Impact Evaluation of the Reducing the Risk Program

April 13, 2017 updated by: Mathematica Policy Research, Inc.
The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Bardstown High School
      • Bowling Green, Kentucky, United States, 42101
        • Warren Central High School
      • Bowling Green, Kentucky, United States, 42101
        • Warren East High School
      • Bowling Green, Kentucky, United States, 42104
        • Greenwood High School
      • Cecilia, Kentucky, United States, 42724
        • Central Hardin High School
      • Edmonton, Kentucky, United States, 42129
        • Metcalfe County High School
      • Elizabethtown, Kentucky, United States, 42701
        • Elizabethtown High School
      • Franklin, Kentucky, United States, 42134
        • Franklin-Simpson High School
      • Hodgenville, Kentucky, United States, 42748
        • LaRue High School
      • Lebanon, Kentucky, United States, 40033
        • Marion County High School
      • Radcliff, Kentucky, United States, 40160
        • North Hardin High School
      • Russellville, Kentucky, United States, 42276
        • Logan County High School
      • Russellville, Kentucky, United States, 42276
        • Russellville Junior/Senior High School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 9th grader
  • Attends participating school

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Reducing the Risk
An eight-lesson (approximately eight-hour) version of Reducing the Risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sexual Initiation
Time Frame: 2-years post intervention
2-years post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Sexual Initiation
Time Frame: 1-year post intervention
1-year post intervention
Contraceptive use
Time Frame: 1-year post intervention
1-year post intervention
Contraceptive use
Time Frame: 2-years post intervention
2-years post intervention
Number of sexual partners
Time Frame: 1-year post intervention
1-year post intervention
Number of sexual partners
Time Frame: 2-years post intervention
2-years post intervention

Other Outcome Measures

Outcome Measure
Time Frame
Attitudes towards healthy relationships and sexual activity
Time Frame: 1-year post intervention
1-year post intervention
Attitudes towards healthy relationships and sexual activity
Time Frame: 2-years post intervention
2-years post intervention
Knowledge of Sexually Transmitted Diseases
Time Frame: 1-year post intervention
1-year post intervention
Knowledge of Sexually Transmitted Diseases
Time Frame: 2-years post intervention
2-years post intervention
Career and Education Goals
Time Frame: 1-year post intervention
1-year post intervention
Career and Education Goals
Time Frame: 2-years post intervention
2-years post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Robert Wood, PhD, Mathematica Policy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PRP699102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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