Self-Management in Parents of Technology-Dependent Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Self-Management in Parents of Technology-Dependent Children (NCT04105244), a randomized na study. The primary outcome is Psychological Outcome- Health Related Quality of Life.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial of a behavioral resourcefulness intervention for parents of technology-dependent children. The study status is completed. The recorded enrollment is 202. The sponsor is University Hospitals Cleveland Medical Center. The registry lists the study start as 2019-07-08 and primary completion as 2022-12-21. The phase is listed as NA.

Participants were assigned to Resourcefulness Training Intervention© or Attention Control. The intervention combines individually tailored instruction in personal and social resourcefulness skills, a resourcefulness video and intervention nurse, journal-writing instruction, and access to a study website with video. The attention-control arm receives weekly phone calls for the first 4 weeks and calls at 2 and 4 months post-enrollment, in addition to the current standard of care described in the record. The registry does not report further details about the allocation process or the intended recipients of masking.

The primary outcome is mental health-related quality of life. Its timeframe is described as change measured over 9 months, with assessments at baseline and 6 weeks, 3 months, 6 months, and 9 months after baseline. The registry also lists secondary outcomes concerning the number of technology-dependent children with ER visits and the number with rehospitalizations. Eight outcome measures and five analyses are recorded, but the record does not give the full analysis specification or results for those measures.

The recorded enrollment and the numbers in the adverse-event risk groups refer to different reporting fields; they should not be combined to infer a total analyzed population. The registry notes that primary-outcome row counts can differ from the overall number analyzed because some participants withdrew or were lost to follow-up. The size and timing of missingness by arm 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: There were 5 participants who signed the consent form but did not complete the baseline surveys and therefore they were not randomized and therefore not analyzed.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.

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 Psychological Outcome- Health Related Quality of Life, measured over Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline.

The primary endpoint is mental health-related quality of life, measured using the Patient-Reported Outcomes Measurement Information System Short Form version 1.2 Global Health measure. The record describes a ten-item instrument with a score range of 10 to 50. It reports a Global Mental Health score converted to a T-score metric, and indicates that the measure produces physical and mental health scores. The primary outcome named in the record is the mental health-related score.

The record states that a higher PROMIS T-score represents more of the concept being measured or better mental health. It also describes the reference metric: the PROMIS scores have a mean of 50 and a standard deviation of 10 in a referent population, and 10 points on the T-score metric correspond to one standard deviation. These details help readers understand the scale; they do not provide the trial’s observed scores or indicate how participants in either arm changed.

Health-related quality of life is used to represent a caregiver-reported aspect of mental health, rather than a direct measure of caregiving tasks or children’s clinical status. The registry sets assessments at baseline and at 6 weeks, 3 months, 6 months, and 9 months after baseline. Repeated assessments can describe how scores change over follow-up, but the record does not report the specific summary contrast or statistical model used. No arm-specific endpoint values, change estimates, confidence intervals, or test results are reported in the registry record, so the endpoint’s observed pattern cannot be assessed from the available record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

In general, randomization assigns participants to study arms using a chance-based process. Its purpose is to reduce systematic differences between groups at the point of assignment, so that a later comparison can be more informative about the intervention. Randomization does not guarantee that the groups will be identical in every characteristic, and it does not remove the need to report how participants were analyzed. The registry identifies this trial as randomized, but does not report the allocation sequence, concealment procedures, or the analysis population.

What does a parallel design mean?

In a parallel trial, participants are assigned to an arm and followed within that arm rather than switching through treatment conditions as part of the design. The record lists this study as parallel and identifies Resourcefulness Training Intervention© and Attention Control as the arms. A comparison between arms would need to account for the outcome definition and follow-up schedule. The registry does not report the exact statistical model or contrast used for the primary endpoint, so a specific analysis method should not be inferred from the design label alone.

How should masking be understood?

