NCT01124721

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

5 years

First QC Date

April 30, 2010

Last Update Submit

May 26, 2017

Conditions

ADHDAttention

Keywords

Cognitive training

Outcome Measures

Primary Outcomes (3)

  • Restricted Academic Situations Task

    Assessment of on-task type behavior while doing a simulated academic task.

    6 weeks

  • Working memory measures

    Assess memory and working memory functioning on computer and or RA administered tests.

    6 weeks

  • Rating scales

    Parent and teacher ratings of behavior and attention

    6 weeks

Secondary Outcomes (2)

  • Fluency and attention measures

    6 weeks

  • Self-control and executive functioning measures

    6 weeks

Study Arms (2)

Cogmed cognitive training

EXPERIMENTAL

Computerized working memory, attention and cognitive tasks

Behavioral: Cognitive training

Active placebo

ACTIVE COMPARATOR

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

Behavioral: Cognitive training-placebo

Interventions

Cognitive trainingBEHAVIORAL

Cognitive computerized training for several days per week.

Also known as: Cogmed
Cogmed cognitive training
Cognitive training-placeboBEHAVIORAL

Cognitive training that only minimally increases in difficulty

Also known as: Cogmed placebo
Active placebo

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCaliforniaDavis MIND Institute

Sacramento, California, 95825, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Julie Schweitzer, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 17, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

US(1)