Actively Recruiting
Novel Doula Intervention to Support Perinatal Intimate Partner Violence Survivors Compared to IPV Advocate Support
Led by University of Pittsburgh · Updated on 2026-04-16
250
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors. This two-armed randomized clinical trial involves perinatal people who experience IPV and aims to measure changes in IPV and related outcomes such as substance use, mental health symptoms, and basic needs over 12 months. The study also explores factors influencing intervention effects and implementation outcomes. Participants are randomly assigned to one of two groups. The doula group receives support from IPV-trained community doulas starting prenatally around 22 weeks gestation and continuing through birth to six months postpartum. These doulas provide full-spectrum services including clinic visit attendance, delivery support, telephone and virtual check-ins, resource connections, and a trauma-informed perinatal workbook. The active control group receives two structured check-ins from IPV advocates provided by a victim services agency, including one prenatal and one postpartum visit, plus access to a 24/7 helpline. During the study, participants complete assessments at enrollment and at 3, 6, and 12 months post-enrollment. Researchers collect data on various types of IPV, substance use, depression, anxiety, unmet basic needs, and intermediate factors like resource use, trust, parenting stress, empowerment, and social support. The study lasts about one year per participant, with ongoing monitoring of intervention effects and implementation experiences.
CONDITIONS
Brief Title
Clinical Trial to Reduce Perinatal Intimate Partner Violence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Comfortable completing the study in Spanish or English
- Age 18 years or older
- No more than 24 weeks and 6 days pregnant at enrollment
- Identify as an intimate partner violence survivor
- Live within 50 miles of Pittsburgh, Pennsylvania
- Able to provide safe and complete contact information or use a study cell phone
You will not qualify if you...
- Unable to provide informed consent
- Do not meet inclusion criteria
- Cannot provide safe contact information or use a study cell phone
- Currently incarcerated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during a prenatal visit
Duration - At enrollment
Participants are enrolled and complete baseline measures including assessments of intimate partner violence, substance use, mental health, and basic needs.
1 visit (in-person or virtual) at enrollment
Duration - Up to 6 months postpartum
Participants receive either full-spectrum doula support from the second trimester through six months postpartum or two structured check-ins with an IPV advocate along with access to a 24/7 helpline.
Doula group: 4 structured visits plus unstructured support including clinic visits, birth attendance, and virtual check-ins; Active control: 2 visits (1 prenatal and 1 postpartum) with IPV advocate
Duration - 12 months post-enrollment
Participants complete follow-up assessments at 3, 6, and 12 months post-enrollment to measure changes in intimate partner violence, substance use, mental health, and unmet basic needs.
3 visits (in-person or virtual) at 3, 6, and 12 months post-enrollment
Trial Site Locations
Total: 3 locations
1
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
2
The Midwife Center
Pittsburgh, Pennsylvania, United States, 15222
Actively Recruiting
3
Family Medicine Department
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
Research Team
M
Maya Ragavan
M
Maya Ragavan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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