An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics (NCT07265141), a na na study. The primary outcome is Acceptability of Intervention Measure.

2. Clinical Question

The clinical question is about the training format and its acceptability, not about patient outcomes or whether firearm storage practices changed. The intervention is intended for clinicians to practice firearm safety counseling, but the primary endpoint is a participant-reported acceptability measure. Its description says that higher scores indicate better acceptability on a scale with a minimum of 1 and a maximum of 5. The registry also labels the outcome as a count of participants, so the measurement description and outcome classification do not fully align.

Because no control condition is reported, the study cannot make a like-for-like comparison of the training with another educational approach. The record also lists secondary survey outcomes concerning behavioral capability, self-efficacy, expectations, and expectancies. These are additional constructs, but the registry record does not report their results or explain how they relate to the primary acceptability question.

3. Trial Design

The registry lists this study as completed, with enrollment of 25. It describes a single-group behavioral intervention and gives the intervention name as an automated virtual reality intervention to support firearm safety counseling in clinicians. The study is not listed as a randomized comparison: allocation is NA, and there is no comparator group in the record. Masking is recorded as none.

The training is described as screen-based. Clinicians practice counseling skills by speaking with virtual characters and receive immediate feedback. The brief description frames the purpose as learning to counsel caregivers of pediatric patients on secure firearm storage. The record does not describe a separate usual-care, alternative-training, or no-training group, so differences between groups cannot be estimated.

The listed start date is 2026-01-20, and the listed primary completion date is 2026-06-03. The study status is COMPLETED. Phase is recorded as NA. The record does not report further details about the setting, clinician specialties, recruitment procedures, intervention duration beyond the primary outcome timeframe, or follow-up beyond the immediate post-intervention assessment.

The primary outcome is acceptability assessed immediately after the 1-day virtual reality intervention. Its analysis population is described as participants who completed training and responded to the AIM survey item, with no participants excluded from that analysis. However, the number of participants who completed training and posted an outcome response is not reported in the registry record. Enrollment of 25 should therefore not be treated as confirmation that 25 participants contributed to the primary endpoint.

The record lists seven outcome measures and no analyses. That distinction matters: an outcome may be named in a registry without a numerical result or statistical analysis being reported. The record does not describe a sample-size justification, a prespecified statistical analysis plan, or interim analyses. These details are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: No significant events occurred between enrollment and assignment. All enrolled participants received the VR curriculum intervention, with no exclusions before the intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 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.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: All participants were included in the baseline analysis.

6. Primary Endpoint

The registry lists the primary outcome as Acceptability of Intervention Measure, measured over Immediately post-intervention (1-day virtual reality intervention).

The primary endpoint is titled “Acceptability of Intervention Measure.” It is intended to capture whether participants consider virtual reality an appealing format for firearm safety counseling training. The registry places the assessment immediately after the 1-day virtual reality intervention and describes a one-item measure. The description states that the score is an average across individual items, while also identifying the measure as one item; this scoring description is not fully clear from the registry record.

The scale is described as having a minimum score of 1 and a maximum score of 5, with higher scores indicating better acceptability. In principle, an acceptability measure can describe participants’ perceptions of the training format, which is relevant when an intervention is delivered through a particular educational approach. It is distinct from evidence that participants acquired counseling skills, used those skills in practice, or changed caregiver behavior.

The registry classifies the endpoint using participants as the unit and a count-of-participants parameter. That classification does not readily explain how the stated 1-to-5 scale score is represented or summarized. The numerical endpoint result, its distribution, and any estimate of uncertainty are not reported in the registry record. The measure’s stated purpose can therefore be described, but the observed level of acceptability cannot.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record gives limited information about the statistical methods. It identifies the primary endpoint and an analysis population, but lists 0 analyses and does not report a statistical analysis plan, an outcome estimate, or a confidence interval. The methods discussion therefore needs to distinguish the outcome’s intended meaning from statistical procedures that are not described in the record.

What does a scale score represent?

A scale score is a numerical representation of responses according to the scale’s scoring rule. In this study, the acceptability measure is described as having values from 1 to 5, with higher values indicating better acceptability. The record says it is a one-item measure but also describes the score as an average across individual items. Those statements do not establish exactly how the response was calculated or summarized. The registry also labels the outcome as a count of participants, which differs in form from a scale score. The precise operational definition is not reported in the registry record.

This distinction matters because different summaries answer different questions. A count of participants describes how many people meet a defined condition. A scale summary describes the values participants reported, and could be presented in several ways depending on the analysis plan. The record does not specify a response threshold, a summary statistic, or a model for this endpoint. No such method should be assumed from the endpoint title alone.

What would an uncertainty interval add?

