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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02519530
Other study ID # 5 TP1AH000017-04-00
Secondary ID
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


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
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