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Domestic ViolenceRISE VetNCT05490004

RISE With Veteran Service Providers

A study testing Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention in people with Domestic Violence and Veterans Family, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Domestic Violence, Veterans Family, Veterans
What is being tested?
Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
1 Aug 2022to 13 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8L 0A4

Other trials in Canada

About this study

Official title: Evaluating an Educational Intervention for Improving Provider Recognition and Response to Intimate Partner Violence (IPV) Experienced by Veterans and Their Families - A Mixed Method Pilot Randomized Trial

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.

Being tested
Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention
Keywords
Family Violence, Medical Education, Education Scholarship, Health Professions Education, Mandatory Reporting, Child Maltreatment, Intimate Partner Violence, Veterans, Veterans Family

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Violence, Evidence, Guidance, Action Project (VEGA) Education InterventionOther

    Also called VEGA Family Violence Education Resources

    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.

Study groups in NCT05490004
Study groupRoleWhat they receive
Facilitator-Led VEGAActive comparatorFacilitator-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.
Receives: Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention
Self-Directed VEGAExperimentalSelf-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.
Receives: Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 4 months

  2. 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.

    Measured: Through study completion, an average of 4 months

  3. 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.

    Measured: Through study completion, an average of 4 months

  4. 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.

    Measured: Through study completion, an average of 4 months

Secondary outcomes (7)

  1. Child Maltreatment Vignette Scale

    Child Maltreatment Vignette scale (Pelletier et al., 2014; Pelletier \& Knox, 2017) is a psychometrically validated measure of knowledge and skill accuracy related to recognizing and responding to child maltreatment. Respondents will be prompted to review 14 distinct analog vignettes that depict a range of signs and symptoms of possible CM exposure and asked if they suspect child maltreatment and if they would report to Child Welfare Services. Changes to the question wording and small changes to the wording of the scenarios were made to align the measure with the Canadian context. A mean "knowledge and skill accuracy" score will be produced for analysis, with higher scores indicative of greater knowledge and skill accuracy related to CM. In a future RCT, this would be one of the primary outcomes of interest since this is a robust measure of practitioner knowledge and skills related to CM.

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

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

    Participants will be asked a series of questions about their knowledge and skills related to recognizing and responding to child maltreatment. These were developed by the VEGA training research team to capture specific aspects of child maltreatment knowledge directly addressed in the VEGA intervention and which are outside the scope of the child maltreatment vignette scale. The questions ask about the following topics (and more not mentioned here): parental/family risk factors for family violence, what future outcomes are associated with child maltreatment, other possible signs of child abuse, and principles for good documentation and providing ongoing care to children experiencing maltreatment. Including this measure in our study will allow us to make cross sample comparisons.

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

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

    The Physician Readiness to Manage Intimate Partner Violence Survey (PREMIS) is a 67-item self-report tool that was developed to assess physician management of intimate partner violence across 10 subscales (Short et al., 2006; Connor et al., 2011). The IPV knowledge section, consisting of multiple answer, multiple choice, and true-false questions will be used to measure IPV knowledge and skills. An IPV "knowledge score" will be computed following previous scoring guidelines (Short et al., 2006). In a future RCT, this would be a primary outcome of interest to measure practitioner knowledge and skills related to IPV.

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

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

    The preparedness subscale of PREMIS asks respondents to indicate the extent to which they feel prepared to address various aspects of IPV recognition and response when working with their clients across 10 items; these aspects include the conduct of safety assessments, asking appropriate questions about IPV, responding to IPV disclosures, among others. Response options are on a 7-item Likert type scale ranging from "Not prepared" (1) to "Quite Well Prepared" (7) and items are averaged to generate a mean score for practitioner preparedness, with higher scores indicative of generally greater preparedness to recognize and respond to IPV. For the purposes of this study, two adapted versions of the preparedness subscale were used to assess preparedness to recognize and respond to IPV and CM.

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

  5. The Physician Readiness to Manage Intimate Partner Violence Survey: Opinions

    The Opinions section of the PREMIS asks respondents to indicate their level of agreement/disagreement with various statements about care of those with IPV across 32 items. Response options are on a 7-item Likert type scale ranging from (1) Strongly Disagree to (7) Strongly Agree. Our adapted version will be used to measure provider attitudes and beliefs about IPV and care of those with IPV in five subscales: (1) preparation, (2) workplace issues, (3) self-efficacy (which will also be assessed at Time 2), (4) alcohol/drugs, and (5) victim understanding. We will follow previous methods to calculate these subscales by averaging the responses to items that make up the subscale (Short et al., 2006). The three items comprising the self-efficacy subscale will be a primary outcome of interest in a future RCT as a measure of provider's self-efficacy to recognize and respond to IPV.

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

  6. Mandatory Reporting Self-Efficacy Scale (MRSES)

    The MRSES is a 7-item self-report measure that asks respondents to indicate the extent to which they perceive their ability to implement a series of behaviours related to mandatory reporting of CM (Ayling, 2019). Informed by Bandura's self-efficacy theory and recommendations for self-efficacy scales (Bandura, 2006), response options are anchored on a scale from 0 to 100 with: "cannot do at all (0)"; moderately can do (50)"; and "highly certain can do (100)." A total score is generated by summing items across the scale for each participant, with higher scores indicative of greater self-efficacy related to recognizing and reporting suspected CM. We anticipate that this measure will be a key mediator of interest in a future definitive RCT given that across provincial and territorial jurisdictions in Canada (including Ontario), a suspicion of CM meets the threshold for a report to child protection authorities (Dubowitz, 2014; Mathews and Kenny, 2008).

