Positive Youth Development in the Metaverse: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Positive Youth Development in the Metaverse (NCT05858593), a na na study. The primary outcome is Usability of VR System and Curriculum Content.

2. Clinical Question

3. Trial Design

This completed pilot study evaluates a virtual reality afterschool program for middle childhood youth. The registry lists an enrollment of 32, a start date of 2023-09-16, and a primary completion date of 2024-07-30. The listed phase is NA. The registry describes the model as single-group, allocation as NA, and masking as none.

The treatment description says that children in the treatment group receive the VR-based curriculum during the afterschool program. A “No Virtual reality curriculum” intervention is also listed, but the registry specifically cautions that the arms are not a like-for-like control comparison and that the study is not randomized. The record does not report enough design detail to establish how, or whether, participants were assigned across those listed interventions. A causal comparison between curriculum and no curriculum is therefore not supported by the design information in the registry.

The primary endpoint is a post-treatment assessment of usability after 4 weeks of exposure to the VR system. The study also lists step count, heart rate, and engagement as secondary outcomes. Five outcome measures are recorded, but the registry reports zero analyses. The statistical analysis plan, the method used to summarize secondary outcomes, and any sample-size justification are not reported in the registry record. The total enrollment should not be taken as the number with complete data for every outcome; the analysis population and outcome-specific completeness are not reported.

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: This was a single arm study and all participants were assigned to the same intervention/treatment.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Detailed open ended responses to the usability questions were obtained from diary measures and reported as a supplementary document in the Study Documents section. Although all participants wore wearables to track their movement and engagement with the VR system, 21 participants out of 32 participants completed the self-reported survey portion of the study.

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: The study required participants to engage with the VR playground at least once a week for 4 weeks and use the smartwatch to track physical activity. Participants were required to wear their smartwatch during waking hours. We recruited and enrolled 32 adolescents (age range 9-17 years old, Mage = 12.46, SDage = 1.40).

6. Primary Endpoint

The registry lists the primary outcome as Usability of VR System and Curriculum Content, measured over One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system..

The primary endpoint is titled “Usability of VR System and Curriculum Content.” It is described as a mean on an ordinal scale, with standard deviation as the measure of dispersion. The assessment took place once after treatment, following 4 weeks of exposure to the virtual reality system.

Scale items used a 5-point Likert scale, from 1 = Strongly Disagree to 5 = Strongly Agree. Five items were adapted from the original System Usability Scale to assess system usability. The description also says five other items were converted to open-ended questions to gather contextual information about usability issues. Detailed open-ended responses from diary measures are described as a supplementary document in the Study Documents section, but those responses are not included in the registry information summarized in the record.

In general, usability assessments can help characterize whether participants find a system understandable and workable, which is useful when evaluating a new program. A mean provides a concise summary of scale responses, while the standard deviation describes their spread. Those summaries do not replace the contextual detail of open-ended responses. No mean, standard deviation, or other primary endpoint result is reported in the registry record, so the actual response pattern cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the primary endpoint as a mean of a continuous measure, while describing its underlying scale as ordinal. The distinction matters: a mean and standard deviation summarize scale scores, but the responses originate from ordered Likert categories. No actual primary endpoint summary or analysis method is reported, so the points below explain the statistical concepts generally rather than describe analyses documented for this study.

What does a mean summarize?

In general, a mean is the arithmetic average of the observed values. For a Likert-type scale, it gives a compact summary of participants’ responses across the permitted response categories. It does not show the pattern of individual answers. The same mean could accompany responses that are tightly grouped or responses that are widely dispersed, so interpreting the mean alongside a measure of spread is useful. The registry names standard deviation as the dispersion measure, but gives no value for either statistic.

Because Likert responses are ordered categories, a numerical mean treats the intervals between adjacent response options as comparable. That convention can be useful for concise reporting, but it is an analytical choice rather than a property established by the response labels alone. In general, distributions or category-level summaries can retain information about how often each response was selected. The registry does not report category frequencies or the specific approach used to analyze the scale items.

What does standard deviation tell the reader?

In general, the standard deviation describes how spread out observations are around their mean. It describes variability among observed responses; it is not the same as a confidence interval and does not by itself indicate how precisely the population mean has been estimated. Precision also depends on the amount and completeness of data and on the analysis. The registry reports neither the primary standard deviation nor a confidence interval, and the number of participants contributing to the primary endpoint is not stated.

How should uncertainty be understood?

In general, a confidence interval gives a range of values that are compatible with the data and the assumptions of the method used to calculate it. A narrow interval indicates greater statistical precision than a wide interval, but neither width nor location can be assessed without the estimate and interval. A p-value, when used, addresses how compatible the data are with a specified null model under the test’s assumptions; it is not the probability that the null hypothesis is true, nor a measure of practical importance. The registry records zero analyses and reports no confidence interval, p-value, or test result.

Why does the design affect interpretation?

The record identifies the model as single-group and allocation as NA. It also lists a no-VR intervention but cautions that the arms are not a like-for-like control comparison. In general, observations after an intervention in a single group cannot separate intervention-related change from other explanations, such as changes over time or differences in who contributes outcome data. A valid controlled contrast depends on a comparator that provides a credible counterfactual. The registry record does not report a randomized comparison or a comparable control group.

The primary assessment is described as occurring once after 4 weeks of exposure. The registry does not report a baseline usability measure or repeated primary assessments. Without those results, a change from baseline cannot be evaluated. A post-treatment description, if reported, would characterize responses at that assessment; it would not by itself establish change or attribute that change to the curriculum.

What do the planning assumptions mean?

In general, a sample-size calculation estimates how many observations a planned study would need under specified assumptions about the effect to detect, variability, significance level, power, and design. The registry’s stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect expressed as a fraction of an observed effect. The record does not give numerical planning results or report the study’s own sample-size justification.

These assumptions describe a planning exercise, not an analysis of the completed study. A planning illustration is not observed power, and it does not establish that a study detected an effect. The assumed two-arm allocation also differs from the registry’s single-group model. The information needed to assess how the observed effect was estimated, or whether the assumptions fit the enrolled study, is not reported in the registry record.

How might over-dispersion matter?

In general, over-dispersion occurs when count data vary more than a statistical model assumes. If count outcomes such as step counts are analyzed using a model that assumes less variability than the data contain, standard errors and uncertainty estimates may be too small. Alternative methods can account for extra variability. This is a general consideration only: the registry lists step count as a secondary outcome but does not report its distribution, model, or any analysis, so it is not possible to say whether over-dispersion occurred or how it was handled.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, including the primary usability endpoint and the secondary outcomes step count, heart rate, and engagement. Assessing several outcomes can create multiplicity: in general, the more statistical tests conducted, the greater the chance of finding at least one apparently unusual result by chance if no adjustment or prespecified hierarchy is used. The registry records zero analyses and does not report whether any multiplicity strategy was planned. It is therefore not possible to determine which comparisons, if any, were intended to be confirmatory.

Missing-data information is also limited. The description says all participants wore wearables, then ends mid-sentence after referring to 21 participants out of 32. The text does not complete what that count refers to. The number with usable data for each outcome, reasons for missing observations, and methods for handling missingness are not reported in the registry record. The primary outcome is described as a one-time post-treatment assessment, but the number who completed it is not stated.

The analysis population is not reported. The record does not say whether analyses were intended to include all enrolled participants, only participants who completed the curriculum, or another defined group. It also does not report an analysis plan, interim analyses, or missing-data sensitivity analyses. These details matter because the analyzed participants and assumptions about missing observations can affect both estimates and their uncertainty. No conclusion about those methods can be drawn from the information recorded.

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.

For the treatment group, the registry records 32 participants at risk for serious adverse events and 0 affected. It also records 32 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse event terms are listed.

These figures describe the events recorded in the registry; they do not establish that no unrecorded events occurred. The record does not provide additional detail about how adverse events were collected, the observation period for safety, or whether the listed counts represent complete follow-up for every participant. The intervention listing includes a no-VR curriculum, but the safety figures shown in the registry are for the treatment group, and the record does not give a like-for-like safety comparison.

In general, a zero count in a study does not prove that an event is impossible or that risk is absent. The amount of information available depends on factors including the number observed and how completely events were captured. No rate or comparative safety estimate should be inferred from these counts alone. The registry record reports no serious adverse events among the 32 participants listed at risk in the treatment group.

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

The record documents a completed pilot study intended to evaluate a virtual reality afterschool curriculum and its usability. It specifies a post-treatment assessment after 4 weeks of exposure, describes scale and open-ended questions, and lists step count, heart rate, and engagement as secondary outcomes. It also records 32 enrolled participants and no serious adverse events or other adverse events in the treatment group counts.

