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Preventing Behavior Problems in Children With ADHD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Lehigh University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Lehigh University
ClinicalTrials.gov Identifier:
NCT00057668
First received: April 4, 2003
Last updated: November 18, 2013
Last verified: August 2006
  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
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:


Further study details as provided by Lehigh University:

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lehigh University
National Institute of Mental Health (NIMH)
  More Information

ClinicalTrials.gov Identifier: NCT00057668     History of Changes
Other Study ID Numbers: R01MH061563 ( US NIH Grant/Contract Award Number )
DSIR CT-S
Study First Received: April 4, 2003
Last Updated: November 18, 2013

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

ClinicalTrials.gov processed this record on June 27, 2017