Clinical trial NCT02610244: Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH)
Official title: Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Cambridge Memorial Hospital
Sponsor class: OTHER
Collaborators: name: University of Waterloo
First posted: 2015-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Youth who are between 8-16 years age.
2. Youth with a primary diagnosis of ADHD per psychiatric and psychological assessment.
3. 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.
4. Youth with reading comprehension at or above a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III).
5. 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:

1. Youth who are younger than 8 or older than 16 at the time of enrollment.
2. Youth who do not have a primary diagnosis of ADHD.
3. 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.
4. 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.
5. 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.
6. 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.

Primary outcomes:
measure: Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test
timeFrame: Baseline,10 weeks, 3 months
measure: Changes assessed on Beck Self-Concept
timeFrame: Baseline,10 weeks, 3 months
measure: Change assessed on Tova Attention Performance Index
timeFrame: Baseline,10 weeks, 3 months
measure: Change assessed on Wiat-111 Reading comprehension and math problem-solving
timeFrame: Baseline,10 weeks, 3 months
measure: Change assessed on Achenbach Reduction in Total Problems Scale
timeFrame: Baseline,10 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Outpatient Mental Health,
state: Ontario
Study officials:
References: