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Completed

NCT Number: NCT03114410

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

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.

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Key information

Conditions

Sexual Behavior Behavior Unprotected Sex Unsafe Sex

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EngenderHealth

Austin, Texas, 78722, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17

Behavioral

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).

Primary outcomes

  1. Ever had sexual intercourse

    Time frame: 12 months after baseline

    Single dichotomous item on self-report questionnaire.

  2. Unprotected sexual intercourse in the past 3 months.

    Time frame: 12 months after baseline

    Single dichotomous item on self-report questionnaire.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Child Trends

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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