Clinical Trial to Reduce Perinatal Intimate Partner Violence
Purpose
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
Conditions
- Domestic Violence
- Perinatal Problems
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
- Masking Description
- The trial will be blinded to the investigators and participants will be unblinded if a participant is experiencing distress or needs support from the primary investigator
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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. |
|
|
Experimental 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. |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15222
Pittsburgh, Pennsylvania 15260
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
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.