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Clinical Trial to Reduce Perinatal Intimate Partner Violence

Clinical Trial to Reduce Perinatal Intimate Partner Violence

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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.

Eligibility

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 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

Exclusion Criteria:

  • Unable to consent
  • Do not meet inclusion criteria
  • Cannot provide safe contact information or take a study cell phone
  • Incarcerated

Study details
    Domestic Violence
    Perinatal Problems

NCT07165860

University of Pittsburgh

1 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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