Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study (NCT02713425), a na na study. The primary outcome is Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session.

2. Clinical Question

The study’s stated aim was to test the feasibility and effectiveness of using an entertaining video game as an addition to traditional therapy for anxiety disorders in youth, particularly youth who may have limited access to mental health treatment in a traditional clinical setting. That aim is broader than the evidence that can be evaluated from the registry information. The described visit evaluates children’s interactions with the game and their reported experience; the record does not describe a comparison with traditional therapy alone or report a clinical effectiveness estimate.

The primary question is therefore best read as a within-session measurement question: how did reported distress change from baseline to the end of the session among children assessed in this single-group study? Without the numerical outcome, its uncertainty, and details of the analysis, the direction and size of any change cannot be assessed from the registry record.

3. Trial Design

This completed study is registered as a single-group feasibility study of an entertaining video game for pediatric anxiety. The registry reports enrollment of 20 and identifies Mayo Clinic as the sponsor. The study started on 2016-10-01, had primary completion on 2017-06-15, and is listed as completed. Its phase and allocation are recorded as NA, and masking is recorded as none.

The arm description outlines a single visit. Children were introduced to the game, interacted with it, and were asked about their experience afterward. The description also says the child could perform a real-life exposure and that the interviewer would ask about the child’s experience; parents were to observe and provide feedback. The game interaction could last up to 30 minutes. These details describe the planned or registered visit procedure, not evidence that every step was completed in the same way for every participant.

Because there is only one group, the design does not provide a concurrent untreated or alternative-treatment group. It is not a randomized comparison, and the registry record itself flags that the arms are not a like-for-like control comparison. Changes in a measure from baseline to the end of the session can be described within the group if results are reported, but such a change alone cannot distinguish an intervention effect from other explanations, such as the passage of time, measurement context, or the experience of the visit.

The registry lists a primary outcome and a secondary outcome concerning the average child rating of preferring the game to not having the game. It records two outcome measures and zero analyses. Numerical outcome results and analysis details are not reported in the registry record. The registry also does not report a protocol-based sample-size justification, an interim-analysis plan, or a detailed statistical analysis plan.

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

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: We had a total of 20 children complete the study.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session, measured over approximately 10 minutes.

The primary endpoint is mean change from baseline in the Subjective Units of Distress Scale (SUDS) at the end of the session. The registry describes SUDS as a child rating from 0 to 10, where 0 indicates no anxiety and 10 indicates maximum distress. The outcome is continuous, and the registry identifies the mean as the summary parameter and standard deviation as the dispersion measure. Its stated timeframe is approximately 10 minutes.

A repeated rating of distress can describe whether participants’ reported anxiety differs between the baseline assessment and a later assessment. Using a mean change focuses on the average within-participant difference, while the standard deviation describes how spread out individual scores are around the group mean. As a general statistical point, the mean can provide a compact summary of a continuous measure, but it does not show whether changes were similar for all participants or varied substantially.

The registry description says children interacted with the game for up to 30 minutes and then had an opportunity to perform a real-life exposure; the interviewer also asked about their experience. The relationship between that sequence and the approximately 10-minute outcome timeframe is not further specified in the registry record. The precise timing of baseline and end-of-session measurements, and the numerical mean change and its uncertainty, are not reported in the registry record.

Without those results, the endpoint definition explains what was intended to be measured but does not establish whether distress increased, decreased, or remained similar. Nor does a within-group change, by itself, establish that the game caused any change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical explanation: a continuous outcome such as a distress rating can be summarized by its mean and standard deviation. The mean describes the group’s average score or average change; the standard deviation describes how much individual observations vary around that mean. Neither summary alone conveys the full distribution. For example, a mean can mask differences in individual responses, and a standard deviation does not identify the shape of the data.

What does mean change represent?

The primary outcome is defined as mean change from baseline in SUDS at the end of the session. In general, a change score is calculated for each participant by comparing a later measurement with that participant’s baseline measurement, and the mean summarizes those individual changes. Interpreting the sign of a change requires knowing the subtraction convention. The registry names mean change but does not explicitly state the calculation convention, and it does not report an observed change estimate. Therefore no direction should be assigned to an unreported result.

A within-participant change can account for each child’s starting score when describing change over the visit. It does not, however, create a control group. A single-group before-and-after comparison cannot by itself separate intervention-related change from other influences occurring over the same period. General statistical principle: a control group supplies a concurrent reference for changes that might occur even without the intervention; random allocation can help make groups comparable on average. Neither feature is part of the registered design.

How should uncertainty be understood?

General statistical explanation: a confidence interval gives a range of values compatible with the data and the method’s assumptions. It communicates precision as well as an estimate’s direction and scale. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on different sides of a null value may leave the direction uncertain. The registry record does not report a confidence interval for the primary outcome, so precision cannot be assessed.

