NCT06576193 Empowering Young Parents: Building Healthy Relationships Study
| NCT ID | NCT06576193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RTI International |
| Condition | Gender-based Violence |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-10-16 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Marni Kan, PhD
STUDY DIRECTOR
RTI International
Frequently Asked Questions
Who can join the NCT06576193 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 21 Years, studying Gender-based Violence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576193 currently recruiting?
Yes, NCT06576193 is actively recruiting participants. Contact the research team at mkan@rti.org for enrollment information.
Where is the NCT06576193 trial being conducted?
This trial is being conducted at Camden, United States, Georgetown, United States, Washington D.C., United States, Albany, United States and 8 additional locations.
Who is sponsoring the NCT06576193 clinical trial?
NCT06576193 is sponsored by RTI International. The principal investigator is Marni Kan, PhD at RTI International. The trial plans to enroll 600 participants.