Cognitive Restructuring in ADHD: Functional Training (CRAFT)
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ClinicalTrials.gov Identifier: NCT02827188 |
Recruitment Status :
Completed
First Posted : July 11, 2016
Last Update Posted : September 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Attention-deficit Hyperactivity Disorder | Other: Mega Team-videogame | Not Applicable |

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 |

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

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
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Jennifer Crosbie | The Hospital for Sick Children |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |