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Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (CATS)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Cognitive Training
Waitlist Control
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, neurofeedback, biofeedback, computer attention training

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of ADHD (any subtype, per report of the child's physician or school psychologist) entering 2nd or 4th grade at the beginning of September 2009 and 2010.
  • combined IQ (Intelligence Quotient) at or above 80,
  • ability to read English sufficiently to complete assessments and intervention protocols

Exclusion Criteria:

  • mental retardation,
  • coexisting diagnosis of conduct disorder,
  • pervasive developmental disorder, or
  • other serious mental illness (eg., bipolar disorder, psychosis, autism)

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Neurofeedback

Cognitive Training

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

Behavioral Observations of Students in School (BOSS)
For the purpose of this study, the BOSS is a double blind classroom observation. Each participant is observed by a trained researcher for 15 minutes three times over the course of two days at each assessment point (before the intervention, after the intervention, and at a 6-month follow up) and is evaluated in the areas of off task behaviors (motor, verbal, and passive) and on task behaviors (active and passive).

Secondary Outcome Measures

Full Information

First Posted
April 16, 2012
Last Updated
July 6, 2017
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01583829
Brief Title
Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder
Acronym
CATS
Official Title
Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study examines the efficacy of two computer-based attention training systems, one with and one without neurofeedback. The training systems intend to help children learn to focus and attend more effectively.
Detailed Description
The current study is examining a neurofeedback (NF) computer attention training system that teaches children to alter their brainwave activity with a Cognitive Training attention training system (CT). The investigators hypothesize that both treatments will show improvement in ADHD symptoms and academic outcomes compared to a control condition. 104 children with ADHD in grades 2 and 4 are randomly assigned to receive the NF, CT, or a Waitlist-Control (WLC) condition that receives NF or CT the following academic year. Children receive forty 45-minute sessions three times a week at school for 4 months. A comprehensive assessment, consists of data completed by teachers, parents, participants, and double-blind classroom observations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, neurofeedback, biofeedback, computer attention training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Intervention Description
3 times per week for 45 minutes for a total of 40 sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
3 times per week for 45 minutes for a total of 40 sessions
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention Description
6 30 minute calm breathing sessions over the course of 4 months
Primary Outcome Measure Information:
Title
Behavioral Observations of Students in School (BOSS)
Description
For the purpose of this study, the BOSS is a double blind classroom observation. Each participant is observed by a trained researcher for 15 minutes three times over the course of two days at each assessment point (before the intervention, after the intervention, and at a 6-month follow up) and is evaluated in the areas of off task behaviors (motor, verbal, and passive) and on task behaviors (active and passive).
Time Frame
up to three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of ADHD (any subtype, per report of the child's physician or school psychologist) entering 2nd or 4th grade at the beginning of September 2009 and 2010. combined IQ (Intelligence Quotient) at or above 80, ability to read English sufficiently to complete assessments and intervention protocols Exclusion Criteria: mental retardation, coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (eg., bipolar disorder, psychosis, autism)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi J Steiner, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder

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