- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610244
Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH) (CMH)
January 21, 2020 updated by: Cambridge Memorial Hospital
Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)
ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks).
The main objectives are to determine whether there is improvement in working memory and attention, a reduction in concerns related to ADHD and social emotional behaviour,and transfer effects for reading and math following participation in our MCT.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The Cogmed working memory training program consists of 5 daily 50-min sessions for 5 weeks.
This program has been identified as a promising intervention for youth with Attention Deficit Hyperactivity Disorder (ADHD) who have deficits in aspects of executive functioning (EF), such as working memory (WM) and attention (ATT), as well as social-emotional behavior (SEB).
Findings regarding the efficacy and generalization of transfer effects associated with Cogmed have been mixed, possibly due to methodological limitations of the standard program.
In our study, these limitations will be addressed with ADHD youth (8-16 years) in a randomized controlled trial using a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks).
The main objective is to determine whether there is improvement in WM and ATT, a reduction in concerns related to ADHD and SEB, and transfer effects for reading and math following participation in our MCT.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Cambridge, Ontario, Canada, N1R 3G2
- Outpatient Mental Health,
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Youth who are between 8-16 years age.
- Youth with a primary diagnosis of ADHD per psychiatric and psychological assessment.
- Youth with an estimated Intelligence Quotient (IQ) equal or greater than 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110.
- Youth with reading comprehension at or above a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III).
- Youth who are receiving medication will have made an adequate adjustment to their medication as shown by stable blood levels, psychiatric consultation, and self and parent report at least 2 weeks prior to the start of their acceptance into this study.
Exclusion Criteria:
- Youth who are younger than 8 or older than 16 at the time of enrollment.
- Youth who do not have a primary diagnosis of ADHD.
- Youth with an estimated Intelligence Quotient (IQ) below 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110. Children with intellectual functioning below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth with reading comprehension below a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III). Children with reading skills below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth do not intend to begin new medication, discontinue existing medication, or change dose in medication - unless indicated per their doctor's instructions - for the duration of their involvement in the study.
- Youth cannot be accepted into the study if they have a significant medical impairment that would preclude their participation, a significant uncorrected visual/hearing deficit that would make it difficult for them to see a computer screen and follow verbal instructions, and/or a significant problem with their fine motor control that would make it difficult for them to use a keyboard.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment As Usual
Standard treatment as usual as directed by the physician.
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|
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Experimental: Modified Cogmed Training
10 weeks of computerized training (3x weekly for 35-minutes each session) that targets thinking skills that are often impaired in individuals diagnosed with ADHD.
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Comparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test
Time Frame: Baseline,10 weeks, 3 months
|
The BRIEF Parent/Teacher ratings of youth's working memory index and Youth 's scores on Alloway Working Memory test at baseline will be compared with scores after 10 weeks modified cogmed training or treament-as-usual, and after 3 months
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Baseline,10 weeks, 3 months
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Changes assessed on Beck Self-Concept
Time Frame: Baseline,10 weeks, 3 months
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Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
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Baseline,10 weeks, 3 months
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Change assessed on Tova Attention Performance Index
Time Frame: Baseline,10 weeks, 3 months
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Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
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Baseline,10 weeks, 3 months
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Change assessed on Wiat-111 Reading comprehension and math problem-solving
Time Frame: Baseline,10 weeks, 3 months
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Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
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Baseline,10 weeks, 3 months
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Change assessed on Achenbach Reduction in Total Problems Scale
Time Frame: Baseline,10 weeks, 3 months
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Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
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Baseline,10 weeks, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
November 12, 2015
First Submitted That Met QC Criteria
November 18, 2015
First Posted (Estimate)
November 20, 2015
Study Record Updates
Last Update Posted (Actual)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADHD-MCT-09092015
- 2015-0563 (Other Identifier: Tri-Hospital Research Ethics Board)
- 20679 (University of Waterloo Ethics)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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