Empowering Young Parents: Building Healthy Relationships Study

NCT06576193 | Recruiting DMC

• 1 other identifier: TP2AH000082
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 12

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.

Conditions

Gender-based Violence; Intimate Partner Violence

Keywords

Young Adult Parents; Adolescent Pregnancy; Adolescent Parents; Healthy Relationships

Outcome Measures

Primary Outcomes (1)

• Condomless vaginal or anal sex (Month 12)

  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.

  Three months, Twelve months

Secondary Outcomes (5)

• Condomless vaginal or anal sex (Month 6)

  Three months, Six months

• Sexual and Reproductive Coercion

  Month 12

• Negotiation of condom use and contraception

  Month 6

• Intimate Partner Violence (IPV)

  Month 12

• Healthy relationship attitudes, beliefs, and behaviors

  Month 6

Study Arms (2)

Safe Dates for Young Parents (SDYP)

EXPERIMENTAL

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.

Behavioral: Safe Dates for Young Parents (SDYP)

Standard Services Only

NO INTERVENTION

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.

Interventions

Safe Dates for Young Parents (SDYP) BEHAVIORAL

SDYP is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" designed for teens, that focuses on pregnant or parenting females. The program consists of ten group-based sessions (50 minutes each) led by a trained facilitator which include interactive discussions, analysis of scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.

Safe Dates for Young Parents (SDYP)

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RTI International: lead

Study Sites (12)

Delaware Adolescent Program, Inc. (DAPI) - Kent County

Camden, Delaware, 19934, United States

RECRUITING

Delaware Adolescent Program, Inc. (DAPI) - Sussex County

Georgetown, Delaware, 19947, United States

RECRUITING

Healthy Generations Program at Children's National Hospital

Washington D.C., District of Columbia, 20020, United States

RECRUITING

GCAPP and Communities In Schools of Albany/Dougherty

Albany, Georgia, 31701, United States

COMPLETED

GCAPP and Covenant House Georgia

Atlanta, Georgia, 30318, United States

COMPLETED

Berrien County Health Department

Benton Harbor, Michigan, 49022, United States

RECRUITING

Eaton Regional Education Service Agency (RESA)

Charlotte, Michigan, 48813, United States

COMPLETED

Pathways Academy

Detroit, Michigan, 48214, United States

RECRUITING

Saginaw Intermediate School District

Saginaw, Michigan, 48601, United States

RECRUITING

The Exchange Club

Graham, North Carolina, 27253, United States

COMPLETED

Children & Family Resource Center

Hendersonville, North Carolina, 28792, United States

COMPLETED

Empowering Connections, Partnership for Children & Families

Sanford, North Carolina, 27330, United States

RECRUITING

Study Officials

• Marni Kan, PhD

  RTI International

  STUDY DIRECTOR

• Alexandra Minnis, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marni Kan, PhD

CONTACT

919-485-2756; mkan@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Field Data Collectors (FDCs) will be masked to the participant group assignments until after the baseline data collection is completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)