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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01124721
First received: April 30, 2010
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
ADHD
Attention
 Behavioral: Cognitive training
Behavioral: Cognitive training-placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Restricted Academic Situations Task [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assessment of on-task type behavior while doing a simulated academic task.

  • Working memory measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assess memory and working memory functioning on computer and or RA administered tests.

  • Rating scales [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Parent and teacher ratings of behavior and attention


Secondary Outcome Measures:
  • Fluency and attention measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measures of fluency and attentional functioning.

  • Self-control and executive functioning measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cogmed cognitive training
Computerized working memory, attention and cognitive tasks
 Behavioral: Cognitive training
Cognitive computerized training for several days per week.
Other Name: Cogmed
Active Comparator: Active placebo
Cognitive training, however the training does not increase in difficulty, or does so to a minimal degree.
 Behavioral: Cognitive training-placebo
Cognitive training that only minimally increases in difficulty
Other Name: Cogmed placebo

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124721

Contacts
Contact: Julie Schweitzer, PhD 916-703-0450 julie.schweitzer@ucdmc.ucdavis.edu

Locations
United States, California
UCaliforniaDavis MIND Institute Recruiting
Sacramento, California, United States, 95825
Contact: Kyle Rutledge         kjrutledge@ucdavis.edu    
Sub-Investigator: Catherine Fassbender, PhD            
Sub-Investigator: Faye Dixon, PhD            
Sub-Investigator: Chloe Green, BA            
Sub-Investigator: David Green, PhD            
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Julie Schweitzer, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Julie Schweitzer, Ph.D., UCaliforniaDavis
ClinicalTrials.gov Identifier: NCT01124721     History of Changes
Other Study ID Numbers: 200816598
Study First Received: April 30, 2010
Last Updated: May 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Cognitive training

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013