Preventing Behavior Problems in Children With ADHD

November 18, 2013 updated by: Lehigh University

Prevention of Behavioral Deficits in Young ADHD Children

This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants are randomly assigned to either a Multi-Setting Early Intervention group or to a Community Intervention group. The Early Intervention group receives parent training and assessment-based behavioral and academic intervention for 1 year, followed by either a high or a low intensity maintenance intervention for an additional 18 months. The Community Intervention group members receive psychotropic medication, special education services, and monthly sessions to obtain information about child development and medical functioning for 2 years. Participants are assessed on six occasions over 4 years. Parents and teachers assess children's behavior, academic performance, and archival data, including medical and school records.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Lehigh University College of Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
  • Preschool, nursery school, or group daycare enrollment at least 2 days per week
  • Parents who can communicate in English

Exclusion Criteria:

  • Plans to move out of the area in the near future
  • Mental retardation, neurological damage, significant motor or physical impairments, or autism or other pervasive developmental disorder
  • Inattentive ADHD or conduct disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lehigh University

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 8, 2003

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH061563 (U.S. NIH Grant/Contract)
  • DSIR CT-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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