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Preventing Behavior Problems in Children With ADHD

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Multi-Setting Early Intervention

Community Intervention

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Lehigh University College of Education

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00057668

First Posted

April 4, 2003

Last Updated

November 18, 2013

Sponsor

Lehigh University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00057668

Brief Title

Preventing Behavior Problems in Children With ADHD

Official Title

Prevention of Behavioral Deficits in Young ADHD Children

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Lehigh University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Multi-Setting Early Intervention

Intervention Type

Behavioral

Intervention Name(s)

Community Intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Lehigh University College of Education

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

12. IPD Sharing Statement

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Preventing Behavior Problems in Children With ADHD

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