Clinical trial NCT06089109: Creating VIP Corps to Reduce Maternal Deaths
Official title: Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Morbidity and Mortality
Keywords: Maternal Morbidity
Maternal Mortality
VIP Corps
Pregnancy-associated injuries
Pregnancy-associated deaths
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2023-10-18
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this observational study is to create and rigorously evaluate a violence intervention and prevention corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students; and to develop a novel maternal injury surveillance system (MISS) to complement an existing maternal violent death registry in Kentucky.

Detailed description: The participant population defined in this study are undergraduate and professional students within their last educational year in a helping professionals program at the University of Kentucky, ages 18-30. This study will permit the creation of effective programming to train the next generation of health and social service professionals prepared to help reduce Kentucky's maternal mortality and injury rates over time with implementation.

Aim 1:

1. Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
2. Develop a novel maternal injury surveillance system (MISS) as a complement to an existing maternal violent deaths registry to accurately and reliably enumerate maternal injuries and deaths due to violence.

Aim 2:

1. Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
2. Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
3. Prospectively evaluate the effectiveness of a novel VIP training as the intervention condition relative to an attention control (SU/D and IPV awareness), to increase knowledge of the effects of intimate partner violence (IPV) on health outcomes, report intimate partner violence (IPV) screening behaviors, intimate partner violence (IPV) detection, and to reduce intimate partner violence (IPV) frequency among patients and clients over time.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in a helping professions program
* 18 years of age through 30 years of age
* Students whom will have direct interaction with patients or clients that may experience interpersonal violence (IPV)

Exclusion Criteria:

* Students not enrolled in a helping professions program
* Students under age 18 or over age 30
* Students with no direct interaction with patients or clients

Primary outcomes:
measure: Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.
timeFrame: Year 2 - Year 4
measure: Knowledge and attitudes toward substance use among pregnant and postpartum people.
timeFrame: Year 2 - Year 4
measure: Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.
timeFrame: Year 2 - Year 4
Secondary outcomes:
measure: Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.
timeFrame: Year 3 - Year 5
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ann L Coker, PhD
role: PRINCIPAL_INVESTIGATOR
References: