NCT02059486

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
465

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

4.4 years

First QC Date

January 30, 2014

Last Update Submit

April 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Unprotected sex in the three months prior to the survey

    6-months post random assignment

Secondary Outcomes (1)

  • Sexual Initiation

    6-months post intervention

Study Arms (2)

Teen Choice

EXPERIMENTAL

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.

Behavioral: Teen Choice

Control

NO INTERVENTION

Business as usual school health curriuclum

Interventions

Teen ChoiceBEHAVIORAL

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.

Teen Choice

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-19
  • Attending one of the participating schools

You may not qualify if:

  • Juvenile Justice Youth
  • School clinician determined trauma histories
  • School clinician determined developmental issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

R.O.A.D.S.

Brooklyn, New York, 11233, United States

Location

Clark Academy

Dobbs Ferry, New York, 10522, United States

Location

Robert H Goddard High School

New York, New York, 11417, United States

Location

Bronx Community High School

The Bronx, New York, 10473, United States

Location

Biondi School

Yonkers, New York, 10705, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Robert Wood, PhD

    Mathematica Policy Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 11, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations