Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID07165860

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during a prenatal visit

Enrollment and Baseline Assessment

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

Behavioral Treatment

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

Follow-up Assessments

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

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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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