Evaluation of the Positive Prevention PLUS Program

Pregnancy in Adolescence Clinical Trial

— PP+  

Official title:

Evaluation of the Positive Prevention PLUS Program Teen Pregnancy Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540278
• Other study ID #: 09-149-1-5
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: September 1, 2015
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: California State University, San Bernardino
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4267
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Must have parental consent and be in the eligible school sites.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pregnancy in Adolescence

Intervention

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.

Locations

Country	Name	City	State
United States	CSUSB	San Bernardino	California

Sponsors (2)

Lead Sponsor	Collaborator
California State University, San Bernardino	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ever had sex (Yes/No)	Ever had sex (Yes/No)	6 months	No
Primary	Ever been pregnant (Yes/No)	Ever Been Pregnant (or gotten someone pregnant) (Yes/No)	6 months	No
Primary	Sex without using birth control in prior 3 months (Yes/No)	Ever had sex without using birth control in prior 3 months (Yes/No)	6 months	No