NCT07226401 · RTI International
Virtual Village for Young Parents
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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. 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.
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 health, how to read food labels, healthy eating, and guidelines for physical activity.
Primary outcome measures
Participant attendance
Time frame: From the first to the last session of SDYP (typically 10 weeks)
Percent of sessions attended (out of 10)
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
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
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
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Durham, North Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 15, 2025 · Source of record for eligibility and locations