Comprehensive Elementary School Risk Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Schonfeld, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00099385
First received: December 13, 2004
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Risk Behavior
Behavioral: Social Development Instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comprehensive Elementary School Risk Prevention

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Self reports of risky behaviors [ Time Frame: Spring of 2008,2009,2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Academic test scores [ Time Frame: annually 2006-2008 ] [ Designated as safety issue: No ]
  • Measure of social problem solving skills: Social Problem Solving Dilemma [ Time Frame: Spring 2007,2008 ] [ Designated as safety issue: No ]

Enrollment: 2620
Study Start Date: September 2004
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Social Development Instruction
    Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.
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.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All regular education students, including students in bilingual classes

Exclusion Criteria:

- Children attending special education classrooms.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00099385

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8064
Sponsors and Collaborators
Investigators
Principal Investigator: David J Schonfeld, MD Yale University
  More Information

No publications provided

Responsible Party: David Schonfeld, Director, Division of Developmental and Behavioral Pediatrics, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00099385     History of Changes
Other Study ID Numbers: R01HD 45362
Study First Received: December 13, 2004
Last Updated: February 15, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
social development
risk behaviors
social emotional education
classroom instruction

ClinicalTrials.gov processed this record on October 23, 2014