Virtual Reality Treatment for Emerging Adults With ADHD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Virtual Reality Treatment for Emerging Adults With ADHD (NCT06454604), a randomized phase 3 study. The primary outcome is Objective On-Task Assessment Algorithm.

2. Clinical Question

The clinical question concerns the performance of emerging adults with ADHD during study tasks in different headset environments. The primary endpoint is an algorithmic measure of the percentage of time classified as on-task. This is a behavioral measure derived from keyboard and mouse activity, rather than a self-reported rating. The registry summary also describes participant reports of concentration and interest in whether participants enjoy and prefer the virtual environment, but those questions are not the registered primary endpoint described in detail.

The conditions distinguish direct viewing of the laptop through the headset from immersion in a virtual room, and distinguish virtual reality with focus feedback from virtual reality without it. This makes the trial relevant to questions about the study environment and the addition of feedback. However, without outcome estimates and direct comparisons in the registry record, the direction or size of any differences among these conditions cannot be described. The record does not report whether participants preferred one condition, nor does it report a statistical test of that question.

3. Trial Design

The registry describes a completed, randomized, open-label, parallel-group trial with a listed enrollment of 60 and a Phase 3 designation. The trial is identified as a pilot randomized clinical trial in its summary. It has three conditions: VR Passthrough, Virtual Reality, and Virtual Reality + Feedback. Participants were not masked according to the registry. The record does not describe the randomization procedure, allocation ratio, concealment of allocation, or whether investigators analyzing the outcomes were masked.

In VR Passthrough, participants wore the same headset used in the other conditions but saw directly through to their laptop, rather than being immersed in a virtual environment. In Virtual Reality, they were immersed in a cabin-like room with windows and viewed their laptop as part of that environment. The Virtual Reality + Feedback condition is described as an immersive environment with a program that tracks keyboard and mouse click data to assess focus. The description is cut off before explaining the feedback itself, so its operation is not reported in the registry record.

The registry lists the intervention as behavioral and names a Meta Quest 3 VR Headset with noise cancelling headphones. It gives a start date of 2024-09-20, a primary completion date of 2025-04-30, and a completed status. The record does not state how participants were recruited, how many were assigned to each condition, or how many completed the study overall. The adverse-event risk counts are listed separately and should not be treated as the allocation counts or as the primary endpoint analysis populations.

Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions, for 12 sessions within 3 weeks. Sessions 1-2 were combined as the baseline time point because participants did not wear headsets for those sessions. Sessions 3-12 were combined as the later time point, when participants wore headsets. The registry says the divisions at sessions 1-7 and 8-12 were used for compensation or motivation, not as outcome measurement time points.

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: We ask the participants their current ADHD medication status because we block randomize based on if they are taking medication or not, to ensure groups are well-balanced between taking medication and not taking medication.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Number of participants analyzed differs between the overall number analyzed as some participants did not complete enough sessions or the sessions were faulty, and they were excluded from this measure. The number analyzed here is even less than the other outcome measures as it is easier to get measure information through surveys if a session is faulty, over the whole focus algorithm, which doesn't capture information if there are glitches in the virtual reality system.

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.

6. Primary Endpoint

The registry lists the primary outcome as Objective On-Task Assessment Algorithm, measured over Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions, equaling 12 sessions within 3 weeks..

The primary endpoint is the Objective On-Task Assessment Algorithm, reported as the percentage of time focused. It uses keyboard and mouse click data to estimate the percentage of time participants were on-task during study sessions. The measure is continuous, and the registered summary statistic is the mean with standard deviation. It is intended to describe task engagement using activity data rather than relying only on participants’ accounts of their concentration.

The registry defines two measurement periods. T1 averages the percentages from sessions 1 and 2, before participants wore the headsets. T2 averages the percentages from sessions 3 through 12, when participants wore the headsets. The record explains that sessions 1 and 2 were treated as baseline because no headset was worn in those sessions. Although sessions 1-7 and 8-12 were used for compensation or motivational purposes, those divisions were not the endpoint measurement periods.

This endpoint can summarize how much time the algorithm classified as on-task, but it does not by itself establish why participants were or were not focused. Its interpretation depends on the algorithm and the availability and quality of keyboard and mouse data. The registry says some participants were excluded from this measure because they did not complete enough sessions or sessions were faulty, and that the number analyzed was lower than for other outcomes. Exact endpoint analysis counts and the algorithm’s detailed operating rules are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial is listed as randomized, parallel, and without masking. Randomization is intended, in general, to make assigned groups comparable on average by distributing measured and unmeasured participant characteristics without systematic selection. It does not guarantee that the groups will be similar in a particular trial, especially when groups are small. The registry does not report the allocation method, the allocation ratio, or baseline characteristics, so the success of randomization cannot be assessed from this record.

What does the parallel design mean?

In a parallel-group design, participants are assigned to a condition and assessed in that condition rather than being described as crossing through each condition. Here, the record names VR Passthrough, Virtual Reality, and Virtual Reality + Feedback. Because the participants and study staff were not masked, awareness of the assigned environment could influence participant reports or behavior. The endpoint is based on recorded keyboard and mouse activity, but the record does not say whether those data were processed without knowledge of condition. It also does not describe procedures intended to reduce expectation effects.

