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

NCT ID: NCT01583829

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neurofeedback

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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

Cognitive Training

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

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

Waitlist Control

Group Type ACTIVE_COMPARATOR

Waitlist Control

Intervention Type OTHER

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

Interventions

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Neurofeedback

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

Intervention Type BEHAVIORAL

Cognitive Training

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

Intervention Type BEHAVIORAL

Waitlist Control

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi J Steiner, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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8926

Identifier Type: -

Identifier Source: org_study_id

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