Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

City of Rochester Teen Outreach Program (TOP™) Evaluation

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: NCT02723292
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
State University of New York at Binghamton, Decker School of Nursing
City of Rochester Department of Recreation and Youth Services
Information provided by (Responsible Party):
Hugh Crean, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Problems Sex Behavior Academic Underachievement Disorder of Childhood or Adolescence Behavioral: TOP Behavioral: Control intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: City of Rochester Teen Outreach Program (TOP™) Evaluation
Study Start Date : September 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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.
Behavioral: TOP
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.
Behavioral: Control intervention



Primary Outcome Measures :
  1. Number of participants who become pregnant [ Time Frame: 21 months ]
  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Layout table for additonal information
Responsible Party: Hugh Crean, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02723292     History of Changes
Other Study ID Numbers: 36508
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided