Preventing Behavior Problems in Children With ADHD

This study is ongoing, but not recruiting participants.

First Received: April 4, 2003 Last Updated: August 15, 2006 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00057668

Purpose

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	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Behavioral: Multi-Setting Early Intervention Behavioral: Community Intervention	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Behavioral Deficits in Young ADHD Children

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	200
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	3 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057668

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided

Study ID Numbers:	R01 MH61563, DSIR CT-S
Study First Received:	April 4, 2003
Last Updated:	August 15, 2006
ClinicalTrials.gov Identifier:	NCT00057668 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on November 27, 2009