Family Supportive Supervisor Training and Workplace Assessment Tool: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Family Supportive Supervisor Training and Workplace Assessment Tool (NCT05080426), a randomized na study. The primary outcome is Change in Family Supportive Supervisor Behaviors.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study and identifies the design as cluster-randomized. Managers and employees are organized into intervention and control groups. Because assignment is clustered, outcomes from employees within the same cluster may be related; analysis that treats every employee as statistically independent could misstate uncertainty. The registry record does not report the precise unit of randomization or the number of randomized clusters.

The intervention was Family Supportive Supervisor Training 2.0. Managers in the intervention group were asked to complete an online survey, take the family-supportive training and leave-use module, track their behaviors, and participate in a webinar. Control-group managers were asked to complete surveys. Employees in both groups were asked to complete surveys. The descriptions refer to repeated assessments, with follow-up timing described in several ways in the record.

The study is listed as single-masked, but the identity of the masked participants or study personnel is not reported in the registry record. Allocation is listed as randomized, the model as parallel, and the phase as NA. The recorded enrollment is 1175. The study status is completed, with a start date of 2022-10-27 and a primary completion date of 2023-05-30. These administrative details describe the record, not the completeness of outcome data or the conduct of the analysis.

The registry summary describes a planned evaluation of supervisor behaviors and employee outcomes. It anticipates changes in family-supportive and leave-supportive behavior, leave use, work-family conflict, emotional exhaustion, depressive symptoms, and turnover intentions. These are stated expectations, not reported findings. The record lists secondary outcomes, but does not provide the corresponding effect estimates or analysis results.

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

Analysis population for the primary outcome, as defined in the registry: Employees of trained managers who completed at least one out of three surveys (baseline, 3-month follow-up, 5-month follow-up). Employees could complete follow-up surveys, even if they did not complete the baseline survey.

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: Participants were invited to complete follow-up surveys, even if they did not complete the baseline surveys. The sample size reported in the "Participant Flow" section includes all managers and employees who completed at least 1 of the 3 surveys. The baseline analysis information only includes participants who completed the baseline survey (which is a smaller sample than those included in the "Participant Flow" section).

6. Primary Endpoint

The registry lists the primary outcome as Change in Family Supportive Supervisor Behaviors, measured over 5 months after the intervention.

The primary endpoint is change in family supportive supervisor behavior, expressed in units on a scale. The original scale ranges from 1 to 5. The registry defines the change as the Time 3 score minus the Time 1 score and describes positive change scores as increases in scale values over time. It labels the endpoint timeframe as 5 months after the intervention and describes the surveys as the 5-month post-baseline survey and baseline survey.

This measure is relevant to the intervention because the training is intended to influence supervisors’ family-supportive behavior. Measuring change in employee ratings therefore focuses on a behavior close to the intervention’s stated purpose, rather than only on more downstream employee experiences. In general, a change score expresses how a measure differs over time for the analyzed participants; it does not by itself establish that an intervention caused the change. A comparison between randomized groups and an appropriate analysis are needed to estimate the intervention contrast.

The record does not report the mean change for either group, the between-group difference, a confidence interval, or a p-value. It also does not explain whether any adjustment was made for baseline differences or clustering. The endpoint definition and scale limits are reported, but the primary result and its statistical precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a change score represent?

In general, a change score is calculated by comparing a participant’s measurement at follow-up with that participant’s measurement at baseline. The registry defines the primary measure as Time 3 minus Time 1. Under that sign convention, positive values indicate an increase in the scale score and negative values indicate a decrease. A group mean change describes the average change among the people included in that group’s analysis. It does not, by itself, estimate the causal effect of the intervention.

For a randomized comparison, the central contrast is the difference in outcome change between intervention and control groups, with the analysis accounting for the way assignment occurred. The registry does not report group change estimates, a contrast, or its uncertainty. It also does not report the exact statistical model, covariates, or handling of baseline measurements. Those details are not reported in the registry record, so they should not be inferred from the outcome definition alone.

Why does clustering matter?

General statistical explanation: in a cluster-randomized study, assignment is made to groups rather than independently to each person. People in the same group may experience shared managers, workplaces, or other conditions, and their measured outcomes may consequently be more alike than outcomes from unrelated groups. This within-cluster similarity is often called intracluster correlation. When it exists, the effective information in the data is less than an analysis that assumes complete independence would imply. Standard errors and confidence intervals can be too small if clustering is ignored.

