Evaluation of the Aevidum Curriculum and Club: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Aevidum Curriculum and Club (NCT05018689), a randomized na study. The primary outcome is Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4).

2. Clinical Question

The study addresses whether adding a club to the curriculum is associated with a different pattern of change in students’ assessment scores. The registry record describes the primary outcome as knowledge scores, while its assessment description gives response options framed as confidence in responding to depression awareness items. That wording should be kept in mind when interpreting what the score represents.

The research question is school-level in its assignment: participating schools were randomized to an intervention approach. Students are assessed within those schools, so the comparison is not simply between unrelated individuals. The record does not report the numerical change in either arm, the estimated difference between arms, or a confidence interval for that difference. Therefore, the posted information does not establish the direction, size, or precision of the observed change.

3. Trial Design

This was a randomized, parallel-group study with no masking. Schools were assigned to implement the Aevidum curriculum alone or the curriculum with an Aevidum club. The registry record initially describes plans to partner with 12 high schools, with 6 assigned to each group; it also notes that ultimately 10 schools were recruited, with 5 assigned to each group. The enrollment listed is 2557, but the record does not clarify how many students completed each assessment or entered each analysis.

The study dates in the registry record are 2021-09-01 for the start and 2022-05-25 for primary completion, and the status is completed. The primary outcome timeframe is baseline before the intervention and post-study completion, described as an average of 9 months. This aligns the outcome with change over the period in which schools delivered the assigned program.

The curriculum is described as a 5-lesson, 3-hour mental health curriculum designed to be integrated into school health curricula. Schools in the curriculum-plus-club group were also to start an Aevidum club. The record describes school selection of faculty and student leaders and a kickoff web-based training, but detailed implementation and adherence results are not reported in the registry record.

Because assignment occurred by school, the number of randomized schools is important for interpreting the design, distinct from the student enrollment. The record specifies a mixed effects linear regression model for statistical analyses but does not report its full specification. It does not describe the allocation procedure beyond random assignment, concealment, or analysis populations. The results available in the registry record do not include outcome estimates, so the effects of the two assigned approaches cannot be compared from the information reported.

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

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 University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4), measured over baseline (pre-intervention) and post-study completion (an average of 9 months).

The primary endpoint is change from baseline in the University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores, identified as category 1 of 4. The assessment is scheduled before the intervention and after study completion, an average of 9 months later. The registry record describes a continuous score and reports that the planned summaries are mean changes from pre-test to post-test within each study arm, with 95% confidence intervals.

The assessment description lists response options of 1 Not at all confident, 2-4 Moderately confident, and 5-7 Extremely confident. This creates an interpretive detail: the endpoint title refers to knowledge scores, while the listed response anchors refer to confidence. The registry record does not further explain this relationship, scoring, or how responses are combined into a total score.

As a general statistical rationale, a continuous assessment score can capture degrees of response rather than reducing results to a yes-or-no classification. A baseline-to-follow-up change can describe how scores shifted during the intervention period. It is also important to distinguish change within each arm from the contrast between arms: change in both groups alone does not tell whether the groups changed differently. The posted record does not give numerical endpoint estimates or the between-group contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is continuous and described using mean change from baseline. The registry record states that p-values were obtained from a mixed effects linear regression model. It does not provide the model equation, covariates, random-effects structure, handling of baseline scores, or the exact contrast tested. These details matter for understanding what the reported comparison would represent.

What does a mean change describe?

For each participant with the relevant assessments, a pre-to-post change represents the difference between the later score and the baseline score. An arm-level mean summarizes those changes. As a general explanation, this is a useful way to express average movement on a continuous scale, but it does not describe how much individuals vary around that average. A mean may also conceal different patterns among participants or schools.

The record says that outcome data include the difference of mean score from pre to post in each study arm. This describes within-arm changes. The primary scientific comparison, however, concerns whether the assigned approaches differ. A model-based test can address a between-group contrast, depending on how the model and contrast are specified. The registry record does not state the exact contrast used, so the p-values cannot be assigned a more specific interpretation than the stated mixed effects analysis.

Why use a mixed effects model?

