The Effect of Play on Social and Motor Skills of Children With ASD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effect of Play on Social and Motor Skills of Children With ASD (NCT04258254), a randomized na study. The primary outcome is Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2).

2. Clinical Question

The central statistical question is whether motor-proficiency scores change over the stated assessment periods across the intervention groups. The registry record does not report group-level scores, estimated changes, between-group contrasts, confidence intervals, or hypothesis-test results. Consequently, the research question can be described, but its answer cannot be determined from the posted results in this record.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study with an enrollment of 46. It lists Multimodal, General Movement, and Standard of Care as behavioral interventions. The record status is Completed. The listed study start date is 2020-06-04, and the primary completion date is 2022-05-31. The phase is recorded as NA. The sponsor is the University of Delaware.

In a randomized study, assignment is intended to create treatment groups by chance rather than by participant or investigator choice. Randomization can reduce systematic differences between groups at the point of assignment, but it does not guarantee that groups will be identical, particularly in a study with limited enrollment. The registry does not report the sequence-generation procedure, allocation concealment, or the method used to implement assignment. Those details are not reported in the registry record.

Single masking means that the registry records one masking category, but it does not specify which people were masked. Because the interventions are behavioral and involve direct interaction, masking may have practical limits; who was masked and how masking was maintained are not reported in the registry record. The record also does not identify the allocation ratio or clarify whether the primary analysis was planned across all three groups or through selected pairwise comparisons.

The summary describes the intervention period as 8 weeks, with follow-up testing 8 weeks from post-test. The listed primary outcome timeframe therefore includes baseline-to-post-test and baseline-to-follow-up assessments. The arm descriptions mention 16 sessions, 2 sessions per week, and approximately 30-45 minutes per session. These details describe the scheduled programs, not observed attendance or adherence; those data are not reported in the registry record.

The study is marked Completed, but completion status alone does not establish that all enrolled participants completed every assessment or that outcome results were analyzed. Participant flow, withdrawals, assessment completion, and the number included in each analysis 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Standard composite scores (Mean=50, SD=10) for body coordination, strength \& agility, manual coordination and fine motor coordination.

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.

6. Primary Endpoint

The registry lists the primary outcome as Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2), measured over Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test.

The primary endpoint is the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2), a measure of gross and fine motor coordination. The registry names four composite domains: body coordination, strength and agility, manual coordination, and fine motor coordination. Body coordination combines balance and bilateral coordination; strength and agility includes running speed and agility; upper-limb coordination and manual dexterity contribute to the manual coordination composite; and fine motor precision and integration contribute to fine manual control.

The registry describes standard composite scores, with a mean of 50 and a standard deviation of 10 for the listed domains. Higher standard scores represent a better outcome. The record notes that BOT-2 results are standard composite scores, not T-scores. These details provide context for interpreting the scale: they describe its scoring convention, not the results for this study’s participants.

Motor proficiency is relevant to the stated study aim of evaluating motor skills following movement-based training. Repeated assessment can describe change over time, while comparisons between randomized groups can help distinguish changes associated with different assigned programs from changes shared across groups. That is a general rationale for such an endpoint, not a claim about the results of this study.

The primary outcome timeframe includes baseline to post-test after 8 weeks of intervention and baseline to follow-up testing after 8 weeks from post-test. No composite-specific scores, changes, variability estimates, or group comparisons are reported in the registry record. The endpoint’s planned measurement is described, but its observed performance in the trial cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes random assignment, a single-masked parallel design, three behavioral intervention groups, and a continuous primary outcome summarized as a mean. It does not report a statistical analysis plan or analysis results. The following concepts explain how such data are commonly analyzed in general; they should not be read as a description of methods used in this trial unless those methods are explicitly identified in the registry record.

What does a mean summarize?

For a continuous outcome such as a standardized test score, a mean represents the arithmetic average of participants’ measured scores in a defined group and at a defined assessment. A mean can summarize the center of a score distribution, but it does not describe the full spread or shape of that distribution. The registry identifies the mean as the summary parameter and standard error as the dispersion measure for the primary outcome. Actual group means and standard errors are not reported in the registry record.

