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

Sexual Behavior Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114410
• Other study ID #: TP2AH000033-01-01
• Secondary ID: TP2AH000033-01-0
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2020
• Source: Child Trends
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: April 30, 2020
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Sexual Behavior
• Unprotected Sex

Intervention

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).

Locations

Country	Name	City	State
United States	EngenderHealth	Austin	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Child Trends	EngenderHealth, The Office of Adolescent Health, HHS, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ever had sexual intercourse	Single dichotomous item on self-report questionnaire.	12 months after baseline
Primary	Unprotected sexual intercourse in the past 3 months.	Single dichotomous item on self-report questionnaire.	12 months after baseline
Secondary	Intentions	Single dichotomous item on self-report questionnaire measuring intentions to have sex in the next year.	3 and 12 months after baseline
Secondary	Knowledge	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
Secondary	Attitudes	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
Secondary	Self-efficacy in avoiding unwanted/unprotected sex and communication with partners	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