- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054026
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
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
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Bowling Green, Kentucky, United States, 42101
- Warren Central High School
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Bowling Green, Kentucky, United States, 42101
- Warren East High School
-
Bowling Green, Kentucky, United States, 42104
- Greenwood High School
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Cecilia, Kentucky, United States, 42724
- Central Hardin High School
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Edmonton, Kentucky, United States, 42129
- Metcalfe County High School
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Elizabethtown, Kentucky, United States, 42701
- Elizabethtown High School
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Franklin, Kentucky, United States, 42134
- Franklin-Simpson High School
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Hodgenville, Kentucky, United States, 42748
- LaRue High School
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Lebanon, Kentucky, United States, 40033
- Marion County High School
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Radcliff, Kentucky, United States, 40160
- North Hardin High School
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Russellville, Kentucky, United States, 42276
- Logan County High School
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Russellville, Kentucky, United States, 42276
- Russellville Junior/Senior High School
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-
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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