Preventing Behavior Problems in Children With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Prevention of Behavioral Deficits in Young ADHD Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00057668
• Other study ID #: R01MH061563
• Secondary ID: R01MH061563DSIR
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 4, 2003
• Last updated: November 18, 2013
• Start date: September 2001
• Est. completion date: August 2006

Study information

• Verified date: August 2006
• Source: Lehigh University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity

Intervention

Behavioral:
• Multi-Setting Early Intervention

• Community Intervention

Locations

Country	Name	City	State
United States	Lehigh University College of Education	Bethlehem	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Lehigh University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,