RISE With Residents

NCT05490121 | Completed

• 1 other identifier: HiREB #14381
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Family Violence; Medical Education; Education Scholarship; Health Professions Education; Mandatory Reporting; Child Maltreatment

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through study completion, an average of 4 months

Secondary Outcomes (6)

• 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: Preparedness Subscale

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

• Mandatory Reporting Self-Efficacy Scale (MRSES)

  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 1 (one week before intervention)

Other Outcomes (4)

• Demographics

  Pre-Intervention

• Previous Training in Child Maltreatment

  Time 1 (one week before intervention)

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

  Time 1 (one week before intervention)

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. 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.

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.

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

Interventions

Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention OTHER

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 VEGA; Self-Directed VEGA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is a resident at a Canadian University.
• Participant is fluent in written and spoken English.

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).

Sponsors & Collaborators

• McMaster University: lead
• Royal College of Physicians and Surgeons of Canada: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8L 0A4, Canada

Location

Related Publications (59)

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  PMID: 38512307 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Counseling

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry & Behavioural Neurosciences

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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)