- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01124721
Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD) (Cog-RAST)
May 26, 2017 updated by: University of California, Davis
Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder
Impaired WM is a central deficit in ADHD.
A computerized training program, Cogmed, has been shown to increase WM capacity in children with ADHD.
It is not known whether the training improves behavior associated with classroom learning, such as remaining on-task and inhibiting off- task behavior.
The aim of this study is to utilize ecologically valid measures to investigate training's effect on observable ADHD behavior in conjunction with more standard measures.
Subjects will be randomly assigned to a Cogmed versus an active "placebo" condition in which the tasks do not increase in difficulty level in a double-blinded fashion.
The effects of the active Cogmed versus placebo computer training will be compared on measures in children with ADHD.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
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
-
-
California
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Sacramento, California, United States, 95825
- UCaliforniaDavis MIND Institute
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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
7 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range 7-14
- At least average academic and intellectual functioning via parent report.
- Must have ADHD (by parent report of previous diagnosis or per telephone screening checklist - to be confirmed via interview and ratings)
- Attentional, hyperactive or impulsive symptoms that interfere with functioning.
Exclusion Criteria:
- Diagnosis of severe mental illness for example, psychotic, bipolar or major depressive disorder, (by history)
- Mental retardation (by history)
- English is not the primary language
- Family does not have a computer
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Cogmed cognitive training
Computerized working memory, attention and cognitive tasks
|
Cognitive computerized training for several days per week.
Other Names:
|
|
ACTIVE_COMPARATOR: Active placebo
Cognitive training, however the training does not increase in difficulty, or does so to a minimal degree.
|
Cognitive training that only minimally increases in difficulty
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Restricted Academic Situations Task
Time Frame: 6 weeks
|
Assessment of on-task type behavior while doing a simulated academic task.
|
6 weeks
|
|
Working memory measures
Time Frame: 6 weeks
|
Assess memory and working memory functioning on computer and or RA administered tests.
|
6 weeks
|
|
Rating scales
Time Frame: 6 weeks
|
Parent and teacher ratings of behavior and attention
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluency and attention measures
Time Frame: 6 weeks
|
Measures of fluency and attentional functioning.
|
6 weeks
|
|
Self-control and executive functioning measures
Time Frame: 6 weeks
|
Attention and working memory components can affect delay discounting and self-control measures.
This measure will assess for change in behavior and ratings associated with executive functioning.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2008
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
April 30, 2010
First Submitted That Met QC Criteria
May 13, 2010
First Posted (ESTIMATE)
May 17, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 26, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200816598
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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