Cognitive Restructuring in ADHD: Functional Training

NCT02827188 | Completed

• 1 other identifier: REB1000045526
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is to develop a non-pharmacological intervention program for children with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention, hyperactivity, and impulsivity. The present study will investigate the validity, feasibility and efficacy of this novel intervention.

Conditions

Attention-deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Response inhibition

  Inhibitory control will be measured using the Stop Signal Task.

  Baseline and post-training study visits (4-5 weeks apart)

• Change in Working memory

  Target accuracy as measured by the N-Back Tasks

  Baseline and post-training study visits (4-5 weeks apart)

Secondary Outcomes (4)

• Change in Inattentive and Hyperactivity Behaviour

  Baseline, week1, week 2, week 3, week 4, and at post-training study visit (week 4-5)

• Change in Planning and Organization

  Baseline and post-training study visits (4-5 weeks apart)

• Change in Academic performance

  Baseline and post-training study visits (4-5 weeks apart)

• Change in Spatial Span

  Baseline and post-training study visits (4-5 weeks apart)

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Other: Mega Team-videogame

Control-waitlist 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-videogame OTHER

Subjects randomly assigned to the treatment group will be instructed to practice Mega Team for 30-35 minutes a day, approximately 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:

• Subject is between 6-12 years old
• Subject has a diagnosis of Attention Deficit Hyperactive Disorder
• Subject is a previous POND baseline study (Attention Deficit Hyperactive Disorder Cognitive deficit and syndrome definition) participant.
• Parent/legal guardian and subject are willing to consent/assent to participate in this study

You may not qualify if:

• IQ below 80 on both verbal and performance scales of the Wechsler Intelligence Scale for children (WISC)-IV/V or Wechsler Abbreviated scale of intelligence (WASI II)
• History of psychosis, schizophrenia or other major mental health diagnosis that will prevent participation/completion of the protocol
• Subject's current medical problems that would preclude his/her participation in the study
• Child younger than 6 years old or older than 12
• Parent/legal guardian and/or subject not willing to consent/assent to participate in this study

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Ehave: collaborator
• Ontario Brain Institute: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (17)

• 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

• Crosbie J, Perusse D, Barr CL, Schachar RJ. Validating psychiatric endophenotypes: inhibitory control and attention deficit hyperactivity disorder. Neurosci Biobehav Rev. 2008;32(1):40-55. doi: 10.1016/j.neubiorev.2007.05.002. Epub 2007 May 18.

  PMID: 17976721 BACKGROUND

• Czamara D, Tiesler CM, Kohlbock G, Berdel D, Hoffmann B, Bauer CP, Koletzko S, Schaaf B, Lehmann I, Herbarth O, von Berg A, Muller-Myhsok B, Schulte-Korne G, Heinrich J. Children with ADHD symptoms have a higher risk for reading, spelling and math difficulties in the GINIplus and LISAplus cohort studies. PLoS One. 2013 May 27;8(5):e63859. doi: 10.1371/journal.pone.0063859. Print 2013.

  PMID: 23724008 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

• Greven CU, Kovas Y, Willcutt EG, Petrill SA, Plomin R. Evidence for shared genetic risk between ADHD symptoms and reduced mathematics ability: a twin study. J Child Psychol Psychiatry. 2014 Jan;55(1):39-48. doi: 10.1111/jcpp.12090. Epub 2013 Jun 3.

  PMID: 23731013 BACKGROUND

• Hazel-Fernandez LA, Klorman R, Wallace JM, Cook S. Methylphenidate improves aspects of executive function in African American children with ADHD. J Atten Disord. 2006 May;9(4):582-9. doi: 10.1177/1087054705284243.

  PMID: 16648225 BACKGROUND

• Schmiedeler S, Schneider W. Attention-deficit hyperactivity disorder (ADHD) in the early years: diagnostic issues and educational relevance. Clin Child Psychol Psychiatry. 2014 Jul;19(3):460-75. doi: 10.1177/1359104513489979. Epub 2013 Jun 19.

  PMID: 23785052 BACKGROUND

• Shue KL, Douglas VI. Attention deficit hyperactivity disorder and the frontal lobe syndrome. Brain Cogn. 1992 Sep;20(1):104-24. doi: 10.1016/0278-2626(92)90064-s.

  PMID: 1389116 BACKGROUND

• Wiers RW, Gunning WB, Sergeant JA. Is a mild deficit in executive functions in boys related to childhood ADHD or to parental multigenerational alcoholism? J Abnorm Child Psychol. 1998 Dec;26(6):415-30. doi: 10.1023/a:1022643617017.

  PMID: 9915649 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

• Schachar R, Tannock R, Marriott M, Logan G. Deficient inhibitory control in attention deficit hyperactivity disorder. J Abnorm Child Psychol. 1995 Aug;23(4):411-37. doi: 10.1007/BF01447206.

  PMID: 7560554 BACKGROUND

• SWANSON IV, J. 2003. SNAP-IV Teacher and Parent Ratings Scale. Therapist's guide to learning and attention disorders, 487-500.

  BACKGROUND

• ROID, G. H., & LEDBETTER, M. 2006. Wide range achievement test, fourth edition - progress monitoring version. Tampa, FL: Psychological Assessment Resources. disorder. Journal of Psychophysiology, 16, 97-106.

  BACKGROUND

• Delis DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System (D-KEFS): Examiner's manual. San Antonio, TX: The Psychological Corporation; 2001.

  BACKGROUND

• GRODZINSKY, G. M. & DIAMOND, R. 1992. Frontal lobe functioning in boys with attention-deficit hyperactivity disorder. Developmental Neuropsychology, 8, 427-445.

  BACKGROUND

• Mataro M, Garcia-Sanchez C, Junque C, Estevez-Gonzalez A, Pujol J. Magnetic resonance imaging measurement of the caudate nucleus in adolescents with attention-deficit hyperactivity disorder and its relationship with neuropsychological and behavioral measures. Arch Neurol. 1997 Aug;54(8):963-8. doi: 10.1001/archneur.1997.00550200027006.

  PMID: 9267970 BACKGROUND

• Woodcock, R. W., McGrew, K. S., & Mather, N. (2001). Woodcock-Johnson tests of achievement III (WJ-III). Rolling Meadows, IL: Riverside Publishing.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jennifer Crosbie

  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: Psychologist

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: July 11, 2016
• Study Start: September 26, 2016
• Primary Completion: April 17, 2017
• Study Completion: April 17, 2017
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)