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Recruiting NCT07165860

Clinical Trial to Reduce Perinatal Intimate Partner Violence

No phase Interventional Domestic Violence Perinatal Problems

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doulas, Thrive.
Who it may be relevant to
Registry conditions: Domestic Violence, Perinatal Problems. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors

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

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.

Interventions

  • Behavioral Doulas
    The intervention will be pairing intimate partner violence survivors with a trained doula
  • Behavioral Thrive
    The active control arm will include pairing intimate partner violence survivors with IPV advocates

Primary outcome measures

  • Perinatal physical, sexual, or emotional abuse (past 3 months) [Time frame: baseline, 3 months, 6 months, 12 months]
  • Substance use coercion (past 3 month) [Time frame: baseline, 3 months, 6 months, and 12 months]
  • Mental health coercion (past 3 month) [Time frame: baseline, 3 months, 6 months, and 12 months]
  • Economic Abuse (past 3 month) [Time frame: baseline, 3 month, 6 months, and 12 months]
  • Reproductive Coercion (past 3 months) [Time frame: baseline, 3 months, 6 months, and 12 months]
  • Sleep coercion (past 3 months) [Time frame: baseline, 3 months, 6 months, and 12 months]
  • Past 3-month Digital coercion [Time frame: baseline, 3, 6, and 12 months]
  • Past 3 month Health-related coercion [Time frame: baseline, 3, 6, and 12 months]
Secondary outcome measures (6)
  • Substance use [Time frame: baseline]
  • Tobacco use [Time frame: baseline, 3 months, 6 months, 12 months]
  • Depressive symptoms [Time frame: baseline, 3 months, 6 months, 12 months]
  • Anxiety [Time frame: baseline, 3 months, 6 months, and 12 months]
  • Unmet basic needs (financial, food, and housing insecurity) [Time frame: Baseline, 12 months]
  • Past 3-month substance use [Time frame: 6 months, 12 months]

Eligibility 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 3 centers
  • Magee Women's Hospital — Pittsburgh
  • The Midwife Center — Pittsburgh
  • Family Medicine Department — Pittsburgh

Identifiers

NCT: NCT07165860 · STUDY24080042 · R01NR021484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