Virtual-reality and Emotion Regulation in Violence-Exposed Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Virtual-reality and Emotion Regulation in Violence-Exposed Youth (NCT05022550), a na na study. The primary outcome is Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey.

2. Clinical Question

The central question is about whether participants reported enjoying the VR simulation experience, not whether DEEP VR changed emotional regulation relative to another treatment or to no treatment. The record also lists secondary measures concerning emotion regulation, physiological arousal, engagement, and PTSD symptoms. Those outcomes can broaden the questions a study asks, but their presence does not establish that findings for them are available. The registry record lists no analyses, and it does not report results for those secondary measures.

3. Trial Design

The registry classifies this study as a completed, single-group investigation of DEEP VR. It lists no phase, no allocation method, and no masking. With only one group and no control arm, the design describes participants’ experience with the intervention but does not provide a randomized comparison against an alternative. The trial is associated with the University of Wisconsin, Madison. Its listed start date is 2022-06-03, and its listed primary completion date is 2025-05-01.

The listed enrollment is 74. Separately, the brief summary says that 135 participants under the age of 17 will be enrolled. These are different enrollment figures in the record, and the reason for the difference is not reported in the registry record. The arm description identifies participants from the Dane County Juvenile Court Program and says they would be asked to experience up to 6 VR-based sessions. It mentions a lightweight, wireless, head-mounted display, identified as an Oculus Quest 2 Enterprise VR Headset. The available arm description is incomplete, so additional session procedures are not reported in the registry record.

The primary outcome timeframe is up to 8 weeks. Its wording identifies a count of participants who enjoyed the VR simulation experience, assessed through a qualitative survey response. The registry lists several secondary outcome topics, including change in emotion regulation and physiological arousal. It does not report a statistical analysis plan, allocation details beyond the single-group classification, or a rationale for the listed enrollment. These omissions limit what can be concluded about the study’s planned analytic approach or how the completed enrollment relates to its initial aim.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 11 Participants did not complete the survey.

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: Baseline demographics were not collected from the participant who withdrew.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey, measured over up to 8 weeks.

The primary endpoint is a count of participants who gave a response from neutral to strongly agree to the statement, "I found the virtual environment to be engaging and enjoyable". The registry labels this a feasibility outcome and specifies participants as the unit. A participant count can describe how many people met a stated response criterion, making the measure relevant to whether the experience was acceptable or engaging to those who answered the survey.

That count is not reported in the registry record. The record notes that 11 participants did not complete the survey, but it does not state how many completed it, how responses were distributed across the response options, or how missing responses were handled. Without the number meeting the criterion and the number of surveyed participants, the endpoint cannot be interpreted as a response rate or as a proportion. A count alone also depends on how many participants were assessed.

As a general measurement consideration, a survey response about enjoyment captures a participant’s reported experience; it is not itself a direct measure of change in emotional regulation or a comparison of clinical outcomes. The registry lists emotion regulation and other measures among its secondary outcomes, but their results are not reported in the registry record. The endpoint is therefore most appropriately understood as a planned indicator of participant experience, with its observed value unavailable in the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary endpoint is defined as a count of participants whose survey response fell between neutral and strongly agree for a statement about whether the virtual environment was engaging and enjoyable. In general, a count is the number of observations meeting a specified condition. It is not automatically a percentage or a rate: interpreting it as a proportion requires knowing the relevant denominator, such as how many participants completed the survey. The registry record notes 11 survey non-completers but does not report the completed-survey denominator or the number meeting the criterion. Thus, neither a proportion nor its precision can be established from the posted results.

The endpoint is described as a qualitative survey measure, while its recorded parameter is a participant count. That wording identifies the kind of response used to define the outcome and the unit being counted. It does not supply the response distribution or explain how neutral responses were combined with agreement responses beyond the stated criterion. The recorded count itself is not reported in the registry record.

What can a single-group design establish?

As a general statistical explanation, a single-group design can describe observations in the group studied. It does not by itself estimate what would have happened to the same participants under a different intervention or without the intervention. Without a comparison group, observed experiences or changes can reflect many influences besides the intervention. The registry classifies this study as single-group and says it is not a randomized comparison. The posted results therefore do not support a treatment-versus-control contrast.

Masking is listed as none. In general, masking is intended to limit the influence of knowledge about assigned treatment on aspects of study conduct or outcome assessment. The registry record does not describe a masked comparison, and the single-group design means there is no separate assigned comparison arm to contrast. Further details about how survey responses were collected or assessed are not reported in the registry record.

How should uncertainty be understood?

In general, a confidence interval is a range calculated from data under a statistical model to communicate uncertainty around an estimate. A narrower interval indicates greater precision under that model; a wider interval indicates more uncertainty. No confidence interval for the primary endpoint is reported in the registry record. Because the endpoint count and its analysis denominator are also not reported, there is no posted estimate around which to interpret precision.

