Domestic ViolenceRISE ResidentsNCT05490121
RISE With Residents
A study testing Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention in people with Domestic Violence and Child Maltreatment, run by McMaster University at 1 site in Canada.
Trial summary
Prevention of child maltreatment (CM) remains a public health priority in Canada; approximately one-third of Canadians report exposure to at least one form of CM. Physicians play an important role in recognizing and responding to CM and its associated sequelae. 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, Child Maltreatment, Pediatric ALL
- 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
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 31 Aug 2023
- 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 resident at a Canadian University.
- Participant is fluent in written and spoken English.
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.
About this study
Official title: Evaluating an Educational Intervention for Improving Residents' Recognition and Response to Child Maltreatment - A Mixed Method Acceptability and Feasibility Study With a Pilot Randomized Trial
Prevention of child maltreatment (CM) remains a public health priority in Canada; approximately one-third of Canadians report exposure to at least one form of CM. Physicians play an important role in recognizing and responding to CM and its associated sequelae. However, increasing evidence indicates that physicians receive insufficient training related to recognizing and responding to CM. CM education is especially pertinent during the pediatric and psychiatry residency period but it remains unclear what the optimal approach is for preparing Canadian physicians with the knowledge and skills to effectively recognize and respond to CM. Those educational interventions that have been evaluated in medical education contexts have comparatively little emphasis on the complex overlap between IPV, children's exposure to IPV, and other forms of CM. The Violence, Evidence, Guidance, Action Project (VEGA) is a novel educational intervention that has the potential to improve the preparation of physicians to be able to effectively recognize and respond to CM in their clinical encounters and takes into account this complex overlap. The purpose of this study is to assess the acceptability and feasibility of a future randomized-controlled trial comparing two approaches to administering the VEGA intervention, facilitator-led or self-directed VEGA and whether/how these approaches can support residents' education.
The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to CM 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). The investigators also predict that these improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.
- Conditions
- Domestic Violence, Child Maltreatment, Pediatric ALL, Psychiatry, Education, Medical, Graduate
- Being tested
- Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention
- Keywords
- Family Violence, Medical Education, Education Scholarship, Health Professions Education, Mandatory Reporting, Child Maltreatment
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 group | Role | What they receive |
|---|---|---|
| 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. 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 (AC) 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 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 Educational 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.
Number of Residents Who Meet Eligibility Criteria
The RC will track the number of residents who meet eligibility criteria, our aims are that we will recruit a total of 80 participants within 8 weeks, an average of 10 residents per week.
Measured: Through study completion, an average of 4 months
Number of Residents who Consent
The RC will track the number of residents 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 residents who contact the research team about participation and who consent to randomization will be 75% or greater.
Measured: Through study completion, an average of 4 months
Number of Residents who Complete Assigned Intervention
The RC will track the proportion of residents 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 residents who are randomized and complete the assigned intervention will be 75% 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
Number of Residents 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 (6)
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 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)
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)
The Physician Readiness to Manage Intimate Partner Violence Survey: Preparedness Subscale
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 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, including asking appropriate questions about IPV and responding to IPV disclosures. 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 greater perceived preparedness to recognize and respond to IPV. All items will be changed to be related to child maltreatment instead of IPV, several items were dropped as they are not relevant in the case of CM.
Measured: Time 1 (one week before intervention), Time 3 (3 month follow-up)
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)
Brief Individual Readiness for Change Scale (BIRCS)
The 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 child maltreatment (CM) in their clinical encounters. Response options range from '0' Strongly Disagree to '4' Strongly Agree. Two items were added, "I believe recognizing and responding to child maltreatment in my practice improves outcomes for my clients," and "I am motivated to learn about child maltreatment" to capture other aspects of residents' readiness to learn about CM and their belief's about how this will impact their practice.
Measured: Time 1 (one week before intervention)
Achievement Goals for Work Domain (AGWD)
The Achievement Goals for Work Domain (AGWD) scale is a 23-item, psychometrically validated measure of work-related achievement goals that map onto the four goal orientations described by Achievement Goal Theory (Daniels \& Daniels, 2018; Baranik et al., 2007). Respondents are asked to indicate their agreement with 23 statements, response options range from '1' strongly disagree to '7' strongly agree and responses are summed to generate a total score for each subscale corresponding to each type of goal orientation; higher scores are more indicative of the respondent's affinity to that goal orientation. In this study, they will be asked about their achievement goals for residency.
