Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD (NCT06301516), a randomized phase 1 study. The primary outcome is Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits).

2. Clinical Question

This is a question about a behavioral intervention and a continuous questionnaire score, not a reported estimate of treatment effect. The registry describes the ICU as a 24-item measure covering traits such as lack of empathy, uncaring behavior, and restricted emotions. Items are rated on a 4-point Likert scale, with scores formed by summing the items; higher scores indicate greater callous-unemotional traits. The registry states that a reduction indicates improvement. These definitions clarify the intended direction of the measure, but they do not reveal whether either group’s scores changed.

The registry’s brief summary refers to a sample of 60 youth, whereas its enrollment field states 220 and its primary outcome description gives 110 youth and 110 caregivers. Those descriptions are not consistent. The record does not explain the difference, so the basis for the stated target or actual enrollment cannot be resolved from the registry entry alone.

3. Trial Design

The study is registered as Phase 1, randomized, and parallel-group, with no masking. The registry reports an enrollment of 220 and a completed status. The recorded start date is 2024-02-16, and the primary completion date is 2024-09-26. These administrative details describe the registered study, but they do not provide an outcome estimate.

The two intervention descriptions distinguish Impact VR from a comparative control. Impact VR consists of four sessions, each 20 minutes, delivered weekly over 4 weeks. The locations may include the lab, participant’s home, school, or a mutually agreed private meeting place. The control is a one-time presentation about emotion expressions and recognizing emotions. The registry does not report whether the groups were matched for time, attention, or other aspects of contact, and it does not describe adherence or fidelity measures.

The primary outcome population description lists 55 youth in each arm and 55 caregivers in each arm. It therefore describes assessments from youth and caregivers as separate respondent groups. The registry does not explain whether caregiver responses were paired with particular youth records for analysis, or how any such pairing would be handled statistically. The enrollment total and the more detailed population counts are also difficult to reconcile with the brief summary’s reference to 60 youth; the registry record does not explain this discrepancy.

Random allocation can, in general, support comparisons by reducing systematic differences between groups at assignment, but the record does not state the randomization method, allocation concealment procedures, or any stratification factors. With no masking, participants and study personnel were not masked according to the registry entry. The record does not describe whether outcome assessors or analysts were masked. It also does not report the planned statistical model, covariate adjustments, analysis population, or rules for handling repeated measurements. These omissions limit interpretation of the design beyond the basic randomized, parallel-group structure.

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

Analysis population for the primary outcome, as defined in the registry: For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.

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: Only the youth participant demographic data was collected and will be reported as an aggregate. The youth participant cohort was 110 total (55 in the Experimental youth arm and 55 in the control youth arm). The caregiver arms are not included in the demographic data.

6. Primary Endpoint

The registry lists the primary outcome as Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits), measured over Baseline, 1-month and 3-months post-randomization.

The primary outcome is callous-unemotional traits assessed using the Inventory of Callous-Unemotional Traits (ICU) questionnaire. The registry describes the ICU as a 24-item measure covering lack of empathy, uncaring behavior, and restricted emotions in youth. Each item uses a 4-point Likert scale ranging from 0, “not at all true,” to 3, “definitely true.” The item ratings are summed, and higher scores indicate greater callous-unemotional traits. The registry states that a reduction in score indicates improvement.

The outcome description says both youth and caregiver subjects were assessed. It gives the timeframe as baseline, 1-month and 3-months post-randomization. These are repeated assessments of a continuous score, rather than a single event outcome. The registry specifies the mean as the outcome measure and standard deviation as the dispersion measure. Those summaries describe the score distribution but do not, by themselves, show how groups differ or how uncertainty around a comparison should be evaluated.

The measure is relevant to the stated question because it operationalizes the traits the intervention is intended to address. Interpretation still depends on the observed scores, the planned group comparison, and the treatment of repeated observations and respondent type. The registry record does not report score values, changes from baseline, between-group estimates, confidence intervals, or analysis details. It therefore does not show the size or precision of any effect on this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Outcome type and summary. The primary outcome is a continuous score, and the registry identifies the mean as the summary measure and the standard deviation as the dispersion measure. In general, a mean describes the center of a set of scores, while a standard deviation describes how spread out individual scores are around that center. These summaries can help characterize each group, but they do not supply a treatment comparison unless the group contrast and its uncertainty are also reported. No ICU means or standard deviations are listed in the registry record.

What would a group comparison represent?

In general, a randomized trial may compare outcome scores between assigned groups at a follow-up time, compare changes from baseline, or model scores across all scheduled times. Each approach targets a different statistical question. A follow-up comparison concerns the groups’ scores at that assessment; a change comparison concerns how scores moved from baseline; a repeated-measures model can use the pattern across assessments. The registry record does not specify which approach was planned, how baseline scores would be used, or whether a single follow-up time would be primary for analysis.