A significance test, in general, evaluates data against a specified null hypothesis under stated assumptions. A p-value is not a measure of effect size or the probability that a treatment works. The registry lists zero analyses and does not report a test or p-value for the primary endpoint. It also does not report the statistical analysis plan in the registry record. No inferential conclusion should be inferred from the endpoint title or from the fact that the study is marked completed.

What does the sample-size illustration mean?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, such a calculation estimates how many participants would be needed under its assumptions for a chosen probability of detecting a specified effect if that effect were present. It is a planning exercise, not an observed result and not observed power. The stated assumptions describe the illustration, not necessarily the trial’s design or its original planning.

Those assumptions include two arms and equal allocation, whereas the registry classifies the study as single-group and not a randomized comparison. The sample-size illustration therefore should not be mistaken for a description of the actual study structure. The record does not report a sample-size justification for the trial itself, and the actual calculated planning values are not described in the registry record for this explanation. No conclusion about whether enrollment was adequate for the study’s aims can be drawn from the illustration alone.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion occurs when observed variability in count data is greater than a model assumes. If a model understates variability, standard errors and uncertainty intervals can be too small, and tests can appear more decisive than the data warrant. Whether over-dispersion is relevant depends on the outcome and the model. The primary endpoint is a participant count, but the registry record reports no fitted model, dispersion estimate, or analysis. It is therefore not possible to say whether over-dispersion was assessed or whether a particular count model was used.

For a simple participant count, interpretation also depends on the definition of who is eligible to be counted and whether every eligible participant has an observed response. The record identifies survey non-completion but does not explain the analysis population or missing-data handling. In general, missing responses can affect both the count and the denominator used to interpret it; assuming that non-completers had positive, negative, or neutral responses would be unjustified. No such assumption is reported in the registry record.

What can the secondary outcomes add?

The registry lists secondary measures covering emotional regulation, heart rate, galvanic skin response, engagement sub-scales, and PTSD symptoms. In general, secondary outcomes may address complementary questions, but their interpretation depends on prespecified measurement details, analysis methods, and the results themselves. The registry record lists no analyses and does not provide results for these outcomes. It does not report whether measurements were compared over time, how repeated observations were handled, or which analysis population was used.

When several outcomes are examined, multiplicity is a general statistical concern: the chance of at least one apparently notable result can rise when many hypotheses are tested. Strategies for addressing multiplicity can include defining a primary outcome, adjusting inference, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy. Because no analyses or outcome results are posted, there is no basis to evaluate whether multiplicity adjustment was performed or to interpret any secondary finding as confirmatory.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("DEEP VR Experiment Group")
n      <- c(63)
events <- c(47)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  DEEP VR Experiment Group  63  47  74.6  62.1  84.7  62.7  83.7  62.6  83.7

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary feasibility endpoint and several secondary outcome topics, but it reports zero analyses. The secondary topics include emotion regulation, heart rate, galvanic skin response, positive and negative engagement sub-scales, and PTSD symptoms. The record does not report which analyses, if any, were planned for these outcomes, whether secondary outcomes were exploratory or confirmatory, or whether any multiplicity adjustment was intended. As a general statistical issue, interpreting many tests without an appropriate plan can increase the chance of apparently notable findings. No conclusion about how this issue was handled can be drawn from the registry record.

For missing primary-outcome data, the record says 11 participants did not complete the survey. It does not report the number who completed it, reasons for non-completion, the missing-data method, or whether non-completers were excluded from an analysis. It also does not report the primary endpoint count. General methods for handling missing data rely on assumptions about why values are missing and how missingness relates to observed information. The registry record does not identify such assumptions or a method, so the impact of missing survey responses cannot be evaluated.

The record does not define an intention-to-treat, per-protocol, or other analysis population. It gives a listed enrollment of 74 but does not say how many participants contributed data to each outcome. The brief summary separately describes an aim to enroll 135 participants; the reason for the difference is not reported in the registry record. It is therefore not possible to determine the denominator for the primary endpoint or whether the secondary measures used a common analysis population.

12. 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.

For the DEEP VR experiment group, the registry lists 73 participants at risk for serious adverse events and zero affected. It also lists 73 at risk for other adverse events and zero affected, along with zero deaths. No top serious adverse-event terms are listed. These are the recorded counts; they should not be read as evidence from a comparison with another group, because the study is classified as single-group.

In general, an at-risk count indicates the number of participants included in a particular safety denominator, while an affected count records how many had an event as represented in the registry. The record does not explain why the listed risk denominator is 73 when enrollment is listed as 74, or whether the safety denominator reflects a particular exposure or follow-up population. That reason is not reported in the registry record.

Zero recorded events means the registry lists none in these categories; it does not establish that no event could occur or that every participant was observed for an identical period. The record does not report detailed safety surveillance methods or event-reporting rules. The counts can be described as posted, but should not be extended into a comparative safety claim.

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

The registry record describes a study of DEEP VR in a single group of youth identified through the Dane County Juvenile Court Program. Its primary question concerns participants’ reported experience of the virtual environment. The record gives the response criterion and notes 11 survey non-completers, but it does not report the number who met the criterion. Consequently, the posted information does not establish how many participants found the environment engaging and enjoyable, nor how precisely that experience was estimated.

