Clinical Trial to Reduce Perinatal Intimate Partner Violence

University of Pittsburgh

Status: Enrolling

Conditions: Perinatal Problems; Domestic Violence

Treatments: Behavioral: Doulas; Behavioral: Thrive

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07165860

R01NR021484 (U.S. NIH Grant/Contract)

STUDY24080042

Details and patient eligibility

About

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

Full 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.

Enrollment: 326 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

Active control arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Thrive

Doula group (intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Doulas