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

Primary Purpose

Unintended Pregnancy, Adolescent Problem Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teen Outreach Program
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Unintended Pregnancy focused on measuring Positive Youth Development, Teen Outreach, Teen Pregnancy Prevention

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Comparison

    Arm Description

    Behavioral: Teen Outreach Program

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

    Outcomes

    Primary Outcome Measures

    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?
    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?

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 31, 2015
    Last Updated
    August 6, 2015
    Sponsor
    University of South Florida
    Collaborators
    Florida Department of Health, The Office of Adolescent Health, HHS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519530
    Brief Title
    Multi-site Evaluation of an Evidence-based Positive Youth Development Program
    Official Title
    Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida
    Collaborators
    Florida Department of Health, The Office of Adolescent Health, HHS

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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?
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unintended Pregnancy, Adolescent Problem Behavior
    Keywords
    Positive Youth Development, Teen Outreach, Teen Pregnancy Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    8161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Behavioral: Teen Outreach Program
    Arm Title
    Comparison
    Arm Type
    No Intervention
    Arm Description
    This group did not receive TOP, they received business as usual health curriculum offered through the public school system
    Intervention Type
    Behavioral
    Intervention Name(s)
    Teen Outreach Program
    Intervention Description
    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 Outcome Measure Information:
    Title
    Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey
    Description
    What is the impact of TOP relative to business as usual on ever having sexual intercourse 10 months after the end of the program?
    Time Frame
    10 months post program
    Title
    Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey
    Description
    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?
    Time Frame
    10 months post program
    Secondary Outcome Measure Information:
    Title
    Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey
    Description
    What is the impact of TOP relative to business as usual on ever having sexual intercourse at the end of the program?
    Time Frame
    Immediately post program
    Title
    Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey
    Description
    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?
    Time Frame
    Immediately post program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ellen Daley, Ph.D
    Organizational Affiliation
    University of South Florida
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eric Buhi, Ph.D
    Organizational Affiliation
    San Diego State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27318427
    Citation
    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. Erratum In: J Adolesc Health. 2016 Nov;59(5):607.
    Results Reference
    derived

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

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