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

July 6, 2017 updated by: Tufts Medical Center

Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Training
Behavioral: Cognitive Training
3 times per week for 45 minutes for a total of 40 sessions
Experimental: Neurofeedback
Behavioral: Neurofeedback
3 times per week for 45 minutes for a total of 40 sessions
Active Comparator: Waitlist Control
Other: Waitlist Control
6 30 minute calm breathing sessions over the course of 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Observations of Students in School (BOSS)
Time Frame: up to three years
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).
up to three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Naomi J Steiner, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 6, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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