ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff (NCT05574764), a non-randomized na study. The primary outcome is Change in the Self-effectiveness of Teachers After Completion of the CARE (Cultivating Awareness and Resilience in Education) Workshop Using the Teachers' Sense of Efficacy Scale (TSES).

2. Clinical Question

The study concerns teachers’ efficacy in engaging students, using instructional strategies, and managing classrooms. The TSES total score ranges from 1 to 9, with higher scores indicating a greater reported sense of efficacy. The registry also describes scores for the engagement, instruction, and management subscales.

The study’s broader stated purpose is to collect information about school employees’ mental health, well-being, and effectiveness before and after the workshop. Its rationale refers to concerns about the mental health of teachers, school staff, and children since the beginning of the COVID-19 pandemic. The investigators state that they hope the information will help schools, local public health officials, and state leaders consider ways to support teachers’ mental health and well-being.

This is a before-and-after question rather than a randomized treatment-versus-control question. Changes over time can be described for measured participants, but without a suitable comparison group the registry design does not by itself isolate the workshop’s contribution from other influences. No primary endpoint estimates or inferential results are reported in the registry record.

3. Trial Design

The registry describes a completed behavioral study with non-randomized allocation, no masking, and a parallel model. Enrollment was 53, and Duke University is listed as the sponsor. The study start date is 2022-10-31, and primary completion is recorded as 2023-10-03. The phase is listed as NA.

Schools offered the CARE professional development program to teachers, staff, and administrators. CARE was planned as three in-person training sessions over two to three months during the school year. The registry identifies cohorts of teachers, administrative staff, and non-administrative staff. The study concerns questionnaires completed by people taking part in CARE; participation in the workshop and questionnaires was optional.

For the primary outcome, the registry specifies assessments before the intervention, one week after the intervention, and two months after the intervention. The summary also describes questionnaire completion before the workshop and two times after completing it. The described timing therefore provides repeated measurements rather than a single post-workshop assessment.

Non-randomized allocation means the registry does not describe participants being assigned by chance to intervention and control conditions. The record also says there was no masking. It does not describe an untreated control group, a randomization procedure, or methods intended to make the staff cohorts equivalent. The listed cohorts are groups of school employees, not evidence of a randomized comparison.

The registry lists 12 outcome measures, while no statistical analyses are listed. It identifies the study as completed, but completion status does not establish that all planned measurements were collected or that the primary outcome was analyzed. The registry record does not report participant flow, the number assessed at each time point, adherence to workshop sessions, or the number contributing to each endpoint.

Although the record describes a planned primary measure and assessment schedule, it does not report a statistical analysis plan, a sample-size justification, interim analyses, or a protocol for handling repeated observations. Those details are not reported in the registry record. The registry’s stated risks are minimal, with loss of confidentiality described as the greatest risk.

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: Administrative and Non-Administrative Staff groups were combined due to low enrollment in those groups. Per protocol, "If the number of workshop participants for the administrative or non-administrative staff group is less than 10, then these participants will be grouped together."

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in the Self-effectiveness of Teachers After Completion of the CARE (Cultivating Awareness and Resilience in Education) Workshop Using the Teachers' Sense of Efficacy Scale (TSES), measured over Prior to intervention (baseline), 1 week post intervention, 2 months post intervention.

The primary endpoint is change in teachers’ self-efficacy after the CARE workshop, measured using the Teachers’ Sense of Efficacy Scale (TSES). The registry specifies a median and a 95% confidence interval as the summary and dispersion format. The assessment times are prior to intervention at baseline, one week post intervention, and two months post intervention.

The TSES is described as rating teachers’ efficacy in engaging students, providing instructional strategies, and managing classrooms. Its total score ranges from 1 to 9, and higher scores indicate a greater sense of efficacy. Separate scores are also calculated for engagement, instruction, and management. These domains can help characterize which aspects of perceived teaching efficacy are measured, though the registry does not report results for the total score or subscales.

Using a repeated measure before and after a workshop can describe how reported efficacy varies over the assessment period. The median is a measure of the center of observed scores. A confidence interval expresses uncertainty around an estimated quantity under the analysis method used; it does not guarantee that the estimate captures the true value. The registry does not provide the confidence interval calculation method or clarify whether the stated interval applies to each median, a change, or another summary.

The endpoint is a reported scale score, not a direct measure of classroom performance or student outcomes. The registry record does not report the observed medians, confidence intervals, participant counts at each assessment, or a statistical test of change. Consequently, the measurement plan is described, but the size and precision of any observed change are not available from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome summary as a median with a 95% confidence interval. It does not report the analysis used to compare assessments, and no statistical analyses are listed. The concepts below explain what these methods mean in general; they should not be read as a description of analyses actually conducted for this study.

