- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02548871
Evaluation of the Teen Outreach Program in Chicago Public Schools
September 11, 2015 updated by: Chapin Hall at the University of Chicago
Evaluation of the Teen Outreach Program in Chicago Public Schools: Replication of an Evidence-Based Teen Pregnancy Prevention Program
The purpose of this study was to determine the impact of TOP® on sexual health behavior.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools (CPS) with equal number of schools randomized to intervention and comparison groups for two cohort years.
Students were administered a scannable paper survey at three time points: baseline, post-program and 1-year post program.
The primary impact analysis used an intent-to-treat approach.
Implementation of TOP® was assessed by conducting classroom observations.
TOP® was delivered in a variety of classroom settings over the school year by facilitators from CPS and partner organizations.
Study Type
Interventional
Enrollment (Actual)
12253
Phase
- Not Applicable
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 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First-time 9th grade student
- Passive parental consent and student assent
Exclusion Criteria:
- Inability to complete survey in languages provided
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 positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels.
The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes.
TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning.
|
|
No Intervention: Comparison
Business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex without a condom in the last 90 days
Time Frame: 9 months after baseline
|
Dichotomous indicator from self-report survey
|
9 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex in the last 90 days
Time Frame: 9 months after baseline
|
Dichotomous indicator from self-report survey
|
9 months after baseline
|
|
Sex without a condom in the last 90 days, by race/ethnicity
Time Frame: 9 months after baseline
|
Dichotomous indicator from self-report survey
|
9 months after baseline
|
|
Sex without a condom in the last 90 days
Time Frame: 21 months after baseline
|
Dichotomous indicator from self-report survey
|
21 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Seshadri R, Smithgall C, Goerge R, Ippolito J, Dasgupta D, Wiegand E, Guiltinan S, Wood M. (2015) Evaluation of the Teen Outreach Program: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program. Chicago, IL: Chapin Hall at the University of Chicago
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
September 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
September 11, 2015
First Posted (Estimate)
September 14, 2015
Study Record Updates
Last Update Posted (Estimate)
September 14, 2015
Last Update Submitted That Met QC Criteria
September 11, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- TP1AH000066
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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