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NCT Number: NCT06089109

Creating VIP Corps to Reduce Maternal Deaths

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

Ann L Coker, PhD

CONTACT

[email protected]

859-323-0429

Ann L Coker, PhD

PRINCIPAL_INVESTIGATOR

Ashley Roark, BS

CONTACT

[email protected]

859-323-0429

Ayse Guler-Das, PhD

SUB_INVESTIGATOR

Hartley Feld, PhD

SUB_INVESTIGATOR

About this study

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:

  • Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
  • 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:

  • Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
  • Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Big 3

Behavioral

Our research team has developed an online, interactive learning management system (LMS) training. This training seeks to provide helping professionals with information and resources to identify, intervene, and prevent maternal injuries from interpersonal violence, substance use/disorder (IPV and SU/D). This training will provide healthcare professionals with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.

Implementation and Effectiveness of VIP Corps Training

Behavioral

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.

Primary outcomes

  1. Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.

    Time frame: Year 2 - Year 4

    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.

  2. Knowledge and attitudes toward substance use among pregnant and postpartum people.

    Time frame: Year 2 - Year 4

    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.

  3. Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.

    Time frame: Year 2 - Year 4

    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.

Secondary outcomes

  1. Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.

    Time frame: Year 3 - Year 5

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann L Coker, PhD

CONTACT

[email protected]

859-323-0429

Ashley Roark, BS

CONTACT

[email protected]

859-323-0429

Sponsors and collaborators

Lead sponsor

Ann Coker

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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