What does a median describe?

In general, the median is the middle value after observations are ordered. It can be useful when a distribution is skewed or includes unusually high or low observations, because extreme values have less influence on the median than on the mean. A median describes the center of a set of scores, but by itself does not describe how widely individual scores vary. The registry specifies a median for the primary outcome but does not report its observed value or the distribution of TSES scores.

What does a confidence interval add?

In general, a confidence interval conveys uncertainty around an estimate under a specified statistical procedure. A narrower interval indicates greater precision under that procedure, while a wider interval indicates more uncertainty. The interval does not show the range of individual participants’ scores, and it does not make an estimate more or less important by itself. The registry names a 95% confidence interval but does not state the calculation method or post any interval values.

How can repeated measurements be analyzed?

General methods for repeated measurements account for the fact that observations from the same participant are related. A comparison of follow-up scores with baseline can be expressed as change scores, or modeled using a method that represents the measurement times and within-person dependence. The choice depends on the question, distribution of the outcome, missingness, and design. These are general possibilities, not reported methods for this study. The registry record does not specify whether the primary analysis would compare medians at each time point, estimate within-person changes, use a repeated-measures model, or follow another approach.

Because the endpoint is summarized by medians, readers should not assume that the intended analysis was a mean-based model. Nor does the registry description establish whether the confidence intervals were calculated for separate time-point medians or for a change between time points. Those details are not reported in the registry record.

Why does allocation matter?

In general, random allocation can help balance measured and unmeasured characteristics across groups, on average. This study is listed as non-randomized and its primary question concerns measurements before and after CARE. Without a randomized comparison group, an observed temporal change cannot by itself separate workshop-related change from other influences occurring over the same period. The listed parallel model and staff cohorts do not make the study a randomized controlled comparison.

What is the role of over-dispersion?

In general, over-dispersion arises when data vary more than a statistical model assumes. If a model fails to account for extra variability, uncertainty estimates can be too small and inferences can be overly confident. This concept is especially relevant for certain count or clustered data models; it is not automatically applicable to every scale-score analysis. The registry does not report an analysis model or identify over-dispersion as an issue for this outcome, so no claim can be made about whether it was assessed.

What can planning calculations tell readers?

In general, sample-size calculations describe how many participants might be needed under assumptions about the effect to detect, variability, significance level, allocation, and analysis. The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect framed as a fraction of an observed effect. Those are planning assumptions, not the trial’s own design justification. The registry does not report a sample-size justification for this study.

Planning illustrations are not observed power. They do not tell readers how likely the completed study was to detect an effect, nor do they establish that an effect occurred. In general, observed power calculated from an observed estimate is not a substitute for reporting the estimate and its uncertainty. Any such planning values should be understood only under the assumptions stated for them, and not as evidence about the actual outcome data.

What analysis details remain unknown?

The registry record does not report the statistical test or model, covariate adjustment, method for calculating confidence intervals, approach to missing measurements, analysis population, or handling of multiple outcomes and time points. It also does not report interim analyses. These details matter because different valid methods can lead to different estimates or uncertainty statements, particularly when measurements are repeated or some follow-up data are unavailable. No particular approach should be inferred from the endpoint description alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures, identifies the TSES change as the primary outcome, and lists no statistical analyses. It does not report a plan for multiplicity: for example, whether inferential testing across outcomes or time points would be adjusted, which comparisons would be considered confirmatory, or how secondary outcomes would be interpreted. Without such a plan, the registry does not establish how the risk of false-positive findings across multiple tests was handled.

The primary endpoint is scheduled at baseline, one week post intervention, and two months post intervention. The record does not specify whether each follow-up would be compared separately with baseline, whether a joint test across follow-ups was intended, or which time point would be the principal contrast. These are important distinctions for interpreting repeated measurements, but no analysis plan is reported.

Missing-data methods and analysis populations are also not described. The record does not state how many participants completed questionnaires at each time point, how incomplete records would be handled, or whether analyses would include all enrolled participants, workshop participants, or only people with complete measurements. Completion status for the study does not answer these questions.

These omissions do not prove that no procedures were used; they mean those procedures are not reported in the registry record. Without results, participant counts by assessment, and analysis details, readers cannot evaluate the consequences of missingness or multiplicity for the primary and other outcomes.

