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Trial record 15 of 84 for:    Developmental Disabilities | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT03502239
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
SPOR CHILD-BRIGHT Network
Ehave
The Governors of the University of Alberta
Information provided by (Responsible Party):
Jennifer Crosbie, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
ADHD ASD CHD - Congenital Heart Disease Other: Mega Team - video game Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation (Mega Team) and Its Effects on Emotional and Behavioral Regulation in ADHD, ASD, and CHD
Actual Study Start Date : May 26, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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

No Intervention: Control- wait list 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, 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).

  2. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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.

  4. 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) ]
    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.



Information from the National Library of Medicine

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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:

  • Sub-Study 1 Inclusion Criteria

    1. Must be 6-12 years of age
    2. Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent.
    3. 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.
    4. Does not have a diagnosis of ASD or CHD [in this case, individuals can be enrolled into Study 2 (ASD) or Study 3 (CHD)].
    5. Have reliable access to the internet
  • Sub-Study 2 inclusion criteria

    1. Must be 6-12 years of age
    2. Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
    3. Meets clinical diagnosis of ASD by referral services (Holland Bloorview, CAMH) supported by ADOS.
    4. Have reliable access to the internet
  • Sub-Study 3 inclusion criteria

    1. Must be 6-12 years of age
    2. Have IQ above 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
    3. Must have a diagnosis of Transposition of the Great Arteries (TGA) or Hypoplastic left heart syndrome
    4. Must have received cardiac surgery before 6 weeks of age.
    5. Have reliable access to the internet

Exclusion Criteria:

  • Sub-Study 1 Exclusion Criteria

    1. Younger than 6 years or older than 12
    2. IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
    3. 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.
    4. 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

    1. Younger than 6 years or older than 12
    2. IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
    3. Does not meet confirmed diagnosis of ASD based on ADOS
  • Sub-Study 3 exclusion criteria

    1. Younger than 6 years or older than 12
    2. IQ below 70 as estimated by two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) or equivalent
    3. Does not have a diagnosis of Transposition of the Great Arteries (TGA) or Hypoplastic left heart syndrome
    4. Did not receive cardiac surgery before 6 weeks of age.

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): NCT03502239


Contacts
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Contact: Mithula Sriskandarajah, Hon.B.Sc, CCR 416-813-7654 ext 208210 mithula.sriskandarajah@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Mithula Sriskandarajah, Hon.B.Sc,CCRP    416-813-7654 ext 208210    mithula.sriskandarajah@sickkids.ca   
Principal Investigator: Dr. Jennifer Crosbie, Ph.D., C.Psych.         
Sponsors and Collaborators
The Hospital for Sick Children
SPOR CHILD-BRIGHT Network
Ehave
The Governors of the University of Alberta
Investigators
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Principal Investigator: Jennifer Crosbie, Ph.D., C.Psych. The Hospital for Sick Children

Publications:
Dahlin, K. I. E. Effects of working memory training on reading in children with special needs. Read. Writ. 24, 479-491 (2011)
Alloway, T. Can interactive working memory training improving learning? J. Interact. Learn. Res. 23, 197-207 (2012)
Wechsler, D. WASI -II: Wechsler abbreviated scale of intelligence - second edition. J. Psychoeduc. Assess. 31, 337-41 (2013)
Logan, G. D., Schachar, R. J. & Tannock, R. Impulsivity and Inhibitory Control. Psychol. Sci. 8, 60-64 (1997)
Delis, D., Kaplan, E. & Kramer, J. Delis-Kaplan executive function system (D-KEFS). Can. J. Sch. Psychol. 20, 117-128 (2001)
Woodcock, R. W., McGrew, K. S. & Mather, N. Woodcock-Johnson III Tests of Achievement. Test 2001, 1-9 (2001)

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Responsible Party: Jennifer Crosbie, Clinical Scientist/Psychologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03502239     History of Changes
Other Study ID Numbers: 1000057380
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data will be shared with our sponsor/funders - ChildBright Network 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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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities