Gender-based ViolenceNCT07226401
Virtual Village for Young Parents
A study testing Virtual Safe Dates for Young Parents and HealthSmart in people with Gender-based Violence and Intimate Partner Violence, run by RTI International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence, Intimate Partner Violence
- What is being tested?
- Virtual Safe Dates for Young Parents and HealthSmart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RTI International
Durham, North Carolina, 27713
Marni Kan, 919-485-2756, mkan@rti.org
Marie Stoner, 5106658285, mcstoner@rti.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Gender-based Violence, Intimate Partner Violence
- Being tested
- Virtual Safe Dates for Young Parents, HealthSmart
- Keywords
- Young Adult Parents, Adolescent Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Safe Dates for Young ParentsBehavioural
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.
HealthSmartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: HealthSmart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant attendance
Percent of sessions attended (out of 10)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Past 3 months measured at baseline and 3 to 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start11 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-based ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Marni Kan, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226401
- Sponsor's protocol ID
- R21HD111729
- Other IDs
- R21HD111729
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Intimate Partner Violence Among Teens Who Are Pregnant or Parenting
- ClinicalTrials.gov ID
- NCT07226401
- Acronym / sponsor ID
- R21HD111729
- Conditions
- Gender-based Violence, Intimate Partner Violence
- Keywords
- Young Adult Parents, Adolescent Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Safe Dates for Young Parents | Experimental | Behavioral: Virtual Safe Dates for Young ParentsParticipants 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. |
| HealthSmart | Active comparator | Behavioral: HealthSmartThe 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. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Safe Dates for Young ParentsSafe 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. | Behavioural | Virtual Safe Dates for Young Parents |
| HealthSmartThe 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. | Behavioural | HealthSmart |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Safe Dates for Young Parents and HealthSmart in people with Gender-based Violence and Intimate Partner Violence, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marni Kan, PhD (919-485-2756, mkan@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant attendance (time frame: From the first to the last session of SDYP (typically 10 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.