Study Stopped
Original sponsor withdrew funding.
Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH)
CMH
3 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 23, 2020
January 1, 2020
4.1 years
November 12, 2015
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test
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
Baseline,10 weeks, 3 months
Changes assessed on Beck Self-Concept
Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Baseline,10 weeks, 3 months
Change assessed on Tova Attention Performance Index
Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Baseline,10 weeks, 3 months
Change assessed on Wiat-111 Reading comprehension and math problem-solving
Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Baseline,10 weeks, 3 months
Change assessed on Achenbach Reduction in Total Problems Scale
Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Baseline,10 weeks, 3 months
Study Arms (2)
Treatment As Usual
NO INTERVENTIONStandard treatment as usual as directed by the physician.
Modified Cogmed Training
EXPERIMENTAL10 weeks of computerized training (3x weekly for 35-minutes each session) that targets thinking skills that are often impaired in individuals diagnosed with ADHD.
Interventions
Comparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cambridge Memorial Hospitallead
- University of Waterloocollaborator
Study Sites (1)
Outpatient Mental Health,
Cambridge, Ontario, N1R 3G2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2015
First Posted
November 20, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 23, 2020
Record last verified: 2020-01