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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: May 8, 2013
Last verified: May 2013
History of Changes

April 16, 2012
May 8, 2013
May 2009
December 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01583829 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder
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.

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.

107 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Behavioral: Neurofeedback
    3 times per week for 45 minutes for a total of 40 sessions
  • Behavioral: Cognitive Training
    3 times per week for 45 minutes for a total of 40 sessions
  • Other: Waitlist Control
    6 30 minute calm breathing sessions over the course of 4 months
  • Experimental: Neurofeedback
    Intervention: Behavioral: Neurofeedback
  • Experimental: Cognitive Training
    Intervention: Behavioral: Cognitive Training
  • Active Comparator: Waitlist Control
    Intervention: Other: Waitlist Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
107
November 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01583829
8926
Yes
Tufts Medical Center
Tufts Medical Center
Not Provided
Principal Investigator: Naomi J Steiner, MD Tufts Medical Center
Tufts Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP