Virtual Village for Young Parents

NCT07226401 | Recruiting

• 1 other identifier: R21HD111729
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gender-based Violence; Intimate Partner Violence

Keywords

Young Adult Parents; Adolescent Pregnancy

Outcome Measures

Primary Outcomes (7)

• Participant attendance

  Percent of sessions attended (out of 10)

  From the first to the last session of SDYP (typically 10 weeks)

• Participant engagement

  Average of facilitator reports of participant engagement across SDYP sessions on a 4-point scale

  From the first to the last session of SDYP (typically 10 weeks)

• Program adherence

  Percent of SDYP activities completed without changes, averaged across sessions and facilitators

  From the first to the last session of SDYP (typically 10 weeks)

• Physical IPV perpetration

  Endorsement of any of 7 items describing physically aggressive acts toward a partner, adapted from the WHO instrument and Safe Dates questionnaire measure

  Past 3 months measured at baseline and 3 to 6 months after baseline

• Physical IPV victimization

  Endorsement of any of 7 items describing physically aggressive acts by a partner, adapted from the WHO instrument and Safe Dates questionnaire measure

  Past 3 months measured at baseline and 3 to 6 months after baseline

• Psychological IPV perpetration

  Endorsement of any of 9 items describing psychologically aggressive acts toward a partner, adapted from the Safe Dates questionnaire measure

  Past 3 months measured at baseline and 3 to 6 months after baseline

• Psychological IPV victimization

  Endorsement of any of 9 items describing psychologically aggressive acts by a partner, adapted from the Safe Dates questionnaire measure

  Past 3 months measured at baseline and 3 to 6 months after baseline

Study Arms (2)

Virtual Safe Dates for Young Parents

EXPERIMENTAL

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.

Behavioral: Virtual Safe Dates for Young Parents

HealthSmart

ACTIVE COMPARATOR

The study 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.

Behavioral: HealthSmart

Interventions

Virtual Safe Dates for Young Parents 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. The investigators 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.

Virtual Safe Dates for Young Parents

HealthSmart 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 health, how to read food labels, healthy eating, and guidelines for physical activity.

HealthSmart

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RTI International: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

RTI International

Durham, North Carolina, 27713, United States

RECRUITING

Central Study Contacts

Marni Kan, PhD

CONTACT

919-485-2756; mkan@rti.org

Marie Stoner, PhD

CONTACT

510-665-8285; mcstoner@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Public Health Analyst 1

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Submission of the study data will occur by the end of the project period.
• Access Criteria: Restricted access study data and associated documentation will be made available to the research community free of charge through openICPSR. Given the sensitive nature of the teen survey data and the small sample sizes in the interview data, it is expected that these data will be designated as restricted-use data. ICPSR requires an application to access such data. As part of the application process, the data user must enter into a Restricted Data Use Agreement with ICPSR among other application components and data security requirements.

Locations

US (1)