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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01583829
First received: April 16, 2012
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: Neurofeedback
Behavioral: Cognitive Training
Other: Waitlist Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Behavioral Observations of Students in School (BOSS) [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    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).


Enrollment: 104
Study Start Date: May 2009
Estimated Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583829

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Naomi J Steiner, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01583829     History of Changes
Other Study ID Numbers: 8926
Study First Received: April 16, 2012
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
ADHD
neurofeedback
biofeedback
computer attention training

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014