The record also does not report analyses or results for the secondary outcomes. Those outcomes include measures related to emotion regulation, physiological arousal, engagement, and PTSD symptoms. The outcome titles alone do not show whether scores changed, whether any change was meaningful, or whether a change could be attributed to the intervention. The registry record does not provide a comparison group, and it classifies the study as not a randomized comparison.

As a general distinction, feasibility and acceptability questions address whether an intervention can be delivered or how participants experience it; they are not equivalent to demonstrating a comparative effect. The primary outcome is a survey-based enjoyment measure, while the record lists other measures that could address different aspects of participants’ experiences. Without their results and analysis details, the relationship between those outcomes cannot be assessed.

The safety entries report zero affected participants in the serious and other adverse-event categories, with 73 at risk in each category and zero deaths. They are descriptive registry counts, not a comparison against another intervention. The record does not state why the safety denominator differs from the listed enrollment of 74.

Accordingly, the posted information supports a careful description of the study design, its intended survey endpoint, the reported survey non-completion, and the recorded safety counts. It does not support a conclusion about the primary outcome’s magnitude, changes in the secondary measures, comparative effectiveness, or comparative safety. Those questions remain unanswered by the results reported in the registry record.

14. Why This Trial Matters Statistically

This trial raises several important statistical interpretation issues in a compact setting. The primary endpoint is a count based on participants’ survey responses, so the count needs both a clear response rule and a known denominator to communicate how common that response was among those assessed. The registry states the criterion and reports 11 survey non-completers, but does not report either the number meeting the criterion or the number completing the survey. That gap prevents assessment of both the observed level of enjoyment and its precision.

The single-group design also makes the scope of inference important. In general, describing participants’ experiences is different from estimating an intervention effect against a comparator. The registry lists no control group, allocation is not applicable, and the study is explicitly not a randomized comparison. The primary feasibility question can still be distinguished from a comparative treatment question, but the posted record does not report the primary outcome value needed to describe the former.

The record further illustrates why sample-size calculations must be read in context. The described planning illustration assumes two arms with equal allocation, whereas the trial is listed as single-group. Such an illustration is not the trial’s observed result, does not establish observed power, and is not evidence that the study was designed or analyzed as a two-arm comparison. The trial’s own sample-size justification is not reported in the registry record.

Finally, the discrepancy between the listed enrollment of 74 and the brief summary’s stated aim to enroll 135 participants, together with the 73-person safety denominator, makes analysis populations and denominators especially relevant. The registry does not explain these differences. Recognizing what is reported and what is not is essential to avoid turning incomplete endpoint information into stronger conclusions than the record can support.

15. 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.

Several limitations specific to this record constrain interpretation. The primary outcome count is not reported, even though the endpoint is described in detail. The record notes 11 survey non-completers but does not report the number who completed the survey, the response distribution, or how non-completion was handled. This leaves both the outcome’s observed value and its denominator unknown.

The design is single-group, with no randomized comparator. As a result, the record does not provide a like-for-like comparison that could distinguish intervention-associated change from other influences. The registry lists no analyses, and it does not report a statistical analysis plan, an analysis population, or methods for assessing repeated or secondary measurements. The results for the named secondary outcomes are not reported in the registry record.

The record lists enrollment as 74, while the brief summary describes an aim to enroll 135. It does not explain the difference. The safety fields list 73 participants at risk, with no explanation of how that denominator was defined or why it differs from enrollment. These figures should be reported as recorded rather than reconciled through assumptions.

The arm description is incomplete, so the full session procedures are not reported in the registry record. The record also does not report a sample-size justification for the trial itself or a multiplicity strategy for the listed outcomes. Together, these omissions limit conclusions about implementation, missingness, precision, and the intended analytic interpretation. They do not establish that the study lacked procedures; they mean that the relevant details are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Virtual-reality and Emotion Regulation in Violence-Exposed Youth — NCT05022550.
• Registry record last updated 2026-07-01; status last verified 2026-06.
• Results first posted 2026-07-01.
• 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.

19. Record Summary

The registry identifies a completed, single-group study of DEEP VR for youth under juvenile justice supervision. It lists the University of Wisconsin, Madison as sponsor, enrollment of 74, no phase, no masking, and a primary completion date of 2025-05-01. Participants were asked to complete up to 6 VR-based sessions. The primary endpoint was the count of participants responding from neutral to strongly agree that the virtual environment was engaging and enjoyable, assessed over up to 8 weeks.

The record notes that 11 participants did not complete the primary survey, but does not report the endpoint count or survey denominator. It lists secondary measures concerning emotion regulation, physiological arousal, engagement, and PTSD symptoms, but no outcome analyses. Safety entries list 73 participants at risk, zero serious and other adverse events, and zero deaths. The reason for the difference between enrollment and the safety denominator is not reported in the registry record. The brief summary’s aim of 135 participants also differs from the listed enrollment; the reason is not reported.