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

NCT01583829 | Completed DMC

• 1 other identifier: 8926
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; neurofeedback; biofeedback; computer attention training

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Neurofeedback

EXPERIMENTAL

Behavioral: Neurofeedback

Cognitive Training

EXPERIMENTAL

Behavioral: Cognitive Training

Waitlist Control

ACTIVE COMPARATOR

Other: Waitlist Control

Interventions

Neurofeedback BEHAVIORAL

3 times per week for 45 minutes for a total of 40 sessions

Neurofeedback

Cognitive Training BEHAVIORAL

3 times per week for 45 minutes for a total of 40 sessions

Cognitive Training

Waitlist Control OTHER

6 30 minute calm breathing sessions over the course of 4 months

Waitlist Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• mental retardation,
• coexisting diagnosis of conduct disorder,
• pervasive developmental disorder, or
• other serious mental illness (eg., bipolar disorder, psychosis, autism)

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback; Cognitive Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Naomi J Steiner, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 24, 2012
• Study Start: May 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: November 1, 2013
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

US (1)