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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02059486
Other study ID # PRP699104
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 30, 2014
Last updated April 13, 2017
Start date January 2014
Est. completion date June 2018

Study information

Verified date April 2017
Source Mathematica Policy Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 465
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Teen Choice
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.

Locations

Country Name City State
United States Bronx Community High School Bronx New York
United States R.O.A.D.S. Brooklyn New York
United States Clark Academy Dobbs Ferry New York
United States Robert H Goddard High School New York New York
United States Biondi School Yonkers New York

Sponsors (1)

Lead Sponsor Collaborator
Mathematica Policy Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unprotected sex in the three months prior to the survey 6-months post random assignment
Secondary Sexual Initiation 6-months post intervention
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