Because both youth and caregivers were assessed, the analysis also needs to define the respondent-level unit of analysis. In general, measurements from the same person over time are correlated rather than independent, and youth and caregiver responses may be linked within a family or participant pair. Statistical methods can account for such dependencies, but the record does not report whether responses were paired, whether they were modeled separately, or whether any dependence structure was planned.

Why do repeated measurements matter?

Repeated observations from the same participant are related. In general, treating them as if they came from unrelated people can misrepresent uncertainty. A repeated-measures approach can model within-person correlation and use information across multiple visits, but its validity depends on the model and assumptions. The registry lists baseline, 1-month and 3-months post-randomization assessments, but does not describe a repeated-measures model, covariance structure, or time-by-group comparison. It is therefore not possible to determine how the multiple time points were intended to contribute to the primary analysis.

In general, a confidence interval gives a range of values compatible with an estimate under the analysis assumptions and conveys precision. A p-value addresses compatibility with a specified null hypothesis under those assumptions, but does not measure the size or practical importance of an effect. Neither confidence intervals nor p-values for the primary outcome are reported in the registry record. No effect estimate is available to interpret.

What can be said about sample-size planning?

The registry’s sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such illustrations are planning scenarios, not observed power and not evidence that the trial was designed around those assumptions. The registry does not report the original sample-size justification or the trial’s own power calculation. Since no primary outcome effect is reported, the record does not provide a result to assess against a planning target.

In general, power calculations depend on the target effect, variability, significance criterion, allocation, and analysis method. A sample-size illustration cannot establish that an analysis had a particular probability of detecting a true effect after the trial has been conducted. Nor can it substitute for the observed estimate and its uncertainty. The registry’s stated planning assumptions should therefore be understood as illustrative rather than as a retrospective measure of study success.

How should randomization and masking be understood?

Random allocation is intended, in general, to make treatment assignment independent of participants’ baseline characteristics on average. It does not guarantee identical groups in a particular trial. The registry states that allocation was randomized, but does not report the sequence-generation method, concealment procedures, or stratification factors. The record lists masking as none. Lack of masking can matter for a self-reported or caregiver-reported questionnaire because expectations or awareness may influence responses; this is a general measurement consideration, not evidence that bias occurred in this study. The registry does not state whether staff scoring or analyzing outcomes were masked.

The primary outcome is presented as a mean continuous measure, but the registry does not state whether assumptions were checked, whether robust methods were planned, or how unusual score distributions would be handled. In general, over-dispersion means observed variability exceeds what a statistical model assumes; addressing it can be important for appropriate uncertainty estimates. This concept is not a reported feature of the ICU data, and the record gives no distributional diagnostics with which to assess it.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome has multiple assessment times and includes both youth and caregiver subjects. The registry record does not specify how multiplicity across time points, respondent groups, or possible comparisons was to be controlled. In general, testing several outcomes or contrasts can increase the chance of a statistically notable result arising by chance; a prespecified primary contrast or an adjustment procedure can help define how results should be interpreted. No such procedure is reported for this study. The record’s note that the outcome was not reduced to one comparison means there is no single primary contrast presented for interpretation.

Missing data are important for repeated assessments because some participants may not contribute observations at every time. The registry does not report the number of completed ICU assessments at each time point, reasons for missingness, or an approach to missing outcome data. It does not state whether the analysis would use complete cases, imputation, likelihood-based methods, or sensitivity analyses. In general, the consequences of missingness depend on why observations are absent and on the assumptions of the analysis; the record does not provide information to assess those assumptions.

The registry also does not report the analysis population, such as whether participants would be analyzed according to randomized assignment or according to intervention received. Although the primary outcome description gives group enrollment counts, it does not establish how many participants were analyzed or whether all randomized participants were included. There are no listed statistical analysis records. These absences do not establish what analyses may have been conducted outside the registry; they mean the registry entry does not document them.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The adverse-event record lists four groups: Experimental Youth, Experimental Caregiver, Comparative Control Youth, and Comparative Control Caregiver. Each group lists 55 participants at risk for serious adverse events and 55 at risk for other adverse events. Each group reports 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse-event terms are listed.

These figures describe what is recorded in the registry for the listed groups. They should not be read as proof that no adverse events occurred in any setting or that the interventions have no risks. The record does not provide event definitions, collection procedures, monitoring duration, severity information beyond the listed categories, or an explanation of whether events were independently reviewed. It also does not report a separate account of withdrawals or the completeness of safety follow-up.

In general, zero reported events means that none were entered in the specified registry categories for the listed participants; it does not establish that the underlying risk is zero. The caregiver groups are included in the adverse-event listings as separate groups, and the registry does not clarify how safety monitoring differed between youth and caregivers. The numbers should therefore be interpreted as registry-reported counts, not as a comprehensive assessment of safety.

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

The registry record establishes that Impact VR was studied in a randomized, parallel-group design against a comparative control and that the primary outcome concerned callous-unemotional traits measured with the ICU questionnaire. It describes the intervention schedule, the control presentation, the assessment times, and the intended direction of score change. These details make the research question understandable.

The record does not establish whether Impact VR reduced ICU scores, whether the groups differed, or whether any observed difference was precise or uncertain. No outcome values, effect estimates, confidence intervals, p-values, or statistical analyses are listed. A completed study status is not itself a result. Similarly, enrollment and intervention descriptions do not show whether participants completed the sessions or assessments.

The registry’s population counts and brief summary are not consistent: the enrollment field states 220, the primary outcome description describes 110 youth and 110 caregivers, and the brief summary refers to 60 youth. The registry does not explain these figures. This limits certainty about how the stated sample description relates to the study’s enrollment and analyses.

In general, an intervention comparison should be interpreted using the estimated between-group effect, its uncertainty, the analysis population, and the methods used to account for repeated measurements and missing data. None of those primary outcome results or analysis details are reported in this registry entry. Accordingly, no conclusion about efficacy or lack of efficacy can be drawn from the record alone. The safety counts indicate zero reported events in the listed categories, but they also do not establish the absence of risk.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are especially relevant to behavioral studies with repeated questionnaire outcomes. The ICU is assessed at baseline and at two post-randomization time points, so the analysis needs to distinguish a single follow-up contrast from a pattern of change over time. Those choices affect both the question answered and the uncertainty attached to the result. The registry does not document the intended model or contrast, making the outcome question clear but its statistical target unspecified.

The inclusion of youth and caregiver responses adds another dimension. In general, different respondents can offer distinct perspectives, and repeated reports may have dependencies that need to be considered. A sound interpretation benefits from knowing whether respondent types were analyzed separately or jointly and how potentially linked observations were handled. The registry does not report these decisions or any respondent-specific results.

The mismatch between the brief summary’s reference to 60 youth, the enrollment figure of 220, and the detailed description of 110 youth and 110 caregivers also matters for statistical interpretation. Enrollment counts are not the same as analysis counts, and the registry does not reconcile the different descriptions or report how many outcome observations were available. This makes it difficult to understand the population underlying any prospective interpretation of the study design.

Finally, the registry identifies no outcome analyses. Without results and analytic details, readers cannot assess the estimated effect, precision, missing-data assumptions, or multiplicity handling. These are not minor reporting details: they determine what comparisons can be interpreted and how much confidence to place in them. The record is informative about the study’s broad design and endpoint, while leaving the central statistical result undocumented.

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 most consequential limitation for interpreting the primary outcome is the absence of posted score summaries and treatment comparisons. The registry does not report means, standard deviations, change scores, effect estimates, confidence intervals, or p-values. It also lists no statistical analyses. Thus the study’s stated endpoint cannot be evaluated for direction, magnitude, or precision from this record.

The outcome is assessed at baseline, 1-month and 3-months post-randomization, but no single comparison is identified in the registry entry. It does not say whether the intended inference was tied to one follow-up time, change from baseline, or an overall repeated-measures trajectory. No multiplicity approach is described for the several time points or for assessments reported by both youth and caregivers.

The record does not explain how youth and caregiver responses were related analytically, whether the same respondents contributed at every time, or whether the data were paired. It also does not report missing-data amounts or methods. The enrollment descriptions are inconsistent: the brief summary refers to 60 youth, while the enrollment field states 220 and the outcome population describes 110 youth and 110 caregivers. The registry does not reconcile those figures.

Additional design information is limited. The randomization procedure and allocation concealment are not reported; masking is listed as none, and the record does not say whether outcome assessors or analysts were masked. The statistical plan, analysis population, sample-size justification, adherence information, and intervention-fidelity results are not reported in the registry record. These limitations concern what can be learned from the entry; they do not establish that the information was unavailable to the investigators.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD — NCT06301516.
• Registry record last updated 2026-06-17; status last verified 2026-06.
• Results first posted 2026-06-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The record describes NCT06301516, a completed Phase 1 randomized, parallel-group study with no masking. It compares Impact VR, delivered as four 20-minute sessions over 4 weeks, with a one-time presentation about recognizing emotions. The primary outcome is the mean ICU questionnaire score, assessed at baseline, 1-month and 3-months post-randomization in youth and caregivers.

The registry states an enrollment of 220 and describes 110 youth and 110 caregivers in the outcome population, while its brief summary refers to 60 youth. It does not explain the difference. The record lists zero serious adverse events, zero other adverse events, and zero deaths in each of four groups of 55 at risk. No primary outcome values or statistical analyses are reported, so the comparative result remains undocumented in the registry record.