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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Neurofeedback
* Behavioral: Cognitive Training
* Other: Waitlist Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Observations of Students in School (BOSS) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, neurofeedback, biofeedback, computer attention training