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Trial record 10 of 15 for:    Recruiting, Not yet recruiting, Available Studies | "Pregnancy in Adolescence"

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

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ClinicalTrials.gov Identifier: NCT03114410
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborators:
EngenderHealth
University of Texas at Austin
The Office of Adolescent Health, HHS
Information provided by (Responsible Party):
Jennifer Manlove, Child Trends

Brief 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 peer educators (who are young parents) will deliver the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth receive roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants will be 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes will either receive an alternative program that focuses on health, nutrition, and fitness, or business as usual. This study is being 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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Unprotected Sex Behavioral: Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17 Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • 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 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 peer educators (who are young parents) will deliver the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth receive roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).


Primary Outcome Measures :
  1. Ever had sexual intercourse [ Time Frame: 12 months after baseline ]
    Single dichotomous item on self-report questionnaire. This outcome will be measured among the subgroup of participants who had never had sex at baseline.

  2. Ever had sexual intercourse [ Time Frame: 3 months after baseline ]
    Single dichotomous item on self-report questionnaire. This outcome will be measured among the subgroup of participants who had never had sex at baseline.


Secondary Outcome Measures :
  1. Unprotected sex [ Time Frame: 12 months after baseline ]
    Single dichotomous item on self-report questionnaire measuring vaginal sex in past 3 months without using contraception.

  2. Unprotected sex [ Time Frame: 3 months after baseline ]
    Single dichotomous item on self-report questionnaire measuring vaginal sex in past 3 months without using contraception.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114410


Contacts
Contact: Bianca Faccio, BA 2402239256 bfaccio@childtrends.org
Contact: Heather Wasik, BA 2402239317 hwasik@childtrends.org

Locations
United States, Texas
EngenderHealth Recruiting
Austin, Texas, United States, 78722
Contact: Amanda Ackerman, LMSW, MPH    212-561-8452    aackerman@engenderhealth.org   
University of Texas Austin Recruiting
Austin, Texas, United States
Contact: Cynthia Osborne         
Sponsors and Collaborators
Child Trends
EngenderHealth
University of Texas at Austin
The Office of Adolescent Health, HHS
Investigators
Principal Investigator: Jennifer Manlove, PhD Child Trends, Senior Program Area Director
Principal Investigator: Jenifer DeAtley EngenderHealth, Director of US Programs & AYSRH Program Advisor

Responsible Party: Jennifer Manlove, Senior Program Area Director, Child Trends
ClinicalTrials.gov Identifier: NCT03114410     History of Changes
Other Study ID Numbers: TP2AH000033-01-01
TP2AH000033-01-01 ( Other Grant/Funding Number: HHS Office of Adolescent Health )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No