NCT05490004

Brief Summary

Veterans and their families are more likely to experience forms of family violence like intimate-partner violence and child maltreatment. Evidence suggests that healthcare and social service providers (HSSPs) need more training to effectively and confidently recognize and respond to these situations. The Violence, Evidence, Guidance, Action (VEGA) Educational Intervention is a novel education intervention aimed at improving provider's preparation for these clinical encounters. The goal of this project is to determine the acceptability and feasibility of a future randomized-controlled trial comparing two approaches (facilitator-led VEGA or self-directed VEGA) to administering the VEGA training to understand whether/how these approaches can support HSSPs continued care of veterans and their families. The investigators aim to generate initial estimates of the effectiveness of both approaches in improving HSSPs knowledge and skills to effectively recognize and respond to intimate-partner violence and related forms of family violence, including child maltreatment. As well, the investigators aim to contribute to the knowledge base regarding optimal educational approaches for HSSP education in family violence. The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to both CM and IPV in both the experimental and AC arms from Time 1 (baseline) to Time 2 (immediately after the intervention) and Time 1 (baseline) to Time 3 (3 month follow-up). These improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2024

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

July 28, 2022

Last Update Submit

February 24, 2026

Conditions

Keywords

Family ViolenceMedical EducationEducation ScholarshipHealth Professions EducationMandatory ReportingChild MaltreatmentIntimate Partner ViolenceVeteransVeterans Family

Outcome Measures

Primary Outcomes (4)

  • Number of Providers Who Meet Eligibility Criteria

    The RC will track the number of providers who meet eligibility criteria, our aims are that we will recruit a total of 80 participants within 16 weeks, an average of 5 providers per week.

    Through study completion, an average of 4 months

  • Number of Providers who Consent

    The RC will track the number of providers who consent to the study and agree to be randomized to either self-directed or facilitator-led VEGA education approaches, both overall and per week of recruitment. Our aim is that the proportion of providers who contact the research team about participation and who consent to randomization will be 70% or greater.

    Through study completion, an average of 4 months

  • Number of Providers who Complete Assigned Intervention

    The RC will track the proportion of providers who are randomized and complete each arm, with completion consisting of reviewing all module content and the animated simulations in the case of self-directed VEGA and full attendance of the virtual workshop in the case of facilitator-led VEGA. Our goal is that the proportion of providers who are randomized and complete the assigned intervention will be 70% or greater for each arm. The acceptability of the facilitator-led and self-directed educational approaches as well as their value and impact will be determined via the coding of qualitative interview data from a sub-sample of participants.

    Through study completion, an average of 4 months

  • Number of Providers who Complete Assessments

    The RC will track the feasibility of collecting trial outcome data (survey assessments) at Time 1, Time 2, and Time 3. Our goal is that the proportion of missing data for each time point will be less than 20%. Qualitative description will be used to expand and extend what we learn about acceptability and feasibility of implementing the associated research activities, we anticipate participants will not identify any fatal flaws related to the conduct of an RCT.

    Through study completion, an average of 4 months

Secondary Outcomes (7)

  • Child Maltreatment Vignette Scale

    Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)

  • Child Maltreatment Knowledge and Skills Questions (Developed by VEGA Team)

    Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)

  • The Physician Readiness to Manage Intimate Partner Violence Survey: IPV Knowledge

    Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)

  • The Physician Readiness to Manage Intimate Partner Violence Survey: Preparedness Subscale

    Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)

  • The Physician Readiness to Manage Intimate Partner Violence Survey: Opinions

    Time 1 (one week before intervention), Time 3 (3 month follow-up)

  • +2 more secondary outcomes

Other Outcomes (4)

  • Previous Training in Intimate Partner Violence and Child Maltreatment

    Time 1 (one week before intervention)

  • Thoughts and Beliefs about Recognizing and Responding to IPV and CM in Professional Roles

    Time 1 (one week before intervention), Time 2 (immediately after the intervention)

  • Satisfaction with VEGA Training

    Time 2 (immediately after the intervention)

  • +1 more other outcomes

Study Arms (2)

Facilitator-Led VEGA

ACTIVE COMPARATOR

Facilitator-led VEGA uses a group-based approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content as a virtual or face-to-face workshop (i.e., facilitator-led VEGA). In this study, all workshops will be virtual to prevent social gathering during COVID-19. If a participant is randomized to this arm, the active control arm, they will be informed that they need to attend a facilitator-led VEGA session via virtual workshop format. The AC intervention will be facilitated via Zoom technology, by two trained facilitators with between 10 to 20 participants in each workshop (keeping the recommended 10:1 participant-to-facilitator ratio) and will last approximately 3 hours. The workshop approach is delivered by trained facilitators and is standardized via the use of a flexibly structured facilitator's guide. Facilitator-led VEGA will deliver material didactically with synchronous lecturing, use case-based role play, and include group-based polling.

Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention

Self-Directed VEGA

EXPERIMENTAL

Self-directed VEGA uses an approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content online as a self-directed educational activity, at their own pace in a series of modules. Individuals will register to access the VEGA Education Resources site. Participants have the option of completing the self-directed VEGA arm in either English or French as the VEGA Educational Resources site offers the content in French and English. If a participant is randomized to the experimental arm, they will be asked to complete the self-directed VEGA at their convenience, within one week of when they are informed they have been asked to complete the self-directed VEGA program. It will take approximately 3 hours for participants to complete all modules. Participants will read didactic material, complete case-based animated simulations, and complete individual multiple-choice questions with response feedback.

Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention

Interventions

VEGA is a novel education intervention that has the potential to improve the preparation of healthcare and social service providers (HHSPs) to be able to effectively recognize and respond to intimate partner violence (IPV) and related forms of family violence, including child maltreatment (CM), in their clinical encounters. VEGA was developed based on systematic reviews and consultation with individuals belonging to 22 national healthcare and social service organizations, including the Royal College of Physicians and Surgeons of Canada. VEGA follows a competency-based framework and a participatory, encounter-based curriculum that includes four learning modules: (a) the epidemiology of IPV and CM; (b) strategies for safely recognizing and responding to (i) IPV and (ii) CM; and (c) principles for ensuring safe clinical encounters for IPV and CM discussions.

Also known as: VEGA Family Violence Education Resources
Facilitator-Led VEGASelf-Directed VEGA

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is a regulated healthcare or social service provider that is an active member in good standing with the associated regulatory college.
  • Participant is fluent in written and spoken English.
  • We are looking for participants who are currently working with or have previous experience working with military and/or RCMP veterans or their family members. Participants must meet one of the following criteria:
  • Participant works with military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity at least one day per week OR
  • Participant has two years or more of experience working with military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity OR
  • Participant has worked with 15 or more patients that were either military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity.

You may not qualify if:

  • Participant has previously accessed VEGA intervention materials.
  • Participant is currently enrolled in or plans to enroll in any other educational intervention focused on family violence within the study time period (approximately next 3 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8L 0A4, Canada

Location

Related Publications (29)

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    PMID: 28748307BACKGROUND
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    PMID: 33372113BACKGROUND
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    PMID: 24165440BACKGROUND
  • MacMillan HL, Kimber M, Stewart DE. Intimate Partner Violence: Recognizing and Responding Safely. JAMA. 2020 Sep 22;324(12):1201-1202. doi: 10.1001/jama.2020.11322. No abstract available.

    PMID: 32960228BACKGROUND
  • Stewart DE, MacMillan H, Kimber M. Recognizing and Responding to Intimate Partner Violence: An Update. Can J Psychiatry. 2021 Jan;66(1):71-106. doi: 10.1177/0706743720939676. Epub 2020 Aug 10. No abstract available.

    PMID: 32777936BACKGROUND
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    PMID: 22721371BACKGROUND
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Related Links

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Melissa Kimber, PhD, MSW, RSW

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The Research Assistant will be blinded to group allocation. The RA will be responsible for following-up with participants to make sure they've completed quantitative assessments (online survey) or, if participants choose to complete the surveys over the phone, the RA will complete them over the phone with the participant.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: To determine the feasibility of evaluating the effectiveness of both of VEGA's educational approaches, as well as to generate preliminary estimates of effect for sampling and effect size calculations, a two-arm pilot randomized controlled trial (RCT) will be used (Eldridge et al., 2016). Eligible participants will be randomly assigned to receive either self-directed (i.e., experimental) or facilitator-led (i.e., active control (AC)) VEGA.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry & Behavioural Neurosciences

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 5, 2022

Study Start

August 1, 2022

Primary Completion

March 13, 2024

Study Completion

March 13, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Requests for data for analyses (e.g. by Research Team Members, graduate trainees) will be managed by the research coordinator and overseen by the PI, including Dr. Melissa Kimber. This will not include identifying information of participants, only de-identified data would be shared.

Locations