Clinical Trial to Reduce Perinatal Intimate Partner Violence

NCT ID: NCT07165860

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2029-10-31

Brief Summary

This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors

Detailed Description

The study team will complete a 2-arm randomized clinical trial to test the effectiveness of IPV-trained doulas compared with an active control in reducing IPV among perinatal IPV survivors. Participants randomized into doula group will be paired community doula who will provide full-spectrum doula services prenatally (22 weeks gestation), through the birthing period, to early postpartum (6 months total). Participants randomized to the active two structured intakes from a victim services agency. Participants will be recruited from their prenatal visit at 1 of 3 sites with 163 perinatal people randomized to the doula group and 163 randomized to active control (N=326). The primary outcome is change in IPV across a range coercive behaviors from baseline to 12-months post enrollment. Secondary outcomes include change in cannabis and tobacco use, as well as depressive symptoms, anxiety, and unmet basic needs. The study will also be assessing changes in intermediate outcomes, including resource utilization, trust of doulas and IPV advocates, parenting stress, safety-related empowerment, and social support. Measures will be completed at enrollment, and then 3-, 6-, and 12-months post-enrollment. In Aim 2, the study team will be assessing potential mediators and moderators driving intervention effects and in Aim 3, collecting information about implementation outcomes.

Conditions

Domestic Violence; Perinatal Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Active control arm

The active control arm will include two structured check-ins by a trained intimate partner violence advocate from a local victim services agency. The IPV advocate will check in twice: once prenatally (after randomization) and the next postpartum. All participants in the active control arm will have access to the 24/7 helpline.

Group Type: ACTIVE_COMPARATOR

Thrive

Intervention Type: BEHAVIORAL

The active control arm will include pairing intimate partner violence survivors with IPV advocates

Doula group (intervention)

The intervention arm will include support rom a community-based doula connected with an IPV survivor during the second trimester and followed for 6 months. The doulas will provide full-spectrum services, which include attending clinic visits, support during the delivery, telephone and virtual check-ins, and connection to resources. Doulas have 4 structured visits (4 hours) and the rest of the time will be unstructured. Doulas will also attend the participant's birth. Doulas will provide a trauma-informed perinatal workbook to the participants that our team developed.

Group Type: EXPERIMENTAL

Doulas

Intervention Type: BEHAVIORAL

The intervention will be pairing intimate partner violence survivors with a trained doula

Interventions

Doulas

The intervention will be pairing intimate partner violence survivors with a trained doula

Intervention Type: BEHAVIORAL

Thrive

The active control arm will include pairing intimate partner violence survivors with IPV advocates

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1) feel comfortable completing the study in Spanish or English
• 2) are age 18 or older
• 3) are no more than 22 weeks gestation
• 4) identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV
• 5) live within a 50 mile radius of Pittsburgh, Pennsylvania
• 6) able to provide safe and complete contact information or take a study cell phone

• Cannot provide safe contact information or take a study cell phone
• Incarcerated

Exclusion Criteria

• Unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Maya Ragavan

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya I Ragavan

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Dara Mendez

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

The Midwife Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Family Medicine Department

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maya Ragavan

Role: CONTACT

ragavanm@chp.edu

4126926545

Maya Ragavan

Role: CONTACT

ragavanm@chp.edu

16506449954

Facility Contacts

Judy Chang

Role: primary

chanjc@upmc.edu

Emily McGahey

Role: primary

e.mcgahey@midwifecenter.org

(412) 321-6880

Stacy Bartlett

Role: primary

bartlettsj2@upmc.edu

412-383-2377

Other Identifiers

R01NR021484

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24080042

Identifier Type: -

Identifier Source: org_study_id