Development of Sleep Intervention for Parent and Child: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Development of Sleep Intervention for Parent and Child (NCT05806450), a randomized na study. The primary outcome is Parental Cognition About Child Sleep.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group study with no masking. The study is listed as completed, with enrollment of 190. Its stated purpose was to develop and test an intervention program intended to help manage parental thoughts in parents experiencing child sleep problems. The condition listed is behavioral insomnia of childhood, and the intervention is behavioral.

Participants were assigned to an intervention condition or an active control condition. The intervention was delivered online as three weekly sessions of cognitive therapy and psychoeducation about child sleep. The active control provided psychoeducation about basic sleep structure and sleep hygiene. The record does not describe additional details about how randomization was carried out, whether allocation was concealed, or how adherence to either program was assessed; these details are not reported in the registry record.

The primary outcome was parental cognition about child sleep, assessed at baseline, post-intervention, and follow-up. The listed timepoints are T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), and T4: 12-Week Follow-Up (Week 16). The study also lists seven secondary outcome areas, including parental sleep, child sleep environment and parental interaction, anxiety, and depression. Across the record, 13 outcome measures are listed.

The registry record reports no analyses for the primary outcome and does not give a numerical result comparing conditions or timepoints. The completion status therefore describes the study's recorded status, not the availability of an analyzed outcome 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: Eligibility was confirmed via structured phone screening. Participants completed baseline assessments including psychological questionnaires and actigraphy and auto-videosomnography and were randomly assigned in a 1:1 ratio using a computer-generated sequence with block sizes of 2 and 4. Allocation concealment was maintained via sequentially numbered, opaque, sealed envelopes (SNOSE), opened to determine group assignment. Participants then completed daily sleep diaries for at least 7 days.

Enrolled

T1: Baseline

Reasons for not completing this period:

T2: Post-intervention (Week 4)

T3: 4-Week Follow-Up (Week 8)

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: One parent-child dyad (n = 2) completed baseline assessments but subsequently withdrew consent and was excluded from the final analysis. Parental cognition was assessed in primary nighttime caregivers only (one caregiver per dyad).

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: One parent-child dyad (n = 2) completed baseline assessments but subsequently withdrew consent and was excluded from the final analysis.

6. Primary Endpoint

The registry lists the primary outcome as Parental Cognition About Child Sleep, measured over T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), T4: 12-Week Follow-Up (Week 16).

The primary endpoint is parental cognition about child sleep. It was assessed using the Parental Understanding and Misperceptions about BAby's Sleep Questionnaire (PUMBA-Q), with results expressed as scores on a scale. The record describes the outcome as a mean with standard deviation. Total scores range from 0 to 92, and higher scores indicate more maladaptive sleep-related cognitions.

This measure is relevant to the stated intervention because the program aims to help parents manage thoughts about child sleep problems. A measure of parental cognition can describe the beliefs and interpretations that the intervention is designed to address. It is distinct from a direct measure of the child's sleep itself: the primary endpoint concerns the caregiver's reported cognitions, not an objective measure of infant sleep.

The record lists assessments at T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), and T4: 12-Week Follow-Up (Week 16). Repeated measurements can be used to describe scores over time, but an interpretation of change requires reported results and a defined comparison. The registry record does not report primary-outcome means, standard deviations, or an analyzed comparison across conditions or timepoints. Consequently, the endpoint's measurement properties and intended role can be described, but the direction and precision of any observed intervention effect cannot be evaluated from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: it is a questionnaire score, summarized in the record as a mean and standard deviation. A mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. Together, these statistics can characterize the group distribution, but they do not by themselves show whether two conditions differ. For that, an explicit comparison and its uncertainty are needed. The registry record does not report the primary-outcome means, standard deviations, or comparison estimates.

What does a group comparison tell the reader?

A between-condition comparison asks whether the observed outcome differs between participants assigned to the intervention and those assigned to the active control. A change-from-baseline comparison asks how scores at a later assessment relate to baseline. A repeated-measures analysis can address how scores evolve over several assessments and whether the pattern differs by condition. These approaches answer related but nonidentical questions. The record lists T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), and T4: 12-Week Follow-Up (Week 16), but does not report which statistical model was used or any estimated contrasts.

How should uncertainty be understood?

