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Completed

NCT Number: NCT02519530

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

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?

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Key information

Conditions

Unintended Pregnancy Adolescent Problem Behavior

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teen Outreach Program

Behavioral

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.

Primary outcomes

  1. 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?

  2. 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?

Secondary outcomes

  1. 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?

  2. 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?

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Florida Department of Health
  • The Office of Adolescent Health, HHS

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 11, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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