Clinical trial NCT02519530: 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
Overall status: COMPLETED
Phase: NA
Conditions: Unintended Pregnancy
Adolescent Problem Behavior
Keywords: Positive Youth Development
Teen Outreach
Teen Pregnancy Prevention
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
name: The Office of Adolescent Health, HHS
First posted: 2015-08-11
Enrollment: 8161
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey
timeFrame: 10 months post program
measure: Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey
timeFrame: 10 months post program
Secondary outcomes:
measure: Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey
timeFrame: Immediately post program
measure: Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey
timeFrame: Immediately post program
Other outcomes:
Locations:
Study officials:
affiliation: University of South Florida
name: Ellen Daley, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Eric Buhi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.