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Completed

NCT Number: NCT00099385

Comprehensive Elementary School Risk Prevention

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.

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Key information

Conditions

Risk Behavior Behavior Risk-Taking

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All regular education students, including students in bilingual classes

Exclusion criteria

  • Children attending special education classrooms.

Treatment and study plan

Social Development Instruction

Behavioral

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

Primary outcomes

  1. Self reports of risky behaviors

    Time frame: Spring of 2008,2009,2010

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2004
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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