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Completed

NCT Number: NCT01583829

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurofeedback

Behavioral

3 times per week for 45 minutes for a total of 40 sessions

Cognitive training

Behavioral

3 times per week for 45 minutes for a total of 40 sessions

Waitlist Control

Other

6 30 minute calm breathing sessions over the course of 4 months

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Acronym: CATS

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Apr 24, 2012
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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