Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia (NCT05822921), a randomized na study. The primary outcome is Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance.

2. Clinical Question

3. Trial Design

NCT05822921 is a completed randomized, parallel-design study with no masking and enrollment of 21. The registry identifies the study as a pilot and feasibility phase intended to inform a future efficacy trial. Its focus was on access to diagnostic assessment and subsequent ASD psychoeducation for parents in rural Southwest Virginia. The listed sponsor is Virginia Polytechnic Institute and State University. The recorded study start was 2019-07-17, and the primary completion date was 2020-09-01.

The brief summary describes randomization to three psychoeducation approaches: in-person psychoeducation, telehealth psychoeducation, or psychoeducation as usual with paper materials. The primary outcome description refers to a psychoeducation condition and a psychoeducation-as-usual condition. For the psychoeducation condition, the record reports that two families had sessions in person and nine had sessions over Zoom; for psychoeducation as usual, all families received paper materials. The record does not explain how this description relates to the three listed intervention names or give enrollment by randomized arm.

The study planned to assess parental satisfaction, empowerment, and ASD knowledge, and to track whether participants sought or received additional ASD-related services through 6-months post-psychoeducation. The listed secondary outcomes include change in parental empowerment, change in parental knowledge, and use of additional ASD-related services. The brief summary says changes in empowerment and knowledge from pre- to post-psychoeducation would be measured using t-tests. It does not report the results of those analyses.

The registry notes that, in April 2020, the investigators were altering the protocol in response to the Virginia governor's stay-at-home order and the university's request to move research remotely where possible. The available description does not report the full amendment or specify its consequences for every assessment or study procedure. The randomization method, allocation concealment, and details of the analysis plan are not reported in the registry 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.

Before assignment: The # of participants completing the study refer to child-parent pairs rather than individuals. A diagnostic evaluation for autism spectrum disorder was conducted for the child. One child did not meet ASD criteria, so that family was not assigned, leaving a final total of 20 parent-child pairs. Due to COVID-19, the protocol was revised such that participants who received either telehealth or in-person psychoeducation were grouped in a single arm (i.e., Psycho-education Clinician-led).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of child-parent pairs enrolled in the study and randomized to each condition. For the PE condition, two families were in person and nine families had sessions conducted over Zoom. For the PAU condition, all families received paper materials.

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: Numbers refer to parent-child pairs, not individual participants. That is, 11 parent-child pairs completed the PE arm and 9 parent-child pairs completed the PAU arm. Baseline characteristics of age, sex, race, ethnicity, and region are reported for the children. Age, sex, and region are also reported for the parents. Reference to either parents or children is specified in the measure description.

6. Primary Endpoint

The registry lists the primary outcome as Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance, measured over Time 1: Baseline/intake (0 weeks); Time 2: Pre-intervention (2 weeks); Time 3: Immediately post-intervention (4 weeks after baseline); Time 4: 6- week followup (10 weeks after baseline); Time 5: 6-month followup (7 months after baseline).

The primary endpoint is the number of parent-child pairs who completed study sessions, assessed by parental attendance. The record defines the measure as retention across study sessions and explicitly notes that only parental attendance at psychoeducation sessions was included; child attendance was not needed for this measure. The scheduled assessments were baseline/intake at 0 weeks, pre-intervention at 2 weeks, immediately post-intervention at 4 weeks after baseline, a 6-week followup at 10 weeks after baseline, and a 6-month followup at 7 months after baseline.

Attendance is useful in a feasibility study because it describes whether participants remain engaged with scheduled study activities. As a general statistical concept, a count of attendance or completion can help characterize implementation and retention, but it does not by itself measure whether knowledge, empowerment, service use, or a clinical condition changed. The registry record does not report the attendance counts for any time point, the number completing each session, or a comparison between conditions. It therefore does not establish how much retention occurred or whether retention differed by delivery approach.

The registry description includes several time points and categories rather than one reduced comparison. The record explicitly indicates that the primary outcome has several categories or time points and was not reduced to one comparison. The relationship between the attendance count at each point and any overall completion definition is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel design without masking. In a randomized study, assignment to conditions is intended to reduce systematic differences between groups at the outset; randomization does not guarantee that groups will be identical, especially in a pilot study. A parallel design means the conditions are assigned as separate study groups rather than describing a planned sequence in which each participant receives every condition. The record does not report the randomization procedure, allocation concealment, or the number assigned to each condition.

What does the attendance endpoint describe?

The primary outcome is a count of parent-child pairs completing study sessions, assessed through parental attendance. This is a measure of participation and retention, not a continuous score such as an empowerment scale and not a direct measure of ASD diagnosis or clinical status. It is reported across multiple scheduled points, from baseline/intake through the 6-month followup. General statistical interpretation of repeated attendance information depends on knowing the denominator at each point, the definition of completion, and how missed sessions are treated. Those details and the actual counts are not reported in the registry record.

