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 163 perinatal people randomized to the doula group 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
326
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGThe Midwife Center
Pittsburgh, Pennsylvania, United States
RECRUITINGFamily Medicine Department
Pittsburgh, Pennsylvania, United States
RECRUITINGPerinatal 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
Time frame: baseline, 3 months, 6 months, 12 months
Substance use coercion (past 3 month)
5 item measure answer choices and yes/no
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 3 months, 6 months, and 12 months
Sleep coercion (past 3 months)
1 item sleep coercion measure (investigator developed, yes/no)
Time frame: baseline, 3 months, 6 months, and 12 months
Substance use
4 item validated measure to assess substance use during pregnancy
Time frame: baseline
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Tobacco use
Type, frequency, use currently and before pregnancy (4 items)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 months
Past 3-month substance use
Substances used in the past 3 months, first yes/no and then type of substance
Time frame: 6 months, 12 months