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
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
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
NCT ID
NCT02519530
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
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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