Empowering Young Parents: Building Healthy Relationships Study (EYP)

Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention

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 Overview

• Status: Recruiting
• Conditions: Intimate Partner Violence; Gender-based Violence
• Intervention / Treatment: Behavioral: Safe Dates for Young Parents (SDYP)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marni Kan, PhD; Phone Number: 919-485-2756; Email: mkan@rti.org

Study Locations

• United States
  • Delaware
    • Camden, Delaware, United States, 19934
      • Recruiting
      • Delaware Adolescent Program, Inc. (DAPI) - Kent County
      • Contact: Maleka Pettyjohn; Phone Number: 302-697-0356; Email: mpettyjohn@dapi.org
    • Georgetown, Delaware, United States, 19947
      • Recruiting
      • Delaware Adolescent Program, Inc. (DAPI) - Sussex County
      • Contact: Kim Wright; Phone Number: 302-722-2261; Email: kwright@dapi.org
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20020
      • Recruiting
      • Healthy Generations Program at Children's National Hospital
      • Contact: Yael Smiley; Phone Number: 202-476-2123; Email: YTSmiley@childrensnational.org
  • Georgia
    • Albany, Georgia, United States, 31701
      • Completed
      • GCAPP and Communities In Schools of Albany/Dougherty
    • Atlanta, Georgia, United States, 30318
      • Completed
      • GCAPP and Covenant House Georgia
  • Michigan
    • Benton Harbor, Michigan, United States, 49022
      • Recruiting
      • Berrien County Health Department
      • Contact: Miranda Dopp; Phone Number: 269-927-5635; Email: mdopp@bchdmi.org
    • Charlotte, Michigan, United States, 48813
      • Completed
      • Eaton Regional Education Service Agency (RESA)
    • Detroit, Michigan, United States, 48214
      • Recruiting
      • Pathways Academy
      • Contact: Debra Meadows; Phone Number: 313-209-3804; Email: DMeadows@pathwaysdetroit.com
    • Saginaw, Michigan, United States, 48601
      • Recruiting
      • Saginaw Intermediate School District
      • Contact: Rosa Davis; Phone Number: 989-399-7453; Email: rdavis@sisd.cc
  • North Carolina
    • Graham, North Carolina, United States, 27253
      • Completed
      • The Exchange Club
    • Hendersonville, North Carolina, United States, 28792
      • Completed
      • Children & Family Resource Center
    • Sanford, North Carolina, United States, 27330
      • Recruiting
      • Empowering Connections, Partnership for Children & Families
      • Contact: Cristal Avalos; Phone Number: 919-774-9496; Email: empoweryounc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Safe Dates for Young Parents (SDYP); 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condomless vaginal or anal sex (Month 6)	Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 6 months follow-up visit using a standard, self-administered questionnaire.	Three months, Six months
Sexual and Reproductive Coercion	Participant-reported occurrence of sexual and reproductive coercion with their primary or recent sexual partner at study Month 12 using a 5-point Likert scale questionnaire.	Month 12
Negotiation of condom use and contraception	Participant-reported ability to successfully negotiate condom and contraceptive-use with their primary or recent sexual partner at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.	Month 6
Intimate Partner Violence (IPV)	Participant-reported history, frequency, and severity of IPV (physical and psychological) at study Month 12 using polar (Yes/No), 5- and 4-point Likert scale self-administered questionnaires.	Month 12
Healthy relationship attitudes, beliefs, and behaviors	Participant-reported attitudes, beliefs, and behaviors about healthy relationships (conflict management skills and emotion regulation) for themselves, their families, or in general at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.	Month 6

Collaborators and Investigators

• Sponsor: RTI International
• Investigators: Study Director: Marni Kan, PhD, RTI International; Principal Investigator: Alexandra Minnis, PhD, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent Pregnancy; Healthy Relationships; Young Adult Parents; Adolescent Parents
• Other Study ID Numbers: TP2AH000082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No