Domestic ViolenceNCT07165860
Clinical Trial to Reduce Perinatal Intimate Partner Violence
A study testing Doulas and Thrive in people with Domestic Violence and Perinatal Problems, run by University of Pittsburgh at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Perinatal Problems
- What is being tested?
- Doulas and Thrive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2025to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to consent
- Do not meet inclusion criteria
- Cannot provide safe contact information or take a study cell phone
- Incarcerated
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Judy Chang, chanjc@upmc.edu
- Recruiting
The Midwife Center
Pittsburgh, Pennsylvania, 15222
Emily McGahey, (412) 321-6880, e.mcgahey@midwifecenter.org
- Recruiting
Family Medicine Department
Pittsburgh, Pennsylvania, 15260
Stacy Bartlett, 412-383-2377, bartlettsj2@upmc.edu
About this study
Official title: Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors
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
Read the 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.
- Conditions
- Domestic Violence, Perinatal Problems
- Being tested
- Doulas, Thrive
- Keywords
- intimate partner violence, perinatal health, doula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoulasBehavioural
The intervention will be pairing intimate partner violence survivors with a trained doula
ThriveBehavioural
The active control arm will include pairing intimate partner violence survivors with IPV advocates
| Study group | Role | What they receive |
|---|---|---|
| Active control arm | Active comparator | 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. Receives: Behavioral: Thrive |
| Doula group (intervention) | Experimental | 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. Receives: Behavioral: Doulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal physical, sexual, or emotional abuse (past 3 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
Measured: baseline, 3 months, 6 months, 12 months
Substance use coercion (past 3 month)
5 item measure answer choices and yes/no
Measured: baseline, 3 months, 6 months, and 12 months
Mental health coercion (past 3 month)
5 item mental health coercion survey with yes and no answer choices
Measured: baseline, 3 months, 6 months, and 12 months
Economic Abuse (past 3 month)
12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse
Measured: baseline, 3 month, 6 months, and 12 months
Reproductive Coercion (past 3 months)
9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion
Measured: baseline, 3 months, 6 months, and 12 months
Sleep coercion (past 3 months)
1 item sleep coercion measure (investigator developed, yes/no)
Measured: baseline, 3 months, 6 months, and 12 months
Past 3-month Digital coercion
4 item measure on digital coercion, scored yes or no
Measured: baseline, 3, 6, and 12 months
Past 3 month Health-related coercion
3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no
Measured: baseline, 3, 6, and 12 months
Secondary outcomes (6)
Substance use
4 item validated measure to assess substance use during pregnancy
Measured: baseline
Tobacco use
Type, frequency, use currently and before pregnancy (4 items)
Measured: baseline, 3 months, 6 months, 12 months
Depressive symptoms
10 item Edinburgh Postnatal Depression Scale; α=0.87, summary scale and mean, higher score means more depression. Scale ranges from 0 to 30
Measured: baseline, 3 months, 6 months, 12 months
Anxiety
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
Measured: baseline, 3 months, 6 months, and 12 months
Unmet basic needs (financial, food, and housing insecurity)
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
Measured: Baseline, 12 months
Past 3-month substance use
Substances used in the past 3 months, first yes/no and then type of substance
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Maya Ragavan, University of Pittsburgh
- Investigators
- Maya I Ragavan, Principal investigator, University of PittsburghDara Mendez, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165860
- Sponsor's protocol ID
- STUDY24080042
- Other IDs
- R01NR021484
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual level data will be shared outside of our team. Aggregated data may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors
- ClinicalTrials.gov ID
- NCT07165860
- Acronym / sponsor ID
- STUDY24080042
- Conditions
- Domestic Violence, Perinatal Problems
- Keywords
- intimate partner violence, perinatal health, doula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active control arm | Active comparator | Behavioral: ThriveThe 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. |
| Doula group (intervention) | Experimental | Behavioral: DoulasThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Unable to consent
- Do not meet inclusion criteria
- Cannot provide safe contact information or take a study cell phone
- Incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoulasThe intervention will be pairing intimate partner violence survivors with a trained doula | Behavioural | Doula group (intervention) |
| ThriveThe active control arm will include pairing intimate partner violence survivors with IPV advocates | Behavioural | Active control arm |
Primary outcome
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
Substance use coercion (past 3 month)
Time frame: baseline, 3 months, 6 months, and 12 months
5 item measure answer choices and yes/no
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
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
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
Sleep coercion (past 3 months)
Time frame: baseline, 3 months, 6 months, and 12 months
1 item sleep coercion measure (investigator developed, yes/no)
Past 3-month Digital coercion
Time frame: baseline, 3, 6, and 12 months
4 item measure on digital coercion, scored yes or no
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. No individual level data will be shared outside of our team. Aggregated data may be shared.
Related trials for Domestic Violence
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Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
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Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya I Ragavan principal investigator
University of Pittsburgh
Dara Mendez principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doulas and Thrive in people with Domestic Violence and Perinatal Problems, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Ragavan (4126926545, ragavanm@chp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal physical, sexual, or emotional abuse (past 3 months) (time frame: baseline, 3 months, 6 months, 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.