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

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ClinicalTrials.gov Identifier: NCT02519530
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Collaborators:
Florida Department of Health
The Office of Adolescent Health, HHS
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 11, 2015
Last Update Posted Date August 11, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
  • 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?
  • 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?
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
  • 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?
  • 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?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-site Evaluation of an Evidence-based Positive Youth Development Program
Official Title  ICMJE Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Unintended Pregnancy
  • Adolescent Problem Behavior
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Behavioral: Teen Outreach Program
    Intervention: Behavioral: Teen Outreach Program
  • No Intervention: Comparison
    This group did not receive TOP, they received business as usual health curriculum offered through the public school system
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2015)
8161
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02519530
Other Study ID Numbers  ICMJE 5 TP1AH000017-04-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE
  • Florida Department of Health
  • The Office of Adolescent Health, HHS
Investigators  ICMJE
Principal Investigator: Ellen Daley, Ph.D University of South Florida
Principal Investigator: Eric Buhi, Ph.D San Diego State University
PRS Account University of South Florida
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP