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

Attention Deficit Hyperactivity Disorder Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583829
• Other study ID #: 8926
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: July 6, 2017
• Start date: May 2009
• Est. completion date: November 2013

Study information

• Verified date: July 2017
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Behavioral:
• Neurofeedback
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

Other:
• Waitlist Control
6 30 minute calm breathing sessions over the course of 4 months

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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