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

The registry record establishes that the study was designed to measure school employees’ mental health, well-being, and effectiveness around participation in CARE, with teacher self-efficacy as the specified primary outcome. It describes the TSES, its score range and domains, and the planned assessment times. It also reports that the study is completed and that enrollment was 53.

It does not establish what happened to TSES scores. No medians, confidence intervals, change estimates, p-values, or analysis results are reported in the registry record. Therefore, the direction, size, and precision of any change cannot be stated. The planned scale and schedule are not evidence of an observed benefit or lack of change.

Even if before-and-after estimates were available, a non-randomized design without a described separate control group would not by itself show that CARE caused any observed change. General influences over time, selection into workshop or questionnaire participation, and differences among schools or staff could matter. These are design considerations, not claims that any particular bias occurred in this study.

The TSES measures a reported sense of efficacy in specified teaching domains. It should not be treated as a direct measure of student mental health, classroom performance, or the mental health of every school employee. The registry describes a broader study purpose, but the primary endpoint is specifically teacher efficacy. Results for other outcomes are not posted in the registry record.

The appropriate interpretation is therefore limited: the registry describes the research question and measurement plan, but does not provide results with which to answer that question. It cannot establish whether scores changed, how reliable an estimate would be, or whether any change was attributable to the workshop.

12. Why This Trial Matters Statistically

This study is statistically interesting because it combines a practical professional development program with repeated measurement of a subjective scale outcome in school staff. The registry makes the primary construct and assessment schedule explicit: teacher efficacy is measured before CARE and at two post-workshop times. That structure raises familiar statistical questions about within-person dependence, change over time, and the interpretation of repeated observations.

The non-randomized design is central to interpreting any potential before-and-after difference. Without a suitable comparison condition, time trends and other contemporaneous influences cannot be cleanly separated from changes associated with workshop participation. This does not make the measurements meaningless; it defines what kinds of claims the design can support.

The registry also identifies several staff cohorts and a broad study purpose involving mental health, well-being, and effectiveness. Keeping the primary endpoint distinct from those broader aims matters: TSES scores represent reported teacher efficacy, while the study’s wider aims do not automatically become measured outcomes or established findings.

Finally, transparent reporting of estimates, uncertainty, participant counts, missing-data handling, and analysis choices is necessary for readers to assess the strength of evidence. The record describes a completed study but posts no outcome analyses. That gap makes it impossible to judge the statistical precision or direction of any change from the registry information alone.

13. 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 main limitation for interpreting this specific registry record is the absence of posted outcome results. Although the primary endpoint and its time points are described, the record does not report the observed TSES scores, confidence intervals, or comparisons. It also lists no statistical analyses. The magnitude and precision of any change therefore cannot be assessed.

The study is non-randomized, has no masking, and does not describe a separate control group. As a result, any eventual pre-post pattern would need to be interpreted with caution regarding causal attribution. The record does not specify methods to address potential differences among participants, schools, or staff cohorts.

The registry does not report participant counts at the individual assessment times, questionnaire completion, workshop attendance, or reasons for missing follow-up data. With enrollment of 53, those details would be relevant to understanding how much information contributed to each outcome and whether the analyzed participants differed from those enrolled.

The record lists 12 outcome measures but does not report analysis methods, a multiplicity plan, an analysis population, or missing-data procedures. It also does not report a sample-size justification or interim analyses. These details are not reported in the registry record and should not be inferred from the planned outcome description or planning illustrations.

Finally, the primary outcome is a self-reported scale of perceived efficacy. Its described domains are teaching-related, but the registry does not establish that it directly measures teaching behavior, student outcomes, or mental health. The record’s stated broader aims should therefore be distinguished from what the primary endpoint itself measures.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff — NCT05574764.
• Registry record last updated 2024-11-12; status last verified 2024-10.
• Results first posted 2024-11-12.
• 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.

17. Record Summary

NCT05574764, titled ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff, is listed as a completed, non-randomized behavioral study sponsored by Duke University. Enrollment was 53. The study start date is 2022-10-31, and primary completion is recorded as 2023-10-03.

Schools offered the CARE professional development workshop in three in-person training sessions over two to three months during the school year. The study concerns optional questionnaires about participants’ demographic information, mental health, well-being, and effectiveness before and after the workshop.

The primary outcome is change in teacher self-efficacy measured by the TSES, with assessments at baseline, one week post intervention, and two months post intervention. The registry lists 12 outcome measures but no statistical analyses. Outcome estimates, confidence intervals, and participant counts by assessment are not reported in the registry record.