Back to resultsA Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD) (CATS)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer attention training systems for children with ADHD
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring EEG-biofeedback, neurofeedback, computer attention training systems, ADHD, ADD, child, children
Eligibility Criteria
Inclusion Criteria:
- child in 6th, 7th or 8th grade
- a diagnosis of ADHD (any subtype) per report of the child's physician
- academic achievement at grade level
- ability to read in English sufficiently to complete assessments and intervention protocols
Exclusion Criteria:
- coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)
Sites / Locations
- Tufts Medical Center / Tufts University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
EEG biofeedback intervention
Non EEG biofeedback computerized attention training
waitlist control
Arm Description
Outcomes
Primary Outcome Measures
Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956605
Brief Title
A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
CATS
Official Title
A Randomized Trial of Computer-based Attention-training Systems With and Without Neurofeedback in Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tufts Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
EEG-biofeedback, neurofeedback, computer attention training systems, ADHD, ADD, child, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EEG biofeedback intervention
Arm Type
Experimental
Arm Title
Non EEG biofeedback computerized attention training
Arm Type
Active Comparator
Arm Title
waitlist control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Computer attention training systems for children with ADHD
Intervention Description
Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants
Primary Outcome Measure Information:
Title
Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention
Time Frame
Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
child in 6th, 7th or 8th grade
a diagnosis of ADHD (any subtype) per report of the child's physician
academic achievement at grade level
ability to read in English sufficiently to complete assessments and intervention protocols
Exclusion Criteria:
coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Steiner, MD
Organizational Affiliation
Tufts Medical Center / Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center / Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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