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

December 2, 2025 updated by: F. Joseph Real, Children's Hospital Medical Center, Cincinnati
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure
Time Frame: From completion of the virtual reality intervention to 2 months
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
Time Frame: From completion of the virtual reality intervention to 2 months
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
Time Frame: From completion of the virtual reality intervention to 2 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
De Novo Survey Item for Assessing Social Cognitive Theory Construct Behavioral Capability
Time Frame: From completion of the virtual reality intervention to 2 months
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
Time Frame: From completion of the virtual reality intervention to 2 months
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
Time Frame: From completion of the virtual reality intervention to 2 months
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
Time Frame: From completion of the virtual reality intervention to 2 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
De Novo Standardized Patient Encounter Assessment Tool - Assessing Fidelity to the Virtual Reality Intervention Components
Time Frame: From completion of the virtual reality intervention to 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings