Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism?: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism? (NCT05373173), a non-randomized na study. The primary outcome is Diagnostic Certainty: Tele-assessment.

2. Clinical Question

The study addresses a practical challenge described in the registry: families seeking autism assessment may face limited specialist availability, long waitlists, and travel to tertiary diagnostic centers. The record highlights that these barriers may affect traditionally underserved groups and communities. Telemedicine is presented as a possible way to make assessment more accessible, but the registry summary also notes the need for validated tools that can be administered remotely.

The approach is intended for preschool-aged children referred for diagnostic assessment, a population the registry distinguishes from earlier work focused on toddlers. The central measurable question in this record is clinician diagnostic certainty after tele-assessment, rather than a reported measure of access or the accuracy of a diagnosis against an independent reference assessment. Those other questions may matter to the broader rationale, but their results are not reported in the registry record. The endpoint is therefore best read as a measure of clinicians’ immediate confidence, not as a complete evaluation of diagnostic validity, service access, or equity.

3. Trial Design

The registry describes a completed behavioral study sponsored by Vanderbilt University Medical Center. It lists an enrollment of 148 and a study period beginning 2022-06-01, with primary completion on 2024-08-14. The status is completed. The phase is listed as NA, which is consistent with the record describing behavioral rather than drug treatment interventions.

The design fields identify the allocation as non-randomized, masking as none, and model as single-group. The intervention section nevertheless names two assessment approaches: “Tele-assessment only” and “Tele-assessment + In-person assessment.” The arm descriptions say families will complete tele-assessment only, or receive an in-person tele-assessment appointment and an in-person evaluation, respectively. The record does not explain how families were assigned to these approaches or how the two named approaches relate to the single-group model. Because allocation is non-randomized, the listed arms should not be treated as a randomized, like-for-like control comparison.

The primary outcome is diagnostic certainty rated by clinicians immediately after completing tele-assessment, at a single timepoint averaging 90 minutes. The scale ranges from 1 to 4, with higher scores indicating stronger clinician certainty. The registry specifies that this endpoint is analyzed for child participants only. It lists four outcome measures in total, but details for the other measures are not reported.

Masking is listed as none. The registry record does not report a protocol-level statistical analysis plan, the procedures used to allocate families, or the rationale for the enrollment target. Nor does it describe any interim analyses. These omissions matter because design and analysis details are needed to assess how strongly observed outcomes could be attributed to the assessment approach. Most importantly for interpreting this page, the record does not include posted results for the primary outcome or statistical analyses.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Children were recruited together with a participating primary caregiver (i.e., parent-child dyads). Study sample size below and throughout results is reflective of parent-child dyads.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Diagnostic certainty is analyzed for child participants only.

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: Baseline data are reported separately for child and parent members of each parent-child dyad. Baseline characteristics were not collected for parent participants in the tele-assessment only arm. Age was not collected for parent in either arm.

6. Primary Endpoint

The registry lists the primary outcome as Diagnostic Certainty: Tele-assessment, measured over Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes.

The primary endpoint is clinician-rated diagnostic certainty immediately after tele-assessment. Clinicians use a 4-point Likert scale: 1 means “Completely Uncertain,” 2 means “Somewhat Uncertain,” 3 means “Somewhat Certain,” and 4 means “Completely Certain.” Higher scores represent greater certainty. The registry summarizes the endpoint as a mean with standard deviation and specifies that the analysis concerns child participants only.

This measure is useful for describing clinicians’ immediate confidence after a remote assessment. A numeric scale can summarize ratings across participants, while the standard deviation describes how much those ratings vary around the mean. The endpoint can therefore speak to the level and consistency of reported certainty in the assessed group, if results are available.

As a general measurement point, certainty is not the same as diagnostic accuracy. A clinician can express strong or weak certainty, but a certainty score alone does not establish whether a classification agrees with an independent comprehensive evaluation. The record’s primary endpoint should therefore be interpreted as clinicians’ certainty, not as a direct measure of correctness, diagnostic sensitivity, or specificity. The registry describes the scale and timing but does not report the mean, standard deviation, or other primary outcome results. The endpoint’s observed level and precision are consequently not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean score summarize?

The primary endpoint is continuous in the registry’s statistical classification and is summarized as a mean with standard deviation. A mean gives a single summary of the scores in a group. The standard deviation describes how spread out individual scores are around that mean. These summaries answer different questions: the mean describes the group’s average rating, while the standard deviation describes variability among ratings.

General statistical context: means are most directly interpretable when the numeric scale’s steps have a reasonable meaning for the question. Here, the registry defines ordered response categories from “Completely Uncertain” through “Completely Certain.” Treating that scale as a numeric measure can be convenient for summarizing ratings, but it does not make the categories more detailed than the response options themselves. The record does not report how clinicians’ scores were distributed across the four response categories.

What would a confidence interval add?

General statistical context: an estimate is subject to sampling uncertainty because the enrolled participants are one group of people observed under the study conditions. A confidence interval expresses uncertainty around an estimate under the specified statistical method. A narrow interval indicates greater precision under that method, while a wide interval indicates less precision. It does not show whether the measurement is valid, remove selection bias, or prove that a result will generalize to other settings.

