NCT02610244

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4.1 years

First QC Date

November 12, 2015

Last Update Submit

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 INTERVENTION

Standard treatment as usual as directed by the physician.

Modified Cogmed Training

EXPERIMENTAL

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.

Other: Modified Cogmed Training

Interventions

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

Modified Cogmed Training

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Outpatient Mental Health,

Cambridge, Ontario, N1R 3G2, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

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

Locations