Evaluation of the Teen Outreach Program in Hennepin County, Minnesota

Study Overview
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Brief Summary
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This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term.

Detailed Description
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This is a cluster randomized controlled trial. Teachers were randomized within schools to the treatment and control conditions. To assess the impact of offering TOP®, students were surveyed three times: at baseline, before the intervention began for the treatment group; 12 months after baseline (short-term impacts); and 24 months after baseline (long-term impacts). Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper surveys were used as back-up for baseline data collection. The pooled survey data from two school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were used to describe program implementation.TOP® was delivered in middle schools, high schools, alternative schools, and public charter schools in Hennepin County. It was implemented during school hours in classes that spanned an entire school year with the same cohort of students. The subject of the class in which TOP® was placed differed across schools (for example, social studies, study hall, health).

Official Title
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Evaluation of the Teen Outreach Program in Hennepin County, Minnesota: Findings From the Replication of an Evidence-Based Teen Pregnancy Prevention Program

Conditions
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Sexual Behavior, Pregnancy Early

Intervention / Treatment
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* Behavioral: Teen Outreach Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in a study teacher's class at the time of the baseline survey Active parental consent and youth assent Exclusion Criteria: Inability to complete survey in the languages provided Prior participation in TOP

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teen Outreach Program<br> | Behavioral: Teen Outreach Program<br>* TOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17.<br>|
| No Intervention: Control<br>Business as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex in the last 90 days | Single dichotomous item on self-report questionnaire | 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex without contraception in the last 90 days | Single dichotomous item on self-report questionnaire | 12 months after baseline | 
| Sex in the last 90 days | Single dichotomous item on self-report questionnaire | 24 months after baseline | 
| Sex without contraception in the last 90 days | Single dichotomous item on self-report questionnaire | 24 months after baseline | 
| Ever had sex | This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire. | 12 months after baseline | 
| Ever had sex | This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire. | 24 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teen pregnancy