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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583829
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : July 7, 2017
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Neurofeedback Behavioral: Cognitive Training Other: Waitlist Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : May 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Neurofeedback Behavioral: Neurofeedback
3 times per week for 45 minutes for a total of 40 sessions

Experimental: Cognitive Training Behavioral: Cognitive Training
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583829

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
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Principal Investigator: Naomi J Steiner, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center Identifier: NCT01583829    
Other Study ID Numbers: 8926
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Keywords provided by Tufts Medical Center:
computer attention training
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases