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

  • United States
    • California
      • 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
Behavioral: Positive Prevention PLUS
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.

Sponsor

California State University, San Bernardino

Collaborators

Department of Health and Human Services

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.

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