Sensory Habituation in Autism Spectrum Disorders: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sensory Habituation in Autism Spectrum Disorders (NCT06247176), a non-randomized na study. The primary outcome is Changes in Neural Response to the Sensory Stimulation.

2. Clinical Question

3. Trial Design

The study, titled “Sensory Habituation in Autism Spectrum Disorders,” was registered as a non-randomized, parallel-group behavioral study. The sponsor was the University of Nebraska. The registry lists no masking and gives the study phase as not applicable. The recorded start date is 2024-01-08, the primary completion date is 2024-10-07, and the status is terminated.

The planned groups were people with autism and sensory over-responsivity, and neurotypical peers. The brief summary describes planned recruitment of 30 people in each group, aged 7–35. The registry record reports enrollment of 1. These figures describe different aspects of the record: planned recruitment in the summary and recorded enrollment in the study entry. They do not establish that a full protocol sequence or an outcome assessment was completed for an analyzed cohort.

The described sequence included a practice MRI visit with questionnaires, an MRI visit before habituation, a virtual-reality systematic desensitization session with physiological recording, and a post-exposure MRI visit. Group descriptions also refer to a mock MRI and pre- and post-habituation MRI. The registry identifies structural and functional MRI collections and physiological recording during the virtual-reality session. It does not report how many participants completed each visit or whether the planned assessments were obtained.

Both groups were described as receiving the habituation protocol. Since allocation was non-randomized and the groups were defined by participant characteristics, differences between them cannot be read as an unconfounded treatment-versus-control contrast. The registry record does not report the recruitment process, eligibility details beyond the descriptions given, or a protocol for adjusting group comparisons.

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: Project was terminated before full scale analysis was performed.

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: Project was terminated before full scale analysis was performed.

6. Primary Endpoint

The registry lists the primary outcome as Changes in Neural Response to the Sensory Stimulation, measured over There are two 1 hour sessions in which the bold response will be measured. The first time point will be during visit 2 of the study. The second time point will be the final visit of the study..

The primary endpoint was the change in neural response to sensory stimulation, expressed as a mean BOLD response measured by functional MRI. The record describes measurements during two one-hour sessions: the first at visit 2 and the second at the final visit. The endpoint was intended to capture how the MRI-measured response differed between the pre-habituation and post-exposure assessments.

In general, BOLD is a functional MRI signal associated with changes in blood oxygenation and blood flow that accompany neural activity. It is an indirect physiological measure, rather than a direct count of neural signals. Using the same kind of measure at more than one visit can describe within-participant change over time, provided the relevant measurements are collected and analyzed. The registry does not report the precise image-processing procedures, the brain region or regions used, or the method for deriving the mean response.

The endpoint was relevant to the stated objective of quantifying neurophysiological responses following systematic desensitization. However, the registry record says the project was terminated before full-scale analysis was performed. It reports no observed mean change, standard deviation, confidence interval, or test of the primary outcome. The planned measure and its rationale can therefore be described, but the record does not show whether the endpoint changed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: a mean BOLD response. A continuous outcome can take values along a measurement scale, rather than being limited to categories such as event or no event. The registry also identifies standard deviation as the dispersion measure. In general, a standard deviation describes how spread out individual measurements are around their mean. It is different from the standard error, which describes the precision of an estimated mean and depends on the amount of data and the analysis.

What does a change score represent?

The primary endpoint is framed as a change between an MRI assessment before habituation and an MRI assessment at the final visit. In general, a participant-level change score is formed by comparing that participant's later measurement with the earlier measurement. An average of such changes describes the mean within-participant change among those with usable paired measurements. The registry record does not report the observed change, the number of paired measurements, or the procedure used to calculate or analyze a change score.

Paired data have a feature that matters statistically: two measurements from the same participant are usually related. In general, an analysis that accounts for this within-participant relationship can differ in precision from one that treats the measurements as independent. The record does not report whether a paired test, a repeated-measures model, or another approach was intended. It also does not give details about how incomplete pairs would be handled.

Why does the non-randomized design matter?

Random allocation can help balance measured and unmeasured characteristics between groups, on average. This study was not randomized. Its two groups were defined as people with autism and sensory over-responsivity and neurotypical peers, and both were described as receiving the protocol. A comparison between these groups would therefore not isolate the protocol effect in the way a randomized treatment-versus-control comparison aims to do. The registry record itself cautions that the arms are not a like-for-like control comparison.

