Multi-site Evaluation of an Evidence-based Positive Youth Development Program

August 6, 2015 updated by: University of South Florida

Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Schools were randomly allocated to either the intervention or the control group. At treatment (intervention) schools, youth participated in TOP in addition to their Health, HOPE, Critical Thinking, Career Research, or Leadership class. At control (non-intervention) schools, youth simply participated in their business-as-usual Health, HOPE, Critical Thinking, Career Research, or Leadership class. Two cohorts of students were recruited for this study, the first cohort joined the study in August 2012 and the second cohort joined the study in August 2013. A survey was given to youth at both treatment and control schools. The paper-and-pencil survey took approximately 30 minutes and asked questions about youth school, grades, peers, health behaviors, and behaviors related to teen pregnancy, including what the participant believes and does in regards to sexual health. The survey was completely confidential and participant names were not linked to survey responses. All survey materials were pre-approved by school administration and the school district office. Participants will be asked to complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention (Cohort 1 only)

Study Type

Interventional

Enrollment (Actual)

8161

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

13 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Teen Outreach Program
Behavioral: Teen Outreach Program
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.
No Intervention: Comparison
This group did not receive TOP, they received business as usual health curriculum offered through the public school system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey
Time Frame: 10 months post program
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
Time Frame: 10 months post program
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey
Time Frame: Immediately post program
What is the impact of TOP relative to business as usual on ever having sexual intercourse at the end of the program?
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
Time Frame: Immediately post program
What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant at the end of the program?
Immediately post program

Collaborators and Investigators

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

Sponsor

University of South Florida

Collaborators

Florida Department of Health
The Office of Adolescent Health, HHS

Investigators

  • Principal Investigator: Ellen Daley, Ph.D, University of South Florida
  • Principal Investigator: Eric Buhi, Ph.D, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5 TP1AH000017-04-00

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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