Empowering Young Parents: Building Healthy Relationships Study

NCT ID: NCT06576193

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-16

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gender-based Violence Intimate Partner Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Field Data Collectors (FDCs) will be masked to the participant group assignments until after the baseline data collection is completed.

Study Groups

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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.

Group Type EXPERIMENTAL

Safe Dates for Young Parents (SDYP)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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RTI International

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marni Kan, PhD

Role: STUDY_DIRECTOR

RTI International

Alexandra Minnis, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

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

Camden, Delaware, United States

Site Status RECRUITING

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

Georgetown, Delaware, United States

Site Status RECRUITING

Healthy Generations Program at Children's National Hospital

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

Site Status RECRUITING

GCAPP and Communities In Schools of Albany/Dougherty

Albany, Georgia, United States

Site Status COMPLETED

GCAPP and Covenant House Georgia

Atlanta, Georgia, United States

Site Status COMPLETED

Berrien County Health Department

Benton Harbor, Michigan, United States

Site Status RECRUITING

Eaton Regional Education Service Agency (RESA)

Charlotte, Michigan, United States

Site Status COMPLETED

Pathways Academy

Detroit, Michigan, United States

Site Status RECRUITING

Saginaw Intermediate School District

Saginaw, Michigan, United States

Site Status RECRUITING

The Exchange Club

Graham, North Carolina, United States

Site Status COMPLETED

Children & Family Resource Center

Hendersonville, North Carolina, United States

Site Status COMPLETED

Empowering Connections, Partnership for Children & Families

Sanford, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marni Kan, PhD

Role: CONTACT

919-485-2756

Facility Contacts

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Maleka Pettyjohn

Role: primary

302-697-0356

Kim Wright

Role: primary

302-722-2261

Yael Smiley

Role: primary

202-476-2123

Miranda Dopp

Role: primary

269-927-5635

Debra Meadows

Role: primary

313-209-3804

Rosa Davis

Role: primary

989-399-7453

Cristal Avalos

Role: primary

919-774-9496

Other Identifiers

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TP2AH000082

Identifier Type: -

Identifier Source: org_study_id

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