratings of attention deficit hyperactivity disorder symptoms: psychometric properties and normative ratings from a school district sample. Assessment. 2008 Sep;15(3):317-28. doi: 10.1177/1073191107313888. Epub 2008 Feb 29.

  PMID: 18310593 BACKGROUND

• Bedard AC, Ickowicz A, Logan GD, Hogg-Johnson S, Schachar R, Tannock R. Selective inhibition in children with attention-deficit hyperactivity disorder off and on stimulant medication. J Abnorm Child Psychol. 2003 Jun;31(3):315-27. doi: 10.1023/a:1023285614844.

  PMID: 12774864 BACKGROUND

• Bedard AC, Martinussen R, Ickowicz A, Tannock R. Methylphenidate improves visual-spatial memory in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2004 Mar;43(3):260-8. doi: 10.1097/00004583-200403000-00006.

  PMID: 15076258 BACKGROUND

• Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.

  PMID: 18283207 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Chein JM, Morrison AB. Expanding the mind's workspace: training and transfer effects with a complex working memory span task. Psychon Bull Rev. 2010 Apr;17(2):193-9. doi: 10.3758/PBR.17.2.193.

  PMID: 20382919 BACKGROUND

• Dahlin E, Nyberg L, Backman L, Neely AS. Plasticity of executive functioning in young and older adults: immediate training gains, transfer, and long-term maintenance. Psychol Aging. 2008 Dec;23(4):720-30. doi: 10.1037/a0014296.

  PMID: 19140643 BACKGROUND

• Jaeggi SM, Buschkuehl M, Jonides J, Perrig WJ. Improving fluid intelligence with training on working memory. Proc Natl Acad Sci U S A. 2008 May 13;105(19):6829-33. doi: 10.1073/pnas.0801268105. Epub 2008 Apr 28.

  PMID: 18443283 BACKGROUND

• Logan, G. D., Schachar, R. J. & Tannock, R. Impulsivity and Inhibitory Control. Psychol. Sci. 8, 60-64 (1997)

  BACKGROUND

• Delis, D., Kaplan, E. & Kramer, J. Delis-Kaplan executive function system (D-KEFS). Can. J. Sch. Psychol. 20, 117-128 (2001)

  BACKGROUND

• Baron IS. Behavior rating inventory of executive function. Child Neuropsychol. 2000 Sep;6(3):235-8. doi: 10.1076/chin.6.3.235.3152. No abstract available.

  PMID: 11419452 BACKGROUND

• Woodcock, R. W., McGrew, K. S. & Mather, N. Woodcock-Johnson III Tests of Achievement. Test 2001, 1-9 (2001)

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jennifer Crosbie, Ph.D., C.Psych.

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist/Psychologist

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 18, 2018
• Study Start: May 26, 2018
• Primary Completion: March 10, 2023
• Study Completion: March 15, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)