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Empowering Young Parents: Building Healthy Relationships Study

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06576193
Acronym
EYP
Enrollment
600
Registered
2024-08-28
Start date
2024-10-16
Completion date
2028-08-31
Last updated
2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender-based Violence, Intimate Partner Violence

Keywords

Young Adult Parents, Adolescent Pregnancy, Adolescent Parents, Healthy Relationships

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.

Interventions

BEHAVIORALSafe 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.

Sponsors

RTI International
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 21 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Condomless vaginal or anal sex (Month 12)Three months, Twelve monthsParticipant-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

MeasureTime frameDescription
Intimate Partner Violence (IPV)Month 12Participant-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.
Condomless vaginal or anal sex (Month 6)Three months, Six monthsParticipant-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.
Sexual and Reproductive CoercionMonth 12Participant-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.
Negotiation of condom use and contraceptionMonth 6Participant-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.
Healthy relationship attitudes, beliefs, and behaviorsMonth 6Participant-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.

Countries

United States

Contacts

Primary ContactMarni Kan, PhD
mkan@rti.org919-485-2756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026