The registry record does not report a mean, standard deviation, confidence interval, or primary-outcome analysis. Consequently, the actual precision of the diagnostic-certainty estimate cannot be assessed from this record. The record’s description of the endpoint alone is not enough to reconstruct an estimate.

Why does allocation matter?

The study is labeled non-randomized. General statistical context: random allocation, when used, helps balance measured and unmeasured participant characteristics between groups on average. In a non-randomized study, group membership may be related to characteristics that also affect the outcome. An observed difference, if reported, could therefore reflect those characteristics rather than the assessment approach alone. Statistical adjustment can address some measured differences, but it cannot guarantee removal of unmeasured confounding.

The registry also labels the model single-group while listing two assessment approaches. It does not explain this combination or describe an allocation procedure. The record therefore does not justify treating the approaches as a controlled comparison. No adjusted or unadjusted analysis is reported.

What does no masking mean?

The registry lists masking as none. General statistical context: masking is intended to limit the influence of knowledge about an intervention or group on aspects of study conduct or outcome assessment. For a clinician-rated endpoint, the possibility that the rater knows which assessment approach was used may be relevant to how certainty ratings are formed. The registry does not report further masking procedures or whether any independent rating was performed. This is a design consideration, not evidence that ratings were biased.

How should planning displays be read?

General statistical context: sample-size planning asks how many participants a future or planned study might need under specified assumptions about an effect, variability, allocation, and statistical test. Such calculations are planning illustrations, not observed power. The registry’s stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. For time-to-event tables, the stated quantity is total events, while other displays use participants per arm.

These assumptions describe an illustration and do not establish that the trial was designed using those assumptions. The registry does not report its own sample-size justification or statistical plan. In particular, an illustration based on an observed effect cannot replace a reported estimate and its uncertainty, and it should not be interpreted as evidence that the study had a particular probability of detecting an effect.

Why can over-dispersion matter?

General statistical context: over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variability, its uncertainty estimates can be too small and its intervals or tests can appear more precise than warranted. This concept is relevant in some kinds of outcome modeling, but the registry does not report an over-dispersion assessment or a model that can be evaluated for it. It should not be inferred that over-dispersion was present or that a particular correction was used.

Overall, the record offers endpoint definitions and design labels, not enough analytic detail to reproduce an analysis. The statistical methods actually used for the primary endpoint are not reported in the registry record.

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("Tele-assessment Only", "Tele-assessment + In-person Assessment")
n   <- c(30, 116)
m   <- c(3.07, 2.85)
sp  <- c(0.83, 0.99)
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  Tele-assessment Only  30  3.070  0.830  2.760  3.380
CARM  Tele-assessment + In-person Assessment  116  2.850  0.990  2.668  3.032

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures but identifies only the diagnostic-certainty measure in the primary-outcome details. Details about the other outcome measures, their timing, and their analysis are not reported in the registry record. It also lists zero analyses, so no outcome-specific estimates or tests are posted in this record.

General statistical context: when a study examines multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase. A statistical analysis plan may specify which outcome is primary, how secondary outcomes are handled, and whether any adjustment for multiple testing is intended. The record identifies a primary endpoint but does not report a multiplicity strategy or a complete plan for handling the other listed outcomes. It is not possible to determine from the record whether such a plan existed outside the registry.

Missing-data procedures are not reported in the registry record. The record does not say how incomplete ratings, withdrawals, or unavailable assessments were handled, nor does it report the amount of missing primary-outcome data. The analysis population is described only to the extent that diagnostic certainty is analyzed for child participants. Further details about inclusion criteria for analysis, exclusions, or any per-protocol or intention-to-treat populations are not reported.

These gaps affect interpretation of both the estimate and its precision. Without the number of participants contributing endpoint data and the approach to missing observations, readers cannot assess whether the analysis represents all enrolled children or a subset. Without the planned multiplicity approach, readers cannot assess how the four listed outcomes were prioritized statistically. These are reporting limitations; they do not establish that the analyses were inappropriate.

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 lists serious adverse events and other adverse events separately for children and parents in each of the two assessment groups. For each listed group, the number affected is recorded as 0 for serious adverse events and 0 for other adverse events. The record also lists 0 deaths in each group. These figures are the safety counts reported for the populations at risk in those entries.

The child entries list 30 at risk in the tele-assessment-only group and 118 at risk in the tele-assessment plus in-person assessment group. The parent entries list the same at-risk counts for their respective approaches. These are registry safety denominators; they should not be assumed to be the number who contributed data to the primary endpoint, whose analysis population is described as child participants only.

General statistical context: a recorded zero means no events were reported in the specified category and group in the posted results. It does not prove that the true risk is zero. The interpretation also depends on how events were defined, the completeness of collection, and the observation period. Those details are not reported in the registry record. The zero counts should therefore be presented as recorded safety figures, not as a guarantee that no adverse events occurred.

