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Completed

NCT Number: NCT02510209

Evaluation of the Teen Outreach Program in Hennepin County, Minnesota

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.

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin County Human Services and Public Health Department

Minneapolis, Minnesota, 55415, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teen Outreach Program

Behavioral

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.

Primary outcomes

  1. Sex in the last 90 days

    Time frame: 12 months after baseline

    Single dichotomous item on self-report questionnaire

Secondary outcomes

  1. Sex without contraception in the last 90 days

    Time frame: 12 months after baseline

    Single dichotomous item on self-report questionnaire

  2. Sex in the last 90 days

    Time frame: 24 months after baseline

    Single dichotomous item on self-report questionnaire

  3. Sex without contraception in the last 90 days

    Time frame: 24 months after baseline

    Single dichotomous item on self-report questionnaire

  4. Ever had sex

    Time frame: 12 months after baseline

    This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.

  5. Ever had sex

    Time frame: 24 months after baseline

    This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.

Sponsors and collaborators

Lead sponsor

Abt Associates

Industry

Collaborators

  • Hennepin County Human Services and Public Health Department

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2015
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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