The record labels the study double-masked. Masking generally means that some people involved in a study are kept unaware of assigned treatment, which can reduce the influence of expectations on some aspects of study conduct or assessment. The registry does not say which people were masked or how masking was maintained. Because the intervention includes instruction, journal writing, and access to video, the label by itself does not establish how masking applied to participants, staff, or outcome assessment.

What does a continuous outcome represent?

The primary outcome is a score on a scale, summarized in the record as a mean with standard deviation. A mean describes the average score in a group, while a standard deviation describes the spread of scores around that average. A group mean alone does not show how individual scores are distributed, and a group’s change from baseline is not automatically the same as the difference in change between arms. A between-arm estimate and its uncertainty are needed to interpret a comparative result. Those estimates are not reported for this endpoint.

The PROMIS measure uses a T-score metric. In general, a standardized score places measurements on a reference scale to support interpretation across respondents or measures. The registry states that the referent population has a mean of 50 and standard deviation of 10, and that 10 points on the metric correspond to one standard deviation. These are scale-reference details, not observed values from this trial. The record also states that higher scores represent more of the measured concept or better mental health.

Why do repeated measurements matter?

The endpoint timeframe includes baseline and follow-up at 6 weeks, 3 months, 6 months, and 9 months. Repeated measurements can show the course of an outcome and may allow comparison of patterns over time. Statistical analysis must account for the fact that measurements from the same participant are related rather than independent. General approaches can model within-person correlation or compare prespecified summaries, but the registry record does not report which approach was used. It therefore does not support attributing any particular model or repeated-measures method to this trial.

When measurements are taken at several follow-up times, the choice of time point or overall summary affects the question being answered. A comparison at a single visit asks whether the arms differ at that visit; a comparison of change asks how changes from baseline differ; and a model of the full trajectory addresses a broader pattern across visits. The registry describes the timeframe but does not specify which of these contrasts underlies the primary analysis. The result estimates and their uncertainty are also absent.

What do standard deviations and confidence intervals convey?

In general, a standard deviation describes participant-to-participant variability, whereas a confidence interval describes uncertainty about an estimated quantity such as a mean or between-arm difference. These statistics answer different questions. Variability can be substantial even when an estimated group average is precise, and precision depends on the amount and structure of information available. The registry lists standard deviation as the outcome dispersion measure, but does not report the observed standard deviations or confidence intervals for the primary endpoint.

A confidence interval is useful because it presents a range of estimates compatible with the data and analysis assumptions, rather than relying only on whether a statistical test crosses a threshold. The interval’s location speaks to direction and size, and its width speaks to precision. No interval is reported for the primary comparison, so neither the plausible range of effects nor the precision of the estimate can be assessed from this record.

What can the sample-size illustration establish?

General sample-size calculations estimate how many participants may be needed to detect a specified effect under stated assumptions. Such calculations are planning illustrations, not results observed in a completed trial. The record describes an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; it says the effect to detect is a stated fraction of the observed effect. It also distinguishes participant-per-arm planning illustrations from total-event illustrations for time-to-event analyses. These assumptions do not establish the trial’s original design rationale or observed power. The registry record does not report the trial’s own sample-size justification.

In general, over-dispersion occurs when the observed variation is greater than a model assumes. If it is ignored, uncertainty may be understated and inference can be unreliable. This is a general consideration for statistical modeling, not a reported feature of this trial. The registry does not describe an over-dispersion assessment or indicate that it was relevant to the primary continuous outcome.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures and five analyses, alongside a primary mental health-related quality-of-life outcome and secondary outcomes concerning ER visits and rehospitalizations. When a study examines multiple outcomes, time points, or statistical comparisons, multiplicity is a general concern: the chance of at least one apparently notable result can increase as the number of tests increases. A prespecified hierarchy or adjustment can help interpret several comparisons, but the registry record does not report a multiplicity strategy. The number of listed outcomes and analyses does not by itself establish how many tests were performed or how they were handled.

