Doula Thrive Clinical Trial to Reduce Perinatal Intimate Partner Violence

Not Applicable

Not yet recruiting

• Conditions: Domestic Violence; Perinatal Problems

• Registration Number: NCT07165860
• Lead Sponsor: University of Pittsburgh

Brief 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 (Doula Thrive) compared with an active control in reducing IPV among perinatal IPV survivors. Participants randomized into Doula Thrive will be paired community doula from the MAYA organization 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 the Women's Center and Shelter (a victim services agency). Participants will be recruited from their prenatal visit at 1 of 3 sites with 163 perinatal people randomized to Doula Thrive 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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-12
• Primary Completion: 2028-10
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 326

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.

Exclusion Criteria

• Unable to consent
• Do not meet inclusion criteria
• Cannot provide safe contact information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perinatal physical, sexual, or emotional abuse (past 3 months)	baseline, 3 months, 6 months, 12 months	15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV
Substance use coercion (past 3 month)	baseline, 3 months, 6 months, and 12 months	5 item measure answer choices and yes/no
Mental health coercion (past 3 month)	baseline, 3 months, 6 months, and 12 months	5 item mental health coercion survey with yes and no answer choices
Economic Abuse (past 3 month)	baseline, 3 month, 6 months, and 12 months	12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse
Reproductive Coercion (past 3 months)	baseline, 3 months, 6 months, and 12 months	9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion
Sleep coercion (past 3 months)	baseline, 3 months, 6 months, and 12 months	1 item sleep coercion measure (investigator developed, yes/no)

Secondary Outcome Measures

Name	Time	Method
Substance use	baseline	4 item validated measure to assess substance use during pregnancy
Tobacco use	baseline, 3 months, 6 months, 12 months	Type, frequency, use currently and before pregnancy (4 items)
Depressive symptoms	baseline, 3 months, 6 months, 12 months	10 item Edinburgh Postnatal Depression Scale; α=0.87, summary scale and mean, higher score means more depression. Scale ranges from 0 to 30
Anxiety	baseline, 3 months, 6 months, and 12 months	7 item validated GAD-7, scores Likert 0 to 3, added up for summary scale, higher score means more anxiety. Scale ranges from 0 to 21
Unmet basic needs (financial, food, and housing insecurity)	Baseline, 12 months	5 item investigator developed scale on food, housing, and utilities insecurity. Answer choices yes or no, more yes choices chosen means more unmet basic needs
Past 3-month substance use	6 months, 12 months	Substances used in the past 3 months, first yes/no and then type of substance

Trial Locations

Locations (3)

Magee Women's Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Midwife Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Family Medicine Department; 🇺🇸 Pittsburgh, Pennsylvania, United States