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Virtual Village for Young Parents

NCT ID: NCT07226401

Last Updated: 2025-11-10

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-31

Brief Summary

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This project will study virtual delivery of Safe Dates for Young Parents (SDYP), a 10-session, group-based intimate partner violence (IPV) prevention program tailored for adolescents and young adults who are pregnant or parenting. This program has the potential to improve the health and well-being of young parents and their children, and virtual delivery may improve participants' ability to attend. The main questions it aims to answer are: (1) Is it feasible and acceptable to implement SDYP in a virtual setting? (2) Are SDYP participants less likely to experience IPV than participants in an alternate health education program? Participants will be invited to a series of virtual program sessions for either SDYP or a health education program focused on physical activity and nutrition and will be asked to complete surveys before the programs begin and up to 6 months later.

Detailed Description

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As many as two-thirds of teens who are pregnant or parenting have been the victims or perpetrators of physical intimate partner violence (IPV) and there is an even higher prevalence of psychological abuse in this population. IPV can endanger teen mothers' own health, the health of their pregnancies, and the well- being of their children. Despite this detrimental impact, there is a lack of evidence-based IPV prevention programs that are tailored for pregnant and parenting teens. Moreover, despite the promise of virtual program delivery, which may help improve teens' ability to attend, research has yet to determine feasibility and outcomes of virtual delivery of IPV prevention programs for teens who are pregnant or parenting. This study is a pilot test of the Safe Dates for Young Parents (SDYP) program adapted for virtual delivery. The original Safe Dates is a 10-session, theoretically based, interactive program with demonstrated efficacy in preventing psychological, physical, and sexual dating abuse among teens. We previously adapted Safe Dates for young parents who are pregnant or parenting by integrating pregnancy and parenting themes throughout program sessions, increasing the focus on overcoming barriers to seeking help for intimate partner violence (IPV), and revising sexual assault content. The programs were delivered exclusively in person. A virtual approach to delivery could improve scale-up of SDYP, via increased reach and lower costs. We recently pre-tested selections from the SDYP program over Zoom with 9 young parents to adapt the prevention curriculum and related intervention materials for virtual delivery. In this study, we will build on this work by evaluating the virtual SDYP intervention in a pilot randomized trial to assess implementation outcomes (i.e. feasibility, acceptability, fidelity, and appropriateness) and preliminary effects on IPV outcomes. We will randomize 80 individual pregnant and parenting young people 1:1 to intervention (SDYP) or equal attention control (virtual health education program lessons that do not address IPV) conditions, and we will conduct surveys at baseline and 3-6-month follow-up to assess IPV and related behavioral outcomes. We will assess implementation outcomes (feasibility, acceptability, fidelity, and appropriateness) through program data, qualitative in-depth interviews (IDIs) with facilitators and participants, and survey data from the intervention group. Research activities will be done virtually with participants recruited from several locations around the United States.

Conditions

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Gender-based Violence Intimate Partner Violence

Keywords

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Young Adult Parents Adolescent Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individual adolescent and young adults (AYA) will be block-randomized to the SDYP intervention (intervention condition) or an equal attention control condition using a 1:1 allocation to ensure balanced assignment, using permuted blocks sizes of 4 and 6. The field data collector will be blinded to the group assignment until after baseline data collection is completed. They will notify each participant of their assigned condition. Implementation staff (i.e. the facilitators) will also be informed about each participant's assignment so that they can support participation in the SDYP intervention for those randomized to the intervention condition or control implementation for those randomized to the control. Both intervention and control programs will be implemented with closed virtual groups of five or more participants; study staff will be responsible for scheduling groups and ensuring attendance. Sessions will be implemented separately from any other agency programs.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Virtual Safe Dates for Young Parents

Participants assigned to the intervention group will be offered the Safe Dates for Young Parents (SDYP) program activities focused on healthy relationships and intimate partner violence (IPV) prevention. This program will consist of 10 modules, with sessions that are 60-90 minutes each. The intervention will be done with groups via zoom and will be led by a trained facilitator.

Group Type EXPERIMENTAL

Virtual Safe Dates for Young Parents

Intervention Type BEHAVIORAL

Safe Dates for Young Parents (SDYP) is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" for pregnant or parenting young adults. We adapted the prevention curriculum and related intervention materials for virtual delivery via Zoom. The program consists of ten group-based sessions (50 minutes of content each) led by a trained facilitator. The program includes interactive discussions, analysis of scenarios, games, role-plays, and brainstorming.

HealthSmart

We will use an equal attention control condition where control group participants will be offered lessons on physical activity and nutrition from the HealthSmart digital high school curriculum. To achieve consistent dosage with SDYP, ten lessons will be chosen from the curriculum. This program will not provide education about IPV or healthy relationships content that composes the SDYP intervention. The intervention will be done with groups via zoom and will be led by a trained facilitator.

Group Type ACTIVE_COMPARATOR

HealthSmart

Intervention Type BEHAVIORAL

The HealthSmart program will use 10 digital high school curriculum lessons focused on physical activity and nutrition. The sessions will be formatted appropriately to be delivered via zoom. Participants may be asked to complete handouts, listen to presentations, and participate in discussions. Topics may include information about different nutrients, how nutrients affect your health, how to read food labels, healthy eating, and guidelines for physical activity.

Interventions

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Virtual Safe Dates for Young Parents

Safe Dates for Young Parents (SDYP) is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" for pregnant or parenting young adults. We adapted the prevention curriculum and related intervention materials for virtual delivery via Zoom. The program consists of ten group-based sessions (50 minutes of content each) led by a trained facilitator. The program includes interactive discussions, analysis of scenarios, games, role-plays, and brainstorming.

Intervention Type BEHAVIORAL

HealthSmart

The HealthSmart program will use 10 digital high school curriculum lessons focused on physical activity and nutrition. The sessions will be formatted appropriately to be delivered via zoom. Participants may be asked to complete handouts, listen to presentations, and participate in discussions. Topics may include information about different nutrients, how nutrients affect your health, how to read food labels, healthy eating, and guidelines for physical activity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Pregnant or parenting youth (Pilot RCT participants)

* Aged 16-21 years.
* Currently pregnant, partner of a pregnant person, or parenting a child (i.e., have contact with child at least once per week).
* Able to speak and read English.
* Willing and able to provide written informed consent.
* Willing and able to provide adequate contact/locator information.

Facilitators (IDI participants)

* Aged 18 years or older.
* Trained and served as a facilitator of the virtual SDYP intervention.
* Able to speak and read English.
* Able and willing to provide verbal informed consent.

Exclusion Criteria

* Has any other condition that, in the opinion of the 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.
* Currently participating or will be participating in a violence prevention education program in the next 3 months.
* Previously participated in the Empowering Young Parents study.
Minimum Eligible Age

16 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role lead

Responsible Party

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Marni Kan

Senior Research Public Health Analyst 1

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RTI International

Durham, 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

Phone: 919-485-2756

Email: [email protected]

Marie Stoner, PhD

Role: CONTACT

Phone: 510-665-8285

Email: [email protected]

Facility Contacts

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Marni Kan

Role: primary

Marie Stoner

Role: backup

Other Identifiers

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R21HD111729

Identifier Type: NIH

Identifier Source: secondary_id

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R21HD111729

Identifier Type: NIH

Identifier Source: org_study_id

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