As a general statistical explanation, mixed effects models can represent data grouped into clusters, such as students within schools, and can account for correlation among observations in a cluster when the model is specified accordingly. Such models can also accommodate repeated measurements, depending on their structure. This is relevant because the study randomized schools and assessed students over time. The registry record names a mixed effects linear regression model, but does not specify which clustering or repeated-measure terms were included. It should not be assumed from the model label alone that any particular structure was used.

Randomization by school also means the student count and the number of randomized schools carry different information. Many student observations do not automatically provide the same amount of independent information as the same number of observations drawn from many separate schools. As a general principle, within-school similarity can reduce the effective information available for estimating an intervention contrast. The registry record gives 10 recruited schools and enrollment of 2557, but does not report a cluster-correlation estimate or analysis details that would quantify this issue.

How should confidence intervals and p-values be read?

The endpoint description specifies 95% confidence intervals for arm-specific mean changes. In general, a confidence interval communicates both an estimate and its uncertainty, subject to the assumptions of the analysis. It does not give the probability that a particular effect is true. A p-value summarizes how surprising the observed data, or more extreme data, would be under a specified null model. It does not tell readers the size or importance of an effect. A p-value and a confidence interval should therefore be interpreted alongside the estimated contrast and its units.

The registry record gives no numerical confidence intervals, estimates, or p-values for the primary outcome. Therefore, neither uncertainty nor statistical evidence for a between-group difference can be characterized. The score is described as a score on a scale, but the record does not provide enough scoring detail to translate a potential mean difference into a concrete interpretation of the assessment.

What do the planning assumptions mean?

The sample-size planning illustrations are described as calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The intended effect is a stated portion of the observed effect. For outcomes other than time-to-event outcomes, the planning quantities are participants per arm. These are planning illustrations, not observed power, and they are not the trial’s own design justification. The registry record does not report a protocol-based sample-size justification.

As a general explanation, such planning calculations ask how many participants per arm might be needed to detect a chosen effect under stated assumptions. They depend on the effect size used, variability, allocation, and test assumptions. They do not show the probability that the completed trial detected an effect, and they cannot substitute for the actual estimate and uncertainty from the completed analysis. Since primary outcome estimates are not reported in the registry record, the observed effect used for the illustrations cannot be assessed from the outcome information.

What model details remain unclear?

The registry record does not report whether covariates were used, how baseline score was handled in the model, how missing assessments were treated, or whether inference was adjusted for school-level randomization. It also does not identify the exact model coefficient or contrast associated with the p-values. These are not cosmetic details: they affect how an estimate is interpreted and which assumptions support its uncertainty. The model name alone is not enough to reconstruct or independently evaluate the analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 15 outcome measures and 56 analyses. The secondary outcomes include 8 listed categories of change in perceptions of school culture. The primary outcome itself is identified as category 1 of 4. With multiple outcomes and analyses, there can be more opportunities for nominally unusual results to arise by chance. As a general statistical principle, multiplicity procedures may be used to control error rates or to distinguish confirmatory from exploratory analyses. The registry record does not report a multiplicity adjustment, a prespecified hierarchy among outcomes, or which analysis was designated as the principal comparison beyond identifying the primary endpoint.

Missing-data handling is not reported in the registry record. It does not give baseline and follow-up completion counts, reasons for missing assessments, or the method used to include participants with incomplete data. The analysis population is also not reported: the record does not specify whether analyses followed all randomized schools or participants, or whether another inclusion rule was used. Enrollment of 2557 should not be read as the number analyzed for every outcome.

These omissions make it difficult to evaluate the potential influence of missing observations or the implications of examining multiple outcomes and analyses. The record also does not report sensitivity analyses for missing data or multiplicity. Their absence from the registry information does not establish that such procedures were or were not conducted; their status is not reported in the registry record.

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

The available registry information establishes that schools were randomized to the Aevidum curriculum or the curriculum plus club and that the primary assessment was intended to measure change from baseline to post-study completion. It does not provide the numerical primary outcome results. For that reason, it cannot show how scores changed, how much the groups differed, or how precise an estimated difference was.

Even if outcome estimates were available, interpretation would depend on their scale, uncertainty, and the model used. General statistical interpretation distinguishes a difference in average scores from its practical meaning. A confidence interval can show whether the estimate is precise enough to rule out a broad range of values, while the score’s measurement properties and context inform what the estimate means. The registry record does not provide score interpretation thresholds or additional validation details.

