Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention (NCT04354337), a na na study. The primary outcome is Feasibility as Assessed by Adherence.

2. Clinical Question

Statistically, this is a feasibility question rather than a comparative treatment-effect question. It concerns whether participants completed the program as defined by the registry, not whether SIPA changed sleep or disease-related symptoms relative to a control. The record describes the project as developing and pilot testing a technology-based self-management intervention for parents of young children with JIA.

The registry lists juvenile idiopathic arthritis as the condition and names the intervention as Sleep Innovations for Preschoolers with Arthritis. Outcomes for sleep, pain, fatigue, or other clinical effects are not described in the primary endpoint information. Whether those measures were collected, and what they showed, is not reported in the registry record.

3. Trial Design

NCT04354337 is a completed, single-group behavioral intervention study sponsored by the University of Washington. The registry lists an enrollment of 16 and describes an 8-week online program with weekly parent modules. The modules addressed sleep topics and behavioral changes intended to improve a child's sleep. The project is described as developing and testing the usability and feasibility of a self-management intervention.

The study is not described as randomized: allocation is listed as NA, and the model is single group. Masking is listed as none. Consequently, the registry record does not describe random assignment or a masked comparison between groups. A separate control group and a like-for-like comparator are not reported. Findings from this design can describe the enrolled group and the program experience recorded, but cannot by themselves distinguish intervention-related changes from changes that might have occurred over time or for other reasons.

The listed start date is 2020-05-01, and the primary completion date is 2021-03-20. The status is completed. The phase is listed as NA. These registry entries describe the study's administrative design and timing; they do not establish what data were collected at each visit or how participants progressed through the program.

The primary endpoint is feasibility as assessed by adherence immediately after intervention. The record defines adherence in terms of dyads completing all intervention modules and dyads enrolled. However, it does not report the completion count or a numerical adherence result. A sample-size justification, detailed protocol, statistical analysis plan, interim analyses, and analysis-population definitions are not reported in the registry record. They should not be inferred from the study's pilot or feasibility description.

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 numbers are parent-child dyads, each dyad consist of one parent and one child.

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: 16 children; because this intervention is intended to improve children's sleep outcomes, we only collected demographic information about the children.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility as Assessed by Adherence, measured over immediately after intervention.

The primary endpoint is titled “Feasibility as Assessed by Adherence.” It is measured in participants and is defined by the registry as the total number of dyads completing all intervention modules divided by the total number of dyads enrolled. The assessment timeframe is immediately after intervention. This definition makes completion of every module the relevant adherence criterion; partial completion would not meet that stated criterion.

Adherence is used in a feasibility study to describe whether participants engage with the intervention as intended. For an online program with weekly modules, completion can help characterize how much of the planned program participants finished. It is a measure of program engagement, not by itself a measure of improvement in sleep or any other clinical outcome.

The registry lists enrollment as 16, but it does not report the number of dyads completing all modules. It therefore does not provide the observed numerator or a numerical adherence result. The listed endpoint unit is participants, while the definition refers to dyads; the registry does not further explain how those terms were operationalized or whether any enrolled dyads were excluded from the adherence calculation. No interpretation of the completion rate can be made without the reported completion count and denominator used for the calculation.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary endpoint count?

The endpoint is a count-based measure of adherence. Its definition focuses on dyads who completed every intervention module, in relation to all dyads enrolled. A count answers how many participants met the specified completion criterion. A proportion expresses that count in relation to a denominator. The registry gives the definition but does not report the completed-module count or a numerical adherence result, so neither the count nor the resulting proportion can be interpreted from the posted information.

The unit is listed as participants, while the endpoint description uses dyads. A dyad generally identifies a linked participant pair, but the registry does not explain the operational details of that pairing. For a reproducible analysis, those details would matter: the record would need to make clear what counted as one dyad, whether completion was assessed for the parent, child, or pair, and how missing module data affected classification. These details are not reported in the registry record.

How should a count endpoint be analyzed?

General statistical explanation: A count can be presented directly, and a binary classification such as completed all modules versus did not complete all modules can also be summarized as a proportion when the denominator is known. For an adherence outcome, the decision rule should be fixed in advance and applied consistently. Here, the registry supplies the all-modules completion rule, but does not report further details about data handling, the numerator, or an analysis method.

A confidence interval is a way to show the uncertainty around an estimated quantity. For a proportion, it communicates how precisely the observed completion proportion estimates a broader underlying rate under the assumptions of the method. A small pilot can yield imprecise estimates, so the observed count and interval would be more informative than a bare claim of feasibility. No adherence estimate or confidence interval is reported in the registry record.

