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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
3 times per week for 45 minutes for a total of 40 sessions
cognitive training
3 times per week for 45 minutes for a total of 40 sessions
(Active Comparator)
waitlist control
6 30 minute calm breathing sessions over the course of 4 months

Primary Outcomes

Behavioral Observations of Students in School (BOSS)
time frame: up to three years

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Tufts Medical Center.