Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RTI International
- Enrollment
- 600
- Locations
- 14
- Primary Endpoint
- Condomless vaginal or anal sex (Month 12)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 14 Years to 21 Years (Child, Adult)
- 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.
Arms & Interventions
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.
Intervention: Safe Dates for Young Parents (SDYP) (Behavioral)
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.
Outcomes
Primary Outcomes
Condomless vaginal or anal sex (Month 12)
Time Frame: Three months, Twelve months
Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 12 months follow-up using a standard, self-administered questionnaire.
Secondary Outcomes
- Sexual and Reproductive Coercion(Month 12)
- Negotiation of condom use and contraception(Month 6)
- Condomless vaginal or anal sex (Month 6)(Three months, Six months)
- Intimate Partner Violence (IPV)(Month 12)
- Healthy relationship attitudes, beliefs, and behaviors(Month 6)