General statistical explanation: A hypothesis test asks whether data are sufficiently inconsistent with a specified null hypothesis under a chosen statistical model. A p-value does not measure the size or practical importance of an effect, and it cannot substitute for an estimate and its uncertainty. The record lists zero analyses, and no p-value or inferential result is reported. Because the primary endpoint is a feasibility measure and the design is single group, a comparative hypothesis test would not be justified by the design information recorded.

What does the design mean for inference?

The single-group model means that observations are not contrasted with a registered control group. A change from before to after intervention, if measured, could reflect multiple influences, including time or other experiences, as well as the intervention. The primary endpoint is completion, not change over time. No baseline-to-follow-up analysis is described in the registry record.

Masking is listed as none. In general, masking can reduce the influence of knowledge about assigned treatment on some aspects of measurement or assessment. In a parent-facing online behavioral program, masking participants to their program experience may not be feasible, but the registry does not state a rationale or describe outcome-assessor procedures. The fact recorded is simply that masking was none.

How should planning calculations be read?

General statistical explanation: Sample-size planning calculations depend on a target effect, variability assumptions, an error threshold, a design, and an analysis method. They are planning aids, not results from participants. The assumptions recorded for planning illustrations specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. They also distinguish participants per arm for most outcomes from total events for time-to-event outcomes.

Those assumptions describe a two-arm planning setup, whereas the SIPA registry design is single group. The registry does not report a trial-specific sample-size justification, nor does it report an observed effect from which to anchor the illustration. Any planning quantities should therefore be read as hypothetical planning illustrations, not as the study's design rationale, observed power, or evidence about adherence. A sample-size calculation cannot fill in the missing endpoint result.

What statistical details remain unknown?

The registry record does not report the statistical analysis plan, sample-size justification, interim analyses, confidence intervals, hypothesis tests, or analysis populations. It also does not describe how missing endpoint data, incomplete modules, or withdrawals were handled. These omissions limit assessment of reproducibility and precision. They do not show that no such methods were used; they mean that the methods are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intervention Group")
n      <- c(16)
events <- c(12)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intervention Group  16  12  75.0  47.6  92.7  50.5  89.8  50.1  89.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and zero analyses. It does not report a multiplicity strategy, such as a hierarchy among outcomes or an adjustment for making several statistical comparisons. Without an analysis plan or reported tests, it is not possible to determine whether multiplicity was considered or whether any adjustment was used. The primary endpoint is identified, but the relationship between that endpoint and the other listed outcome measure is not described in the registry record.

Missing-data methods are also not reported. In particular, the registry does not say how participants with missing module records, incomplete participation, or unavailable follow-up information were classified for the adherence endpoint. The endpoint definition refers to dyads completing all modules and dyads enrolled, but it does not state whether missing information counted as noncompletion, was excluded, or was handled in another way. The registry also does not report the number with missing endpoint data.

The record does not define an intention-to-treat, per-protocol, or other analysis population. Enrollment of 16 should therefore not be interpreted as confirmation that all 16 contributed evaluable endpoint data. Nor does the record indicate whether all enrolled dyads received the intervention or whether any were excluded from analysis.

These are reporting gaps, not proof that the study lacked internal procedures. The registry record does not report the details needed to reproduce the endpoint analysis, assess possible bias from missingness, or understand how the two listed outcomes were handled together.

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 16 participants at risk in the intervention group for serious adverse events and reports zero affected by serious adverse events. It also reports zero deaths. These are the serious-event figures recorded for that group; they do not provide a complete description of every possible adverse event or of the timing and duration of safety monitoring.

A zero count means that no serious adverse events are recorded among the participants represented in this registry entry. It does not establish that the underlying risk is zero, particularly when the group is small. In general, event counts describe what was observed in the monitored group, while uncertainty about events that could occur in a broader population remains. The registry does not report confidence intervals or additional safety analyses.

The record lists no serious adverse event terms. It does not describe non-serious adverse events in the information available for this analysis, nor does it report how safety events were collected or adjudicated. The zero serious-event count should therefore be read narrowly as a registry report for the intervention group, not as a comprehensive safety conclusion.

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

The study record describes a completed pilot project focused on developing and testing a technology-based sleep self-management intervention for parents of young children with JIA. SIPA consisted of an 8-week online program with weekly modules. The primary feasibility endpoint was defined around completion of all modules, with assessment immediately after intervention.

The registry record does not report how many dyads completed all modules. As a result, the primary endpoint's observed value and precision cannot be assessed from the registry information. Enrollment of 16 is not a substitute for the completion count, and completed study status does not establish that a particular adherence threshold was met.

