- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02514811
Replication of the Teen Outreach Program in the Pacific Northwest
September 14, 2020 updated by: Philliber Research & Evaluation
Northwest Coalition for Adolescent Health (NWCAH) Teen Outreach Program Replication Study
The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon, and Washington.
The purpose of this study is to measure: at the end of the program year, were TOP students less likely than control group students to report ever being pregnant or causing someone to be pregnant?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8686
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 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has parental consent and student assent
- Attends one of the schools and/or classes chosen for the program
Exclusion Criteria:
- Lack of consent or assent
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The Teen Outreach Program
TOP is a youth development and service learning program for youth 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 months: (1) weekly curriculum sessions, (2) community service learning, and (3) positive adult guidance and support.
The TOP Changing Scenes Curriculum is separated into four age-/stage-appropriate levels, Level 1 is typically for youth ages 12 or 13 and Level 4 is typically for youth age 17.
The intended program dosage for each participant is a minimum of 25 weekly sessions and at least 20 hours of community service learning over nine months.
One or two facilitators, who plan the order of sessions based on the needs and interest of youth, implemented TOP in a group of 10 to 25 youth.
|
Students received the Teen Outreach Program as described previously.
|
No Intervention: Control Group
Students in the control condition receive a benign intervention called the Community Voices (CV) program, which like TOP, meets in a group setting.
The CV students are convened four times during the program year.
Sessions are the same length as the TOP sessions.
The first and last CV sessions are primarily focused on survey data gathering.
At the two other sessions, CV students are convened to discuss current issues among young people in their community.
The CV program specifically does not include any sexuality education or community service learning opportunities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancies
Time Frame: 9 months
|
In the spring at the end of the program year, did the Teen Outreach Program students report significantly fewer pregnancies or births than the students in the Community Voices (the counterfactual) program?
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancies at follow up
Time Frame: 21 months
|
In the spring, one year following the end of the program year, did the Teen Outreach Program students report significantly fewer pregnancies or births than the students in the Community Voices (the counterfactual) program?
|
21 months
|
Sexual behavior
Time Frame: 9 months
|
In the Spring, at the end of the program year, what is the impact of the Teen Outreach program relative to the Community Voices program (the counterfactual) on sexual behavior?
|
9 months
|
Contraceptive use
Time Frame: 9 months
|
In the Spring, at the end of the program year, what is the impact of the Teen Outreach program relative to the Community Voices program (the counterfactual) on contraception use?
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Philliber, PhD, Philliber Research Associates
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, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 27, 2015
First Submitted That Met QC Criteria
August 3, 2015
First Posted (Estimate)
August 4, 2015
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Philliber10-15ppgnw
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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