Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program

April 28, 2021 updated by: Mathematica Policy Research, Inc.
Under contract to the Office of Population Affairs (OPA), Mathematica is conducting an impact study of the Making Proud Choices! (MPC) teen pregnancy prevention program. The impact study is designed to estimate the impact of MPC, compared to the business-as-usual condition, on risk and protective factors, sexual behaviors, and longer term health goals including pregnancy and sexually transmitted infections.

Study Overview

Detailed Description

This evaluation used a cluster randomized controlled trial (RCT) design to assess the effectiveness of MPC, with schools within districts randomly assigned to one of two conditions: (1) MPC implemented by health educators, or (2) business as usual. In total, 31 school clusters were randomly assigned to condition, including roughly 2800 students, in four geographic areas across the U.S.

The study was implemented over the course of three school years (2016-17, 2017-18 and 2018-19), with youth in each year considered a separate evaluation cohort, and with participating schools (and new cohorts of eligible youth) randomized to condition each year.

There are two main sources of data for this study: outcome and implementation data. Youth in the study completed two waves of self-report surveys: (1) a baseline survey administered before programming began, and (2) a follow-up outcome survey administered approximately six months after the end of programming (approximately 9 months after baseline, on average). The surveys measured antecedents to sexual behavior (risk and protective factors), sexual behaviors, and ultimately, MPC's health goals of reducing sexually transmitted infections and teen pregnancies. Program implementation data included fidelity and attendance logs, observations, interviews, study youth focus groups, staff surveys, and technical assistance logs.

The benchmark analytic approach for estimating program impacts focuses on individuals with observed (non-missing) outcome data, and will statistically adjust for several baseline and location variables to produce credible and precise estimates of program effectiveness. Several sensitivity analyses will be conducted to understand the robustness of the findings across alternative specifications, and to understand the effect of MPC across a variety of subgroups.

Study Type

Interventional

Enrollment (Actual)

2810

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

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled in a study school
  • Attending the targeted class (e.g. health class) for the first time

Exclusion Criteria:

  • None

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: Making Proud Choices
This evaluation tests the effect of the MPC School Edition, the version of the MPC 5th Edition designed for implementation in school. This edition includes 9.5 hours of content implemented in 14 40-minute modules. Schools assigned to the MPC condition received MPC in a targeted class.
Active Comparator: Business as usual
The control group continued with their regular programming in the targeted class, which was often a health or Reserve Officer Training Corps (ROTC) class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about HIV
Time Frame: Survey administered 6 months post program
Proportion of knowledge items about HIV/STDs answered correctly.
Survey administered 6 months post program
Knowledge about pregnancy
Time Frame: Survey administered 6 months post program
Proportion of knowledge items about pregnancy answered correctly.
Survey administered 6 months post program
Knowledge about condoms
Time Frame: Survey administered 6 months post program
Proportion of knowledge items about condom use answered correctly.
Survey administered 6 months post program
Knowledge about other forms of contraception
Time Frame: Survey administered 6 months post program
Proportion of knowledge items about contraceptive use answered correctly.
Survey administered 6 months post program
Belief that sex may adversely affect future goals
Time Frame: Survey administered 6 months post program
Proportion of statements about how sexual activity will interfere with goals and dreams that the respondent agrees or strongly agrees with.
Survey administered 6 months post program
Belief that condoms can be pleasurable
Time Frame: Survey administered 6 months post program
Proportion of statements about how condoms can be pleasurable that the respondent agrees or strongly agrees with.
Survey administered 6 months post program
Attitudes about condoms
Time Frame: Survey administered 6 months post program
Proportion of statements about condom use that the respondent either agrees or strongly agrees with.
Survey administered 6 months post program
Condom self-efficacy
Time Frame: Survey administered 6 months post program
Proportion of statements about self-efficacy using condoms that the respondent agrees or strongly agrees with.
Survey administered 6 months post program
Condom negotiation
Time Frame: Survey administered 6 months post program
Proportion of statements about self-efficacy negotiating condom that the respondent agrees or strongly agrees with.
Survey administered 6 months post program
Refusal skills
Time Frame: Survey administered 6 months post program
Proportion of statements about self-efficacy refusing sex with a partner that the respondent agrees or strongly agrees with.
Survey administered 6 months post program
Ever any sex (vaginal, oral, or anal)
Time Frame: Survey administered 6 months post program
Binary variable representing if the respondent reported having ever had vaginal, oral, or anal sex.
Survey administered 6 months post program
Any sex (in past 3 months)
Time Frame: Survey administered 6 months post program
Binary variable representing if the respondent reported having vaginal, oral, or anal sex in the three month period before completing the follow-up survey.
Survey administered 6 months post program
Times having any sex (in past 3 months)
Time Frame: Survey administered 6 months post program
Count variable representing the total number of times respondent had vaginal, oral and/or anal sex in the three month period before completing the follow-up survey.
Survey administered 6 months post program
Count of vaginal sex partners (in the past 3 months)
Time Frame: Survey administered 6 months post program
Count variable representing the number of partners for vaginal sex in the three month period before completing the follow-up survey.
Survey administered 6 months post program
Any sex without a condom (in past 3 months)
Time Frame: Survey administered 6 months post program
Binary variable representing if respondent reported having any risk for STD/STI sex (sex without a condom) in the three month period before completing the follow-up survey.
Survey administered 6 months post program
Times having any sex without a condom in past 3 months
Time Frame: Survey administered 6 months post program
Count variable representing the total number of times respondent had risky sex in the three months before completing follow-up survey.
Survey administered 6 months post program
Sex without birth control in past 3 months
Time Frame: Survey administered 6 months post program
Binary variable representing if respondent reported having had unprotected vaginal sex in the three months before completing the follow-up survey.
Survey administered 6 months post program
Times having sex without birth control (in past 3 months)
Time Frame: Survey administered 6 months post program
Count variable representing the total number of times the respondent had unprotected vaginal sex in the three month period before completing the follow-up survey.
Survey administered 6 months post program
Ever pregnant
Time Frame: Survey administered 6 months post program
Binary variable representing if the respondent reported a pregnancy or has gotten someone pregnant.
Survey administered 6 months post program
Any sexually transmitted infection (STI)
Time Frame: Survey administered 6 months post program
Binary variable representing if the respondent indicated having been told they have a sexually transmitted infection.
Survey administered 6 months post program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HHSP23337014T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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