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VEGA Education for Child Abuse (RISE Residents Trial)

N/A

Waitlist Available

Led By Melissa Kimber, PhD, MSW, RSW

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time 1 (one week before intervention)

Awards & highlights

RISE Residents Trial Summary

This trial aims to assess an educational intervention to help Canadian physicians recognize and respond to child maltreatment. It will measure changes in preparedness, knowledge and skills, and self-efficacy to recognize and respond to CM.

Who is the study for?

This trial is for psychiatry or pediatrics residents at McMaster University or the University of Toronto who speak and write English fluently. It's not open to those who've used VEGA materials before or will be in another family violence educational program soon.Check my eligibility

What is being tested?

The study tests the VEGA education intervention, designed to help doctors recognize and respond to child maltreatment (CM) effectively. Residents will either lead themselves through it or have a facilitator guide them, and their preparedness will be measured over time.See study design

What are the potential side effects?

Since this is an educational intervention rather than a medical treatment, traditional side effects are not applicable. However, participants may experience stress or discomfort when discussing sensitive topics like CM.

RISE Residents Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time 1 (one week before intervention), time 2 (immediately after the intervention), time 3 (3 month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time 1 (one week before intervention), time 2 (immediately after the intervention), time 3 (3 month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time 1 (one week before intervention), time 2 (immediately after the intervention), time 3 (3 month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Residents Who Meet Eligibility Criteria

Number of Residents who Complete Assessments

Number of Residents who Complete Assigned Intervention

+1 more

Secondary outcome measures

Achievement Goals for Work Domain (AGWD)

Brief Individual Readiness for Change Scale (BIRCS)

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

+3 more

Other outcome measures

Demographics

Previous Training in Child Maltreatment

Satisfaction with VEGA Training

+1 more

RISE Residents Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Directed VEGAExperimental Treatment1 Intervention

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.

Group II: Facilitator-Led VEGAActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,597,757 Total Patients Enrolled

Royal College of Physicians and Surgeons of CanadaOTHER

6 Previous Clinical Trials

409 Total Patients Enrolled

Melissa Kimber, PhD, MSW, RSWPrincipal InvestigatorMcMaster University

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05490121 — N/A

Domestic Violence Research Study Groups: Facilitator-Led VEGA, Self-Directed VEGA

Domestic Violence Clinical Trial 2023: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention Highlights & Side Effects. Trial Name: NCT05490121 — N/A

Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490121 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient cohort for this experiment inclusive of individuals aged 35 or higher?

"The age restrictions for this clinical trial are 18 years or older and below 100 years old."

Answered by AI

Are new participants able to join this research endeavor?

"This clinical trial is actively seeking out participants, as indicated on the information hosted by clinicaltrials.gov. It was first posted in early August of 2022 and has been updated recently on April 3rd 2023."

Answered by AI

Who is qualified to take part in this clinical trial?

"This investigation is accepting up to 80 adults between 18 and 100 years old with a background in psychiatry. In order to be eligible, candidates must satisfy the following prerequisites: being enrolled in residency training at either McMaster University or University of Toronto; fluency in spoken and written English language; residence within psychiatry or pediatrics specialty fields."

Answered by AI

What is the current enrollment count for this clinical trial?

"Affirmative. The clinical trial data posted on clinicaltrials.gov indicates the current recruitment of participants for this study, which went live on August 1st 2022 and was last updated April 3rd 2023; 80 individuals are required from a single site."

Answered by AI

What outcomes is this exploration attempting to determine?

"This trial will be conducted over a four month period and aims to assess the number of consenting participants. Secondary objectives include assessing participant skill accuracy in recognizing signs of child maltreatment with the Child Maltreatment Vignette Scale, gauging practitioner preparedness by measuring responses to Intimate Partner Violence (IPV) through the Physician Readiness to Manage IPV Survey: Preparedness Subscale, and determining Mandatory Reporting Self-Efficacy via The MRSES scale."

Answered by AI

Recent research and studies

BmjJournal

Developing and Evaluating Complex Interventions: The New Medical Research Council Guidance

Craig, Peter, Paul Dieppe, Sally Macintyre, Susan Michie, Irwin Nazareth, and Mark Petticrew. 2008. “Developing and Evaluating Complex Interventions: The New Medical Research Council Guidance”. Bmj. BMJ. doi:10.1136/bmj.a1655.

BMC Medical Research MethodologyJournal

A Tutorial on Pilot Studies: The What, Why and How

Thabane, Lehana, Jinhui Ma, Rong Chu, Ji Cheng, Afisi Ismaila, Lorena P Rios, Reid Robson, Marroon Thabane, Lora Giangregorio, and Charles H Goldsmith. 2010. “A Tutorial on Pilot Studies: The What, Why and How”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/1471-2288-10-1.

Plos OneJournal

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

Eldridge, Sandra M., Gillian A. Lancaster, Michael J. Campbell, Lehana Thabane, Sally Hopewell, Claire L. Coleman, and Christine M. Bond. 2016. “Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework”. Edited by Chiara Lazzeri. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0150205.

Australian & New Zealand Journal of PsychiatryJournal