Preventing Behavior Problems in Children With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057668
Recruitment Status : Unknown
Verified August 2006 by Lehigh University.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2003
Last Update Posted : November 19, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Lehigh University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: Multi-Setting Early Intervention Behavioral: Community Intervention Phase 2

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  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Behavioral Deficits in Young ADHD Children
Study Start Date : September 2001
Study Completion Date : August 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057668

United States, Pennsylvania
Lehigh University College of Education
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
Lehigh University
National Institute of Mental Health (NIMH) Identifier: NCT00057668     History of Changes
Other Study ID Numbers: R01MH061563 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2003    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: August 2006

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders