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Comprehensive Elementary School Risk Prevention

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ClinicalTrials.gov Identifier: NCT00099385
Recruitment Status : Completed
First Posted : December 14, 2004
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Risk Behavior Behavioral: Social Development Instruction

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive Elementary School Risk Prevention
Study Start Date : September 2004
Primary Completion Date : June 2010
Study Completion Date : July 2010
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Self reports of risky behaviors [ Time Frame: Spring of 2008,2009,2010 ]

Secondary Outcome Measures :
  1. Academic test scores [ Time Frame: annually 2006-2008 ]
  2. Measure of social problem solving skills: Social Problem Solving Dilemma [ Time Frame: Spring 2007,2008 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All regular education students, including students in bilingual classes

Exclusion Criteria:

- Children attending special education classrooms.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099385

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8064
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: David J Schonfeld, MD Yale University
More Information

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: R01HD045362 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2004    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by David Schonfeld, Children's Hospital Medical Center, Cincinnati:
social development
risk behaviors
social emotional education
classroom instruction