Measured: Time 1 (one week before intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Physicians and Surgeons of Canada
- Responsible party
- Principal investigator, Melissa Kimber, PhD, MSW, RSW, McMaster University
- Investigators
- Melissa Kimber, PhD, MSW, RSW, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490121
- Sponsor's protocol ID
- HiREB #14381
- Acronym
- RISE Residents
- Status last verified
- May 2026
- First submitted
- 28 Jul 2022
- Last updated
- 8 May 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 26978655Pelletier 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 29026450Connor 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 20587479Short 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 16459217Mathews 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 18174348Daniels L, Daniels V. Internal medicine residents' achievement goals and efficacy, emotions, and assessments. Can Med Educ J. 2018 Nov 12;9(4):e59-e68. eCollection 2018 Nov.
PubMed 30498544MacMillan 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 32960228Stewart 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 32777936Kimber 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 30729594Kimber M, McTavish JR, Luo C, Couturier J, Dimitropoulos G, MacMillan H. Mandatory reporting of child maltreatment when delivering family-based treatment for eating disorders: A framework analysis of practitioner experiences. Child Abuse Negl. 2019 Feb;88:118-128. doi: 10.1016/j.chiabu.2018.11.010. Epub 2018 Nov 23.
PubMed 30476720McTavish JR, Kimber M, Devries K, Colombini M, MacGregor JCD, Wathen CN, Agarwal A, MacMillan HL. Mandated reporters' experiences with reporting child maltreatment: a meta-synthesis of qualitative studies. BMJ Open. 2017 Oct 16;7(10):e013942. doi: 10.1136/bmjopen-2016-013942.
PubMed 29042370Alnasser Y, Albijadi A, Abdullah W, Aldabeeb D, Alomair A, Alsaddiqi S, Alsalloum Y. Child maltreatment between knowledge, attitude and beliefs among Saudi pediatricians, pediatric residency trainees and medical students. Ann Med Surg (Lond). 2017 Feb 21;16:7-13. doi: 10.1016/j.amsu.2017.02.008. eCollection 2017 Apr.
PubMed 28275426Flaherty EG, Sege R, Price LL, Christoffel KK, Norton DP, O'Connor KG. Pediatrician characteristics associated with child abuse identification and reporting: results from a national survey of pediatricians. Child Maltreat. 2006 Nov;11(4):361-9. doi: 10.1177/1077559506292287.
PubMed 17043321Flaherty EG, Sege R, Binns HJ, Mattson CL, Christoffel KK. Health care providers' experience reporting child abuse in the primary care setting. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 2000 May;154(5):489-93. doi: 10.1001/archpedi.154.5.489.
PubMed 10807301Regnaut O, Jeu-Steenhouwer M, Manaouil C, Gignon M. Risk factors for child abuse: levels of knowledge and difficulties in family medicine. A mixed method study. BMC Res Notes. 2015 Oct 30;8:620. doi: 10.1186/s13104-015-1607-9.
PubMed 26514128
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Educational Intervention for Improving Residents' Recognition and Response to Child Maltreatment - A Mixed Method Acceptability and Feasibility Study With a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05490121
- Acronym / sponsor ID
- RISE Residents / HiREB #14381
- Conditions
- Domestic Violence, Child Maltreatment, Pediatric ALL, Psychiatry, Education, Medical, Graduate
- Keywords
- Family Violence, Medical Education, Education Scholarship, Health Professions Education, Mandatory Reporting, Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Royal College of Physicians and Surgeons of Canada
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention of child maltreatment (CM) remains a public health priority in Canada; approximately one-third of Canadians report exposure to at least one form of CM. Physicians play an important role in recognizing and responding to CM and its associated sequelae. However, increasing evidence indicates that physicians receive insufficient training related to recognizing and responding to CM. CM education is especially pertinent during the pediatric and psychiatry residency period but it remains unclear what the optimal approach is for preparing Canadian physicians with the knowledge and skills to effectively recognize and respond to CM. Those educational interventions that have been evaluated in medical education contexts have comparatively little emphasis on the complex overlap between IPV, children's exposure to IPV, and other forms of CM. The Violence, Evidence, Guidance, Action Project (VEGA) is a novel educational intervention that has the potential to improve the preparation of physicians to be able to effectively recognize and respond to CM in their clinical encounters and takes into account this complex overlap. The purpose of this study is to assess the acceptability and feasibility of a future randomized-controlled trial comparing two approaches to administering the VEGA intervention, facilitator-led or self-directed VEGA and whether/how these approaches can support residents' education.