The record identifies the study as cluster-randomized and explicitly cautions that a simple individual-level re-analysis would be misleading. The clusters’ exact definition, their number, and the method used to account for clustering are not reported in the registry record. The sponsor’s own analysis takes precedence; the record does not include that analysis or its numerical findings.

What do confidence intervals and p-values tell readers?

General statistical explanation: a confidence interval communicates the precision of an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while both the interval’s location and width matter for interpretation. An interval can help readers assess which effect sizes remain compatible with the data. A p-value addresses how unusual the observed data would be under a specified null hypothesis and analysis model. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect.

No confidence interval or p-value for the primary endpoint is reported in the registry record. The stated significance level in the planning assumptions is 0.05, but that alone does not establish the test used for the trial’s outcome analysis. The analysis plan, test specification, and any adjustment for clustering are not reported.

How should the planning illustrations be understood?

The registry describes sample-size illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For outcomes other than time-to-event outcomes, the stated quantity is participants per arm; for time-to-event outcomes, it is the total number of events. These are planning illustrations, not observed power and not evidence that the trial was designed or analyzed using those assumptions.

The sample-size justification for the trial itself is not reported in the registry record. Because the primary effect estimate is also not reported, the record does not let readers evaluate the observed-effect basis for any planning illustration or judge whether its assumptions match the trial’s clustered design. A planning calculation should not be confused with the actual number analyzed or the precision achieved.

What can be inferred from the endpoint scale?

The original measure has a minimum value of 1 and a maximum value of 5. That bounds individual scale values, but it does not reveal the observed distribution, mean, variability, or amount of missing data. The endpoint is described as a mean of a continuous measure with standard deviation as the dispersion measure. The registry does not report the group means, standard deviations, or how the scale was summarized in the actual analysis.

Overall, the available methods description identifies the outcome and important design features, but leaves the analysis procedure and results unreported. General statistical interpretation can clarify why randomization, clustering, precision, and missingness matter; it cannot substitute for the missing outcome estimates or sponsor analysis.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Intervention Group - Employees", "Control Group - Employees")
n   <- c(630, 293)
m   <- c(-0.08, 0.06)
sp  <- c(0.78, 0.79)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Intervention Group - Employees  630  -0.080  0.780  -0.141  -0.019
CARM  Control Group - Employees  293  0.060  0.790  -0.031  0.151

11. Multiplicity, Missing Data and Analysis Populations

The record lists 18 outcome measures, including the primary endpoint and secondary employee outcomes. It lists zero analyses. No multiplicity strategy is reported: readers are not told whether outcomes were tested as a family, whether any adjustment was planned, or whether the primary outcome was treated as the sole confirmatory test. When many outcomes are examined, the chance of at least one apparently notable result can increase if each is evaluated independently. General statistical approaches can address this issue, but the registry does not identify an approach used for this study.

Missing-data handling is also not reported. The primary population is described as employees of trained managers who completed at least one of three surveys, and follow-up surveys could be completed without a baseline survey. This definition means the analyzed outcome population is not described as requiring a complete set of baseline and follow-up measurements. The record does not say how change was calculated for people without a baseline score, how incomplete follow-up was handled, or whether any imputation or sensitivity analysis was used.

The analysis population and exclusions are not reported beyond the endpoint population description. It is not stated whether analyses followed randomized assignment, whether participants were excluded after randomization, or how the cluster structure was represented. These omissions limit assessment of selection, attrition, and the extent to which the analysis preserved the randomized comparison. The missing-data and multiplicity methods are not reported in the registry record.

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 reports serious adverse events, other adverse events, and deaths separately for intervention and control managers and employees. For each listed group, the number affected by serious adverse events is 0, the number affected by other adverse events is 0, and deaths are 0. The record also lists no top serious-event terms.

The at-risk counts differ by group: 172 for intervention managers, 80 for control managers, 630 for intervention employees, and 293 for control employees. These are the group-specific denominators reported in the safety record. They should be read alongside the corresponding affected counts, not added together or treated as evidence about outcomes beyond the reported categories.

Zero reported events means that no affected participants were recorded in these registry fields for the listed categories. It does not prove that no event occurred outside the recorded reporting process, and it does not provide detail about event definitions, surveillance, reporting completeness, or exposure time. The registry record does not report those details. These safety figures describe what was recorded and should not be interpreted as a general guarantee of safety.

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

The record establishes that a randomized, parallel-group, cluster-randomized study evaluated Family Supportive Supervisor Training 2.0 and defined change in family supportive supervisor behavior as its primary outcome. It also describes the manager and employee groups, the intervention components, survey assessments, and several secondary outcomes. These registry entries explain the intended comparison and the endpoint’s meaning.