What does the endpoint summary represent?

The endpoint is continuous and is summarized using a mean and standard deviation. In general, a mean provides a measure of the center of a distribution, while the standard deviation describes its spread. Those summaries can be useful when the distribution is reasonably represented by them, but they do not show the full distribution or individual patterns. The registry does not report endpoint values, distributional checks, or the analysis model. It is therefore not possible to tell whether the reported plan accounted for any special distributional features of the measure.

The endpoint uses data from multiple sessions, reduced to an average for each of two periods. Repeated observations from a participant are generally related to one another, rather than independent in the way observations from unrelated participants might be. General statistical practice accounts for that dependence when modeling session-level data. Averaging sessions can provide a period summary, but it can also conceal variation between sessions. The registry describes the averaging but does not report whether the statistical analysis used period averages, session-level data, or another approach.

How should the time points be understood?

The record calls sessions 1-2 T1 and sessions 3-12 T2. T1 serves as the baseline average because participants did not wear headsets for those sessions. T2 represents the average while participants wore headsets. These definitions are important: the sessions 1-7 and 8-12 divisions were used for compensation or motivational purposes, not as endpoint time points. The listed endpoint therefore does not represent a comparison of those compensation intervals. No numerical values for either time point are reported.

What can be said about planning assumptions?

The record describes sample-size planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that the illustrations are participants per arm, rather than observed power. These are planning illustrations, not evidence of the probability that the completed trial detected an effect. The actual illustration values are not reported in the registry record presented for interpretation, and the record does not report the trial’s own sample-size justification or design assumptions. The two-arm illustration assumptions should not be mistaken for a description of how participants were allocated among the three listed conditions.

In general, power is a design quantity relating a specified effect, variability, significance threshold, and sample size to the chance of detecting that effect under stated assumptions. It is not a measure of whether a completed study has a reliable result. A post hoc calculation based on an observed estimate would not substitute for examining that estimate and its confidence interval. No observed effect estimate is reported, and no recalculated effect or power estimate is available to interpret.

What analysis details are missing?

The registry record reports no analyses. It does not describe the primary statistical test, model covariates, handling of the repeated measurements, adjustment for baseline, or criteria for excluding data beyond the endpoint description that faulty sessions or insufficient session completion could lead to exclusion. It does not report how missing session data were handled or whether sensitivity analyses were conducted. Nor does it report an analysis plan, interim analyses, or a sample-size justification. Those omissions limit the ability to evaluate whether the analysis matched the design and the endpoint’s structure.

General statistical interpretation also distinguishes a numerical effect from its uncertainty and from its practical meaning. A small p-value, if reported, would not by itself quantify the effect; a confidence interval, if reported, would help characterize precision. Neither is available for the primary endpoint in the registry record. The design and measure can be described, but the trial’s statistical findings cannot be reconstructed without group-level results and analysis details.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint, the Objective On-Task Assessment Algorithm, as well as the Homework Effort Index and Homework Motivation Index as secondary outcomes. The summary also refers to participant reports of concentration, enjoyment, and preference. The registry does not report a statistical plan describing which outcomes or contrasts were confirmatory, how many comparisons were planned, or whether any adjustment for multiple testing was intended.

Multiplicity matters when several outcomes, time points, or group contrasts are examined. In general, conducting many statistical tests can make chance findings more likely if each test is interpreted as though it were the only one. Adjustment procedures or a prespecified hierarchy can address this issue, but the registry record does not state whether such methods were used. It also does not report the analyses or test results, so the extent of any multiplicity cannot be assessed.

Missing data are relevant to the primary endpoint because the registry says some participants did not complete enough sessions or had faulty sessions and were excluded from this measure. It says the number analyzed for this endpoint was lower than for other outcome measures. The exact number analyzed, the reasons by condition, and the rules used to determine whether there were enough sessions are not reported in the registry record. The record does not explain whether missing values were imputed, whether partial data were retained, or whether sensitivity analyses assessed the effect of exclusions.

The registry also does not report the analysis population, such as whether participants were analyzed according to randomized assignment or only when they contributed sufficient endpoint data. Without this information, it is difficult to assess whether exclusions could have affected comparability among conditions. No conclusion about bias from missingness is possible from the record alone; the relevant counts, patterns, and analytic choices are not reported in the registry record.

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 registry lists serious adverse events, other adverse events, and deaths by group. For VR Passthrough, the listed risk counts are 22 for serious adverse events and 22 for other adverse events, with 0 affected in each category and 0 deaths. For Virtual Reality, the corresponding risk counts are 18 and 18, with 0 affected in each category and 0 deaths. For Virtual Reality + Feedback, the risk counts are 20 and 20, with 0 affected in each category and 0 deaths. No top serious adverse event terms are listed.

These entries mean that the registry record reports zero affected participants in the listed adverse-event categories for the stated risk counts. They do not show that adverse events were impossible, nor do they establish that every participant was assessed in the same way or over the same duration. The record does not provide event definitions, surveillance procedures, severity details beyond the serious-versus-other categories, or additional narrative safety information.

