Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder (NCT05778526), a randomized na study. The primary outcome is Riggio Social Skills Inventory Assessment.

2. Clinical Question

The trial’s stated aims also included developing a social VR intervention, examining social skills and selected executive-functioning outcomes, and assessing acceptability and compliance. Its hypothesis anticipated better social interaction skills in the social VR group than in the traditional training group, while the waitlist group was expected to show no change relative to the intervention groups. The posted primary comparisons, however, are against the waitlist group; they do not by themselves test the stated hypothesis as a direct VR-versus-traditional comparison.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group pilot trial with three groups: Social VR Intervention, Traditional Social Skills Training, and Waitlist Control Group. Enrollment was 90. The trial status is completed. The recorded start was 2023-02-18, and primary completion was 2024-08-31.

The intervention period is described as 3 weeks. Social VR sessions used a head-mounted display and lasted a maximum of 20 minutes per session. Traditional training was led by an experienced SEN teacher and used instruction and role-play activities. The waitlist group received no training during the intervention period and could participate in social VR training afterwards. The registry description also states that waitlist participants were not allowed to initiate or change pharmacological treatment during the 3-week intervention.

At the primary outcome assessment, the registry reports data from participants who completed assessments, including waitlist participants who did not receive the intervention during that period. It describes 30 participants in each group. The primary assessment was scheduled for 3 weeks post-intervention. The registry does not report which people were masked, how the random sequence was generated or concealed, or how adherence to the masking procedures was assessed.

The trial is identified as a pilot randomized controlled trial. A pilot can provide information about intervention delivery and outcome patterns, but estimates from a pilot may be imprecise and should not automatically be treated as stable estimates for a larger study. The registry record does not report the trial’s original sample-size justification or the detailed statistical analysis plan, so those design choices cannot be evaluated from the 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data were collected from all participants who completed the assessments, including those from the waitlist control group who did not receive the intervention. This resulted in an analysis population of 30 participants in each group: 30 in the Social VR Intervention group, 30 in the Traditional Social Skills Training group, and 30 in the Waitlist Control group.

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: (1) aged between 6 and 12 years; (2) Chinese ethnicity; (3) residing in Hong Kong; (4) having received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private practice; (5) stable on pharmacological and psychological treatment for ADHD 8 weeks before baseline; (6) no initiation or change of pharmacological treatment for ADHD during the intervention period; (7) ability to read Chinese and speak and listen to Cantonese by the child.

6. Primary Endpoint

The registry lists the primary outcome as Riggio Social Skills Inventory Assessment, measured over 3 weeks post-intervention.

The primary outcome was the Riggio Social Skills Inventory Assessment at 3 weeks post-intervention. It is a continuous score intended to measure social interaction skills. The inventory has 10 items, each scored from 1 (Never) to 4 (Always), and the item scores are summed. The total score ranges from 10 to 40; higher scores indicate better social interaction skills. The inventory includes subscales addressing verbal and non-verbal communication.

A continuous score preserves gradations in the measured skill rather than reducing participants to a binary category. The registry reports group means and standard deviations, allowing the average score and variation within each group to be described. The mean difference between a training group and waitlist gives the estimated separation in average scores on the inventory’s own scale. This makes the result interpretable in score units, while still requiring caution about how meaningful a score difference is in everyday functioning.

The registry’s outcome description explains that the initial protocol focused on feasibility, including attendance and compliance, while the final pilot trial designated blinded clinical assessment of social skills as the primary outcome to address the intervention’s therapeutic objective. The reason for this realignment is described in the record; further details about when or how the change was made are not reported there.

7. Results Posted in the Registry

• Social VR Intervention: mean 38.20 versus 24.50 on control; difference 13.70 (95% CI 11.59 to 15.81), standardized effect d = 3.29; z-test p = <0.001.
• Traditional Social Skills Training: mean 30.63 versus 24.50 on control; difference 6.13 (95% CI 3.14 to 9.12), standardized effect d = 1.04; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Behaviour Rating Inventory of Executive Function

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Social VR Intervention: mean 16.83 versus 19.63 on control; difference -2.80 (95% CI -4.87 to -0.73), standardized effect d = -0.68; z-test p = 0.008.
  • Traditional Social Skills Training: mean 17.98 versus 19.63 on control; difference -1.65 (95% CI -3.65 to 0.35), standardized effect d = -0.42; z-test p = 0.106.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Social VR Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Traditional Social Skills Training and the control. The interval gives the range of effects that remain compatible with the data.

Satisfaction of the Intervention

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Traditional Social Skills Training: mean 6.70 versus 6.80 on control; difference -0.10 (95% CI -0.94 to 0.74), standardized effect d = -0.06; z-test p = 0.815.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Traditional Social Skills Training and the control. The interval gives the range of effects that remain compatible with the data.

The secondary results present a mixed pattern rather than a uniform separation across all measured domains. For the Behaviour Rating Inventory of Executive Function, the social VR comparison with waitlist has an interval that excludes zero, while the traditional-training comparison has an interval that includes zero. The satisfaction comparison between the two active groups also has an interval that includes zero. These observations complement the primary social-skills result but do not independently establish a broad effect across all secondary domains.

The secondary outcomes address different questions from the primary endpoint. Executive-function ratings concern a separate construct, while satisfaction concerns participants’ appraisal of an intervention. Neither is interchangeable with the Riggio measure of social interaction skills. The satisfaction comparison also uses social VR as its reference group rather than waitlist, so its contrast is not directly aligned with the primary comparisons.

The registry names acceptability and compliance, Behaviour Rating Inventory of Executive Function, satisfaction, and simulator sickness among secondary outcomes. Detailed results for acceptability and compliance and simulator sickness are not reported in the registry record. The available secondary results therefore give only a partial account of the stated secondary aims.

Unadjusted secondary results carry less weight because several outcomes or comparisons can create more opportunities for chance findings, especially when no multiplicity strategy is reported. The record does not report adjustment for multiple testing or a full analysis plan. Secondary results are best treated as descriptive or hypothesis-generating evidence alongside the primary outcome, rather than as independent confirmation of the primary pattern. Their interpretation also depends on the scales’ scoring and on methods that are not fully described in the registry.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Acceptability and Compliance
• Behaviour Rating Inventory of Executive Function
• Satisfaction of the Intervention
• Simulator Sickness Questionnaire

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so the registry reports a mean and standard deviation for each group. The mean describes the group’s average score; the standard deviation describes the spread of individual scores around that average. The means retain the Riggio inventory’s original score units. The standard deviations are not confidence intervals: they describe variation among scores, whereas a confidence interval expresses uncertainty about an estimated group difference.

What does a mean difference describe?

For each primary comparison, the posted mean difference contrasts an intervention group with the waitlist group. A positive difference means the intervention group’s average score is higher, consistent with the inventory’s scoring direction. The Social VR comparison is reported as 13.7 points, and the traditional-training comparison as 6.13 points. These are unadjusted differences based on the posted group summaries. They should not be interpreted as adjusted effects from a model, because an adjusted model is not reported in the registry record.

The posted uncertainty intervals accompany those mean differences. In general, a confidence interval gives a range of values compatible with the data and the calculation method, expressing how precisely an effect has been estimated. An interval that does not include zero is consistent with a nonzero mean difference under that method. It does not prove that the difference is important to participants, and it does not remove concerns about bias, selection, measurement, or missing information.

How should the p-values be read?

The primary comparisons have unadjusted p < 0.001. A p-value describes how unusual data at least as discordant with a no-difference model would be, if that model and the statistical assumptions held. It is not the probability that the no-difference model is true, and it is not a measure of effect size. Here, the p-values are unadjusted: no correction for multiple outcomes or comparisons is reported. The registry record does not describe the original analysis procedure used by the investigators, and it lists no reported analyses. The comparisons shown are simple unadjusted re-calculations from the posted summary statistics; the discrepancy indicator is false.

General statistical context: when several outcomes and contrasts are examined, the chance of obtaining one or more small p-values by chance can increase. Adjustment procedures can address that issue, but the choice depends on which outcomes and comparisons were planned and how they relate. Those details and any multiplicity strategy are not reported in the registry record, so the posted p-values should not be treated as multiplicity-adjusted.

What does the standard deviation contribute?

The group standard deviations show that scores were not identical within groups. For the primary outcome, the recorded standard deviations were 2.83 for social VR, 6.57 for traditional training, and 5.17 for waitlist. General statistical context: variability affects how precisely a group mean and a between-group difference can be estimated. The same mean difference can be estimated with different precision depending on the spread of scores and the amount of data. These summaries do not reveal the shape of the score distributions or whether unusual observations influenced the means.

The comparison details also report pooled standard deviations and standardized effect sizes. A pooled standard deviation combines the within-group spread into a common scale for a standardized comparison, while a standardized effect expresses a mean difference relative to that spread. Such a standardized measure can aid comparisons across outcomes with different units, but it is less directly interpretable than the difference in Riggio score points. The posted standardized values are descriptive calculations, not a separate clinical threshold.

What is not established by the reported methods?

The registry reports randomized allocation and double masking, but it does not identify who was masked, describe the allocation sequence or concealment, or explain how outcomes were analyzed beyond the posted summary comparisons. It also does not report covariate adjustment, a missing-data method, an intention-to-treat analysis, or a per-protocol analysis. The absence of these details means readers cannot assess whether the displayed comparisons match a prespecified analysis plan or how they would change under alternative analytic choices.

General statistical context: randomization is intended to make groups comparable on average at baseline, but it does not guarantee that all measured or unmeasured characteristics are balanced in a pilot trial. Masking can reduce some opportunities for expectations to influence assessment or reporting, but the record’s label alone does not show how masking worked in practice. These design features inform interpretation; they do not eliminate the need to inspect reporting and analysis methods.

11. Confidence Intervals and Precision

The primary mean difference for social VR versus waitlist is 13.7 points, with a confidence interval from 11.59 to 15.81. For traditional training versus waitlist, the mean difference is 6.13 points, with a confidence interval from 3.138 to 9.122. Both intervals are entirely above zero. This indicates that the posted unadjusted estimates are positive and that their calculated intervals do not include no average difference.

Precision is about the range of values still compatible with the data under the interval calculation. A narrower interval conveys more precise estimation than a wider interval, all else equal. The two primary intervals have different widths, and they should be considered alongside the group standard deviations and the pilot context. The interval is not a guarantee that the true effect lies within its endpoints, nor does it capture uncertainty from possible bias, outcome selection, incomplete reporting, or generalizability.

The score scale ranges from 10 to 40, and the social VR mean is 38.2. Because the observed mean is near the scale maximum, interpretation should also consider that the measure has limited upward range at that level. The registry does not report whether score distributions were concentrated near the maximum, so the scale limit alone cannot determine whether estimated differences or precision were affected.

These intervals concern the two intervention-versus-waitlist comparisons. They do not provide an interval for a direct social VR-versus-traditional training contrast. That direct comparison is not reported in the registry record, and it should not be inferred by comparing the two separate confidence intervals. A formal contrast would require its own estimate and uncertainty calculation.

The registry record does not specify the confidence level or the investigators’ original inferential procedure. The intervals accompanying the posted summary-statistic comparisons therefore communicate precision for those calculations, not necessarily the full uncertainty under an unreported prespecified analysis.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. The calculation uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It illustrates sample sizes for detecting a stated fraction of the observed effect. Time-to-event planning figures, when present, would instead be total events; the outcomes in this trial are continuous, so the displayed planning figures are per arm.

The 80% power column means the illustrated number of participants per arm for an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions were correct. The 90% column represents a higher target chance of detection, which generally requires more participants per arm. These are planning calculations, not observed power for this completed pilot.

The rows scale the effect to be detected: 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. Smaller effects need more participants to detect with the same power, so the required counts rise as the assumed fraction falls. The observed effects in a pilot may be unstable, and these illustrations do not establish a suitable sample size for a future study. The registry record does not report the trial’s own original sample-size assumptions or justification.

The planning display and curve should be read as an illustration of how required sample size changes with the effect assumed for planning. The results depend on the specified calculation assumptions and are not guarantees of a future study’s achieved power or precision. For the comparisons where planning values are listed, the group contrast and assumed effect should be kept in view when interpreting those per-arm figures.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 13.700; pooled standard deviation σ = 4.168.
2. n = 2 × (1.96 + 0.842)² × 4.168² / 13.700² = 1.5, rounded up to 2 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 13.7                      # observed difference in means
sigma <- 4.16760122852463                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5778526)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2 (80% power), 2 (90% power)
 75% of observed effect: n per arm = 3 (80% power), 4 (90% power)
 50% of observed effect: n per arm = 6 (80% power), 8 (90% power)
power.t.test: 2.8 
Simulated power at n = 2 per arm: 0.439 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record identifies one primary outcome and several secondary outcomes, with comparisons across treatment groups. Multiple outcomes and contrasts raise a multiplicity question: if many statistical tests are considered, isolated small p-values can arise by chance even when there are no corresponding effects. The registry record does not report a correction procedure, a hierarchy among secondary outcomes, or a family of hypotheses defined for multiplicity control. The posted p-values are unadjusted, so they should not be read as controlling the overall false-positive risk across all outcomes.

The outcome description states that the initial protocol focused on feasibility, including attendance and compliance, and that the final pilot RCT refined the primary focus to clinical efficacy, using a blinded clinical assessment of social skills. This is an important change in emphasis. The record does not report when the change was made, whether it was made before outcome data were examined, or how the change related to a prespecified statistical analysis plan. Without those details, readers cannot fully assess the potential for outcome-selection effects.

The primary analysis population is described as participants who completed assessments, including waitlist participants who did not receive intervention during the intervention period. The record gives 30 participants in each group. It does not report how many participants were randomized to each group separately from the assessment population, whether all randomized participants contributed data, or how missing outcome values were handled. The number or reasons for missing assessments and any imputation or sensitivity analyses are not reported in the registry record.

The registry also does not report whether the primary comparison followed an intention-to-treat principle, whether analyses excluded participants for protocol deviations, or whether an adjusted model was planned. These omissions do not prove that the study had missing data or analysis problems; they limit the ability to evaluate how robust the posted estimates are to those possibilities. The reported completer-based population should therefore be distinguished from an assumption that all randomized participants were included in an analysis.

15. 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 reports zero serious adverse events in the Social VR Intervention group, zero in the Traditional Social Skills Training group, and zero in the Waitlist Control Group. The number at risk for serious adverse events is reported as 30 in each group. Deaths are also recorded as zero in each group. The registry lists no serious adverse-event terms.

These figures mean that no serious adverse events were recorded in the posted safety results for the groups and population described. They do not establish that no adverse effects of any kind occurred, because the record’s serious-event counts do not describe all possible symptoms or experiences. Simulator sickness is named as a secondary outcome, but its results are not reported in the registry record.

Zero recorded events in a pilot does not demonstrate that an event cannot occur or precisely quantify the risk of uncommon harms. The duration of observation and details of event collection are not reported in the registry record. Safety interpretation should therefore remain limited to the recorded counts, rather than extending them to a broader conclusion about safety.

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

The primary posted results show higher average Riggio Social Skills Inventory scores in each intervention group than in the waitlist group at 3 weeks post-intervention. The positive mean differences and intervals above zero describe a clear separation in this pilot’s observed group summaries. Higher scores represent better social interaction skills on the inventory, so the direction of those differences corresponds to higher assessed skills in the intervention groups at that time point.

The result does not establish that social VR is superior to traditional social skills training. The registry does not report a direct comparison between those active groups, and the separate comparisons against waitlist cannot substitute for that contrast. It also does not establish that a score difference is meaningful in daily life, that it persists beyond the recorded assessment, or that results would apply to children outside the study population and setting.

The trial was registered as a pilot. A pilot result can be informative about whether a signal merits further evaluation, but estimates can be less stable than those from a larger confirmatory study. The scale’s upper bound is also relevant: the social VR group mean was 38.2 on a scale ranging from 10 to 40. This does not invalidate the comparison, but it limits the room for higher scores and warrants attention to score distributions in future evaluation.

The available information does not settle questions about missing data, multiplicity, masking implementation, or the investigators’ full analysis plan. Nor do the secondary results establish a consistent change across all assessed constructs. The defensible conclusion is narrow: the posted completer-assessment summaries show higher mean social-skills scores in both intervention groups than in waitlist at the specified assessment, with unadjusted comparisons and the limitations of a pilot registry record.

17. Why This Trial Matters Statistically

This trial raises several statistical issues that are common in behavioral intervention research. Its outcome is a continuous scale score, so the mean difference is directly expressed in the inventory’s units. That provides an understandable contrast, but interpretation still depends on knowing the scale’s range, direction, and measurement properties. Here, the scale direction and limits are described, allowing readers to distinguish higher scores from lower scores and to recognize the proximity of the social VR mean to the upper bound.

The three-arm design includes two active training approaches and a waitlist. The primary posted comparisons place each active group against waitlist, while the study hypothesis also concerns social VR relative to traditional training. This distinction matters: evidence that each group differs from a common comparator does not answer whether the active approaches differ from one another. The contrast must match the research question.

The record also illustrates why pilot results should be interpreted with attention to precision, planning, and analysis transparency. Planning numbers based on observed effects are illustrations, not evidence that a pilot had adequate power or that the observed effects will recur. The shift from a feasibility focus to a clinical-efficacy primary outcome makes transparent outcome selection and timing especially relevant. The registry does not provide enough detail to resolve those questions.

Finally, secondary outcomes broaden the assessment beyond social skills, but interpreting several outcomes requires care about multiplicity and completeness of reporting. The record names additional domains, while detailed results are not available for every named outcome. Distinguishing the primary finding from secondary, unadjusted, and unreported results helps prevent a limited set of pilot summaries from being treated as a comprehensive evaluation.

18. 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 registry does not provide a full account of the randomization procedure, allocation concealment, or which people were masked. Although the trial is labeled randomized and double-masked, the record does not explain how those procedures were implemented. This limits assessment of potential selection and measurement biases.

The primary population is described as assessment completers, and the record does not detail missing assessments, their reasons, or methods for handling missing data. It also does not report whether analyses followed intention-to-treat or another population definition. The group summaries therefore cannot be assumed to represent all randomized participants without additional information.

The primary outcome was realigned from a feasibility emphasis in the initial protocol to a clinical social-skills outcome in the final pilot RCT. The record does not state when that decision occurred relative to data collection or analysis. It also does not report a complete statistical analysis plan, multiplicity adjustment, or adjusted comparisons. These omissions limit evaluation of selective outcome emphasis and the inferential status of unadjusted results.

The posted primary comparisons are against waitlist, not direct comparisons between the two active interventions. The measurement was conducted at 3 weeks post-intervention, and longer-term outcome results are not reported in the registry record. The social VR group’s mean is near the top of the stated score range, but distributional information and an assessment of scale ceiling effects are not reported. Detailed results for some named secondary outcomes, including acceptability and compliance and simulator sickness, are also not reported. As a pilot, the trial provides limited evidence about how precisely these estimates would reproduce in another study.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder — NCT05778526.
• Registry record last updated 2026-08-25; status last verified 2024-06.
• Results first posted 2025-03-28.
• 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.

22. Record Summary

The registry describes a completed, randomized, double-masked, parallel, three-arm pilot trial of social VR and traditional social skills training versus a waitlist group in children with ADHD. Enrollment was 90, with 30 assessment completers reported in each group for the primary outcome.

The primary endpoint was the Riggio Social Skills Inventory Assessment at 3 weeks post-intervention. The posted mean differences versus waitlist were 13.7 points for social VR and 6.13 points for traditional training; both unadjusted p-values were < 0.001. The record does not report a direct comparison between the active interventions.

Interpretation is limited by unreported details about the analysis plan, multiplicity, missing data, masking procedures, and some secondary outcomes. The results describe this pilot’s posted assessment summaries and should not be treated as a definitive estimate of effectiveness or of longer-term outcomes.