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Recruiting NCT06576193

Empowering Young Parents: Building Healthy Relationships Study

No phase Interventional Gender-based Violence Intimate Partner Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safe Dates for Young Parents (SDYP).
Who it may be relevant to
Registry conditions: Gender-based Violence, Intimate Partner Violence. Basic parameters: 14 years — 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Condomless vaginal or anal sex (Month 12) [Time frame: Three months, Twelve months]
Secondary outcome measures (5)
  • Condomless vaginal or anal sex (Month 6) [Time frame: Three months, Six months]
  • Sexual and Reproductive Coercion [Time frame: Month 12]
  • Negotiation of condom use and contraception [Time frame: Month 6]
  • Intimate Partner Violence (IPV) [Time frame: Month 12]
  • Healthy relationship attitudes, beliefs, and behaviors [Time frame: Month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 12 centers
  • Delaware Adolescent Program, Inc. (DAPI) - Kent County — Camden
  • Delaware Adolescent Program, Inc. (DAPI) - Sussex County — Georgetown
  • Healthy Generations Program at Children's National Hospital — Washington D.C.
  • GCAPP and Communities In Schools of Albany/Dougherty — Albany
  • GCAPP and Covenant House Georgia — Atlanta
  • Berrien County Health Department — Benton Harbor
  • Eaton Regional Education Service Agency (RESA) — Charlotte
  • Pathways Academy — Detroit
  • … and 4 more centers

Identifiers

NCT: NCT06576193 · TP2AH000082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