NCT02519530

Brief Summary

Investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the Teen Outreach Program) on high school youth in Florida. This study will answer the following questions: What is the impact of the Teen Outreach Program on sexual activity and positive youth development at the end of the program and 10 months after the program?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

August 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 31, 2015

Last Update Submit

August 6, 2015

Conditions

Unintended PregnancyAdolescent Problem Behavior

Keywords

Positive Youth DevelopmentTeen OutreachTeen Pregnancy Prevention

Outcome Measures

Primary Outcomes (2)

  • Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey

    What is the impact of TOP relative to business as usual on ever having sexual intercourse 10 months after the end of the program?

    10 months post program

  • Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey

    What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant 10 months after the end of the program?

    10 months post program

Secondary Outcomes (2)

  • Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey

    Immediately post program

  • Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey

    Immediately post program

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Teen Outreach Program

Behavioral: Teen Outreach Program

Comparison

NO INTERVENTION

This group did not receive TOP, they received business as usual health curriculum offered through the public school system

Interventions

Teen Outreach ProgramBEHAVIORAL

The Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content.

Intervention

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in a class selected for evaluation
  • Had parental consent
  • Proficient in English
  • Capable of independently taking a paper and pencil survey

You may not qualify if:

  • Not enrolled in a class randomly selected for the evaluation
  • They joined a participating class after the completion of the parental consent process
  • Not sufficiently proficient in English
  • Could not independently take a paper and pencil survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Marhefka SL, Noble CA, Walsh-Buhi ER, Turner D, Mahony H, Singleton A, DeBate R, Daley EM. Key Considerations and Recommended Strategies for Conducting a School-Based Longitudinal RE-AIM Evaluation: Insights From a 28-School Cluster Randomized Trial. Health Promot Pract. 2023 Jan;24(1):160-171. doi: 10.1177/15248399211042339. Epub 2021 Oct 4.

    PMID: 34605711DERIVED

  • Walsh-Buhi ER, Marhefka SL, Wang W, Debate R, Perrin K, Singleton A, Noble CA, Rahman S, Maness SB, Mahony H, Ziemba R, Malmi M, Marwah E, Hall K, Turner D, Blunt-Vinti H, Noble SM, Daley EM. The Impact of the Teen Outreach Program on Sexual Intentions and Behaviors. J Adolesc Health. 2016 Sep;59(3):283-290. doi: 10.1016/j.jadohealth.2016.05.007. Epub 2016 Jun 16.

    PMID: 27318427DERIVED

Study Officials

  • Ellen Daley, Ph.D

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Eric Buhi, Ph.D

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 11, 2015

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-07