A p-value, when reported, evaluates how unusual data would be under a specified statistical null model and its assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The registry information does not report a primary-outcome p-value or analysis. Therefore statistical significance cannot be evaluated, and it would not in any case replace interpretation of an effect estimate and its uncertainty.

What role does the study design play?

The registry identifies a single-group model, no masking, and no randomized comparison. In general, masking can reduce the influence of knowledge about the intervention on assessment or behavior, depending on what is masked and how outcomes are measured. The record lists masking as none. It does not explain whether outcome assessors were independent of the intervention or whether ratings were collected using any additional safeguards.

For this study, participants were introduced to the game during a single visit, and the described session included interaction, a possible real-life exposure, an interview, and parent feedback. These components matter when interpreting any change because the endpoint is measured in the context of the visit. The registry does not report enough detail to determine how the endpoint’s assessment timing relates to each activity or whether procedures were identical across participants.

What do the planning assumptions mean?

General statistical explanation: sample-size planning asks how much information a future study might need under stated assumptions about the effect to detect, variability, significance threshold, allocation, and statistical model. The registry’s planning description says the illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of an observed effect. It distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event calculations.

Those are planning assumptions, not a description of this trial’s design. This study is registered as a single group, rather than a two-arm comparison. The planning illustration does not establish that the trial was designed with those assumptions, and it is not observed power. The numerical outputs and the observed effect on which such an illustration would be based are not reported in the registry record. No planning value should be treated as an observed trial finding.

General statistical explanation: over-dispersion arises when variation in the data exceeds what a statistical model assumes. If present, it can make standard errors too small under a model that does not account for the extra variation, leading to overly precise inference. This consideration can matter for some outcome types, but the registry record does not describe an over-dispersion assessment or a model for the primary endpoint. It would be inappropriate to assume that over-dispersion was present or that any particular adjustment was used.

The registry records two outcome measures and zero analyses. It does not report the estimation method, model specification, handling of repeated observations, or approach to uncertainty. These omissions prevent a detailed appraisal of the statistical analysis. The listed mean and standard deviation identify intended descriptive summaries, but do not specify all analytic choices or establish which participants contributed to a result.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Single Arm - Entertaining Video Game")
n   <- c(20)
m   <- c(0.74)
sp  <- c(2.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Single Arm - Entertaining Video Game  20  0.740  2.400  -0.383  1.863

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and a secondary outcome, and records two outcome measures. Multiple outcomes can create a multiplicity issue: when several hypotheses are tested, the chance of at least one apparently unusual result can increase if each is assessed without accounting for the others. General statistical approaches include prespecifying a hierarchy of outcomes or adjusting inference for multiple testing. The registry record does not report a multiplicity strategy, a hierarchy beyond the primary and secondary labels, or any analyses. It is therefore not possible to determine whether multiplicity was addressed.

Missing-data handling is also not reported in the registry record. The record does not state whether any outcome measurements were missing, how missing observations would be handled, or whether an analysis depended on complete cases or another approach. No assumptions about the amount or causes of missing data can be made from the enrollment or completion status alone.

The analysis population is not reported in the registry record. In general, an analysis population specifies which participants are included in a particular analysis and can affect how results should be interpreted. The record does not say whether all enrolled participants were included in outcome analyses, whether participants had to complete particular procedures, or whether any exclusions were made.

The registry records zero analyses and does not report numerical outcome findings. As a result, neither the treatment of multiplicity nor the handling of missing observations can be checked against reported estimates. Details of an analysis plan, deviations from that plan, and outcome-specific denominators are not reported in the registry record.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry’s adverse-event summary lists 20 participants at risk in the single arm, with 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. No serious adverse-event terms are listed. These are the safety counts recorded for the arm; they should be read as registry-reported figures rather than as proof that no adverse events of any kind occurred outside the definitions, observation period, or reporting process used.

The record does not report detailed safety definitions, the method or frequency of safety monitoring, the duration of safety follow-up, or whether events were actively solicited. It also does not provide event descriptions beyond the absence of listed serious terms. Without those details, the counts cannot establish the completeness of ascertainment or characterize the nature of any events.

These safety figures are descriptive and come from a single-group study. They do not compare event rates with another group, and they do not establish whether an event would be related to the game. The absence of reported events in the registry summary should not be interpreted as a general guarantee of safety.

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

The registry record documents a completed, single-group study that evaluated a session involving an entertaining video game for youth with anxiety. It identifies a primary outcome based on mean change in SUDS and a secondary outcome concerning children’s preference for the game. It also records the session procedures and adverse-event counts. These details clarify what the investigators intended to examine and how the visit was described.

