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Cognitive Restructuring in ADHD: Functional Training (CRAFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02827188
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Ehave
Ontario Brain Institute
Information provided by (Responsible Party):
Jennifer Crosbie, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Attention-deficit Hyperactivity Disorder Other: Mega Team-videogame Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Restructuring in ADHD: Functional Training
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Subjects randomly assigned to this arm will train on the Mega Team video game.
Other: Mega Team-videogame
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.
Other Name: Mega Team

No Intervention: Control-waitlist group
Subjects randomly assigned to this arm will be the wait-list group. They are allowed to play the video games that they usually play.



Primary Outcome Measures :
  1. Change in Response inhibition [ Time Frame: Baseline and post-training study visits (4-5 weeks apart) ]
    Inhibitory control will be measured using the Stop Signal Task.

  2. Change in Working memory [ Time Frame: Baseline and post-training study visits (4-5 weeks apart) ]
    Target accuracy as measured by the N-Back Tasks


Secondary Outcome Measures :
  1. Change in Inattentive and Hyperactivity Behaviour [ Time Frame: Baseline, week1, week 2, week 3, week 4, and at post-training study visit (week 4-5) ]
    Measured by SNAP IV

  2. Change in Planning and Organization [ Time Frame: Baseline and post-training study visits (4-5 weeks apart) ]
    will be measured using the Tower Test from the Delis-Kaplan Executive Function System

  3. Change in Academic performance [ Time Frame: Baseline and post-training study visits (4-5 weeks apart) ]
    Academic efficiency and accuracy will be assessed using the fluency measures from the Woodcock Johnson III (WJ III) test of achievement

  4. Change in Spatial Span [ Time Frame: Baseline and post-training study visits (4-5 weeks apart) ]
    We will use the spatial span item from the WISC to estimate the child's visuo-spatial span



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827188


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Ehave
Ontario Brain Institute
Investigators
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Principal Investigator: Jennifer Crosbie The Hospital for Sick Children
Publications:
SCHACHAR, R. J., TANNOCK, R. & LOGAN, G. 1993. Inhibitory control, impulsiveness, and attention deficit hyperactivity disorder. Clinical Psychology Review, 13, 721-739.
SWANSON IV, J. 2003. SNAP-IV Teacher and Parent Ratings Scale. Therapist's guide to learning and attention disorders, 487-500.
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.
Delis DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System (D-KEFS): Examiner's manual. San Antonio, TX: The Psychological Corporation; 2001.
GRODZINSKY, G. M. & DIAMOND, R. 1992. Frontal lobe functioning in boys with attention‐deficit hyperactivity disorder. Developmental Neuropsychology, 8, 427-445.
Woodcock, R. W., McGrew, K. S., & Mather, N. (2001). Woodcock-Johnson tests of achievement III (WJ-III). Rolling Meadows, IL: Riverside Publishing.

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Responsible Party: Jennifer Crosbie, Psychologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02827188    
Other Study ID Numbers: REB1000045526
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data will be shared with our sponsor/funders- Ontario Brain Institute and ehave.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders