Creating VIP Corps to Reduce Maternal Deaths

Healthy Participants Clinical Trial

Official title:

Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06089109
• Other study ID #: 77241
• Secondary ID: 5 ASTWH210102-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: April 2027

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2800
• Est. completion date: April 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Students enrolled in a helping professions program and in their senior year

• 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 4

• Students under age 18 or over age 30

• Students with no direct interaction with patients or clients

Related Conditions & MeSH terms

• Death
• Healthy Participants

Intervention

Behavioral:
• Kentucky Violent Death Reporting System
The Kentucky Violent Death Reporting System (KYVDRS) addresses the need for accurate surveillance and data analysis by combining data from death certificates, coroner/medical examiner reports, police reports, crime laboratory reports, toxicology reports, and child fatality review team reports.
• Implementation and Effectiveness of VIP Corps Training
Implement and evaluate the effectiveness of VIP Corps training aimed at students enrolled in helping professions in their last program year. intervention efficacy to change in students' knowledge, attitudes, and practices of intimate partner violence (IPV) screening, detection, and referrals; participant practices will be the primary, longer-term outcome; while changes in knowledge and attitudes will be short-term outcomes. Secondary outcomes will include changes in detecting symptoms of a) SU/D and b) depression and/or anxiety and providing appropriate resources.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Ann Coker	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (2)

Maiuro RD, Vitaliano PP, Sugg NK, Thompson DC, Rivara FP, Thompson RS. Development of a health care provider survey for domestic violence: psychometric properties. Am J Prev Med. 2000 Nov;19(4):245-52. doi: 10.1016/s0749-3797(00)00230-0. — View Citation

Peters, J. (2008). Measuring Myths about Domestic Violence: Development and Initial Validation of the Domestic Violence Myth Acceptance Scale. Journal of Aggression, Maltreatment & Trauma, 16(1), 1-21. https://doi.org/10.1080/10926770801917780

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.	Change in knowledge of intimate partner violence (IPV) and attitudes toward those experiencing IPV by condition over time. Knowledge of pregnancy-associated causes of maternal mortality and morbidity created for this randomized controlled trial (RCT). This is a 17-item scale ranging from 0-35 with higher scores indicating greater (accurate) knowledge.	Year 2 - Year 4
Primary	Knowledge and attitudes toward substance use among pregnant and postpartum people.	Change in knowledge of substance use and attitudes toward those using substances or having a substance use disorder by condition over time. Attitudes toward pregnant or postpartum people experiencing: a) intimate partner violence (IPV), substance use, and anxiety or depression. This measure is based on the Domestic Violence Myth Acceptance and expanded to substance use and anxiety or depression. 45 items and 3 subscales. Response options: 1-5 indicating ranging from strongly agree to strongly disagree. Lower scores are desired indicating greater acceptance and increased willingness to address intimate partner violence (IPV), substance use, and anxiety or depression among pregnant or postpartum people.	Year 2 - Year 4
Primary	Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.	Change in knowledge of anxiety or depression and attitudes toward those with anxiety or depression by condition over time. The Violence Against Women Health Care Provider Survey expanded to providers' willingness to ask clients about: a) Intimate partner violence (IPV), b) substance use, and c) anxiety or depression. 41 items querying self-confidence and actions in asking clients about risk factors for maternal morbidity. The response options 1-5 indicate strongly agree to strongly disagree. Higher scores are desired as indicators of greater self confidence and likelihood of actions with clients.	Year 2 - Year 4
Secondary	Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.	Change in willingness, perceived efficacy, reports of asking clients about intimate partner violence (IPV) by condition and over time. New Bystander Action Survey developed for this randomized controlled trial (RCT). There are 20 items that measure the opportunity to take action with clients, friends or family members; actions taken, and perceived impact. There are 6 response options ranging from 0 times to more than 12 times (in the past 6 months). More actions and a higher score, are desired as indicators of greater actions to identify risk of maternal morbidity and provide resources to reduce this risk.	Year 3 - Year 5

External Links

•   Official University of Kentucky website pertinent to this study