Comprehensive Elementary School Risk Prevention

Risk Behavior Clinical Trial

Official title:

Comprehensive Elementary School Risk Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099385
• Other study ID #: R01HD045362
• Status: Completed
• Phase: N/A
• First received: December 13, 2004
• Last updated: February 15, 2012
• Start date: September 2004
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2620
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

• All regular education students, including students in bilingual classes

Exclusion Criteria:

• Children attending special education classrooms.

Study Design

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

Related Conditions & MeSH terms

• Risk Behavior

Intervention

Behavioral:
• Social Development Instruction
Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reports of risky behaviors		Spring of 2008,2009,2010	No
Secondary	Academic test scores		annually 2006-2008	No
Secondary	Measure of social problem solving skills: Social Problem Solving Dilemma		Spring 2007,2008	No