An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics

Clinicians will complete a screen-based automated virtual reality training intervention to learn how to counsel caregivers of pediatric patients on secure firearm storage.

Study Overview

• Status: Not yet recruiting
• Conditions: Medical Education; Virtual Reality; Motivational Interviewing; Gun Violence Prevention; Artificial Intelligence (AI)
• Intervention / Treatment: Behavioral: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

Detailed Description

The investigators will recruit pediatric clinicians to participate in an automated screen-based virtual reality intervention. Clinicians will be recruited from clinical locations that offer a variety of setting types (urban, suburban, and rural).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis J Real, MD, MEd; Phone Number: 513-636-9261; Email: francis.real@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
      • Contact: Francis Real; Phone Number: 513-636-9261; Email: francis.real@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Pediatric Clinicians must meet one of the following inclusion criteria at each study site: Physicians (attending, fellow or resident), Licensed Nurse Practitioner, Physician's Assistant

Exclusion Criteria:

• Unable to read and write in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians; The automated virtual reality intervention allows clinicians to deliberately practice firearm safety counseling skills through verbal interactions with virtual characters with receipt of immediate feedback to support behavior change and mastery learning.	Behavioral: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians; The automated virtual reality intervention allows clinicians to deliberately practice firearm safety counseling skills through verbal interactions with virtual characters with receipt of immediate feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure	Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better acceptability	From completion of the virtual reality intervention to 2 months
Appropriateness of the Intervention Measure	Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better appropriateness	From completion of the virtual reality intervention to 2 months
Feasibility of the Intervention Measure	Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better feasibility	From completion of the virtual reality intervention to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
De Novo Survey Item for Assessing Social Cognitive Theory Construct Behavioral Capability	One item, Scale score of individual items, Minimum score: 1, Maximum score: 5. higher score indicates more behavioral capability	From completion of the virtual reality intervention to 2 months
De Novo Survey Items for Assessing Social Cognitive Theory Construct Self-Efficacy	Eight items, Scale score for individual items, Minimum score: 0, Maximum score: 4. Higher scores indicate more self-efficacy.	From completion of the virtual reality intervention to 2 months
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectations	Three items, Scale score of individual items, Minimum score: 1, Maximum score: 5. Higher scores indicate more expectations.	From completion of the virtual reality intervention to 2 months
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectancies	Six items, Scale score of individual items, Minimum score: 1, Maximum score: 5. higher scores indicate higher expectancies for prioritizing firearm safety discussions across different ages for well-child visits.	From completion of the virtual reality intervention to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
De Novo Standardized Patient Encounter Assessment Tool - Assessing Fidelity to the Virtual Reality Intervention Components	Participant's will engage in a standardized patient encounter to assess fidelity to behavioral skills reviewed during the virtual reality intervention, 20 items, maximum score: 20, minimum score: 0, scaled scores for firearm counseling skills and motivational interviewing skills, scaled scores determined by adding together individual items, 17 items related to firearm safety counseling, 3 items related to motivational interviewing	From completion of the virtual reality intervention to 6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• March M, Zackoff M, Fleck J, Meisman A, Humphrey K, MacDougall MC, Ehrlich S, Griggs C, Sacks C, Masiakos P, Klein M, Real F. A Randomized Trial of Virtual Reality Training to Improve Firearm Safety Counseling Skills. Acad Pediatr. 2025 Jan-Feb;25(1):102560. doi: 10.1016/j.acap.2024.08.005. Epub 2024 Aug 10.
• Real FJ, Griggs C, March M, Masiakos PT, Meisman A, Felopulos G, Sacks CA, Zackoff MW. Feasibility and Acceptability of a Virtual Reality Curriculum to Support Firearm Safety Counseling Skills Among Pediatric Residents. J Grad Med Educ. 2024 Dec;16(6):740-746. doi: 10.4300/JGME-D-24-00022.1. Epub 2024 Dec 13.
• March ML, Meisman AR, Zackoff MW, Klein MD, Real FJ. Caregivers' and Community Members' Perspectives on Firearm Safety Screening and Counseling During Pediatric Primary Care Visits. J Pediatr Clin Pract. 2024 Mar 14;12:200099. doi: 10.1016/j.jpedcp.2024.200099. eCollection 2024 Jun.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; Medical Education; Gun violence prevention
• Other Study ID Numbers: 2024-0538; K18HD117377 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) for survey data will include clinician participants' (a maximum of n=30) demographic data (race, age, gender, role, practice setting, experience counseling on firearm safety), responses to items related to implementation (acceptability, appropriateness, and feasibility), and responses to items related to psychosocial constructs (behavioral capability, self-efficacy, expectations and expectancies). Data will include demographic information, baseline characteristics, outcome measures, and adverse event data. Access will be granted to researchers with a methodologically sound proposal, subject to review by the study team and institutional policies. Data be to be shared will be archived in DASH through the NICHD repository.
• IPD Sharing Time Frame: Data access included in associated publications or the end of the award period, whichever comes first.
• IPD Sharing Access Criteria: Requests for data access should be submitted to the Principal Investigator or through the data sharing plan website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No