An Evaluation of Re:MIX: a Teen Pregnancy Prevention Program With Young Parents as Peer Educators, EngenderHealth

April 30, 2020 updated by: Jennifer Manlove, Child Trends
This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

621

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
    • Texas
      • Austin, Texas, United States, 78722
        • EngenderHealth

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students in 8-10th grade classrooms in three public charter schools in Travis County, Texas

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: Re:MIX
In the experimental arm, the Re:MIX curriculum was implemented. The Re:MIX curriculum is a comprehensive teen pregnancy prevention consisting of ten hour-long sessions, delivered approximately once per week. The Re:MIX curriculum is taught by a professional health educator, partnered with a young parent educator who is a young parent (aged 18-25).
Behavioral: Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17
Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).
No Intervention: Comparison
In the comparison arm, teachers were given the option of implementing the Healthy Youth, Healthy You curriculum (focusing on nutrition, mental health, and fitness) or proceed with "business as usual" (no curriculum).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ever had sexual intercourse
Time Frame: 12 months after baseline
Single dichotomous item on self-report questionnaire.
12 months after baseline
Unprotected sexual intercourse in the past 3 months.
Time Frame: 12 months after baseline
Single dichotomous item on self-report questionnaire.
12 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intentions
Time Frame: 3 and 12 months after baseline
Single dichotomous item on self-report questionnaire measuring intentions to have sex in the next year.
3 and 12 months after baseline
Knowledge
Time Frame: 3 and 12 months after baseline
Outcome was measured using items on a self-report questionnaire related to knowledge about condoms, STI prevention and birth control efficacy
3 and 12 months after baseline
Attitudes
Time Frame: 3 and 12 months after baseline
Outcome was measured using items on a self-report questionnaire related to attitudes about gender roles, gender and sexual identities, early sex, condom use, early pregnancy and being a teen parent.
3 and 12 months after baseline
Self-efficacy in avoiding unwanted/unprotected sex and communication with partners
Time Frame: 3 and 12 months after baseline
Outcome was measured using items on a self-report questionnaire related to self-efficacy in obtaining birth control, negotiating condom use avoiding unwanted sexual contact, asking for, and providing consent and assertive communication.
3 and 12 months after baseline

Collaborators and Investigators

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

Sponsor

Child Trends

Collaborators

University of Texas at Austin
EngenderHealth
The Office of Adolescent Health, HHS

Investigators

  • Principal Investigator: Jennifer Manlove, PhD, Child Trends, Senior Program Area Director
  • Principal Investigator: Monica Armendariz, EngenderHealth: Project Director/Co-Principal Investigator

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)

July 1, 2016

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TP2AH000033-01-01 (Other Grant/Funding Number: HHS Office of Adolescent Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Sexual Behavior

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe