- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00099385
Comprehensive Elementary School Risk Prevention
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520-8064
- Yale University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All regular education students, including students in bilingual classes
Exclusion Criteria:
- Children attending special education classrooms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self reports of risky behaviors
Time Frame: Spring of 2008,2009,2010
|
Spring of 2008,2009,2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Academic test scores
Time Frame: annually 2006-2008
|
annually 2006-2008
|
Measure of social problem solving skills: Social Problem Solving Dilemma
Time Frame: Spring 2007,2008
|
Spring 2007,2008
|
Collaborators and Investigators
Investigators
- Principal Investigator: David J Schonfeld, MD, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01HD045362 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Risk Behavior
-
Bournemouth UniversityDorset HealthCare University NHS Foundation TrustWithdrawnRisk Behavior | Violence | Risk Behavior, Health
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedRisk Behavior | Risk Reduction | Emotion RegulationUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedHealth Behavior | Risk Reduction BehaviorUnited States
-
University of Colorado, DenverSmith-Richardson FoundationCompletedRisk Reduction Behavior | Reproductive BehaviorUnited States
-
University of MiamiEnrolling by invitation
-
Ginger YangUniversity of IowaRecruitingRisk Behavior | Adolescent Behavior | DriveUnited States
-
Pro-Change Behavior SystemsCommunity Health Center, Inc.Unknown
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingBehavior, RiskUnited States
-
Lehigh UniversityAlliance of Border Collaboratives; Programa CompañerosUnknownRisk BehaviorUnited States, Mexico
-
University of UtahNational Institute of Environmental Health Sciences (NIEHS)RecruitingRisk Reduction | Environmental Exposure | Risk Behavior, HealthUnited States
Clinical Trials on Social Development Instruction
-
Kessler FoundationEnrolling by invitationMultiple Sclerosis | Emotional DisturbancesUnited States
-
Education University of Hong KongRecruitingAutism Spectrum Disorder | Social Engagement | Robotic InterventionHong Kong
-
Chinese University of Hong KongRecruitingMental Well-being | Development, Child | MindfulnessHong Kong
-
Centre for Injury Prevention and Research BangladeshNot yet recruitingEarly Childhood Developmental Disability (Disorder)
-
Chinese University of Hong KongNot yet recruitingDevelopment, Child | MindfulnessHong Kong
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedAdolescent Health | Adolescent Problem Behavior
-
National Research Centre, EgyptEgyptian Liver HospitalCompletedHepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village
-
University of VirginiaRecruitingHuman Papillomavirus Infection | Vaccination HesitancyUnited States
-
University of Dublin, Trinity CollegeRecruitingPhysical InactivityIreland