Early Prevention of Conduct Problems | NCT00051714

Studies
Early Prevention of Conduct Problems

NCT00051714

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Jul 16, 2013Estimated

Enrollment

1,050Actual

Phase

Phase 4

Conditions

Conduct Disorder

Interventions

Family-Based Preventive Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH055188	U.S. NIH Grant/Contract		View source
DSIR 84-CTP

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1997

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Jan 15, 2003

First Submission Date that Met QC Criteria

Jun 3, 2003

First Posted Date

Jun 4, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurie Brotman, Professor Science Professor of Child & Adolescent Psychiatry, NYU Langone HealthPrincipal Investigator

Lead Sponsor

NYU Langone HealthOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,050Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early Primary Prevention	Experimental		Behavioral: Family-Based Preventive Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Family-Based Preventive Intervention	Behavioral		Early Primary Prevention

Measure	Description	Time Frame
behavior problems		March 1997 - December 2012

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sibling of youth adjudicated in Family Court

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

33 Months

Maximum Age

63 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University Child Study Center		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D019955	Conduct Disorder

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided