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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Neurofeedback; Other: Waitlist Control; Behavioral: Cognitive Training

• Registration Number: NCT01583829
• Lead Sponsor: Tufts Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2012-12
• Study Completion: 2013-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Neurofeedback	-
Waitlist Control	Waitlist Control	-
Cognitive Training	Cognitive Training	-

Primary Outcome Measures

Name	Time	Method
Behavioral Observations of Students in School (BOSS)	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).

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States