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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR021484 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doulas | Behavioral | The intervention will be pairing intimate partner violence survivors with a trained doula |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 3 months, 6 months, 12 months |
| Substance use coercion (past 3 month) | 5 item measure answer choices and yes/no | 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 | 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 | 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 | baseline, 3 months, 6 months, and 12 months |
| Sleep coercion (past 3 months) | 1 item sleep coercion measure (investigator developed, yes/no) | baseline, 3 months, 6 months, and 12 months |
| Past 3-month Digital coercion | 4 item measure on digital coercion, scored yes or no |
| Measure | Description | Time Frame |
|---|---|---|
| Substance use | 4 item validated measure to assess substance use during pregnancy | baseline |
| Tobacco use | Type, frequency, use currently and before pregnancy (4 items) |
| Measure | Description | Time Frame |
|---|---|---|
| Resource utilization | 21 items; investigator developed examining utilization of local and national community-based resources; answer choices are yes and no | baseline, 3 months, 6 months, 12 months |
| Safety related empowerment |
Inclusion Criteria: Perinatal IPV survivors are eligible if they:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Ragavan | Contact | 4126926545 | ragavanm@chp.edu | |
| Maya Ragavan | Contact | 16506449954 | ragavanm@chp.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maya I Ragavan | University of Pittsburgh | Principal Investigator |
| Dara Mendez | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Women's Hospital | Not yet recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
No individual level data will be shared outside of our team. Aggregated data may be shared.
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| ID | Term |
|---|---|
| D059037 | Doulas |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
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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
| Thrive | Behavioral | The active control arm will include pairing intimate partner violence survivors with IPV advocates |
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| 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 | baseline, 3, 6, and 12 months |
| 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 | 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 | 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 | Baseline, 12 months |
| Past 3-month substance use | Substances used in the past 3 months, first yes/no and then type of substance | 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
| baseline, 3 months, 6 months, 12 months |
| Trust of healthcare, doula and IPV advocate | 3 item investigator developed, answer choices 0 to 4. Each item analyzed separately (doula, IPV advocate, and physician) | baseline, 3 months, 6 months, 12 months |
| Social support | 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 | baseline, 3 months, 6 months, 12 months |
| Sleep coercion (lifetime) | 1 item sleep coercion measure (investigator developed, yes/no) | baseline |
| Reproductive Coercion (lifetime) | 9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion | baseline |
| Economic Abuse (lifetime) | 12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse | baseline |
| Mental health coercion (lifetime) | 5 item mental health coercion survey with yes and no answer choices | baseline |
| Lifetime Health-related coercion | 3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no | baseline |
| Lifetime Digital coercion | 4 item measure on digital coercion, scored yes or no | baseline |
| Lifetime substance use coercion | 5 item measure answer choices and yes/no | baseline |
| Lifetime physical, sexual, or emotional abuse | 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 | baseline |
| Self-efficacy | 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 | baseline, 3, 6 and 12 months |
| Parenting Stress | 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 | 6 months, 12 months |
| The Midwife Center | Recruiting | Pittsburgh | Pennsylvania | 15222 | United States |
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| Family Medicine Department | Recruiting | Pittsburgh | Pennsylvania | 15260 | United States |
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| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |