Empowering Young Parents: Building Healthy Relationships Study (NCT06576193) | Clinical Trial Compass
RecruitingNot Applicable
Empowering Young Parents: Building Healthy Relationships Study
United States600 participantsStarted 2024-10-16
Plain-language summary
The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting.
The main questions it aims to answer are:
* Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period?
* Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)?
* Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships?
Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention.
Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.
Who can participate
Age range
14 Years – 21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adolescent and Young Adult (AYA) \[EYP study participants\]
* Aged 14-21 years (inclusive) at Screening.
* Assigned female sex at birth.
* Currently pregnant or parenting their child who lives with them at least part-time.
* Able to speak and read English or Spanish.
* Able and willing to provide verbal informed consent for enrollment in the EYP study.
* Able and willing to provide adequate contact/locator information.
* Able and willing to complete protocol requirements, including completion of three study interviews over one year.
Study Facilitators (process evaluation participants)
* Aged 18 years or older.
* Trained and served as a facilitator of the SDYP intervention.
* Able to speak and read English.
* Able and willing to provide verbal informed consent.
Exclusion Criteria:
* Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
* Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.