Comprehensive Elementary School Risk Prevention

Not Applicable

Completed

• Conditions: Risk Behavior

• Registration Number: NCT00099385
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Detailed Description

Educational programs to promote the adoption of healthy behaviors and to decrease the onset of risky behaviors in pre-adolescents are far more likely to be successful than attempts to alter established patterns of high-risk behaviors. The project involves an evaluation of a comprehensive 4-year elementary school prevention initiative starting in 3rd grade. The prevention initiative, grounded in social cognitive, influence, and development theories is embedded within a pre-existing comprehensive elementary school social development program and will employ an evidence-based social skills curriculum (PATHS) in selected schools. The aim of the program is to teach children to use problem-solving and communication skills to negotiate and prevent high-risk behaviors.

Students attending schools that will receive the enhanced social development program will be compared to students attending schools that will receive the current, standard social development curriculum. The study hypothesizes that students who participate in the 4-year enhanced social development program will self-report fewer risk behaviors when surveyed by the school system in grades 6-8.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-12-13
• Study First Submitted QC: 2004-12-13
• Study First Posted: 2004-12-14
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2620

Inclusion Criteria

• All regular education students, including students in bilingual classes

Exclusion Criteria

• Children attending special education classrooms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self reports of risky behaviors	Spring of 2008,2009,2010

Secondary Outcome Measures

Name	Time	Method
Academic test scores	annually 2006-2008
Measure of social problem solving skills: Social Problem Solving Dilemma	Spring 2007,2008

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States