Virtual Village for Young Parents

RTI International

Status: Enrolling

Conditions: Gender-based Violence; Intimate Partner Violence

Treatments: Behavioral: HealthSmart; Behavioral: Virtual Safe Dates for Young Parents

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07226401

R21HD111729 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Virtual Safe Dates for Young Parents

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Safe Dates for Young Parents

HealthSmart

Active Comparator group

Description:

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.

Treatment:

Behavioral: HealthSmart