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Early Prevention of Conduct Problems

Primary Purpose

Conduct Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Family-Based Preventive Intervention

About this trial

This is an interventional prevention trial for Conduct Disorder focused on measuring Social Behavior Disorders

Eligibility Criteria

33 Months - 63 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Sibling of youth adjudicated in Family Court

Sites / Locations

New York University Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early Primary Prevention

Arm Description

Outcomes

Primary Outcome Measures

behavior problems

Secondary Outcome Measures

Full Information

NCT ID

NCT00051714

First Posted

January 15, 2003

Last Updated

July 12, 2013

Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00051714

Brief Title

Early Prevention of Conduct Problems

Official Title

Early Primary Prevention of Conduct Problems

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

March 1997 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to examine the immediate and long-term effects of a prevention program in children at risk for developing conduct problems and antisocial behavior.

Detailed Description

Participants are randomly assigned to a year-long family-based intervention or to a no contact control group. The intervention focuses on improving parenting practices, parent-child interactions, and child social competence. Children are assessed at the beginning of the study and again after one year. The development of conduct problems, social competence, and school functioning is assessed from second through fifth grade. Assessments are made through observations, parent and teacher ratings, and diagnostic interviews.

6. Conditions and Keywords

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

Conduct Disorder

Keywords

Social Behavior Disorders

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Primary Prevention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Family-Based Preventive Intervention

Primary Outcome Measure Information:

Title

behavior problems

Time Frame

March 1997 - December 2012

10. Eligibility

Sex

All

Minimum Age & Unit of Time

33 Months

Maximum Age & Unit of Time

63 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sibling of youth adjudicated in Family Court

Facility Information:

Facility Name

New York University Child Study Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Early Prevention of Conduct Problems

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