A standard error describes the uncertainty in an estimated mean, given the data and the assumptions of the calculation. It is not the same as the standard deviation, which describes variation among individual observations. The BOT-2 description gives a standard deviation of 10 for its standard composite scores; that scale reference is distinct from the study’s reported dispersion field. The registry does not provide study-specific standard errors or standard deviations.

How can change over time be compared?

When a measure is collected at baseline and later assessments, analysis may focus on change within each group, differences in change between groups, or adjusted follow-up scores that account for baseline values. These approaches answer related but not identical questions. A within-group change describes how scores changed among participants assigned to that group; it does not by itself show that the change differs from another group. A between-group contrast directly compares outcomes across assigned groups. The analysis approach used for the BOT-2 is not reported in the registry record.

Repeated observations from the same participant are related rather than independent. General statistical methods for repeated measures account for that relationship and can use information from more than one assessment. Such methods require decisions about the outcome scale, time points, group contrasts, and assumptions about missing observations and correlations. The registry does not report which, if any, repeated-measures method was used.

What does a confidence interval add?

General statistical explanation: a confidence interval pairs an estimate with a range reflecting sampling uncertainty under a statistical model. A narrower interval usually indicates greater precision, while a wider interval indicates less precision. The interval does not resolve biases caused by missing data, measurement problems, or an unsuitable analysis. No confidence intervals for this study’s primary or secondary outcomes are reported in the registry record.

A p-value, when used, summarizes how incompatible data are with a specified null hypothesis under the model and assumptions. It does not measure the size or importance of an effect, and it does not establish that a treatment caused an outcome. The registry record does not report p-values or identify a testing procedure. The significance level of 0.05 appears only in the stated planning framework, not as a reported result or a complete account of the trial’s inferential methods.

Why do outcome choices matter?

The BOT-2 endpoint includes several composite domains and assessment periods. If multiple outcomes, times, or group contrasts are examined, the chance of at least one apparently notable result can increase when each is tested without a plan for multiplicity. General approaches include defining a primary contrast in advance, adjusting inference across selected tests, or treating secondary analyses as exploratory. The registry record does not describe a multiplicity strategy or identify one primary comparison among the listed domains and times.

The record says the primary outcome has several categories or time points and is not reduced to one comparison. This means no single numerical contrast is available for a focused interpretation. It does not establish which comparison investigators intended to emphasize or whether results were evaluated in a particular sequence.

What can planning assumptions tell readers?

The stated sample-size framework is a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not observed trial outcomes or observed power. The framework also distinguishes total events for time-to-event settings from participants per arm for other settings. The primary outcome is continuous, but no planning sample-size values are reported in the registry record.

Because no observed effect estimate is reported, no interpretation of a planning illustration as evidence about the study’s findings is possible. Sample-size illustrations describe hypothetical design conditions. They do not show whether the study detected an effect, whether an estimate is precise, or whether the study had adequate power for a particular comparison. The actual sample-size justification and any design calculations used by investigators are not reported in the registry record.

What is not specified about the analysis?

The registry lists 0 analyses. It does not state an analysis population, an intention-to-treat approach, a per-protocol approach, covariate adjustment, a model for repeated outcomes, or a method for handling missing observations. It also does not report an analysis plan, interim analyses, or a prespecified hierarchy of outcomes. These omissions limit the ability to assess whether any eventual estimate would match a prespecified question or depend on particular modeling choices.

General statistical explanation: model assumptions matter because estimates and uncertainty measures depend on how the data are represented. For example, over-dispersion arises when observed variability exceeds what a model assumes; if ignored, standard errors and inferential conclusions can be unreliable. That concept is not evidence that over-dispersion occurred in this trial. The registry does not report a model or distributional checks for the BOT-2 data.

Overall, statistical interpretation would require outcome values, the defined comparison, the analysis population, missing-data methods, and uncertainty estimates. The registry record describes the intended measurements and broad design, but does not report those analytical details or results.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is reported across several BOT-2 composite domains and at more than one assessment period. The registry record explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. It does not identify which domain or time contrast should be treated as the single primary statistical test, nor does it report an adjustment for multiple comparisons.

