Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder
This trial is active, not recruiting.
|Condition||attention deficit hyperactivity disorder|
|Treatments||neurofeedback, cognitive training, waitlist control|
|Sponsor||Tufts Medical Center|
|Start date||May 2009|
|End date||December 2012|
|Trial size||104 participants|
|Trial identifier||NCT01583829, 8926|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, outcomes assessor)|
Behavioral Observations of Students in School (BOSS)
time frame: up to three years
Male or female participants from 6 years up to 12 years old.
- 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
- mental retardation,
- coexisting diagnosis of conduct disorder,
- pervasive developmental disorder, or
- other serious mental illness (eg., bipolar disorder, psychosis, autism)
|Official title||Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)|
|Principal investigator||Naomi J Steiner, MD|
|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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