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Impact Evaluation of the Reducing the Risk Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054026
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mathematica Policy Research, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Behavioral: Reducing the Risk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact Evaluation of the Reducing the Risk Program
Study Start Date : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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



Primary Outcome Measures :
  1. Sexual Initiation [ Time Frame: 2-years post intervention ]

Secondary Outcome Measures :
  1. Sexual Initiation [ Time Frame: 1-year post intervention ]
  2. Contraceptive use [ Time Frame: 1-year post intervention ]
  3. Contraceptive use [ Time Frame: 2-years post intervention ]
  4. Number of sexual partners [ Time Frame: 1-year post intervention ]
  5. Number of sexual partners [ Time Frame: 2-years post intervention ]

Other Outcome Measures:
  1. Attitudes towards healthy relationships and sexual activity [ Time Frame: 1-year post intervention ]
  2. Attitudes towards healthy relationships and sexual activity [ Time Frame: 2-years post intervention ]
  3. Knowledge of Sexually Transmitted Diseases [ Time Frame: 1-year post intervention ]
  4. Knowledge of Sexually Transmitted Diseases [ Time Frame: 2-years post intervention ]
  5. Career and Education Goals [ Time Frame: 1-year post intervention ]
  6. Career and Education Goals [ Time Frame: 2-years post intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9th grader
  • Attends participating school

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054026


Locations
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United States, Kentucky
Bardstown High School
Bardstown, Kentucky, United States, 40004
Warren Central High School
Bowling Green, Kentucky, United States, 42101
Warren East High School
Bowling Green, Kentucky, United States, 42101
Greenwood High School
Bowling Green, Kentucky, United States, 42104
Central Hardin High School
Cecilia, Kentucky, United States, 42724
Metcalfe County High School
Edmonton, Kentucky, United States, 42129
Elizabethtown High School
Elizabethtown, Kentucky, United States, 42701
Franklin-Simpson High School
Franklin, Kentucky, United States, 42134
LaRue High School
Hodgenville, Kentucky, United States, 42748
Marion County High School
Lebanon, Kentucky, United States, 40033
North Hardin High School
Radcliff, Kentucky, United States, 40160
Logan County High School
Russellville, Kentucky, United States, 42276
Russellville Junior/Senior High School
Russellville, Kentucky, United States, 42276
Sponsors and Collaborators
Mathematica Policy Research, Inc.
Investigators
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Study Director: Robert Wood, PhD Mathematica Policy Research

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Responsible Party: Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier: NCT02054026    
Other Study ID Numbers: PRP699102
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No