The primary outcome includes baseline and follow-up at 6 weeks, 3 months, 6 months, and 9 months. The registry does not say whether the primary comparison focused on a single follow-up, change from baseline, or an overall trajectory. Nor does it report whether the analysis plan designated one primary time point or controlled inference across the measurement schedule. Without that information, the relative status of any time-specific result cannot be assessed.

Missing data are also relevant. The record states that outcome row counts differ from the overall number analyzed because some participants withdrew or were lost to follow-up. It does not report how many observations were missing at each visit, whether missingness differed between arms, why participants withdrew or were lost, or how missing measurements were handled. General methods may use assumptions or models to address incomplete follow-up, but the method and assumptions used are not reported in the registry record.

The analysis population is not specified. The record does not say whether the primary analysis followed original randomized assignment, included only participants with observed outcomes, or used another population definition. These details affect what a treatment comparison estimates and how it should be interpreted. In the absence of reported outcome estimates, analysis methods, and missing-data details, the primary result cannot be evaluated for multiplicity, attrition, or population-specific interpretation.

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 reports serious adverse events, other adverse events, and deaths separately for the listed arms. For Attention Control, the risk groups are 97 for serious and other adverse events, with 0 serious events, 0 other events, and 0 deaths recorded. For Resourcefulness Training Intervention©, the corresponding risk groups are 100, with 0 serious events, 0 other events, and 0 deaths recorded. These are the registry’s reported safety figures for the categories shown.

A zero in a reported event count means that the record lists no events in that category for the stated risk group. It does not, by itself, establish that an event is impossible or that no events could occur outside the reporting period or definitions. General interpretation of safety data also depends on the duration of observation, event definitions, completeness of reporting, and the population included in the risk group. Further detail on these matters is not reported in the registry record.

The safety counts should not be used as a substitute for the primary outcome results. They concern adverse-event reporting, whereas the primary endpoint concerns mental health-related quality of life. The record lists no top serious-event terms and provides no event descriptions beyond the zero counts. The recorded enrollment is 202, but it should not be combined with the arm-specific risk-group figures to create a new denominator or total.

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

The record establishes that a randomized, double-masked, parallel study of Resourcefulness Training Intervention© was conducted in parents of technology-dependent children, with Attention Control as the comparator. It describes the intervention components, the planned primary mental health-related quality-of-life measure, and the follow-up schedule. It also records the study as completed and includes safety counts for the listed arms. These registry entries describe the trial and its reporting, not the intervention’s effect.

The registry record does not report primary outcome scores, arm-specific changes, a between-arm estimate, confidence intervals, or a statistical test. Therefore, the direction and size of the primary comparison are unknown from this record, as is its precision. It is not possible to say whether the observed data favored either arm, whether the arms were similar, or whether a clinically meaningful difference was present. The stated study goal cannot substitute for those missing results.

The scale description supports interpretation of the measure in general: higher PROMIS T-scores represent more of the measured concept or better mental health, and the score is referenced to a population metric described in the record. That information does not reveal the participants’ scores. Similarly, the measurement schedule indicates when outcomes were intended to be assessed, but does not establish that every assessment was completed or show how scores changed over time.

The registry also lists children’s ER visits and rehospitalizations as secondary outcomes without reporting their results. The absence of reported results for these outcomes means their patterns cannot be assessed from the record. The safety entries report zero serious events, other events, and deaths in the listed risk groups, but they do not resolve questions about the primary endpoint or the study’s broader objectives.

In general, a trial result should be interpreted using its estimate, uncertainty, analysis population, and missing-data handling, together with the outcome’s meaning and study context. Several of these elements are not reported in the registry record. The conclusions supported are consequently limited to the documented design, measures, follow-up plan, and recorded safety counts—not an assessment that the intervention did or did not improve caregiver health.

13. Why This Trial Matters Statistically

This trial addresses a statistical question in a population for whom the registry describes substantial caregiving demands: whether a behavioral resourcefulness intervention is associated with a difference in caregivers’ mental health-related quality of life compared with an attention-control condition. The question combines a patient-reported continuous score with repeated follow-up, making the definition of change and the treatment contrast important to interpretation.

