City of Rochester Teen Outreach Program (TOP™) Evaluation

Sex Behavior Clinical Trial

Official title:

City of Rochester Teen Outreach Program (TOP™) Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723292
• Other study ID #: 36508
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 8, 2018
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: February 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1188
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Academic Underachievement Disorder of Childhood or Adolescence
• Adolescent Problems
• Sex Behavior

Intervention

Behavioral:
• TOP

• Control intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	City of Rochester Department of Recreation and Youth Services, State University of New York at Binghamton, Decker School of Nursing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who become pregnant		21 months
Primary	Number of youth who report ever having had sexual intercourse	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
Primary	Amount of sexual intercourse in preceding 3 months without an effective means of birth control	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	Number of failing grades on report card	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