Multiplicity is a general statistical concern when several outcomes, time points, or group contrasts are examined. If many tests are conducted, some may appear noteworthy by chance even when there is no underlying difference. Prespecifying a primary contrast, adjusting for a defined family of tests, or treating additional comparisons as exploratory are common ways to make interpretation clearer. Which approach, if any, was used in this trial is not reported in the registry record.

The record lists 12 outcome measures and names four secondary measures: the 2-Minute Walk Test, Timed-Up & Go Test (TUG), Developmental Coordination Disorder-Questionnaire, and Sensory Processing Measure (SPM). It does not provide a complete account of how the outcomes were prioritized or how multiplicity across outcomes was addressed.

Missing-data methods are also not reported. The registry does not state how incomplete assessments, withdrawals, or other missing values were handled, whether participants were analyzed according to randomized assignment, or which participants were included in each analysis. The analysis population is not reported in the registry record. These details matter because different assumptions about incomplete data can affect estimates and their uncertainty.

The record lists 46 enrolled participants, but does not report assessment-specific or analysis-specific counts. Enrollment alone cannot show how many participants contributed data at each time point. Without outcome counts and analysis methods, readers cannot evaluate potential attrition bias or determine how sensitive results might be to assumptions about missing observations.

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 lists adverse-event figures by group. For Multimodal, 15 participants are listed at risk for serious adverse events and 0 are listed as affected; the corresponding figures for other adverse events are 15 at risk and 0 affected. For General Movement, the serious-event figures are 16 at risk and 0 affected, and the other-event figures are also 16 at risk and 0 affected. For Standard of Care, the figures are 15 at risk and 0 affected for serious events and 15 at risk and 0 affected for other events. Deaths are listed as 0 in each group.

These entries describe what the registry reports; they do not establish that no adverse events occurred outside the categories or reporting period represented in the record. The definitions, collection procedures, observation period, and completeness of adverse-event reporting are not reported in the registry record. Zero listed events should therefore be read as zero events recorded in these fields, not as proof of no risk.

The at-risk counts are group-specific counts in the safety record and should not be treated as evidence that every enrolled participant contributed to every efficacy assessment. The registry does not report further participant-flow detail. These safety figures also do not answer the primary motor-proficiency question, for which outcome results are not reported.

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

The record establishes that a randomized, single-masked, parallel-group study was conducted to compare behavioral interventions for children with ASD, with motor proficiency measured using the BOT-2. It reports an enrollment of 46, describes three groups, and identifies assessment periods from baseline to post-test and follow-up. These registry entries define the study question and its intended measurement framework.

The record does not report the BOT-2 results, group comparisons, uncertainty estimates, or statistical tests. Therefore, it does not show whether scores changed, whether changes differed across groups, or whether any observed difference was precise. No conclusion that one intervention performed better, worse, or similarly to another can be drawn from the information recorded.

The record’s study summary discusses social communication, motor skills, and cortical markers. It describes the study’s aims and expectations, not observed findings. The listed primary endpoint is motor proficiency, and results for social communication or neural measures are not reported in the registry record. The listed secondary outcomes likewise have no posted estimates in this record.

General statistical explanation: a statistically significant result, if one were reported, would not by itself establish that a difference is large, meaningful, or free from bias. Conversely, a non-significant result would not establish that groups are equivalent. Interpretation requires the estimated contrast, its precision, the chosen comparison, and an understanding of missing data and analysis choices. None of those outcome-specific details is reported in the registry record.

The safety fields list zero serious adverse events, zero other adverse events, and zero deaths for the groups, alongside the stated at-risk counts. These entries are a limited registry summary and do not establish the full scope or completeness of safety monitoring.

The appropriate reading is therefore descriptive: the study was completed and its registry record states a randomized comparison and a planned motor outcome, but the record does not provide results with which to judge the observed outcomes. The research question remains unanswered by the outcome information recorded in this registry entry.