It does not establish what happened to the primary outcome. No group-level change, between-group effect estimate, confidence interval, or p-value is reported in the registry record. The study’s stated expectations about improving supportive behaviors and employee outcomes should not be read as findings. The completed status indicates a study status, not that its results are available in the record.

Even if outcome estimates were available, interpretation would need to account for the clustered randomization and the endpoint population. Employees within clusters can have correlated outcomes, and the endpoint population includes employees who completed at least one survey, even if they did not complete baseline. The record does not state how clustering or missing measurements were handled. Those analysis details affect both the estimated effect and its uncertainty.

The registry’s timing descriptions also require care: the primary endpoint is labelled 5 months after intervention and described using a 5-month post-baseline survey, while the general summary mentions follow-ups at 3 and 6 months after intervention. The record does not reconcile these labels. Accordingly, the endpoint should be understood according to its stated definition, with timing ambiguity acknowledged.

The absence of posted results cannot be interpreted as evidence that the intervention had no effect, just as the study rationale cannot be interpreted as evidence that it had an effect. The record supports a description of the research question and design, but not a conclusion about effect direction, size, precision, or practical importance.

14. Why This Trial Matters Statistically

This study raises statistical issues that are important in workplace intervention research. The intervention is directed at managers, while the primary endpoint is reported by employees. That design links a manager-level intervention to employee-level measurements. A cluster-randomized analysis must respect the structure of assignment so that uncertainty reflects the shared group context rather than treating each employee as fully independent.

The outcome also distinguishes a change within a group from a difference between groups. A positive change score indicates an increase over time under the registry’s sign convention, but the intervention’s comparative effect depends on how that change differs from the control group’s change. Reporting both the estimate and its uncertainty is essential for understanding what the randomized comparison shows.

The record identifies multiple outcomes and repeated surveys, which makes transparent reporting of analysis choices especially relevant. Readers need to know how the primary comparison was defined, how multiplicity was handled, and how incomplete measurements were treated. These details help distinguish planned analysis from exploratory examination and clarify the limits of any conclusion.

Finally, the registry record illustrates the difference between a completed study record and a results record that permits statistical interpretation. Design and endpoint definitions are informative, but they cannot replace effect estimates, precision measures, and an account of the analysis. In this case, the primary result and analysis are not reported in the registry record, so the statistical question remains unresolved.

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.

Several trial-specific limitations in the available record constrain interpretation. First, the primary outcome result is not reported. There is no estimate for either group, no between-group contrast, and no measure of statistical precision. The record therefore does not support a quantitative judgment about the endpoint.

Second, although the study is identified as cluster-randomized, the exact unit of randomization, number of clusters, and method for accounting for clustering are not reported. This matters because the analysis needs to reflect the assignment structure. The record cautions against simple individual-level re-analysis and says the sponsor’s analysis takes precedence, but does not provide that analysis.

Third, the timing descriptions are not fully aligned. The primary endpoint timeframe is stated as 5 months after intervention, and its definition refers to a 5-month post-baseline survey. The general study summary describes assessments at 3 and 6 months after intervention. The record does not explain how these time references correspond.

Fourth, the endpoint population includes employees with at least one survey and permits follow-up without baseline completion. The methods for missing baseline or follow-up data, the analysis population, and any sensitivity analyses are not reported. Multiplicity procedures for the listed outcomes are likewise not described.

Finally, masking details are limited: the study is listed as single-masked, but the masked party is not identified. The registry also does not report the sample-size justification or a full statistical analysis plan. These gaps limit assessment of precision, bias, and the reproducibility of the sponsor’s analysis.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Family Supportive Supervisor Training and Workplace Assessment Tool — NCT05080426.
• Registry record last updated 2024-10-08; status last verified 2024-09.
• Results first posted 2024-08-09.
• 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

NCT05080426 is a completed, randomized, parallel-group, cluster-randomized study of Family Supportive Supervisor Training 2.0. The recorded enrollment is 1175. The listed primary outcome is change in family supportive supervisor behaviors, measured on a scale with values from 1 to 5 and defined as Time 3 minus Time 1. The primary population includes employees of trained managers who completed at least one survey.

The record describes intervention and control groups of managers and employees, and lists secondary employee outcomes. It reports no primary outcome estimates or analyses. The sponsor’s analysis, missing-data methods, multiplicity approach, and details of cluster adjustment are not reported in the registry record. Safety fields show zero affected by serious or other adverse events and zero deaths in each listed group. The result and its precision cannot be determined from this record.