Virtual RealityNCT07265141

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

A study testing An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians in people with Virtual Reality and Medical Education, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Virtual Reality, Medical Education, Motivational Interviewing
What is being tested?: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2026to 3 Jun 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Unable to read and write in English

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

Read the 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).

Conditions: Virtual Reality, Medical Education, Motivational Interviewing, Gun Violence Prevention, Artificial Intelligence (AI)
Being tested: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians
Keywords: virtual reality, Medical Education, Gun violence prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in CliniciansBehavioural
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.

Study groups in NCT07265141
Study group	Role	What they receive
An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians	Experimental	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. Receives: Behavioral: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of Intervention Measure
one item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better acceptability
Measured: Immediately post-intervention (1-day virtual reality intervention)
Appropriateness of the Intervention Measure
One item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better appropriateness
Measured: Immediately post-intervention (1-day virtual reality intervention)
Feasibility of the Intervention Measure
One item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better feasibility
Measured: Immediately post-intervention (1-day virtual reality intervention)

Secondary outcomes (4)

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. Self-rated competence in providing anticipatory guidance to families regarding firearm safety was assessed using survey item administered at baseline and at the 2-month follow-up. Participants rated their current level of competence on a 5-point ordinal scale: 1 = Novice (no experience providing anticipatory guidance), 2 = Minimally Knowledgeable, 3 = Competent, 4 = Highly Experienced, and 5 = Expert (able to help other clinicians tailor anticipatory guidance). Higher scores indicate greater self-rated competence in providing firearm safety counseling.
Measured: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.
De Novo Survey Items for Assessing Social Cognitive Theory Construct Self-Efficacy
Five items, Scale score for individual items, Minimum score: 0, Maximum score: 4. Higher scores indicate more self-efficacy.
This secondary outcome measure assessed participants' self-efficacy (confidence) in firearm injury prevention counseling practices using five investigator-developed survey items based on Social Cognitive Theory self-efficacy constructs. Participants rated their confidence before and after the intervention in: (1) counseling patients in firearm injury prevention, (2) providing information about firearm storage devices (e.g., cable locks, trigger locks, lock boxes), (3) asking permission to provide patients with firearm safety information, (4) supporting patient autonomy by emphasizing patient choices, and (5) using affirming statements to emphasize patients' strengths, actions, or efforts. Changes in confidence scores from pre-intervention to post-intervention were analyzed.
Measured: Baseline (immediately before the virtual reality intervention) and immediately post-intervention (1-day virtual reality intervention)
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectations
Two items, Scale score of individual items, Minimum score: 1, Maximum score: 5. Higher scores indicate more expectations.
Expectations regarding firearm safety counseling were assessed using two investigator-developed survey items administered at baseline and at the 2-month follow-up. Participants rated their agreement with the statements, "I will offend a patient if I discuss firearm safety with them" and "I would be offended if my health care provider discussed firearm safety with me," using a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Each item was analyzed separately, with higher scores indicating greater agreement with the statement.
Measured: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectancies
Two 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.
Expectations regarding the effectiveness of firearm safety counseling were assessed using two investigator-developed survey items administered at baseline and at the 2-month follow-up. The first item, "Patients will change their actions around firearm storage based on counseling from a healthcare provider," was rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree), with higher scores indicating greater agreement. The second item assessed participants' perceptions of the effectiveness of firearm storage counseling in reducing firearm-related injuries using a 5-point scale ranging from 0 (Not at all effective) to 4 (Extremely effective), with higher scores indicating greater perceived effectiveness. Each item was analyzed separately.
Measured: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20263 Jun 2026