The design is single group, with no registered comparator. It therefore does not provide a direct comparative estimate of SIPA against another intervention or control condition. The primary outcome is adherence, not a clinical effect. The registry's rationale discusses sleep problems and related concerns such as pain and fatigue, but the endpoint details do not report results for those outcomes. Whether additional clinical outcomes were collected or analyzed is not reported in the registry record.

These limitations do not make the feasibility question unimportant. They define what can be concluded from the registered information: the program and adherence criterion are described, but the adherence result is not. Statistical interpretation requires both a clear outcome definition and an observed estimate, with information about how that estimate was obtained. Here, the definition is available while the count, analysis methods, missing-data handling, and uncertainty are not reported.

The zero serious adverse events and zero deaths recorded among 16 participants at risk are safety observations for this intervention group. They do not establish the absence of all harms or characterize risks beyond the observed group. Taken together, the registry supports a description of the pilot's design and recorded serious-event counts, but does not support a conclusion about adherence performance or clinical effectiveness.

14. Why This Trial Matters Statistically

Feasibility studies address questions that are different from comparative efficacy questions. Before a larger or more definitive evaluation can be interpreted, it is useful to know whether participants can engage with the intervention as intended. SIPA's primary endpoint makes that purpose explicit by defining adherence in terms of completion of all modules.

The statistical value of this endpoint depends on transparent reporting. A completion count, denominator, and clear treatment of missing module information would allow readers to judge engagement and the precision of the estimate. The registry record provides the endpoint definition and enrollment, but not the completion count or numerical adherence result. This distinction is important: a well-defined outcome does not itself show what the study observed.

The single-group design also illustrates why design and research question must be read together. A pilot can describe program uptake and feasibility within its enrolled group. Without a registered comparator, it cannot provide a like-for-like estimate of how outcomes differ from another condition. The registry's primary endpoint is aligned with feasibility, but it does not answer a comparative clinical-effect question.

For statistical interpretation, the record also shows why planning illustrations must be kept separate from evidence. Planning assumptions describe hypothetical designs and target effects; they are not observed outcomes, and they cannot be used to reconstruct a missing adherence result. The two-arm assumptions recorded for planning do not change the single-group design listed for SIPA.

Finally, reporting of analysis populations, missing data, uncertainty, and multiplicity helps readers assess how robustly a feasibility estimate was obtained. Those details are not reported in the registry record. Identifying these gaps is not a judgment about the conduct of the study; it clarifies what can be learned from the registered information and what remains uncertain.

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 most direct limitation for interpreting the primary endpoint is that the registry defines adherence but does not report the number of dyads completing all intervention modules. The registered enrollment is 16, but the record does not provide an endpoint numerator, an analysis denominator, or a numerical adherence result. The endpoint's precision therefore cannot be assessed.

The design is single group, with allocation listed as NA and masking listed as none. A separate control group is not reported, so comparative conclusions are outside what this design description supports. The registry record also does not report baseline or follow-up clinical outcome results, including results for sleep, pain, or fatigue.

Several details needed to judge the endpoint analysis are not reported in the registry record: the analysis population, how missing module data were handled, whether any dyads withdrew, and whether adherence was assessed for all enrolled dyads. The record does not describe the statistical analysis plan, a sample-size justification, interim analyses, confidence intervals, or hypothesis tests. Although two outcome measures are listed, the record does not describe how they were analyzed together.

The planning assumptions recorded describe a two-arm setup, unlike the single-group study design. No trial-specific sample-size justification is reported. These assumptions should not be interpreted as a design description for SIPA or as evidence of observed power.

The safety information is limited to serious adverse events and deaths as recorded for the intervention group. The registry does not report non-serious event details or the safety monitoring procedures. These limitations concern what is reported in the registry record; they do not establish whether additional information exists outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention — NCT04354337.
• Registry record last updated 2025-03-10; status last verified 2025-02.
• Results first posted 2025-03-10.
• 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

NCT04354337 is a completed, single-group behavioral pilot sponsored by the University of Washington. The registry lists 16 enrolled participants and describes SIPA as an 8-week online program with weekly modules for parents of young children with juvenile idiopathic arthritis. Masking is listed as none, and allocation is listed as NA.

The primary endpoint is feasibility as assessed by adherence immediately after intervention. It is defined by the number of dyads completing all modules relative to the number enrolled. The registry record does not report the completion count or numerical adherence result. It lists two outcome measures and zero analyses.

For the intervention group, the registry reports 16 participants at risk for serious adverse events, zero affected, and zero deaths. The study is not a randomized comparison, and no like-for-like control group is reported. The registry record does not report the statistical analysis plan, missing-data methods, analysis populations, or clinical outcome results.