In general, a confidence interval expresses the uncertainty around an estimate under the assumptions of the statistical method. It helps readers distinguish a precisely estimated quantity from one that remains uncertain. An interval does not remove limitations in study design, repair unclear outcome scoring, or establish that a finding applies beyond the participants studied. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated.

Likewise, a p-value would address a particular statistical hypothesis under specified assumptions, but it would not by itself describe the size or practical meaning of an outcome. The registry lists no analyses and reports no p-value. There is therefore no inferential test to interpret. The record does not say whether any hypothesis test was planned, whether results were adjusted, or whether a particular threshold for statistical evidence was prespecified.

Why does the single-group design matter?

A single-group study observes participants who receive the intervention without a concurrent comparison group. It can describe outcomes in that group if results are reported, but cannot estimate a treatment contrast against another group. A contrast requires information from both conditions and a defined comparison. Here, allocation is NA, masking is none, and no comparator is listed. Statistical methods cannot create a control group that the design does not include.

For that reason, the study’s primary question is appropriately read as descriptive: what did participants report about acceptability after training? It should not be reframed as a comparative effectiveness question. Nor does an immediate acceptability response establish a change in clinical counseling practice. The record names counseling skill practice as the training purpose, while the primary outcome is acceptability.

How should planning calculations be understood?

In general, sample-size planning calculations estimate the number of participants needed under stated assumptions to detect a specified effect with a chosen statistical procedure. They are planning illustrations, not observations, and do not measure the probability that a completed study has found a true effect. The calculation assumptions named for the planning illustration include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect is a fraction of the observed effect.

Those assumptions describe a hypothetical two-arm planning setup, whereas this registry record describes a single-group study with no comparator. The record does not report a primary endpoint result from which an observed effect can be characterized. Any planning illustration should therefore be read as conditional on its stated assumptions, not as a result of the study or as observed power. It does not establish that the enrolled sample was adequate for the study’s actual design.

What is not specified?

The record does not state how the scale outcome was summarized, how missing responses were handled, whether any covariates were considered, or whether an analysis was adjusted. It also does not report an interim analysis or a sample-size justification. These absences prevent reconstruction of a statistical analysis from the registry description. General statistical principles can clarify what analyses would mean, but cannot fill in methods that are not reported in the registry record.

Given the available information, the most defensible statistical reading is limited: the record names an immediate acceptability endpoint and an eligible analysis population, but provides neither an outcome value nor an analysis. No numerical conclusion about acceptability or its precision can be drawn.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures: the primary acceptability measure and secondary survey items concerning behavioral capability, self-efficacy, expectations, and expectancies. Listing multiple outcomes raises a general multiplicity issue when statistical tests are conducted: the more hypotheses examined, the greater the chance that at least one result may appear unusual by chance if each is interpreted separately. Statistical plans can address this in different ways, but the record does not report a multiplicity procedure or a hierarchy for interpreting the outcomes.

The registry lists 0 analyses. It does not give outcome estimates or tests for the primary or secondary measures, so there are no reported findings to assess for multiplicity. The absence of a stated adjustment should not be interpreted as evidence that one was or was not used outside the registry record.

The primary analysis population is described as participants who completed the virtual reality training and responded to the AIM item, with no participants excluded from that analysis. The number meeting that description is not reported in the registry record. The enrollment field lists 25, but that figure alone does not establish the number with a completed, usable primary outcome response.

Missing-data handling is also not described. The record does not say how unanswered items, incomplete training, or other incomplete observations were handled, and it does not report the amount or pattern of missing outcome data. Without those details, it is not possible to assess whether the analyzed participants differed from those without an outcome response. The analysis population definition clarifies who was intended to contribute, but does not supply a response count or explain missingness.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists 25 participants at risk, 0 affected by a serious adverse event, and 0 deaths. These are the registry’s reported figures for the adverse-event group. They should be read as event counts for the recorded observation, not as a comparison between the intervention and a control condition.

Because the study is listed as single-group and no comparator is reported, these figures do not estimate a difference in serious adverse events between training approaches. The record does not provide further detail about adverse-event definitions, collection procedures, observation duration, or non-serious events. The figures also do not establish that an event could not have occurred outside the period or process represented in the registry entry.

Zero recorded serious events is a descriptive observation, not proof of zero risk. The available safety information is limited to the counts in the registry record, and no comparative statistical analysis is reported.

12. What the Result Does, and Does Not, Mean

The study addresses an educational question: whether clinicians find an automated virtual reality format acceptable for practicing firearm safety counseling. It is a single-group behavioral intervention, and the named primary outcome is an immediate post-intervention acceptability measure. These features define what the study is set up to describe, but they do not supply the missing endpoint result.

