Evaluation of the Teen Outreach Program in Hennepin County, Minnesota

July 27, 2015 updated by: Abt Associates

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

1644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Human Services and Public Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teen Outreach Program
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.
No Intervention: Control
Business as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex in the last 90 days
Time Frame: 12 months after baseline
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
Time Frame: 12 months after baseline
Single dichotomous item on self-report questionnaire
12 months after baseline
Sex in the last 90 days
Time Frame: 24 months after baseline
Single dichotomous item on self-report questionnaire
24 months after baseline
Sex without contraception in the last 90 days
Time Frame: 24 months after baseline
Single dichotomous item on self-report questionnaire
24 months after baseline
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.
12 months after baseline
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.
24 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Kimberly Francis, PhD, Abt Associates Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Francis, K., Woodford, M., and Kelsey, M. (2015). "Evaluation of the Teen Outreach Program in Hennepin County, MN: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program." Cambridge, MA: Abt Associates Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP1AH000078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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