The primary outcome description also says that only parental attendance to psychoeducation sessions was included and child attendance was not required. That definition distinguishes the study's attendance measure from a measure requiring both members of a pair to be present. The record does not clarify whether every scheduled study visit or only psychoeducation sessions contributes to the outcome at each named time point. It notes multiple categories or time points and that these were not reduced to one comparison, so a single effect estimate cannot be extracted from the record.

What do the listed t-tests imply?

The brief summary says that changes in parental empowerment and ASD knowledge from pre- to post-psychoeducation would be measured using t-tests. In general, a t-test evaluates whether a difference in means is compatible with sampling variation under a specified null hypothesis. For a pre- and post-measure, the analysis could concern within-participant change or a contrast between groups, but the record does not specify which form was used, which conditions were contrasted, or whether a test was paired or independent. Those details are not reported in the registry record.

A test result alone would not communicate the size or precision of a change. General interpretation would also consider an estimated difference and its confidence interval, which describes a range of values compatible with the data and model. The registry does not report effect estimates, confidence intervals, test statistics, or p-values for empowerment or knowledge. The specific t-test assumptions and any assessment of them are also not reported in the registry record.

How should the design and analysis be distinguished?

Randomization is a feature of the design; it does not establish that every outcome was analyzed using a comparison between randomized groups. The summary mentions pre- to post-psychoeducation changes, while the primary outcome is attendance across multiple occasions. These are different data structures and answer different questions. A count of attendees describes retention, whereas a change score for a scale describes change in measured responses. The registry does not report a unified statistical model connecting these outcomes or specify whether analyses followed randomized assignment.

General analysis of several outcomes and repeated observations can require choices about which comparisons are primary, how correlated measurements are handled, and how uncertainty is estimated. These choices matter because repeated observations from the same participant are not generally independent, and repeated testing across outcomes can increase the chance of finding a nominally unusual result by chance. No repeated-measures model, multiplicity adjustment, or other method for handling those issues is reported in the registry record.

What can sample-size illustrations say?

The sample-size assumptions describe planning illustrations based on the observed effect, not the trial's own design justification. They use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm for 80% power or other listed planning targets; time-to-event illustrations use a total event count. These are hypothetical planning quantities, not observed power and not evidence about the result of the completed trial. A sample-size justification for the study itself is not reported in the registry record.

General power calculations depend on assumptions about an effect size, variability, allocation, outcome type, and analysis. Their outputs are planning aids: they estimate the sample needed under the assumptions, rather than the probability that a particular observed finding is true. Because the registry does not report the relevant outcome estimates or full analysis details, no additional numerical interpretation of the planning illustrations is warranted. Over-dispersion is a general concern for count data when observed variability exceeds what a simple count model assumes; the record does not report a count model or evidence of over-dispersion, so it cannot be said to have been present or addressed.

10. Multiplicity, Missing Data and Analysis Populations

The study lists five outcome measures and three analyses, but the registry record does not report which analysis corresponds to each outcome or which comparisons were designated as primary. It does not report whether a multiplicity adjustment was planned or used. In general, testing several outcomes or contrasts can raise the chance of at least one apparently notable finding arising by chance; adjustment methods and a prespecified hierarchy are ways studies may address this. Whether such methods were considered in this study is not reported in the registry record.

Missing-data handling is not reported in the registry record. There is no stated method for handling absent scale responses, missed followup visits, or incomplete service-use surveys. The attendance endpoint makes participation itself an outcome, but that does not explain how missing responses for the other outcomes were handled. The record also does not report whether analyses used all randomized participants, only participants with observed data, or another analysis population. Imputation, sensitivity analyses, and reasons for missingness are not reported.

The registry describes a change toward remote research conduct in April 2020 in response to the stay-at-home order and university request. It also reports that some psychoeducation sessions occurred in person and others over Zoom. The record does not describe whether or how this operational change was incorporated into the analysis, whether modality was treated as a factor, or whether any participants had unavailable outcome data because of the change. These details limit interpretation of both missingness and comparisons across delivery approaches.

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

The record supports a description of the study's purpose and planned outcomes, but it does not report results for the primary attendance endpoint or the listed secondary outcomes. It therefore cannot establish whether participants completed study sessions at a particular rate, whether attendance differed by condition, or whether empowerment, ASD knowledge, satisfaction, or service use changed. The absence of reported results is not a finding of no difference and does not show that conditions were equivalent.

The study was explicitly described as a pilot and feasibility phase intended to inform a future, fully powered efficacy trial. That context matters: the stated purpose includes testing an approach to delivering diagnostic assessment and psychoeducation, while the registry supplies no outcome estimates with which to judge its performance. Enrollment of 21 is a reported design characteristic, not a measure of efficacy or precision. Without estimates and confidence intervals, the size and uncertainty of any outcome effect cannot be assessed.