The registry record does not report a numerical acceptability score, a response distribution, or an analysis. Consequently, it does not show whether participants considered the format appealing, how responses varied, or how precisely acceptability was estimated. The direction of the scale is described—higher scores indicate better acceptability—but the observed values are not reported. No conclusion about the level of acceptability can be drawn from that scale description alone.

The record also does not establish that the intervention improves counseling skill, changes clinicians’ behavior, or affects caregivers’ firearm storage practices. Those outcomes are distinct from participants’ views of the training. Although the intervention description refers to deliberate practice and feedback, the registry’s primary endpoint is acceptability, not a direct measure of counseling performance or patient outcomes.

There is no concurrent comparator group, so the study does not provide a direct estimate of how this training compares with another educational approach. The single-group structure can describe participants’ experiences if outcome results are reported, but cannot isolate the effect of the intervention from other explanations for observed outcomes. The registry record does not report a randomized allocation or a comparative analysis.

The named secondary outcomes concern behavioral capability, self-efficacy, expectations, and expectancies. Their inclusion indicates that these concepts were listed for assessment, but their results are not reported. The record’s outcome classification and description of the primary measure also leave uncertainty about how the acceptability response was intended to be scored and summarized.

Accordingly, the record supports a description of the intervention, study structure, endpoint intent, and recorded serious adverse-event counts. It does not support a claim about acceptability results, intervention effects, comparative performance, or the precision of an outcome estimate.

13. Why This Trial Matters Statistically

This study is statistically interesting because its design and endpoint ask a focused, descriptive question about an educational format. Acceptability can matter when evaluating whether participants regard a training approach as appealing, but its interpretation depends on a clear definition of the measure and a reported result. The registry record names an immediate post-training AIM item and describes a 1-to-5 scale, yet does not report the response values or a summary.

The distinction between an outcome being registered and an outcome being analyzed is important. The record lists seven outcome measures but 0 analyses. That means the constructs are identifiable, while estimates and statistical evidence are not available in the registry record. Readers cannot determine the observed level of acceptability or the variability in responses from the endpoint description alone.

The design also illustrates why a study question should be matched to the available comparison. A single-group study can address what participants report after taking part, but it does not estimate a difference between this training and another approach. The absence of a comparator is not a problem that can be solved by a more elaborate statistical test; it defines the scope of the evidence the design can produce.

Finally, the mismatch between the one-item scale description, the statement that the score is an average across individual items, and the count-of-participants classification makes outcome reporting especially important. Clear scoring and a transparent summary would help readers understand exactly what was measured. With no numerical result or analysis in the registry record, the statistical value of the study cannot be judged from the registered endpoint description alone.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation for interpreting the registry record is the absence of a numerical primary outcome result or analysis. The record names acceptability as the primary endpoint but does not report participants’ scores, a summary, or uncertainty. The study’s primary question therefore remains unanswered by the reported information.

The endpoint description is not fully consistent. It calls the measure one item, describes the scale score as an average across individual items, and classifies the endpoint as a count of participants. The record does not explain the scoring or summarize the responses, so the precise quantity intended for analysis is uncertain.

The single-group design has no concurrent comparator, and the record reports no randomized allocation. As a result, the study cannot provide a direct comparison with another training approach. Its primary outcome is an immediate participant-reported assessment; the registry does not report a direct measure of counseling performance, caregiver response, or firearm storage behavior.

The analysis population is described as participants who completed training and responded to the AIM item, but the number of such participants is not reported. Although enrollment is listed as 25, the record does not establish that all 25 completed training and provided a usable primary outcome response. Missing-data procedures and the amount or pattern of missingness are not reported.

The registry also lists seven outcomes but 0 analyses. It does not report a statistical analysis plan, multiplicity approach, sample-size justification, interim analyses, or the methods used to summarize the endpoint. These details are not reported in the registry record, and their absence limits assessment of the planned and completed statistical analysis.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics — NCT07265141.
• Registry record last updated 2026-11-02; status last verified 2026-10.
• Results first posted 2026-11-02.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes a completed, single-group behavioral study of automated virtual reality training for clinicians learning firearm safety counseling in pediatrics. Enrollment is listed as 25. The intervention involves verbal practice with virtual characters and immediate feedback. Allocation is NA, masking is none, and no comparator group is reported.

The primary outcome is an immediate post-intervention Acceptability of Intervention Measure assessment. Its description refers to a one-item measure on a 1-to-5 scale, with higher scores indicating better acceptability, while the outcome classification refers to a count of participants. The registry lists seven outcome measures and 0 analyses. It does not report a numerical primary outcome result, its precision, or a statistical analysis. The adverse-event record lists 0 serious adverse events among 25 at risk and 0 deaths.