Clinical Trial to Reduce Perinatal Intimate Partner Violence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pittsburgh
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Unable to consent
Do not meet inclusion criteria
Cannot provide safe contact information or take a study cell phone
Incarcerated
Trial design
Design model
Parallel
Treatments tested in this trial
Doulas
BehavioralThe intervention will be pairing intimate partner violence survivors with a trained doula
Thrive
BehavioralThe active control arm will include pairing intimate partner violence survivors with IPV advocates
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Active control armActive comparator 1 intervention
Group B: Doula group (intervention)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
baseline, 3 months, 6 months, 12 months2
Substance use coercion (past 3 month)
5 item measure answer choices and yes/no
Time frame
baseline, 3 months, 6 months, and 12 months3
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 months4
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 monthsSecondary outcomes
1
Substance use
4 item validated measure to assess substance use during pregnancy
Time frame
baseline2
Tobacco use
Type, frequency, use currently and before pregnancy (4 items)
Time frame
baseline, 3 months, 6 months, 12 months3
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 months4
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 monthsOther outcomes
1
Resource utilization
21 items; investigator developed examining utilization of local and national community-based resources; answer choices are yes and no
Time frame
baseline, 3 months, 6 months, 12 months2
Safety related empowerment
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
Time frame
baseline, 3 months, 6 months, 12 months3
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)
Time frame
baseline, 3 months, 6 months, 12 months4
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
Time frame
baseline, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov