NCT00956605

Brief Summary

This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

1.1 years

First QC Date

August 7, 2009

Last Update Submit

August 10, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

EEG-biofeedbackneurofeedbackcomputer attention training systemsADHDADDchildchildren

Outcome Measures

Primary Outcomes (1)

  • Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention

    Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.

Study Arms (3)

EEG biofeedback intervention

EXPERIMENTAL
Behavioral: Computer attention training systems for children with ADHD

Non EEG biofeedback computerized attention training

ACTIVE COMPARATOR
Behavioral: Computer attention training systems for children with ADHD

waitlist control

NO INTERVENTION

Interventions

Computer attention training systems for children with ADHDBEHAVIORAL

Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants

EEG biofeedback interventionNon EEG biofeedback computerized attention training

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child in 6th, 7th or 8th grade
  • a diagnosis of ADHD (any subtype) per report of the child's physician
  • academic achievement at grade level
  • ability to read in English sufficiently to complete assessments and intervention protocols

You may not qualify if:

  • coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center / Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Naomi Steiner, MD

    Tufts Medical Center / Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 11, 2009

Study Start

May 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

US(1)