- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059486
Impact Evaluation of the Teen Choice Program
April 13, 2017 updated by: Mathematica Policy Research, Inc.
The purpose of this study is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York.
Study Overview
Detailed Description
This study uses a randomized controlled design to compare the impacts of the Teen Choice Program to the "business-as-usual" school curriculum.
The Teen Choice curriculum is designed for adolescents aged 12 to 19 and will be delivered in different formats that range in length from 6 to 12 weeks.
Teen Choice will be offered during the regular school day to middle and high school aged youth.
This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
Study Type
Interventional
Enrollment (Actual)
465
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
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New York
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Bronx, New York, United States, 10473
- Bronx Community High School
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Brooklyn, New York, United States, 11233
- R.O.A.D.S.
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Dobbs Ferry, New York, United States, 10522
- Clark Academy
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New York, New York, United States, 11417
- Robert H Goddard High School
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Yonkers, New York, United States, 10705
- Biondi 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
12 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 12-19
- Attending one of the participating schools
Exclusion Criteria:
- Juvenile Justice Youth
- School clinician determined trauma histories
- School clinician determined developmental issues
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 |
---|---|
Experimental: Teen Choice
The curriculum provides comprehensive sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence).
It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress.
The curriculum can be delivered in different formats that range in length from 6 to 12 weeks.
|
The curriculum provides sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence).
It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress.
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No Intervention: Control
Business as usual school health curriuclum
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Unprotected sex in the three months prior to the survey
Time Frame: 6-months post random assignment
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6-months post random assignment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexual Initiation
Time Frame: 6-months post intervention
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6-months post intervention
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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 (Actual)
January 1, 2014
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
February 7, 2014
First Posted (Estimate)
February 11, 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
- PRP699104
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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