General statistical explanation: an estimate describes the size and direction of an observed difference, while a confidence interval describes the range of values compatible with the data under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval. A p-value, when reported, addresses how compatible the data are with a specified null hypothesis under the analysis assumptions; it does not measure the size or practical importance of a difference. None of these primary-outcome results is reported in the registry record, so there is no estimate of effect or precision to interpret.

What does randomization contribute?

Randomization is intended to make assigned conditions comparable with respect to both measured and unmeasured characteristics, on average across repeated allocation processes. In a particular study, chance imbalances can still occur. The registry record states that allocation was randomized, but it does not report the randomization procedure, allocation concealment, or baseline characteristics by condition. The record also describes the study as unmasked. That is a design feature to keep in mind when assessing questionnaire outcomes, although the record does not report whether expectations or other influences were measured.

What are the planning calculations for?

General statistical explanation: sample-size planning asks how many participants per arm might be needed to detect a chosen effect under stated assumptions. A planning illustration based on an observed effect is not observed power, and it is not the original trial's design justification. The record's stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect set as a stated fraction of the observed effect. It also says that non-time-to-event planning quantities are expressed as participants per arm. The registry record does not report the observed effect used for such a calculation, any resulting sample-size estimates, or the study's own sample-size justification. Those details are not reported in the registry record.

What can be concluded when no analysis is listed?

The record lists no analyses for the primary outcome, and its notation indicates that the primary outcome's multiple categories or timepoints were not reduced to one comparison. This is not the same as a result showing no difference. It means that an analyzed comparison is not available in the registry record. Without estimates and uncertainty measures, readers cannot distinguish a small, imprecise difference from a larger difference or determine the direction of a result. Any statistical conclusion about the primary outcome would go beyond the information reported.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 13 outcome measures, including the primary measure of parental cognition about child sleep and secondary outcomes covering parental sleep, child sleep environment and parental interaction, anxiety, and depression. Multiple outcomes and repeated assessments create multiple possible comparisons. General statistical explanation: when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for multiplicity. The registry record does not report whether any adjustment or other multiplicity strategy was planned or used.

The primary outcome is assessed at T1: Baseline, T2: Post-intervention (Week 4), T3: 4-Week Follow-Up (Week 8), and T4: 12-Week Follow-Up (Week 16). The record indicates that its multiple categories or timepoints were not reduced to one comparison. It does not identify a single primary contrast among these assessments or report analyses for the outcome. The statistical analysis plan, including the intended handling of repeated measurements and multiplicity, is not reported in the registry record.

For missing data, the record identifies one parent-child dyad (n = 2) that completed baseline assessments, subsequently withdrew consent, and was excluded from the final analysis. It does not state how other missing observations, if any, were handled, whether all randomized participants were included in an analysis, or what analysis population was used. The approach to missing data and the definition of analysis populations are not reported in the registry record.

These reporting gaps limit the interpretation of any outcome claim. The record's completion status and listing of outcome measures do not provide a substitute for analysis details or results.

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 record lists adverse-event counts separately for parents and children in each condition. For the intervention condition, the record lists 47 parents and 47 children at risk; for the active control condition, it lists 48 parents and 48 children at risk. It reports zero serious adverse events and zero other adverse events in each of these four listed groups, and zero deaths in each group.

These figures describe what is recorded for the listed groups; they do not establish that no adverse events occurred outside the registry's recorded categories or observation period. The record does not provide further information about how adverse events were defined, how they were collected, the duration of safety follow-up, or whether events were assessed for relation to the intervention. Such details are not reported in the registry record.

Zero recorded events should not be interpreted as proof that an intervention is risk-free. A reader would need the event definitions, monitoring procedures, and relevant follow-up information to assess how fully the counts capture safety. The figures also do not provide evidence about benefit or about the primary outcome, which is parental cognition about child sleep.

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

The record describes a randomized, parallel-group study comparing a structured online intervention of cognitive therapy and child-sleep psychoeducation with an active control providing basic sleep-structure and sleep-hygiene education. Its primary endpoint is parental cognition about child sleep, measured using PUMBA-Q. This information clarifies the question the study was designed to address and the type of outcome it assessed.

It does not establish whether the intervention changed parental cognition or whether scores differed between conditions. No primary-outcome results, estimated effects, confidence intervals, or p-values are reported in the registry record. The study's completed status does not fill that gap. Without analyzed results, it is not possible to describe a benefit, lack of benefit, direction of difference, or precision of an effect.