What the record does not establish is the actual primary outcome result. A numerical mean change, its variability, and an estimate of uncertainty are not reported in the registry record. The secondary outcome result is likewise not reported. Consequently, readers cannot determine from this information whether children’s distress ratings changed, how large any change was, how consistent it was, or how precisely it was estimated.

The single-group design also constrains causal interpretation. A before-and-after difference, if reported, would not alone show that the game caused the difference. The study does not include a concurrent control group or randomized comparison to help distinguish effects of the game from other influences on ratings during the visit. The stated interest in adding the game to traditional therapy is an aim; the registry does not report a comparison of that approach with traditional therapy alone.

The study may be relevant as a feasibility investigation because it describes participant interaction and feedback within a session. However, numerical feasibility findings are not reported in the registry record, so the extent to which the procedures were feasible cannot be assessed from the record information. The listed safety counts are reassuring only as a description of what the registry records; limited detail on ascertainment prevents broader conclusions.

In short, the record supports a description of the study’s question and design, not a conclusion about effectiveness. A completed status confirms the registry’s status entry, not the presence of interpretable outcome results. Statistical conclusions would require reported estimates, uncertainty, analysis details, and consideration of the limitations of the single-group design.

14. Why This Trial Matters Statistically

This trial is statistically useful to examine because it illustrates the difference between a clearly stated outcome and a reported result. The registry specifies a continuous distress measure, a mean-change estimand, a dispersion measure, and an assessment timeframe. Those elements help define what investigators intended to quantify. But without the observed estimate and uncertainty, readers cannot assess the outcome itself.

The single-group design also highlights a central issue in clinical research: describing change is not the same as estimating a causal effect. A within-group measurement can document what happened between assessments, but without a suitable comparison it cannot separate intervention-related change from other factors. This distinction is especially important when a study’s stated aim includes effectiveness, while the design is registered as a feasibility study without a randomized comparator.

The registry also makes visible the gap between a planning illustration and the design actually used. Its sample-size assumptions describe a hypothetical two-arm framework. Such planning calculations can be informative when their assumptions match a proposed future study, but they do not transform this single-group study into a comparative trial and do not constitute observed power.

Finally, the record shows why statistical interpretation depends on more than a study’s completed status or enrollment. Outcome results, uncertainty, analysis populations, missing-data methods, and multiplicity decisions all influence how findings can be read. Their absence limits the conclusions available from the registry, regardless of the study’s stated aims.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation is the absence of numerical outcome results in the registry record. The primary endpoint is defined, but no mean change, standard deviation, confidence interval, or p-value is reported. The secondary preference outcome also lacks a numerical result. This prevents assessment of direction, size, variability, precision, and statistical evidence.

The study is registered as a single group with no randomized comparison. Any within-session change, if available elsewhere, would not by itself establish that the video game caused it. The record’s stated interest in using the game as an addition to traditional therapy does not amount to a comparison of combined care with traditional therapy alone.

The registered procedure combines several activities: interaction with the game, an opportunity for real-life exposure, an interview, and parent feedback. The registry does not report how these components were delivered in practice, whether delivery varied, or precisely how the SUDS assessment was timed in relation to them. Thus, even the exposure represented by an outcome change is not fully characterized.

Further details that would support appraisal are not reported in the registry record, including eligibility criteria, participant characteristics beyond the stated population, outcome-specific analysis populations, missing-data handling, and the statistical analysis plan. The record also does not provide detailed safety-monitoring methods or follow-up duration. Enrollment and completed status do not resolve these uncertainties.

Finally, the study’s stated feasibility and effectiveness aims cannot be evaluated in equal measure from the registry information. There are no numerical feasibility findings, and the single-group design cannot provide a controlled effectiveness contrast. These limitations are specific to the available study description and registry reporting; they should not be mistaken for evidence of a particular direction of outcome.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study — NCT02713425.
• Registry record last updated 2019-09-04; status last verified 2019-08.
• Results first posted 2019-09-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02713425 is a completed, single-group feasibility study sponsored by Mayo Clinic, with enrollment of 20. The study is listed as starting on 2016-10-01 and reaching primary completion on 2017-06-15. Phase and allocation are recorded as NA, and masking is listed as none.

The registered intervention is an entertaining video game. The described single visit includes introduction to and interaction with the game, questions about the child’s experience, an opportunity for real-life exposure, and parent feedback. The primary outcome is mean change from baseline in SUDS at the end of the session, with an approximately 10-minute timeframe. The secondary outcome concerns the average child rating of preferring the game to not having the game.

The registry records two outcome measures and zero analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record. The safety summary records 0 serious adverse events, 0 other adverse events, and 0 deaths in the single arm, with no serious terms listed. The design does not include a randomized control comparison.