Several aspects are statistically relevant. The randomized parallel design supports a between-arm comparison in principle, while the repeated assessments create a need to account for within-person correlation. The registry also notes withdrawal or loss to follow-up, making the amount and handling of missing data important. Multiple outcome measures and analyses raise a general need to understand which comparisons were primary and how other analyses were interpreted. The record does not report enough detail to resolve these analysis questions.

The endpoint is expressed on a T-score metric with reference information, which can help readers understand the scale’s direction and units. Yet scale interpretation alone cannot establish an intervention effect. An estimate and its confidence interval are necessary to describe both the observed difference and its precision. Because these results are absent, the record does not permit evaluation of the primary comparison or its uncertainty.

The registry’s planning illustration is also distinct from trial evidence. A planning calculation can show what sample sizes might be associated with stated assumptions, but it does not reveal the realized precision or prove that the study was adequately powered. The record explicitly describes the illustration as based on the observed effect rather than the trial’s own design, and the trial’s own sample-size justification is not reported.

For readers assessing clinical-trial evidence, this record illustrates why design information and outcome results must be read separately. A completed randomized study and a detailed measure description do not replace reported estimates, uncertainty, and analysis methods. Those missing details limit the statistical conclusions that can be drawn.

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 central limitation for interpreting this trial from the registry record is that the primary endpoint results are not reported. There are no arm-specific scores, changes, between-arm estimates, confidence intervals, or test results. The record therefore does not permit assessment of the primary outcome’s direction, magnitude, or precision.

The endpoint is assessed repeatedly from baseline through 9 months, but the specific primary comparison is not described. The record does not report whether the analysis targets a particular follow-up, change from baseline, or an overall pattern across visits. It also does not specify the statistical model or whether baseline values were incorporated into the primary analysis. These omissions prevent a detailed assessment of the estimand and its assumptions.

The record states that some participants withdrew or were lost to follow-up and that outcome row counts can differ from the overall number analyzed. It does not report missingness by arm or visit, reasons for missing data, or the method used to address incomplete observations. The analysis population is also not specified. These details are important for judging whether the analysis represents the randomized groups or a subset with observed outcomes.

The registry lists multiple outcome measures and analyses, but does not report a multiplicity strategy or the statistical plan. The intervention components and comparator procedures are described, but treatment receipt, adherence, and fidelity are not reported. The masking designation is recorded as double, while the people masked and the procedures used to maintain masking are not specified. The record does not report the original sample-size justification; the described sample-size material is a planning illustration based on the observed effect, not the trial’s own design rationale.

These limitations concern the information available in the registry record. They do not establish that the study lacked analyses or procedures; they mean those details are not reported in the registry record. Consequently, the record supports description of the design and planned measures but not a complete appraisal of the primary outcome findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Self-Management in Parents of Technology-Dependent Children — NCT04105244.
• Registry record last updated 2024-06-06; status last verified 2024-05.
• Results first posted 2024-06-06.
• 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 NCT04105244, a completed randomized, double-masked, parallel trial of Resourcefulness Training Intervention© for parents of technology-dependent children. The comparator is Attention Control, with weekly phone calls for the first 4 weeks and calls at 2 and 4 months post-enrollment, alongside the described standard of care. The recorded enrollment is 202; the sponsor is University Hospitals Cleveland Medical Center.

The primary outcome is mental health-related quality of life measured with the PROMIS Short Form version 1.2 Global Health measure. Assessments are described at baseline and 6 weeks, 3 months, 6 months, and 9 months. Secondary outcomes concern ER visits and rehospitalizations among technology-dependent children. The record reports zero serious adverse events, other adverse events, and deaths in each listed risk group.

Primary outcome results, analysis details, and missing-data methods are not reported in the registry record. Accordingly, the record documents the trial question, design, outcome measure, and safety counts, but does not establish the direction, size, or precision of the primary comparison.