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

  7. Brief Individual Readiness for Change Scale

    The Brief Individual Readiness for Change (BIRCS) scale is a 5-item readiness for change tool (Goldman, 2009). The scale's purpose is to screen for practitioners' readiness for change, in other words their receptivity to learning and applying new evidence-based research practices. For the purpose of this study, the items were adapted to assess provider's readiness to recognize and respond to all forms of (a) IPV and (b) CM in their practice. Response options range from '0' Strongly Disagree to '4' Strongly Agree. Two items were added, "I believe recognizing and responding to [IPV/CM] in my practice improves outcomes for my clients," and "I am motivated to learn about [IPV/CM]" to capture other aspects of providers' readiness to learn about IPV and CM and their belief's about how this will impact their practice.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start1 Aug 2022
  3. Primary completion13 Mar 2024
  4. Study completion13 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490004
Sponsor's protocol ID
HiREB # 14243
Acronym
RISE Vet
Status last verified
Feb 2026
First submitted
28 Jul 2022
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

    PubMed 26978655

  • Pelletier HL, Knox M. Incorporating Child Maltreatment Training into Medical School Curricula. J Child Adolesc Trauma. 2017;10(3):267-274. doi: 10.1007/s40653-016-0096-x. Epub 2016 May 12.

    PubMed 29026450

  • Connor PD, Nouer SS, Mackey ST, Tipton NG, Lloyd AK. Psychometric properties of an intimate partner violence tool for health care students. J Interpers Violence. 2011 Mar;26(5):1012-35. doi: 10.1177/0886260510365872. Epub 2010 Jun 28.

    PubMed 20587479

  • Short LM, Alpert E, Harris JM Jr, Surprenant ZJ. A tool for measuring physician readiness to manage intimate partner violence. Am J Prev Med. 2006 Feb;30(2):173-180. doi: 10.1016/j.amepre.2005.10.009.

    PubMed 16459217

  • Mathews B, Kenny MC. Mandatory reporting legislation in the United States, Canada, and Australia: a cross-jurisdictional review of key features, differences, and issues. Child Maltreat. 2008 Feb;13(1):50-63. doi: 10.1177/1077559507310613.

    PubMed 18174348

  • Afifi TO, Taillieu T, Zamorski MA, Turner S, Cheung K, Sareen J. Association of Child Abuse Exposure With Suicidal Ideation, Suicide Plans, and Suicide Attempts in Military Personnel and the General Population in Canada. JAMA Psychiatry. 2016 Mar;73(3):229-38. doi: 10.1001/jamapsychiatry.2015.2732.

    PubMed 26817953

  • Afifi TO, Sareen J, Taillieu T, Stewart-Tufescu A, Mota N, Bolton SL, Asmundson GJG, Enns MW, Ports KA, Jetly R. Association of Child Maltreatment and Deployment-related Traumatic Experiences with Mental Disorders in Active Duty Service Members and Veterans of the Canadian Armed Forces: Association de la Maltraitance des Enfants et des Experiences Traumatisantes Liees au Deploiement Avec les Troubles Mentaux Chez les Membres du Service Actif et Les Anciens Combattants des Forces Armees Canadiennes. Can J Psychiatry. 2021 Nov;66(11):961-970. doi: 10.1177/0706743720987086. Epub 2021 Jan 21.

    PubMed 33472392

  • Marshall AD, Panuzio J, Taft CT. Intimate partner violence among military veterans and active duty servicemen. Clin Psychol Rev. 2005 Nov;25(7):862-76. doi: 10.1016/j.cpr.2005.05.009.

    PubMed 16006025

  • Sparrow K, Kwan J, Howard L, Fear N, MacManus D. Systematic review of mental health disorders and intimate partner violence victimisation among military populations. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1059-1080. doi: 10.1007/s00127-017-1423-8. Epub 2017 Jul 26.

    PubMed 28748307

  • Griffith J, J Bryan C. Deployment Experiences and Suicidal Behaviors Related to Interpersonal Violence Perpetration Among Army National Guard Soldiers. Violence Vict. 2020 Dec 1;35(6):841-860. doi: 10.1891/VV-D-18-00174.

    PubMed 33372113

  • Zamorski MA, Wiens-Kinkaid ME. Cross-sectional prevalence survey of intimate partner violence perpetration and victimization in Canadian military personnel. BMC Public Health. 2013 Oct 28;13:1019. doi: 10.1186/1471-2458-13-1019.

    PubMed 24165440

  • 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.

    PubMed 32960228

  • 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.

    PubMed 32777936

  • Beynon CE, Gutmanis IA, Tutty LM, Wathen CN, MacMillan HL. Why physicians and nurses ask (or don't) about partner violence: a qualitative analysis. BMC Public Health. 2012 Jun 21;12:473. doi: 10.1186/1471-2458-12-473.

    PubMed 22721371

  • Kimber M, McTavish JR, Couturier J, Le Grange D, Lock J, MacMillan HL. Identifying and responding to child maltreatment when delivering family-based treatment-A qualitative study. Int J Eat Disord. 2019 Mar;52(3):292-298. doi: 10.1002/eat.23036. Epub 2019 Feb 6.

    PubMed 30729594

Questions about this trial

What is this clinical trial studying?

A study testing Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention in people with Domestic Violence and Veterans Family, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Providers Who Meet Eligibility Criteria (time frame: Through study completion, an average of 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490004, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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