NCT00099385

Brief Summary

This project will evaluate the benefit of an enhanced social development program in grades 3-6 to decrease the onset of risky behaviors in pre-adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2004

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

5.8 years

First QC Date

December 13, 2004

Last Update Submit

February 15, 2012

Conditions

Risk Behavior

Keywords

social developmentrisk behaviorssocial emotional educationclassroom instruction

Outcome Measures

Primary Outcomes (1)

  • Self reports of risky behaviors

    Spring of 2008,2009,2010

Secondary Outcomes (2)

  • Academic test scores

    annually 2006-2008

  • Measure of social problem solving skills: Social Problem Solving Dilemma

    Spring 2007,2008

Interventions

Social Development InstructionBEHAVIORAL

Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg \& Kusche) curriculum.

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All regular education students, including students in bilingual classes

You may not qualify if:

  • \- Children attending special education classrooms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

Location

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David J Schonfeld, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Developmental and Behavioral Pediatrics

Study Record Dates

First Submitted

December 13, 2004

First Posted

December 14, 2004

Study Start

September 1, 2004

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)