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

• ClinicalTrials.gov Identifier: NCT02519530
• Recruitment Status: Completed
• First Posted: August 11, 2015
• Last Update Posted: August 11, 2015
• Sponsor: University of South Florida
• 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: July 31, 2015
• First Posted Date: August 11, 2015
• Last Update Posted Date: August 11, 2015
• Study Start Date: August 2012
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention

Condition

• Unintended Pregnancy
• Adolescent Problem Behavior

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 6, 2015): 8161
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 22 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02519530
• Other Study ID Numbers: 5 TP1AH000017-04-00
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of South Florida
• 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

• PRS Account: University of South Florida
• Verification Date: July 2015