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Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD) (Cog-RAST)

Primary Purpose

ADHD, Attention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive training
Cognitive training-placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Cognitive training

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age range 7-14
  2. At least average academic and intellectual functioning via parent report.
  3. Must have ADHD (by parent report of previous diagnosis or per telephone screening checklist - to be confirmed via interview and ratings)
  4. Attentional, hyperactive or impulsive symptoms that interfere with functioning.

Exclusion Criteria:

  1. Diagnosis of severe mental illness for example, psychotic, bipolar or major depressive disorder, (by history)
  2. Mental retardation (by history)
  3. English is not the primary language
  4. Family does not have a computer

Sites / Locations

  • UCaliforniaDavis MIND Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cogmed cognitive training

Active placebo

Arm Description

Computerized working memory, attention and cognitive tasks

Cognitive training, however the training does not increase in difficulty, or does so to a minimal degree.

Outcomes

Primary Outcome Measures

Restricted Academic Situations Task
Assessment of on-task type behavior while doing a simulated academic task.
Working memory measures
Assess memory and working memory functioning on computer and or RA administered tests.
Rating scales
Parent and teacher ratings of behavior and attention

Secondary Outcome Measures

Fluency and attention measures
Measures of fluency and attentional functioning.
Self-control and executive functioning measures
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.

Full Information

First Posted
April 30, 2010
Last Updated
May 26, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01124721
Brief Title
Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
Cog-RAST
Official Title
Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention
Keywords
Cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cogmed cognitive training
Arm Type
Experimental
Arm Description
Computerized working memory, attention and cognitive tasks
Arm Title
Active placebo
Arm Type
Active Comparator
Arm Description
Cognitive training, however the training does not increase in difficulty, or does so to a minimal degree.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
Cogmed
Intervention Description
Cognitive computerized training for several days per week.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training-placebo
Other Intervention Name(s)
Cogmed placebo
Intervention Description
Cognitive training that only minimally increases in difficulty
Primary Outcome Measure Information:
Title
Restricted Academic Situations Task
Description
Assessment of on-task type behavior while doing a simulated academic task.
Time Frame
6 weeks
Title
Working memory measures
Description
Assess memory and working memory functioning on computer and or RA administered tests.
Time Frame
6 weeks
Title
Rating scales
Description
Parent and teacher ratings of behavior and attention
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fluency and attention measures
Description
Measures of fluency and attentional functioning.
Time Frame
6 weeks
Title
Self-control and executive functioning measures
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Schweitzer, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCaliforniaDavis MIND Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States

12. IPD Sharing Statement

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Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD)

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