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NCT Number: NCT06576193

Empowering Young Parents: Building Healthy Relationships Study

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.

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Key information

Conditions

Gender-Based Violence Intimate Partner Violence

Age range

14 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Condomless vaginal or anal sex (Month 6)

    Time frame: Three months, Six months

    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.

  2. Sexual and Reproductive Coercion

    Time frame: Month 12

    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.

  3. Negotiation of condom use and contraception

    Time frame: Month 6

    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.

  4. Intimate Partner Violence (IPV)

    Time frame: Month 12

    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.

  5. Healthy relationship attitudes, beliefs, and behaviors

    Time frame: Month 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marni Kan, PhD

CONTACT

[email protected]

919-485-2756

Sponsors and collaborators

Lead sponsor

RTI International

Other

Registry information

Official study title

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

Acronym: EYP

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2024
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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