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

Adolescent Problem Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519530
• Other study ID #: 5 TP1AH000017-04-00
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: August 6, 2015
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8161
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 22 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Problem Behavior
• Unintended Pregnancy

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	Florida Department of Health, The Office of Adolescent Health, HHS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	10 months post program	No
Primary	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?	10 months post program	No
Secondary	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?	Immediately post program	No
Secondary	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?	Immediately post program	No