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Preventing Behavior Problems in Children With ADHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00057668
First received: April 4, 2003
Last updated: August 15, 2006
Last verified: August 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Behavioral Deficits in Young ADHD Children

Resource links provided by NLM:

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

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013