The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to CM 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). The investigators also predict that these improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Facilitator-Led VEGA | Active comparator | Other: Violence, Evidence, Guidance, Action Project (VEGA) Education InterventionFacilitator-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. 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 (AC) 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. |
| Self-Directed VEGA | Experimental | Other: Violence, Evidence, Guidance, Action Project (VEGA) Education InterventionSelf-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 Educational 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is a resident at a Canadian University.
- Participant is fluent in written and spoken English.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Violence, Evidence, Guidance, Action Project (VEGA) Education InterventionAlso: VEGA Family Violence Education ResourcesVEGA 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. | Other | Facilitator-Led VEGA, Self-Directed VEGA |
Primary outcome
Number of Residents Who Meet Eligibility Criteria
Time frame: Through study completion, an average of 4 months
The RC will track the number of residents who meet eligibility criteria, our aims are that we will recruit a total of 80 participants within 8 weeks, an average of 10 residents per week.
Number of Residents who Consent
Time frame: Through study completion, an average of 4 months
The RC will track the number of residents 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 residents who contact the research team about participation and who consent to randomization will be 75% or greater.
Number of Residents who Complete Assigned Intervention
Time frame: Through study completion, an average of 4 months
The RC will track the proportion of residents 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 residents who are randomized and complete the assigned intervention will be 75% 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.
Number of Residents who Complete Assessments
Time frame: Through study completion, an average of 4 months
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.
6 secondary outcomes
Child Maltreatment Vignette Scale
Time frame: 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 frame: 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 frame: Time 1 (one week before intervention), Time 3 (3 month follow-up)
Mandatory Reporting Self-Efficacy Scale (MRSES)
Time frame: Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)
Brief Individual Readiness for Change Scale (BIRCS)
Time frame: Time 1 (one week before intervention)
Achievement Goals for Work Domain (AGWD)
Time frame: Time 1 (one week before intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 26978655Eldridge 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.
- Background: PubMed 29026450Pelletier 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.
- Background: PubMed 20587479Connor 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.
- Background: PubMed 16459217Short 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.
- Background: PubMed 18174348Mathews 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.
- Background: PubMed 30498544Daniels L, Daniels V. Internal medicine residents' achievement goals and efficacy, emotions, and assessments. Can Med Educ J. 2018 Nov 12;9(4):e59-e68. eCollection 2018 Nov.
- Background: PubMed 32960228MacMillan 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.
- Background: PubMed 32777936Stewart 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.
- Background: PubMed 30729594Kimber 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.
- Background: PubMed 30476720Kimber M, McTavish JR, Luo C, Couturier J, Dimitropoulos G, MacMillan H. Mandatory reporting of child maltreatment when delivering family-based treatment for eating disorders: A framework analysis of practitioner experiences. Child Abuse Negl. 2019 Feb;88:118-128. doi: 10.1016/j.chiabu.2018.11.010. Epub 2018 Nov 23.
- Background: PubMed 29042370McTavish JR, Kimber M, Devries K, Colombini M, MacGregor JCD, Wathen CN, Agarwal A, MacMillan HL. Mandated reporters' experiences with reporting child maltreatment: a meta-synthesis of qualitative studies. BMJ Open. 2017 Oct 16;7(10):e013942. doi: 10.1136/bmjopen-2016-013942.
- Background: PubMed 28275426Alnasser Y, Albijadi A, Abdullah W, Aldabeeb D, Alomair A, Alsaddiqi S, Alsalloum Y. Child maltreatment between knowledge, attitude and beliefs among Saudi pediatricians, pediatric residency trainees and medical students. Ann Med Surg (Lond). 2017 Feb 21;16:7-13. doi: 10.1016/j.amsu.2017.02.008. eCollection 2017 Apr.
- This is the VEGA Project website, where the public can access VEGA Family Violence Education Resources. More information can be found here about the development of VEGA.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Kimber, PhD, MSW, RSW principal investigator
McMaster University
1 site in 1 country: see every site and its status.
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 Child Maltreatment, 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 2 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 8 May 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 Residents 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 NCT05490121, which also lists 59 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 8 May 2026.