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NCT07165860NARecruitingAccepts Healthy Volunteers

Clinical Trial to Reduce Perinatal Intimate Partner Violence

University of Pittsburgh

Start Date

11/1/2025

Completion Date

5/1/2029

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 125 perinatal people randomized to the doula group and 125 randomized to active control (N=250). 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Perinatal IPV survivors are eligible if they: * 1\) feel comfortable completing the study in Spanish or English * 2\) are age 18 or older * 3\) are no more than 24 weeks 6 days gestation (note: participants enrolled earliest at 18 weeks, baseline at 22 weeks with a 3 week window) * 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 Exclusion Criteria: * Unable to consent * Do not meet inclusion criteria * Cannot provide safe contact information or take a study cell phone * Incarcerated

Interventions

BEHAVIORAL

Doulas

BEHAVIORAL

Thrive

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Conditions

Domestic ViolencePerinatal Problems

Locations

Magee Women's Hospital

Pittsburgh, Pennsylvania 15213

United States

The Midwife Center

Pittsburgh, Pennsylvania 15222

United States

Family Medicine Department

Pittsburgh, Pennsylvania 15260

United States