The endpoint is a caregiver questionnaire score, not a direct measure of infant sleep. The record lists secondary outcome areas that include parental sleep and child sleep environment, but it does not provide their analyzed results either. Findings about parental cognition, even if available, would not automatically establish changes in those other outcomes.

Similarly, the listed adverse-event counts are descriptive safety information and do not establish that an intervention is risk-free. A registry entry is useful for understanding study design, endpoint definitions, and what outcomes were recorded. To assess the study's findings, readers need the outcome analyses and enough information about methods, missing data, and uncertainty to interpret them. Those results and details are not reported in the registry record.

13. Why This Trial Matters Statistically

This study addresses an important statistical distinction: the intervention is intended to affect parental thoughts about child sleep, and the primary endpoint is a questionnaire about those cognitions. The outcome is therefore aligned with the stated focus of the intervention, but it should not be confused with a direct measure of infant sleep. Keeping the target construct and the measured endpoint distinct is essential when interpreting results.

The active control also matters to the comparison. The question is not simply whether families receiving an intervention changed over time; it is whether the intervention condition differed from a condition that also received sleep-related education. That comparison would help separate effects associated with the structured cognitive-therapy program from changes that might occur with basic sleep education, but the registry record does not report an analyzed comparison.

The assessment schedule includes baseline, post-intervention, and follow-up measurements. Repeated assessments can help distinguish an immediate pattern from one that is sustained at later follow-up. They also introduce choices about which contrast is most important and how repeated measurements should be analyzed. The record lists multiple timepoints and notes that the primary outcome was not reduced to one comparison, while the analysis plan and results are not reported.

For biostatisticians and clinical researchers, the record highlights why design details and results must be read together. Randomization, an active comparator, a defined scale, and a stated follow-up schedule describe a study framework; they do not substitute for estimates, uncertainty intervals, and transparent analysis methods. The absence of reported analyses limits what can be inferred, while making clear which information is needed to evaluate the trial statistically.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpretation is that the registry record reports no primary-outcome analyses. It provides no group means or standard deviations for parental cognition, no estimated between-condition or within-condition contrasts, and no uncertainty measures. Accordingly, the record cannot support a statistical conclusion about the primary endpoint.

The primary outcome has multiple timepoints, and the record indicates that these were not reduced to one comparison. The specific contrast of interest, repeated-measures model, and handling of multiplicity are not reported in the registry record. Without those details, even a later isolated result would be difficult to place within the intended analysis framework.

The record describes the study as randomized and unmasked but does not report the randomization procedure, allocation concealment, baseline characteristics by condition, or adherence information. Since the endpoint is a questionnaire measure of parental cognition, the absence of masking may be relevant to interpretation; however, the record does not report whether potential expectation effects were evaluated.

The record notes that one parent-child dyad (n = 2) withdrew consent after baseline and was excluded from the final analysis. It does not describe the handling of other missing observations, the analysis population, or whether any additional participants were excluded. The rationale for the enrollment target and the trial's own sample-size justification are also not reported in the registry record.

Finally, the adverse-event entries do not include definitions, collection procedures, or a stated safety follow-up period. These limitations are specific to the information available in the registry record and should not be mistaken for evidence that the study itself did or did not address these matters.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Development of Sleep Intervention for Parent and Child — NCT05806450.
• Registry record last updated 2026-10-30; status last verified 2026-08.
• Results first posted 2026-10-30.
• 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 describes a completed, randomized, unmasked, parallel-group study of an online cognitive-behavioral intervention for parents of children with behavioral insomnia of childhood. Enrollment is listed as 190. The intervention consisted of three weekly online sessions of cognitive therapy and psychoeducation about child sleep; the active control provided education about basic sleep structure and sleep hygiene.

The primary outcome was parental cognition about child sleep, assessed with PUMBA-Q at baseline, post-intervention, and follow-up. Higher scores indicate more maladaptive sleep-related cognitions. The record lists 13 outcome measures and reports no analyses. It does not report an analyzed primary-outcome comparison or the statistical plan, missing-data approach, and multiplicity strategy.

Adverse-event entries report zero serious events, zero other events, and zero deaths in each listed parent and child group. Further details about event definitions and safety follow-up are not reported in the registry record.