The intervention descriptions also require care. The summary names in-person psychoeducation, telehealth psychoeducation, and paper materials, while the primary outcome population description refers to a psychoeducation condition and a psychoeducation-as-usual condition. It reports that two families had in-person sessions and nine had Zoom sessions within the psychoeducation condition, but does not provide arm-level attendance results or explain the analysis categories. Thus those details do not establish a comparative effect of delivery modality.

The adverse-event entries report zero events in the two listed groups, but the registry does not explain ascertainment or provide a comparative analysis. Those entries should be read as registry counts, not as a comprehensive conclusion about risk. Overall, the record offers no basis for a claim that a particular psychoeducation approach is more effective, less effective, or equivalent to another, and it does not support medical advice.

12. Why This Trial Matters Statistically

This study raises a useful statistical distinction between feasibility outcomes and efficacy outcomes. Attendance can describe whether parents remain engaged across study activities, while empowerment, knowledge, satisfaction, and service use address different aspects of participants' experience. A feasibility study can inform the design of later research by identifying what needs to be measured and how study procedures may be carried out. In this case, however, the registry record does not report the attendance or secondary outcome results needed to assess those questions.

The design also illustrates how delivery conditions can become more complex during a study. The record describes a planned set of psychoeducation approaches and a move toward remote research conduct in April 2020, with some sessions reported as in person and others over Zoom. For statistical interpretation, clear reporting of assigned groups, actual delivery, outcome definitions, and analysis contrasts is important. Without that information, a reader cannot distinguish the effect of an assigned approach from variation in how it was implemented.

The primary endpoint spans multiple study times, which highlights the value of prespecifying how repeated attendance information will be summarized and compared. A single count at one time point may not represent the same aspect of retention as attendance across the full schedule. The registry explicitly leaves the endpoint unreduced to one comparison, and it reports no corresponding estimates. This makes transparent outcome reporting especially important for a feasibility study intended to guide future trial planning.

The record states that a future, fully powered efficacy trial was anticipated, but it does not report a sample-size justification for this pilot or outcome estimates that could support planning. The general lesson is that planning illustrations and observed study findings serve different purposes. Clear results, uncertainty estimates, missing-data information, and analysis definitions would be needed to translate feasibility experience into a well-specified future study.

13. 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 leaves important details about the trial's conduct and results unclear. It reports enrollment of 21 but does not report participant characteristics, numbers assigned to each randomized condition, or numbers contributing data at each followup. It also does not give the attendance counts that define the primary outcome. Without these details, retention and the completeness of followup cannot be quantified.

The intervention descriptions do not fully align across the record: three psychoeducation approaches are listed, while the primary outcome description refers to a psychoeducation condition and psychoeducation as usual. The record reports a mix of in-person and Zoom delivery within the psychoeducation condition, but it does not explain whether those modes were analyzed separately or how they relate to the randomized groups. Details about session content, duration, and adherence to the intended approach are not reported in the registry record.

Although the summary names t-tests for pre- to post-psychoeducation changes in empowerment and ASD knowledge, it does not identify the exact tests, contrasts, analysis populations, or assumptions. No estimates, confidence intervals, or p-values for the primary or secondary outcomes are reported. Multiplicity procedures and missing-data methods are not reported in the registry record, nor are the methods used to handle repeated measurements or incomplete followup.

The record notes a shift toward remote conduct during the study but does not describe the full protocol amendment or its impact on recruitment, assessments, and analysis. It also does not provide detailed adverse-event collection methods. These reporting gaps limit interpretation of feasibility, comparisons between conditions, and planning for subsequent research.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia — NCT05822921.
• Registry record last updated 2023-12-22; status last verified 2023-10.
• Results first posted 2023-12-22.
• 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.

17. Record Summary

NCT05822921 is a completed randomized, parallel study without masking, with enrollment of 21. The study was described as a pilot and feasibility phase for a future efficacy trial focused on accessible diagnostic evaluation and psychoeducation for parents of children with ASD or suspected ASD in rural Southwest Virginia. The listed approaches were in-person psychoeducation, telehealth psychoeducation, and paper psychoeducation materials.

The primary outcome counted parent-child pairs completing study sessions through parental attendance across five scheduled time points, from baseline/intake to a 6-month followup. The registry record does not report the primary outcome counts or numerical results for the listed secondary outcomes. It states that t-tests were planned for pre- to post-psychoeducation changes in parental empowerment and ASD knowledge. Adverse-event entries list zero serious events, other events, and deaths in each of two recorded groups.

The record reports a change toward remote research conduct during April 2020. It does not report a complete statistical analysis plan, missing-data methods, multiplicity procedures, or outcome estimates and confidence intervals.