NCT02723292

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Status
completed

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

September 1, 2011

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

4.6 years

First QC Date

February 4, 2016

Last Update Submit

February 8, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants who become pregnant

    21 months

  • 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

  • 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 Outcomes (1)

  • Number of failing grades on report card

    21 months

Study Arms (2)

Experimental group services

EXPERIMENTAL

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

Control group services

ACTIVE COMPARATOR

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

Interventions

TOPBEHAVIORAL
Experimental group services
Control group services

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • age at enrollment of less than 11 or greater than 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

March 30, 2016

Study Start

September 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 12, 2018

Record last verified: 2018-02