13. Why This Trial Matters Statistically

This trial is statistically notable as a randomized comparison of behavioral movement programs with a motor-proficiency endpoint measured at multiple times. The combination of three intervention groups, several BOT-2 composites, and more than one assessment period creates choices about which contrasts are most important. Clear specification of those choices is essential for readers to distinguish the central question from secondary or exploratory analyses.

The endpoint description also illustrates why measurement details matter. The BOT-2 composites represent different aspects of motor coordination, and the registry states that higher standard scores represent a better outcome. A single overall statement about motor proficiency could obscure differences among domains. At the same time, examining many domains and time points without a clear multiplicity strategy can make results harder to interpret.

Repeated assessment offers a way to examine change over time, including whether patterns persist at follow-up. Statistically, however, repeated observations from the same participant are related, and the analysis should account for that structure. The registry record does not state what method was used, so the intended design cannot be connected to a specific model or set of estimates.

The record also demonstrates the distinction between a completed trial and a complete statistical account. It records enrollment, intervention groups, outcome definitions, and safety counts, but does not report outcome estimates or analysis methods. Without those details, readers cannot assess magnitude, precision, missing-data effects, or the robustness of any comparison. This is a limitation of what the registry record reports, not evidence that the study did or did not produce findings.

Finally, the study summary describes cortical markers as a research aim. Such measures could raise distinct questions about prediction and change, but the registry does not report results or analyses addressing those aims. Keeping planned hypotheses separate from reported estimates is important for sound statistical interpretation.

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.

A major limitation for interpreting this trial from its registry record is the absence of posted outcome results. Although the primary endpoint and assessment periods are described, there are no BOT-2 values, changes, contrasts, confidence intervals, or p-values. The primary motor outcome therefore cannot be evaluated statistically from this record.

The primary outcome covers multiple composites and assessment periods, and the registry notes that it is not reduced to one comparison. The record does not specify which domain, time contrast, or between-group comparison was the principal inferential target. The absence of a reported multiplicity approach further limits interpretation of any selected result, were one available.

Participant flow is not reported. The registry lists 46 enrolled participants and group-specific safety counts, but does not state how many completed each assessment or were included in each analysis. Withdrawals, missing assessments, adherence, and analysis exclusions are not reported. This prevents evaluation of attrition and limits understanding of how the enrolled sample relates to the outcome analyses.

Important design and analysis details are also absent. The record does not identify who was masked, how randomization was implemented, the allocation ratio, the analysis population, a statistical model, covariate adjustment, missing-data handling, or a prespecified analysis plan. These items are not reported in the registry record, so their presence or absence in the conduct of the study cannot be inferred.

The intervention descriptions are incomplete in the registry record. The available text identifies the session schedule and gives a broad description of the groups, including seated play for Standard of Care, but does not provide full details of the activities. The record also does not report adherence or intervention fidelity. These limits make it difficult to characterize the exact contrast between programs.

Finally, the safety entries list zero events in the recorded categories, but definitions, monitoring procedures, and reporting completeness are not described. The record’s safety summary should not be taken as a comprehensive assessment of all possible harms.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effect of Play on Social and Motor Skills of Children With ASD — NCT04258254.
• Registry record last updated 2023-11-21; status last verified 2023-11.
• Results first posted 2023-11-21.
• 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 registry record concerns NCT04258254, titled The Effect of Play on Social and Motor Skills of Children With ASD, with the official title A Multisystem, Multimodal Intervention for Children With ASD. The sponsor is the University of Delaware. The study is marked Completed, with an enrollment of 46, randomized allocation, single masking, and a parallel model. The listed phase is NA.

The study compares Multimodal, General Movement, and Standard of Care behavioral groups. The summary describes 8-week interventions, and the arm descriptions state 16 sessions, 2 sessions per week, and approximately 30-45 minutes of interaction time per session. The primary outcome is the BOT-2, assessed from baseline to post-test and follow-up.

The record lists four secondary measures and 12 outcome measures overall. It reports safety counts by group, with 0 serious adverse events, 0 other adverse events, and 0 deaths listed in each group. It does not report primary or secondary outcome results, analysis methods, missing-data handling, or participant flow. Thus, the record describes the trial’s planned comparison and measurements but does not provide the outcome evidence needed to assess the study findings.