Recruiting

SDYP

Sponsor:

RTI International

Code:

NCT06576193

Conditions

Gender-based Violence

Intimate Partner Violence

Eligibility Criteria

Sex: Female

Age: 14 - 21

Healthy Volunteers: Accepted

Interventions

Safe Dates for Young Parents (SDYP)

Study Details

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

Study ID

NCT06576193

Start date

Oct 16, 2024

Status verified date

Oct, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 21

Healthy Volunteers: Accepted

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

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Condomless vaginal or anal sex (Month 12) [ Time Frame: Three months, Twelve months ]

Central Contacts and Locations

Central contacts

Marni Kan, PhD

919-485-2756mkan@rti.org

Locations

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

Recruiting

Camden, Delaware, United States, 19934

Contacts

Maleka Pettyjohn

302-697-0356mpettyjohn@dapi.org

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

Recruiting

Georgetown, Delaware, United States, 19947

Contacts

Kim Wright

302-722-2261kwright@dapi.org

Healthy Generations Program at Children's National Hospital

Recruiting

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

Contacts

Yael Smiley

202-476-2123YTSmiley@childrensnational.org

Berrien County Health Department

Recruiting

Benton Harbor, Michigan, United States, 49022

Contacts

Miranda Dopp

269-927-5635mdopp@bchdmi.org

Pathways Academy

Recruiting

Detroit, Michigan, United States, 48214

Contacts

Debra Meadows

313-209-3804DMeadows@pathwaysdetroit.com

Saginaw Intermediate School District

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Rosa Davis

989-399-7453rdavis@sisd.cc

Empowering Connections, Partnership for Children & Families

Recruiting

Sanford, North Carolina, United States, 27330

Contacts

Cristal Avalos

919-774-9496empoweryounc@gmail.com

More Information

Sponsor

RTI International

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Young Adult Parents
  • Adolescent Pregnancy
  • Adolescent Parents
  • Healthy Relationships

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RTI International on 2025-10-30.