Those design and safety details do not reveal the usability results. No primary endpoint estimate, dispersion, confidence interval, or statistical analysis is reported in the registry record. The posted information therefore cannot show how participants rated the system, how variable their responses were, or how precisely any average was estimated. It also cannot quantify changes in movement, heart rate, or engagement.

The study is identified as single-group, and the registry cautions that the listed intervention arms are not a like-for-like control comparison. As a result, the record does not support a causal estimate comparing the VR curriculum with no curriculum. Even if post-treatment ratings were available, ratings after exposure alone would describe participants’ reported experience, not prove that the curriculum caused a particular response.

In general, a pilot can provide information about the feasibility of delivering a program and about questions that may merit further study. The registry description indicates an interest in replicating programming content and supporting shared participation through VR, but no measured feasibility or usability result is reported. The study should therefore be read as documenting an evaluation question and its design, not as establishing a favorable or unfavorable result. The record does not report a sample-size justification, analysis population, or detailed statistical plan that would allow further assessment of the strength of evidence.

13. Why This Trial Matters Statistically

This study raises a statistical question that is important in early evaluations of digital and behavioral programs: how can usability be measured while distinguishing participants’ experience from evidence of an intervention effect? The registry defines usability as the primary endpoint and combines scale items with open-ended questions. Such mixed measurement can offer both a concise summary and contextual descriptions, but the interpretation depends on reporting the results and methods for each type of information.

The study also illustrates why the design description matters as much as the outcome label. A no-VR intervention appears in the intervention listing, yet the registry identifies a single-group model and explicitly cautions that the arms are not a like-for-like comparison. Without a credible comparison, estimates should not be framed as controlled treatment effects. Clear communication of that distinction helps readers avoid attributing post-treatment observations to the curriculum alone.

Reporting completeness is central to statistical interpretation. The record gives enrollment and a primary assessment timeframe, but no endpoint estimate, analysis, or complete outcome-specific participation information. Without these details, readers cannot assess response variability, precision, missingness, or the relationship between the planned assessment and analyzed participants. The entry therefore demonstrates the limits of interpreting a completed study from design information alone.

Finally, the stated planning assumptions are useful to recognize as assumptions rather than results. They use a two-arm planning framework despite the listed single-group model, and the registry does not give numeric planning outputs or its own sample-size justification. Keeping planning calculations distinct from observed evidence is essential when considering what a pilot can establish.

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 central limitation for statistical interpretation is that the registry reports no outcome estimates and records zero analyses. There is no primary usability mean or standard deviation, and no result for the listed secondary outcomes. Effect size, direction, and precision cannot be evaluated from the recorded results.

The design information also limits causal interpretation. The registry identifies a single-group model, allocation as NA, and no masking. Although both a VR curriculum and a no-VR curriculum are listed, the record cautions that the arms are not a like-for-like control comparison. The assignment process and any usable comparative data are not reported in the registry record.

The primary endpoint uses ordinal Likert items but is summarized as a mean. The registry does not report item-level distributions, scoring details, or the method used to combine items. The number of participants contributing primary endpoint data is not stated. The description of participants and wearable data is incomplete, ending after the phrase about 21 participants out of 32; the meaning of that count cannot be established from the unfinished text.

Additional limitations include the absence of a reported statistical analysis plan, sample-size justification, analysis population, missing-data methods, and multiplicity approach. The registry lists five outcome measures but does not identify which were analyzed or how. These gaps prevent assessment of whether results, if recorded elsewhere, would reflect prespecified methods or complete follow-up. The registry also does not report detailed adverse-event collection procedures or safety follow-up duration.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Positive Youth Development in the Metaverse — NCT05858593.
• Registry record last updated 2026-04-21; status last verified 2026-02.
• Results first posted 2026-04-21.
• 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

This is a completed, single-group pilot study of a virtual reality afterschool curriculum for middle childhood youth, with enrollment of 32. The primary endpoint is usability of the VR system and curriculum content, assessed once after 4 weeks of exposure using adapted scale items and open-ended questions. Step count, heart rate, and engagement are listed as secondary outcomes.

The registry reports 0 analyses and no numerical outcome results. It identifies allocation as NA and cautions that the listed VR and no-VR interventions are not a like-for-like control comparison. For the treatment group, it records 0 serious adverse events, 0 other adverse events, and 0 deaths among 32 participants at risk. The statistical plan, analysis population, missing-data approach, and sample-size justification are not reported in the registry record.