NCT06089109

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Sep 2023Sep 2027

Study Start

First participant enrolled

September 25, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2027

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

September 29, 2023

Last Update Submit

October 2, 2025

Conditions

Maternal Morbidity and Mortality

Keywords

Maternal MorbidityMaternal MortalityVIP CorpsPregnancy-associated injuriesPregnancy-associated deaths

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

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

    Year 3 - Year 5

Study Arms (2)

Maternal Injury and Death Intervention

EXPERIMENTAL

Our research team created a VIP Corps online, interactive learning management system (LMS) training. This VIP Corps online training will be offered to students enrolled in a helping profession. Students are randomized to this experimental intervention arm. 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 students with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.

Behavioral: Implementation and Effectiveness of VIP Corps Training

Development of a Maternal Injury Surveillance System

ACTIVE COMPARATOR

Proposal of a novel Maternal Injury Surveillance System (MISS) as a complement to the existing maternal mortality surveillance available within Kentucky Violent Death Reporting System (KVDRS)

Behavioral: The Big 3

Interventions

The Big 3BEHAVIORAL

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.

Development of a Maternal Injury Surveillance System
Implementation and Effectiveness of VIP Corps TrainingBEHAVIORAL

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.

Maternal Injury and Death Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ann L Coker, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann L Coker, PhD

CONTACT

859-323-0429ann.coker@uky.edu

Ashley Roark, BS

CONTACT

859-323-0429ashley.roark@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 18, 2023

Study Start

September 25, 2023

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

September 29, 2027

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)