In general, adjustment for measured characteristics can sometimes address observed differences between groups, but it cannot automatically remove bias from unmeasured or poorly measured differences. No statistical adjustment plan is reported in the registry record. It would be inappropriate to assume that an adjusted comparison was planned or performed.

What can precision and significance tell readers?

A confidence interval describes uncertainty around an estimated quantity under the specified statistical method. A narrow interval indicates greater precision than a wide interval, while the interval's location helps show which effect sizes are compatible with the estimate. A p-value, when reported, summarizes how unusual data at least as incompatible with a null hypothesis would be under that hypothesis and the test's assumptions. Neither measure alone establishes clinical importance or resolves design limitations.

No primary endpoint estimate, confidence interval, or p-value is reported. The registry lists no outcome analyses. Accordingly, there is no basis in the record for interpreting statistical significance or precision for the primary outcome.

How should planning illustrations be read?

Any sample-size illustrations associated with the posted results are planning calculations, not observed power. The registry describes the assumptions as a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect expressed as a stated fraction of an observed effect. Those calculations should not be read as the study's original design justification: the record says they are planning illustrations, and does not report the trial's own sample-size justification. The registry also does not report a primary outcome analysis from which a reader could evaluate an observed effect. Planning calculations cannot replace an estimate and its uncertainty from completed outcome data.

More generally, a sample-size calculation depends on assumptions about the effect to detect, variability, allocation, and analysis. Changing those assumptions changes the required sample size. Such calculations describe a hypothetical design under stated assumptions; they do not show that a study had a particular probability of finding an effect after it was conducted.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome, change in neural response to sensory stimulation, and three secondary physiological outcomes: galvanic skin response, skin temperature, and heart rate. It also states that there are four outcome measures. No outcome analyses are listed, and no results are reported for the primary or secondary measures.

When several outcomes or statistical tests are examined, the chance of at least one apparently notable finding can increase. In general, multiplicity refers to this issue and to methods for controlling or describing it, such as prespecifying a primary analysis or adjusting inference across tests. The registry record does not report a multiplicity strategy, a hierarchy among the secondary outcomes, or whether any interim analyses were planned or conducted. Those details should not be inferred from the outcome list.

The record does not report an analysis population, such as whether analyses were to include all enrolled participants, only those completing both MRI visits, or another defined group. It also does not describe how missing MRI scans, incomplete physiological recordings, or missed visits would be handled. The registry reports enrollment of 1 and states that full-scale analysis was not performed; it does not say how many outcome observations were available or whether any outcome data were analyzed.

In general, missingness can affect both the amount of information available and the interpretation of an estimate, especially if the reason a measurement is missing is related to the outcome or participant characteristics. Without counts of completed assessments and a missing-data method, the impact cannot be evaluated. No statistical analysis plan is 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's serious adverse event fields report the Autism Spectrum Disorder Habituation Group with 1 at risk and 0 affected by serious adverse events, and the Neurotypical Habitation Group with 0 at risk and 0 affected. Deaths are reported as 0 in each group. The record lists no serious adverse event terms.

These figures are counts recorded in the registry entry, not estimates of comparative safety. In particular, the neurotypical group's at-risk count is 0, so its zero affected count should not be interpreted as evidence of an observed absence of events among participants at risk. The record's enrollment figure and the at-risk counts in the adverse-event fields should not be assumed to represent the same analysis population.

In general, adverse-event counts need context about who was monitored, for how long, and how events were defined and collected. The registry record does not report those details or provide a fuller safety analysis. The listed counts therefore describe what was entered in the serious-event fields, but do not establish a comparative risk or support a broad safety conclusion.

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

The registry record documents a planned investigation of neural and physiological responses around a virtual-reality sensory habituation protocol. It specifies a continuous primary endpoint based on mean BOLD response, measured at a pre-habituation visit and a final visit. It also describes secondary measures involving galvanic skin response, skin temperature, and heart rate.

The record does not report analyzed outcome results. It states that the project was terminated before full-scale analysis was performed, and it lists no analyses. There is no reported estimate of primary endpoint change, no confidence interval, and no result for the secondary outcomes. The record therefore cannot establish the direction or size of any observed response, how precise an estimate might be, or whether a statistical test found evidence of a difference.

This absence of a reported analysis should not be translated into a finding of no change, no effect, or no physiological response. Those would be conclusions about data that the registry does not present. It is also not possible to infer that the protocol caused a change from the planned measurement schedule alone.

