- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07226401
Virtual Village for Young Parents
December 9, 2025 updated by: Marni Kan, RTI International
Preventing Intimate Partner Violence Among Teens Who Are Pregnant or Parenting
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
The investigators 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.
The investigators 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, the investigators 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.
The study 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 conduct surveys at baseline and 3-6-month follow-up to assess IPV and related behavioral outcomes.
The investigators 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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marni Kan, PhD
- Phone Number: 919-485-2756
- Email: mkan@rti.org
Study Contact Backup
- Name: Marie Stoner, PhD
- Phone Number: 510-665-8285
- Email: mcstoner@rti.org
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27713
- Recruiting
- RTI International
-
Contact:
- Marni Kan
- Phone Number: 919-485-2756
- Email: mkan@rti.org
-
Contact:
- Marie Stoner
- Phone Number: 5106658285
- Email: mcstoner@rti.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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 (Pilot RCT participants):
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: HealthSmart
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant attendance
Time Frame: From the first to the last session of SDYP (typically 10 weeks)
|
Percent of sessions attended (out of 10)
|
From the first to the last session of SDYP (typically 10 weeks)
|
|
Participant engagement
Time Frame: From the first to the last session of SDYP (typically 10 weeks)
|
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
Time Frame: From the first to the last session of SDYP (typically 10 weeks)
|
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
Time Frame: Past 3 months measured at baseline and 3 to 6 months after baseline
|
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
Time Frame: Past 3 months measured at baseline and 3 to 6 months after baseline
|
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
Time Frame: Past 3 months measured at baseline and 3 to 6 months after baseline
|
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
Time Frame: Past 3 months measured at baseline and 3 to 6 months after baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
November 7, 2025
First Submitted That Met QC Criteria
November 7, 2025
First Posted (Estimated)
November 10, 2025
Study Record Updates
Last Update Posted (Actual)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 9, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21HD111729 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Restricted access study data and associated documentation will be made available to the research community free of charge through a self-publishing repository for social, behavioral, and health sciences research data.
Participants' identifying information (names and contact information) will not be included in shared data.
IPD Sharing Time Frame
Submission of the study data will occur by the end of the project period.
IPD Sharing 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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