The comparison is between assignment to curriculum alone and assignment to curriculum plus club; both groups were assigned the curriculum. Thus, the intended contrast concerns the added club component in the context of the curriculum, not the curriculum versus no program. Since assignment took place at schools, findings would also need to be interpreted in light of the participating schools and implementation conditions. The record does not report delivery fidelity or participation in the club.

The posted adverse-event summary has zeros for serious events, other events, and deaths in both groups. These counts should be read as entries in the registry summary, not as proof of the absence of every possible adverse experience. Most importantly, neither the adverse-event entries nor the study’s completed status answer the primary outcome question. No conclusion that the program did or did not change the measured scores can be drawn without the outcome estimates.

12. Why This Trial Matters Statistically

This study raises a design issue common in school-based research: the intervention is assigned to schools, but outcomes are measured among students. That structure makes it important to distinguish the number of enrolled students from the number of randomized clusters. The record reports 2557 enrolled participants but ultimately recruited 10 schools, with 5 assigned to each group. The student enrollment alone is not enough to judge the precision of a school-level comparison.

Another statistical issue is the difference between within-group change and the contrast between groups. The registry record describes mean pre-to-post changes for each arm and model-based p-values. Clear interpretation requires knowing whether the statistical test addresses the difference between assigned approaches, rather than treating a change in one arm as evidence of a comparative effect. The exact model contrast is not reported in the registry record.

The study also lists multiple outcomes and analyses, including several school-culture outcomes. This makes transparent reporting of outcome priorities, multiplicity handling, and analysis populations important for readers assessing the strength of evidence. Those details are not reported in the registry record. The primary endpoint description also pairs a knowledge-score title with confidence-oriented response anchors, highlighting why operational definitions and scoring rules matter.

These features make the trial statistically informative as a design example even though the outcome estimates are unavailable in the registry record. Its interpretation depends on the school-level allocation, how the score is defined, which contrast is tested, and how uncertainty and multiple analyses are handled. Without those numerical results and details, the record supports careful questions about analysis, not a substantive conclusion about the program’s effect.

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.

A key limitation of the registry information is that it does not report numerical primary outcome results. The mean changes, 95% confidence intervals, and p-values described in the outcome plan are not present in the outcome details for this analysis. The direction, magnitude, and precision of change therefore cannot be evaluated.

The registry record notes a change from an initial plan involving 12 high schools to a final recruitment of 10 schools. It does not explain the reason for this change or provide information about its implications for recruitment or analysis. With school-level randomization, the number of schools is relevant to precision and inference; participant enrollment does not replace that design information.

Important analytical details are not reported in the registry record, including the mixed model specification, the exact between-group contrast, the analysis population, and handling of incomplete assessments. Multiplicity procedures for the 15 outcome measures and 56 analyses are not reported. These gaps limit independent assessment of the statistical approach.

The endpoint wording is another trial-specific limitation: the title describes knowledge scores, but the response options in the description are framed as confidence. The scoring and interpretation are not further explained. The record also does not report intervention fidelity or club participation, so it is not possible to characterize how consistently the assigned approaches were delivered. These limitations concern the available record and should not be interpreted as proof that the study team did not collect or analyze the information.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Evaluation of the Aevidum Curriculum and Club — NCT05018689.
• Registry record last updated 2024-10-18; status last verified 2024-07.
• Results first posted 2024-10-18.
• 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

The registry record describes a completed, randomized, parallel-group study with no masking, comparing the Aevidum curriculum with the curriculum plus club. Although the initial plan described 12 high schools, the record states that 10 were ultimately recruited, with 5 schools assigned to each group. Enrollment was 2557. The study dates were 2021-09-01 through primary completion on 2022-05-25.

The primary endpoint is change in assessment scores from baseline to post-study completion, an average of 9 months. The record specifies mean change summaries with 95% confidence intervals and p-values from a mixed effects linear regression model. It does not report the numerical primary outcome results, detailed model specification, missing-data approach, analysis populations, or multiplicity handling. The adverse-event summary records zero serious events, zero other events, and zero deaths in each group. These registry entries describe the study record but do not establish whether the assigned approaches changed the measured scores.