The risk counts are not necessarily the same as the number enrolled in each condition or the number analyzed for the primary endpoint. They should be read as the denominators associated with the safety entries, not as outcome-analysis sample sizes. The listed figures describe what the registry reports; they do not replace a fuller assessment of safety data or provide a comparison of risk between conditions.

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

The registry describes a randomized comparison of three study environments and specifies an algorithm-based measure of on-task time. It also gives the timing of the endpoint measurements and states that some participants were excluded from this measure because session data were insufficient or faulty. These details help define the question the trial set out to examine. They do not, by themselves, answer whether concentration differed across conditions or changed over time.

The result does not establish that virtual reality improves concentration, that it has no effect, or that feedback changes concentration. Numerical primary-outcome estimates and statistical tests are not reported in the registry record. There are also no reported outcome values for the secondary measures or for participant enjoyment and preference. The completed status and randomized design cannot substitute for those results.

Even if an estimate were available, its statistical interpretation would require attention to its uncertainty, the analysis population, missing session data, repeated observations, and the comparisons examined. Practical meaning would also depend on what change in the algorithmic percentage represents in real study behavior and how participants experienced the environment. The record does not define a threshold for a meaningful difference or report evidence linking the algorithm’s score to a broader outcome.

The findings described in the record are specific to the study conditions and the measurement approach: an immersive cabin-like virtual setting, a headset passthrough condition, and an immersive setting with focus feedback, assessed using keyboard and mouse activity during homework and study tasks. The record does not establish whether these results apply to other settings, populations, devices, tasks, or forms of support. No medical advice or treatment recommendation follows from the available information.

13. Why This Trial Matters Statistically

This trial raises a useful statistical measurement question: whether keyboard and mouse activity can provide a quantitative account of on-task behavior during study sessions in different environments. The registry’s description separates a pre-headset baseline average from an average during headset use. It also distinguishes the immersive environment from direct laptop viewing and from the version described as including focus feedback. These features make the endpoint and the intervention conditions explicit enough to identify what comparisons would matter.

The design also illustrates why randomized assignment alone does not settle interpretation. The endpoint draws on repeated sessions, and some sessions or participants could be excluded when data were faulty or incomplete. The final analysis therefore depends on how repeated observations were summarized, how missing information was handled, and who was included. Those details are not reported in the registry record, and the primary numerical results are also absent.

For researchers, the distinction between a study’s measurement schedule and its administrative schedule is important. The registry identifies sessions 1-2 and sessions 3-12 as endpoint periods, while the sessions 1-7 and 8-12 divisions relate to compensation or motivation. Keeping those purposes distinct prevents a mistaken reading of the measurement design.

The record also shows why results reporting is essential. Without estimates and uncertainty, readers cannot judge the size, direction, or precision of the primary outcome, and cannot compare the three conditions statistically. The trial’s question is clear, but its quantitative answer is not reported in the registry record.

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 limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. It gives no condition-specific means or standard deviations, no changes across the two measurement periods, and no contrasts or uncertainty intervals. The record lists no analyses. This prevents assessment of effect size, precision, and statistical evidence.

The description of the Virtual Reality + Feedback condition is incomplete. It says the program tracks keyboard and mouse click data to assess focus, but does not explain what feedback participants received or how it was delivered. The registry also does not report the detailed operation or validation of the Objective On-Task Assessment algorithm. These omissions constrain interpretation of both the intervention and the endpoint.

For this measure, participants with insufficient session completion or faulty sessions could be excluded, and the number analyzed was lower than for other outcome measures. Exact analysis counts and exclusion patterns by condition are not reported. Without those details, it is not possible to assess whether endpoint availability differed across conditions or how exclusions affected the comparison.

The record does not report the randomization procedure, group allocation counts, baseline characteristics, detailed analysis model, handling of repeated sessions, missing-data methods, or multiplicity plan. Although the trial is listed as randomized and open-label, the absence of these details limits assessment of bias and statistical validity. Participant reports, enjoyment, and preference are part of the study question, but their numerical findings are not reported in the registry record. These limitations are specific to the information available in the trial record and do not establish what the full study dataset may contain.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Virtual Reality Treatment for Emerging Adults With ADHD — NCT06454604.
• Registry record last updated 2026-01-02; status last verified 2025-11.
• Results first posted 2026-01-02.
• 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

NCT06454604 is a completed randomized, open-label, parallel-group trial listed as Phase 3, with enrollment of 60. It concerns virtual reality study environments for emerging adults age 18-25 with ADHD. The three listed conditions are VR Passthrough, Virtual Reality, and Virtual Reality + Feedback. The record identifies the primary endpoint as the Objective On-Task Assessment Algorithm, a continuous measure reported as the mean percentage of time focused, based on keyboard and mouse activity.

The primary endpoint averages sessions 1-2 as baseline and sessions 3-12 as the later headset period. The registry reports that some participants were excluded from this outcome because of insufficient or faulty session data, but does not give the endpoint analysis counts. Numerical primary and secondary outcome results, statistical analyses, and detailed missing-data methods are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in each condition’s stated risk group.