First posted4 Dec 2025
Study start20 Jan 2026
Primary completion3 Jun 2026
Study completion3 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Virtual RealityStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07265141
Sponsor's protocol ID: 2024-0538
Other IDs: K18HD117377
Status last verified: Oct 2026
First submitted: 13 Jun 2025
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 39128562
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.
PubMed 39677314
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.
PubMed 39949418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics
ClinicalTrials.gov ID: NCT07265141
Acronym / sponsor ID: 2024-0538
Conditions: Virtual Reality, Medical Education, Motivational Interviewing, Gun Violence Prevention, Artificial Intelligence (AI)
Keywords: virtual reality, Medical Education, Gun violence prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 20 Jan 2026 (actual)
Primary completion: 3 Jun 2026 (actual)
Study completion: 3 Jun 2026 (actual)
First posted: 4 Dec 2025 (actual)
Results: Posted 2 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians	Experimental	Behavioral: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in CliniciansThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Unable to read and write in English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in CliniciansThe automated virtual reality intervention allows clinicians to deliberately practice firearm safety counseling skills through verbal interactions with virtual characters with receipt of immediate feedback.	Behavioural	An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

Primary outcome

Acceptability of Intervention Measure
Time frame: Immediately post-intervention (1-day virtual reality intervention)
one item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better acceptability
Appropriateness of the Intervention Measure
Time frame: Immediately post-intervention (1-day virtual reality intervention)
One item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better appropriateness
Feasibility of the Intervention Measure
Time frame: Immediately post-intervention (1-day virtual reality intervention)
One item, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better feasibility

4 secondary outcomes

De Novo Survey Item for Assessing Social Cognitive Theory Construct Behavioral Capability
Time frame: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.
De Novo Survey Items for Assessing Social Cognitive Theory Construct Self-Efficacy
Time frame: Baseline (immediately before the virtual reality intervention) and immediately post-intervention (1-day virtual reality intervention)
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectations
Time frame: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.
De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectancies
Time frame: Baseline (prior to the virtual reality intervention) and 2 months post-intervention.

Results and safety

Results posted to the registry on 2 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians	25	25

Primary outcome: Acceptability of Intervention Measure

Time frame: Immediately post-intervention (1-day virtual reality intervention). Count of participants. Unit: Participants

Measure	An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians n = 25
Strongly disagree	0
Disagree	0
Neutral	2
Agree	10
Strongly agree	13

Population analysed: The analysis population included all participants who completed the virtual reality training and provided a response to the AIM survey item assessing whether virtual reality was an appealing (acceptable) format for firearm safety counseling training. No participants were excluded from this analysis due to missing responses or other criteria. The number of participants analyzed reflects the number of participants with available data for this specific outcome measure.

Primary outcome: Appropriateness of the Intervention Measure

Time frame: Immediately post-intervention (1-day virtual reality intervention). Count of participants. Unit: Participants

Measure	An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians n = 25
Strongly disagree	0
Disagree	0
Neutral	0
Agree	10
Strongly agree	15

Population analysed: The analysis population included all participants who completed the virtual reality training and provided a response to the IAM survey item assessing whether virtual reality seemed a suitable (i.e. appropriate) format for firearm safety counseling training. No participants were excluded from this analysis due to missing responses or other criteria. The number of participants analyzed reflects the number of participants with available data for this specific outcome measure.

Primary outcome: Feasibility of the Intervention Measure

Time frame: Immediately post-intervention (1-day virtual reality intervention). Count of participants. Unit: Participants

Measure	An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians n = 25
Strongly disagree	0
Disagree	0
Neutral	0
Agree	10
Strongly agree	15

Population analysed: The analysis population included all participants who completed the virtual reality training and provided a response to the FIM survey item assessing whether communication strategies reviewed during the virtual reality training seem doable (i.e. feasible to implement) in clinical practice. No participants were excluded from this analysis due to missing responses or other criteria.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through completion of the 2-month follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Limitations and caveats (from the sponsor): This study had limitations. Selection bias is possible, as clinicians interested in VR/AI or firearm safety may have been more likely to participate. However, for acceptability, appropriateness, and feasibility testing, greater interest in the technology or content may have been beneficial. The single-site, pediatric academic setting may limit generalizability. Finally, we assessed self-reported rather than observed counseling behaviors; future studies should evaluate real-world effectiveness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 39128562March 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.
Background: PubMed 39677314Real 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.
Background: PubMed 39949418March 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention Measure (time frame: Immediately post-intervention (1-day virtual reality intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07265141, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.