Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program

Teen Pregnancy Prevention Clinical Trial

Official title:

Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863326
• Other study ID #: HHSP23337014T
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2810
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• Enrolled in a study school

• Attending the targeted class (e.g. health class) for the first time

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• Making Proud Choices

• Business as usual

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	Office of Population Affairs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge about HIV	Proportion of knowledge items about HIV/STDs answered correctly.	Survey administered 6 months post program
Primary	Knowledge about pregnancy	Proportion of knowledge items about pregnancy answered correctly.	Survey administered 6 months post program
Primary	Knowledge about condoms	Proportion of knowledge items about condom use answered correctly.	Survey administered 6 months post program
Primary	Knowledge about other forms of contraception	Proportion of knowledge items about contraceptive use answered correctly.	Survey administered 6 months post program
Primary	Belief that sex may adversely affect future goals	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
Primary	Belief that condoms can be pleasurable	Proportion of statements about how condoms can be pleasurable that the respondent agrees or strongly agrees with.	Survey administered 6 months post program
Primary	Attitudes about condoms	Proportion of statements about condom use that the respondent either agrees or strongly agrees with.	Survey administered 6 months post program
Primary	Condom self-efficacy	Proportion of statements about self-efficacy using condoms that the respondent agrees or strongly agrees with.	Survey administered 6 months post program
Primary	Condom negotiation	Proportion of statements about self-efficacy negotiating condom that the respondent agrees or strongly agrees with.	Survey administered 6 months post program
Primary	Refusal skills	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
Primary	Ever any sex (vaginal, oral, or anal)	Binary variable representing if the respondent reported having ever had vaginal, oral, or anal sex.	Survey administered 6 months post program
Primary	Any sex (in past 3 months)	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
Primary	Times having any sex (in past 3 months)	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
Primary	Count of vaginal sex partners (in the past 3 months)	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
Primary	Any sex without a condom (in past 3 months)	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
Primary	Times having any sex without a condom in past 3 months	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
Primary	Sex without birth control in past 3 months	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
Primary	Times having sex without birth control (in past 3 months)	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
Primary	Ever pregnant	Binary variable representing if the respondent reported a pregnancy or has gotten someone pregnant.	Survey administered 6 months post program
Primary	Any sexually transmitted infection (STI)	Binary variable representing if the respondent indicated having been told they have a sexually transmitted infection.	Survey administered 6 months post program