The design further constrains interpretation. Allocation was non-randomized, and the two groups were different participant populations rather than randomized treatment and control arms. Even if a group comparison had been reported, it would require careful interpretation and could not by itself isolate an effect of the protocol. The record does not report a statistical plan that would clarify how such a comparison was intended to be handled.

In general, a result is most interpretable when the estimate, its uncertainty, the analysis population, and the analysis method are reported together. Those elements are not available for the primary endpoint in this registry record. The supportable conclusion is limited to what was planned, what design features were recorded, and the fact that full-scale analysis was not performed.

13. Why This Trial Matters Statistically

This study raises a statistically important question about how physiological measurements are used to describe responses to sensory stimulation. Its primary endpoint was a mean BOLD response, a continuous measure collected at a pre-habituation and a final visit. The planned repeated measurement is relevant because it focuses on change over time rather than a single measurement at one visit.

The design also illustrates why a comparator's role matters. The study described an autism group and a neurotypical group, with both groups receiving the habituation protocol. Since allocation was non-randomized and the groups differed by participant characteristics, the neurotypical group does not function as a randomized control for the autism group. Clear distinction between a descriptive group comparison and a causal treatment contrast is essential when interpreting such designs.

The registry's termination and lack of full-scale analysis are equally important to statistical interpretation. A planned endpoint is not an outcome finding. Without an estimate and an account of its uncertainty, readers cannot assess the magnitude or precision of change. Reporting study status and analysis availability prevents the planned scientific question from being mistaken for a completed result.

The record also shows why outcome and analysis details matter. Several physiological outcomes were listed, but the registry does not report a multiplicity strategy, a missing-data approach, or an analysis population. These are not merely technical details: they affect what quantities can be estimated and how strongly conclusions can be supported. Their absence limits interpretation without implying that a particular method was or was not used outside the registry record.

Finally, the gap between the recruitment plan in the brief summary and the recorded enrollment highlights the need to distinguish planned study scale from recorded enrollment and analyzed data. Each speaks to a different stage of a study. None, by itself, supplies the missing primary outcome result.

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 registry record provides limited information for evaluating the study's conduct and results. It reports enrollment of 1 and a terminated status, and it explicitly states that full-scale analysis was not performed. It does not report how many participants completed the planned visits, whether the pre- and post-habituation MRI measurements were usable, or how many records contributed to any exploratory analysis.

The planned recruitment described in the brief summary is not evidence that recruitment reached that target. Likewise, the planned visit sequence does not establish that each visit occurred for an enrolled participant. The record does not describe reasons for termination, so the reason the project stopped should not be inferred.

The primary endpoint is identified as mean BOLD response, but the registry does not specify the brain region or regions, image-processing pipeline, quality-control criteria, or exact statistical definition of change. It also does not report an analysis population, missing-data approach, or statistical analysis plan. This leaves important aspects of reproducibility and interpretation unknown.

The non-randomized design and different group populations limit any potential group contrast. The record cautions that the arms are not a like-for-like control comparison. No adjustment plan is reported, and it would not be appropriate to assume that measured or unmeasured group differences were addressed.

Safety interpretation is also constrained: the adverse-event fields provide small at-risk counts, with no serious event terms listed, but the record does not explain the monitoring period or event-collection procedures. Overall, the registry supports description of the study plan and status, but not a full appraisal of efficacy, precision, missingness, or comparative safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Sensory Habituation in Autism Spectrum Disorders — NCT06247176.
• Registry record last updated 2026-05-29; status last verified 2024-10.
• Results first posted 2026-05-29.
• 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 University of Nebraska registry entry describes a non-randomized, unmasked, parallel-group behavioral study of a virtual-reality sensory habituation protocol. Its planned groups were people with autism and sensory over-responsivity and neurotypical peers. The primary endpoint was change in mean BOLD response measured by functional MRI before habituation and at the final visit.

The brief summary describes planned recruitment of 30 people in each group, while the registry reports enrollment of 1. The study is listed as terminated, with recorded start and primary completion dates of 2024-01-08 and 2024-10-07. The registry states that termination occurred before full-scale analysis was performed and lists no outcome analyses. Consequently, it reports no primary endpoint estimate or secondary outcome results. The serious adverse event fields list 0 affected in each group and no serious event terms, with the recorded at-risk counts differing between groups.