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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01124721
Other study ID # 200816598
Secondary ID
Status Completed
Phase N/A
First received April 30, 2010
Last updated May 26, 2017
Start date January 2008
Est. completion date January 2013

Study information

Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive training
Cognitive computerized training for several days per week.
Cognitive training-placebo
Cognitive training that only minimally increases in difficulty

Locations

Country Name City State
United States UCaliforniaDavis MIND Institute Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Restricted Academic Situations Task Assessment of on-task type behavior while doing a simulated academic task. 6 weeks
Primary Working memory measures Assess memory and working memory functioning on computer and or RA administered tests. 6 weeks
Primary Rating scales Parent and teacher ratings of behavior and attention 6 weeks
Secondary Fluency and attention measures Measures of fluency and attentional functioning. 6 weeks
Secondary 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. 6 weeks
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