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Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH) (CMH)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Modified Cogmed Training

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outpatient Mental Health,

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment As Usual

Modified Cogmed Training

Arm Description

Standard treatment as usual as directed by the physician.

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.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02610244

First Posted

November 12, 2015

Last Updated

January 21, 2020

Sponsor

Cambridge Memorial Hospital

Collaborators

University of Waterloo

1. Study Identification

Unique Protocol Identification Number

NCT02610244

Brief Title

Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH)

Acronym

CMH

Official Title

Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

Original sponsor withdrew funding.

Study Start Date

November 2015 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cambridge Memorial Hospital

Collaborators

University of Waterloo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment As Usual

Arm Type

No Intervention

Arm Description

Standard treatment as usual as directed by the physician.

Arm Title

Modified Cogmed Training

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Modified Cogmed Training

Intervention Description

Comparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up.

Primary Outcome Measure Information:

Title

Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test

Description

Time Frame

Baseline,10 weeks, 3 months

Title

Changes assessed on Beck Self-Concept

Description

Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Time Frame

Baseline,10 weeks, 3 months

Title

Change assessed on Tova Attention Performance Index

Description

Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Time Frame

Baseline,10 weeks, 3 months

Title

Change assessed on Wiat-111 Reading comprehension and math problem-solving

Description

Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Time Frame

Baseline,10 weeks, 3 months

Title

Change assessed on Achenbach Reduction in Total Problems Scale

Description

Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Time Frame

Baseline,10 weeks, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Outpatient Mental Health,

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 3G2

Country

Canada

12. IPD Sharing Statement

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Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH)

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