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NCT Number: NCT07165860

Clinical Trial to Reduce Perinatal Intimate Partner Violence

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

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Key information

Conditions

Domestic Violence Perinatal Problems

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family Medicine Department, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doulas

Behavioral

The intervention will be pairing intimate partner violence survivors with a trained doula

Thrive

Behavioral

The active control arm will include pairing intimate partner violence survivors with IPV advocates

Primary outcomes

  1. Perinatal physical, sexual, or emotional abuse (past 3 months)

    Time frame: 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

  2. Substance use coercion (past 3 month)

    Time frame: baseline, 3 months, 6 months, and 12 months

    5 item measure answer choices and yes/no

  3. Mental health coercion (past 3 month)

    Time frame: baseline, 3 months, 6 months, and 12 months

    5 item mental health coercion survey with yes and no answer choices

  4. Economic Abuse (past 3 month)

    Time frame: 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

  5. Reproductive Coercion (past 3 months)

    Time frame: 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

  6. Sleep coercion (past 3 months)

    Time frame: baseline, 3 months, 6 months, and 12 months

    1 item sleep coercion measure (investigator developed, yes/no)

  7. Past 3-month Digital coercion

    Time frame: baseline, 3, 6, and 12 months

    4 item measure on digital coercion, scored yes or no

  8. Past 3 month Health-related coercion

    Time frame: baseline, 3, 6, and 12 months

    3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no

Secondary outcomes

  1. Substance use

    Time frame: baseline

    4 item validated measure to assess substance use during pregnancy

  2. Tobacco use

    Time frame: baseline, 3 months, 6 months, 12 months

    Type, frequency, use currently and before pregnancy (4 items)

  3. Depressive symptoms

    Time frame: 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

  4. Anxiety

    Time frame: 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

  5. Unmet basic needs (financial, food, and housing insecurity)

    Time frame: 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

  6. Past 3-month substance use

    Time frame: 6 months, 12 months

    Substances used in the past 3 months, first yes/no and then type of substance

Other outcomes

  1. Resource utilization

    Time frame: baseline, 3 months, 6 months, 12 months

    21 items; investigator developed examining utilization of local and national community-based resources; answer choices are yes and no

  2. Safety related empowerment

    Time frame: baseline, 3 months, 6 months, 12 months

    13 item Measures of Victim Empowerment Related to Safety survey; α=0.87, answer choices 0 to 4, summary score created, higher score means more empowerment

  3. Trust of healthcare, doula and IPV advocate

    Time frame: baseline, 3 months, 6 months, 12 months

    3 item investigator developed, answer choices 0 to 4. Each item analyzed separately (doula, IPV advocate, and physician)

  4. Social support

    Time frame: baseline, 3 months, 6 months, 12 months

    12 item Multidimensional Scale of Perceived Social Support; α=0.93. Likert scale 1 to 7, summary score created, higher score means more feelings of social support

  5. Sleep coercion (lifetime)

    Time frame: baseline

    1 item sleep coercion measure (investigator developed, yes/no)

  6. Reproductive Coercion (lifetime)

    Time frame: baseline

    9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion

  7. Economic Abuse (lifetime)

    Time frame: baseline

    12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse

  8. Mental health coercion (lifetime)

    Time frame: baseline

    5 item mental health coercion survey with yes and no answer choices

  9. Lifetime Health-related coercion

    Time frame: baseline

    3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no

  10. Lifetime Digital coercion

    Time frame: baseline

    4 item measure on digital coercion, scored yes or no

  11. Lifetime substance use coercion

    Time frame: baseline

    5 item measure answer choices and yes/no

  12. Lifetime physical, sexual, or emotional abuse

    Time frame: baseline

    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

  13. Self-efficacy

    Time frame: baseline, 3, 6 and 12 months

    Validated 8 item New General Self Efficacy Scale. Likert scale 1 to 5, summary scale created, a higher score means more self-efficacy. The score ranges from 10 to 40

  14. Parenting Stress

    Time frame: 6 months, 12 months

    Validated Parenting Stress Scale; 18 items; Likert Scale 1 to 5, summary score created, a higher score means more parenting stress. The range is 18 to 90

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Ragavan

CONTACT

[email protected]

4126926545

Maya Ragavan

CONTACT

[email protected]

16506449954

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 10, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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