- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02510209
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
Conditions
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
-
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Human Services and Public Health Department
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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.
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No Intervention: Control
Business as usual.
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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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