RISE With Residents

Pediatric ALL Clinical Trial

— RISE Residents  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05490121
• Other study ID #: HiREB #14381
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: December 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Child Maltreatment
• Domestic Violence
• Education, Medical, Graduate
• Pediatric ALL
• Psychiatry

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Royal College of Physicians and Surgeons of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (58)

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Sociodemographic characteristics will be collected for all participants who are screened for the study, whether they are ineligible or eligible. These will include their age, their program (psychiatry or pediatrics), their sex at birth and their self-identified gender.	Pre-Intervention
Other	Previous Training in Child Maltreatment	Participants will be asked questions to gauge their previous education or training in various areas of CM. Participants will be given a definition of CM and asked in what areas they have received education or training related to CM, in what environment(s) they have learned about CM, and in which of these environments they have learned the most.	Time 1 (one week before intervention)
Other	Thoughts and Beliefs about Recognizing and Responding to CM in Professional Roles	Participants will be asked to rate their agreement with two statements about how much they believe (1) recognizing and (2) responding to CM is a part of their professional role. In qualitative interviews we will ask participants how often they believe they will encounter family violence in their future practice (how relevant it is to their future professional role as a psychiatrist or pediatrician), the purpose of these questions is to gauge this in our entire sample.	Time 1 (one week before intervention)
Other	Satisfaction with VEGA Training	Participants will complete a series of multiple choice and short-answer questions asking what they thought about the VEGA training. These questions will apply to all participants whether they completed self-directed or facilitator-led VEGA. Questions will include whether they believe the intended learning outcomes were achieved, what they thought of the instructional materials and educational scenarios, and how they would rate the usefulness of VEGA.	Time 2 (immediately after the intervention)
Primary	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
Primary	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
Primary	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
Primary	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	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.	Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)
Secondary	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.	Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)
Secondary	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.	Time 1 (one week before intervention), Time 3 (3 month follow-up)
Secondary	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).	Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)
Secondary	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.	Time 1 (one week before intervention)
Secondary	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.	Time 1 (one week before intervention)

External 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.