City of Rochester Teen Outreach Program (TOP™) Evaluation

February 8, 2018 updated by: Hugh Crean, University of Rochester
As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1188

Phase

  • Not Applicable

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

11 years to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must be registered at a participating RC
  • age 11 through 14 years
  • participants must assent and parent(s) or legal guardian(s) provide permission to participate
  • basic understanding of the English language

Exclusion Criteria:

  • age at enrollment of less than 11 or greater than 14 years
  • for facilitators, age less than 21 is an exclusion criterion

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group services
This study will replicate the evidence-based TOP™ in after-school sessions held during RC hours. The primary components of TOP™ include: Comprehensive age-appropriate sexuality education; 90-minute sessions, once a week after-school, during the school year for nine months, using the Changing Scenes© curriculum, and at least twenty hours of youth-led service learning, which involves youth in planning, implementing and reflecting on, community service and leadership.
ACTIVE_COMPARATOR: Control group services
Youth in the control arm will receive a work readiness training curriculum focused on competencies to secure employment. This will include such topics as building customer service skills, clear and direct communication, and creating a work portfolio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who become pregnant
Time Frame: 21 months
21 months
Number of youth who report ever having had sexual intercourse
Time Frame: 21 months
For youth who were sexually naive at baseline, the outcome is the number of youth who report ever having had sexual intercourse at the 21 month assessment point.
21 months
Amount of sexual intercourse in preceding 3 months without an effective means of birth control
Time Frame: 21 months
The number of times a youth reports having had sexual intercourse without using an effective means of birth control measured at the 21 month assessment point.
21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of failing grades on report card
Time Frame: 21 months
This is a self-report measure of the number of courses failed on the last report card received, measured at the 21 month assessment point.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

September 1, 2011

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (ESTIMATE)

March 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 36508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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