Domestic Violence, Perinatal Problems
Conditions
Keywords
intimate partner violence, perinatal health, doula
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 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
BEHAVIORALDoulas
The intervention will be pairing intimate partner violence survivors with a trained doula
BEHAVIORALThrive
The active control arm will include pairing intimate partner violence survivors with IPV advocates
Sponsors
University of Pittsburgh
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Past 3-month Digital coercion | baseline, 3, 6, and 12 months | 4 item measure on digital coercion, scored yes or no |
| Past 3 month Health-related coercion | baseline, 3, 6, and 12 months | 3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMaya Ragavan
PRINCIPAL_INVESTIGATORMaya I Ragavan
University of Pittsburgh
PRINCIPAL_INVESTIGATORDara Mendez
University of Pittsburgh
Outcome results
None listed