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

This record is informative about the question the study addressed: clinician diagnostic certainty after tele-assessment for children undergoing assessment in the context of autism spectrum disorder. It defines the response scale, identifies the timing of the primary endpoint, and lists two tele-assessment approaches. It also records enrollment of 148, a completed study status, and the design labels used in the registry.

It does not show the primary outcome results. No mean diagnostic-certainty score, standard deviation, confidence interval, or statistical analysis is reported in the registry record. Therefore, readers cannot use this record to describe the observed level of certainty, determine how much ratings varied, or estimate a difference between the two named approaches. The absence of posted results is not evidence that an approach did or did not change certainty.

The study’s non-randomized allocation and single-group model label also prevent a simple causal interpretation of any contrast between the approaches. Even if outcome estimates were available, the record does not provide enough allocation or adjustment details to establish that the groups were comparable. The primary endpoint itself measures clinician certainty, not diagnostic accuracy, access to services, or whether disparities were reduced.

The safety entries report zero serious and zero other adverse events in the listed child and parent groups. These figures are limited to what is recorded, and the event definitions and collection details are not reported. They should not be interpreted as proof that the approach is free of risk.

Accordingly, the record supports a careful description of study design and measurement, not a conclusion about effectiveness or accuracy. General statistical context: a result is most useful when the estimate, its precision, analysis population, and analysis methods are all clear. Those outcome and method details are not available. The findings needed to answer the clinical question are not reported in the registry record.

14. Why This Trial Matters Statistically

The study raises a statistically important question about evaluating tele-assessment for a population described as preschool-aged children referred for diagnostic assessment. The registry rationale emphasizes barriers such as limited specialist availability, long waitlists, and travel to tertiary centers, and notes the potential relevance for traditionally underserved groups and communities. In this setting, measurement needs to be interpreted carefully: clinician certainty is an immediate rating, while diagnostic accuracy and access are distinct questions.

The record makes the endpoint’s scale and timing explicit, which helps readers understand what the measure represents. It also identifies the primary analysis population as children. At the same time, the non-randomized allocation and single-group model label, alongside two named approaches, make the design difficult to interpret as a comparative study. Clear reporting of how families entered each approach would be important for assessing whether outcome groups could be compared fairly.

General statistical context: study design and statistical analysis answer different parts of the evidence question. A precise estimate can still be biased if comparison groups differ in important ways; a careful design can still yield an uncertain estimate if data are limited or variable. Readers need both design information and outcome estimates with uncertainty. Here, the registry record does not report the primary results or analysis methods, so neither the level of certainty nor its precision can be evaluated.

The record also shows why reporting matters. Enrollment and completion status alone do not reveal how many children contributed endpoint data, how missing observations were handled, or whether the two approaches were assessed under comparable conditions. The safety counts provide a separate description but do not answer the primary endpoint question. This trial matters statistically because it connects a relevant access-oriented research question to the need for transparent measurement, allocation, and outcome reporting.

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.

Several limitations specific to this record constrain interpretation. First, primary outcome results are not reported. The registry describes diagnostic certainty and its scoring scale, but gives no mean, standard deviation, confidence interval, or analysis. The study’s central endpoint therefore cannot be quantitatively evaluated from the record.

Second, the design fields identify non-randomized allocation and a single-group model, while the intervention section names tele-assessment-only and tele-assessment plus in-person assessment approaches. The registry does not explain how these approaches fit the single-group label or how participants were assigned. This makes it inappropriate to read the entries as a randomized comparison and leaves the potential for differences between groups unresolved.

Third, the primary endpoint captures clinician certainty, not diagnostic accuracy. The record does not report whether the certainty ratings were compared with an independent reference assessment. The wider rationale discusses access and disparities, but results for access or disparity-related outcomes are not reported. Thus, the endpoint definition alone cannot answer whether identification improved or whether any disparity changed.

Fourth, details needed to assess the analysis are absent. The record lists four outcomes but reports no analyses, and does not describe multiplicity, missing-data procedures, the number contributing primary endpoint data, or the statistical methods used. Its sample-size justification and full statistical plan are not reported in the registry record. Finally, the safety entries give zero counts but do not provide event definitions or collection details. These reporting gaps limit the conclusions that can be drawn from this registry record; they do not establish what the investigators may have documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism? — NCT05373173.
• Registry record last updated 2025-08-24; status last verified 2025-08.
• Results first posted 2025-08-24.
• 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

This completed study, sponsored by Vanderbilt University Medical Center, enrolled 148 participants and examined tele-assessment approaches in the context of autism assessment for preschool-aged children. The registry labels the allocation non-randomized, masking none, and model single-group, while listing tele-assessment-only and tele-assessment plus in-person assessment approaches.

The primary endpoint is clinician diagnostic certainty immediately after tele-assessment, measured on a scale ranging from 1 to 4 and analyzed for child participants. The registry lists four outcome measures but reports zero analyses. The primary outcome estimate and its precision are not reported in the registry record.

Safety entries record zero serious adverse events, zero other adverse events, and zero deaths in the listed child and parent groups. These are descriptive registry counts. With outcome results and key analysis details absent, this record permits a description of the study question and design, but not an assessment of the observed diagnostic-certainty outcome or a causal comparison between approaches.