Empowering Young Parents: Building Healthy Relationships Study
Purpose
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.
Conditions
- Gender-based Violence
- Intimate Partner Violence
Eligibility
- Eligible Ages
- Between 14 Years and 21 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Individual AYA will be block-randomized to the SDYP intervention with standard prenatal and post-partum services (intervention condition) or standard services only (control condition) using a 1:1 allocation within each site (stratified randomization) to ensure balanced assignment, using permuted blocks sizes of 4 and 6.
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Field Data Collectors (FDCs) will be masked to the participant group assignments until after the baseline data collection is completed.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Safe Dates for Young Parents (SDYP) |
Participants will receive and complete SDYP intervention activities focused on healthy relationships and intimate partner violence (IPV) prevention plus standard services offered at the study site. |
|
|
No Intervention Standard Services Only |
Participants will only receive standard-of-care programming that typically includes services such as one-on-one strength-based case management and comprehensive sex education. The standard services will not address IPV or healthy relationships content that composes the SDYP intervention. Referrals to additional services will be offered to all participants, as needed. |
|
Recruiting Locations
Children's National and nearby locations
Washington D.C. 4140963, District of Columbia 4138106 20020
More Details
- NCT ID
- NCT06576193
- Status
- Recruiting
- Sponsor
- RTI International