Evaluation of the Positive Prevention PLUS Program (PP+)
September 1, 2015 updated by: Robert G. LaChausse, California State University, San Bernardino
Evaluation of the Positive Prevention PLUS Program Teen Pregnancy Prevention Program
This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A clustered randomized controlled trial (CRCT) was employed where participating high school sites were randomly assigned either to a treatment group that implemented the Positive Prevention PLUS program or a control group.
Students completed a self-administered survey at baseline (prior to program implementation) and a 6 month follow-up survey (post program implementation).
Eligible students in the sample included all male and female 9th-grade students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical education classes, to which the district assigns students randomly.
Of the 7,042 eligible students, 4,267 received parental consent and were enrolled in the study.
Outcome variables include initiation of sexual activity, ever been pregnant, and birth control use.
Study Type
Interventional
Enrollment (Actual)
4267
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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California
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San Bernardino, California, United States, 92407
- CSUSB
-
-
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:
- Must have parental consent and be in the eligible school sites.
Exclusion Criteria:
-
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Received the 11 lesson Positive Prevention Curriculum
|
PP+ has elven 45 minute lessons: (1) Getting Started, (2) Life Planning, (3) Healthy Relationships, (4) Relationship Violence, (5) Family Planning and Contraceptives, (6) Myths and Stereotypes, (7) HIV Disease and AIDS, (8) Recognizing and Reducing Risk, (9) Peer and Media Pressures, (10) Human Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) Testing and Community Resources, and (11) Steps to Success.
|
|
No Intervention: Control
Did not receive any sex-related instruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ever had sex (Yes/No)
Time Frame: 6 months
|
Ever had sex (Yes/No)
|
6 months
|
|
Ever been pregnant (Yes/No)
Time Frame: 6 months
|
Ever Been Pregnant (or gotten someone pregnant) (Yes/No)
|
6 months
|
|
Sex without using birth control in prior 3 months (Yes/No)
Time Frame: 6 months
|
Ever had sex without using birth control in prior 3 months (Yes/No)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
August 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
August 25, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (Estimate)
September 3, 2015
Study Record Updates
Last Update Posted (Estimate)
September 3, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 09-149-1-5
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.