Text Size

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
History of Changes

December 13, 2004
February 15, 2012
September 2004
June 2010   (final data collection date for primary outcome measure)
Self reports of risky behaviors [ Time Frame: Spring of 2008,2009,2010 ] [ Designated as safety issue: No ]
  • Self reports of risky behaviors
  • Measures of social skills
Complete list of historical versions of study NCT00099385 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Comprehensive Elementary School Risk Prevention
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Risk Behavior
Behavioral: Social Development Instruction
Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2620
July 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All regular education students, including students in bilingual classes

Exclusion Criteria:

- Children attending special education classrooms.
Both
7 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099385
R01HD 45362
No
David Schonfeld, Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: David J Schonfeld, MD Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP