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NCT00051714 Clinical Trial

Early Prevention of Conduct Problems

Conduct Disorder Clinical Trial

Official title:
Early Primary Prevention of Conduct Problems

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00051714
Other study ID # R01MH055188
Secondary ID R01MH055188DSIR
Status Completed
Phase Phase 4
First received January 15, 2003
Last updated July 12, 2013
Start date March 1997

Study information
Verified date July 2013
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1050
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 33 Months to 63 Months
Eligibility Inclusion Criteria:

- Sibling of youth adjudicated in Family Court

Study Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Family-Based Preventive Intervention

Locations
Country Name City State
United States New York University Child Study Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
New York University School of Medicine National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary behavior problems March 1997 - December 2012 No
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