The Elders' Resilience Curriculum: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Elders' Resilience Curriculum (NCT06045273), a na na study. The primary outcome is Change in Reasons for Life as Assessed by the Reasons for Life Scale.

2. Clinical Question

3. Trial Design

The registry record describes a completed, single-group behavioral intervention study of the Elders' Resilience Curriculum. Enrollment is listed as 72. The intervention group is described as youth aged 9-14 who received the curriculum. The study has no listed phase, and allocation is recorded as NA. Masking is recorded as none. These details indicate that the registry does not describe a randomized, masked comparison between intervention and control groups.

The intervention was developed as a culturally grounded, strengths-based, school-based program taught by White Mountain Apache Tribe Elders. The stated research goal was to better understand whether and how it promotes connectedness, cultural strengths, and reasons for living among American Indian youth. This aim is broader than the primary outcome alone: the listed primary measure is change in Reasons for Life Scale scores, and a secondary outcome concerns change in awareness of connectedness.

The study start date is 2023-11-15, the primary completion date is 2024-05-16, and status is completed. The primary outcome timeframe is baseline and 26 weeks. The registry lists 3 outcome measures and 3 analyses, but does not report the full set of outcome definitions or the methods used for each analysis.

Because this is a single-group study, any change over time is a within-group observation. Without a concurrent control group, the record cannot distinguish change associated with receiving the curriculum from change that might have occurred for other reasons. Allocation procedures beyond the registry's NA entry, recruitment details, and additional design features 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.

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 Reasons for Life as Assessed by the Reasons for Life Scale, measured over Baseline, 26 weeks.

The primary endpoint is change in Reasons for Life Scale score, measured from baseline to 26 weeks. It uses 11 self-report items about beliefs and experiences that make youth feel life is enjoyable, worthwhile, and meaningful. Each response ranges from 1 (not at all) to 3 (a lot); higher scores indicate more reasons for life. Total scores range from 11-33, with higher totals also indicating more reasons for life. The record says change was calculated from the difference between endline and baseline responses.

This measure is relevant to the program's stated goal of promoting reasons for living. A repeated score can describe whether participants' reported reasons for life changed over the study timeframe. It is a self-report measure, so it reflects participants' answers to the scale rather than an independently observed behavior or event. The record does not report details about how the scale was administered, whether assistance was available, or how incomplete item responses were handled.

The endpoint's interpretation depends on the actual change estimate and its uncertainty. Neither is reported in the registry record. Therefore, the endpoint description alone cannot show whether scores increased or decreased, the size of any change, or how precisely that change was estimated. Nor can a within-group change by itself establish that the curriculum caused a change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a change score represent?

The primary outcome is a continuous measure, and the registry identifies the summary parameter as a mean. Change is defined as the difference between endline and baseline responses. In general, a mean change describes the average within-participant shift in a score over the measurement interval. Its interpretation depends on the scoring direction: here, higher Reasons for Life Scale scores represent more reasons for life. The registry record does not report the mean change, so its direction and size cannot be stated.

The record identifies standard error as the dispersion measure. In general, a standard error describes the precision of an estimated mean, rather than the spread of individual participants' scores. It can help readers understand how much uncertainty surrounds a sample mean estimate. A confidence interval would provide a range of values compatible with the data and analysis assumptions, but no confidence interval is reported in the registry record. The scale's range and response options describe possible scores; they do not reveal the observed distribution of scores in this study.

What would a comparison add?

For a continuous outcome, a controlled comparison would ordinarily contrast outcome changes or endpoint values between intervention and comparison groups, with an estimate of uncertainty. This study is listed as single-group, with allocation recorded as NA and no separate comparator described. Its design therefore supports a description of change over time in curriculum recipients, but not a direct treatment-versus-control contrast.

This distinction matters because a pre-intervention measurement is not the same as a concurrent control group. The baseline score provides a reference for describing later scores, but does not capture other influences that may affect outcomes over time. General examples include changes in circumstances, maturation, or measurement conditions; the registry record does not say whether any such influences occurred in this study. Consequently, an observed within-group change, if reported, would not alone identify the curriculum's causal effect.

How should uncertainty be read?

In general, estimates from a study are subject to sampling variability. A standard error or confidence interval communicates some of that uncertainty. A narrow interval indicates greater precision under the analysis assumptions, while a wide interval indicates less precision. Precision is not the same as validity: an estimate may be precise yet still be affected by design limitations, measurement issues, or missing data. Here, no primary outcome estimate or uncertainty interval is reported in the registry record, so neither statistical precision nor the compatibility of the data with different possible changes can be evaluated.

The registry record does not describe the statistical model, distributional checks, covariate adjustment, or handling of repeated measurements. It is therefore not possible to determine whether the analysis used a simple mean change or another method, or what assumptions were checked. No inferential conclusion should be inferred from the endpoint definition alone.

What do the planning illustrations mean?

The planning illustrations are described as calculations based on the observed effect, rather than as the trial's own design justification. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. For continuous outcomes, the illustrations are participants per arm; time-to-event illustrations, if present, give total events. These assumptions describe a hypothetical planning exercise, not the design of this single-group study.

Such illustrations can show how a hypothetical future comparison's size would vary with the target effect and assumptions. They do not establish the probability that this completed study detected an effect, and they are not observed power. The registry record does not report the study's sample-size justification or the protocol's planning assumptions. The illustration should therefore be kept separate from the question of how the actual study was designed.

Finally, no sponsor analysis result is reported for the primary outcome in the registry record, and no recalculated estimate is available to interpret. Any eventual analysis should be read with its stated estimand, population, missing-data handling, and uncertainty in view. Those details are not reported in the registry record.

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("Elders' Resilience Curriculum Recipients")
n   <- c(72)
m   <- c(2.36)
sp  <- c(0.0351)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
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  Elders' Resilience Curriculum Recipients  72  2.360  0.298  2.290  2.430

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and 3 analyses. The primary outcome is change in Reasons for Life Scale score; a listed secondary outcome is change in awareness of connectedness. The record does not give the complete outcome set, identify which analysis corresponds to each outcome, or describe whether additional outcomes or comparisons were examined.

When multiple outcomes or analyses are considered, the chance of at least one apparently notable result can increase if each is assessed separately. Methods such as prespecifying a primary outcome, controlling an overall error rate, or treating secondary analyses as exploratory can help readers interpret a collection of findings. These are general statistical considerations. The registry record does not report whether multiplicity was addressed, whether analyses were prespecified, or whether any adjustment was used. With no posted estimates or test results, the impact of multiplicity cannot be evaluated.

The record does not report the number of participants with observed primary outcome measurements at baseline or 26 weeks, the amount or pattern of missing data, or the approach to incomplete records. It also does not state whether all enrolled participants were included in each analysis or define an analysis population. Those omissions matter because the participants contributing to a change estimate may differ from the enrolled group if measurements are missing. No imputation, sensitivity analysis, or complete-case approach can be assumed.

The listed enrollment is 72, but it should not be treated as the denominator for every endpoint analysis without reported analysis-specific data. The record does not report whether participants who did not complete measurement were retained in an analysis or how their data were handled. Consequently, the representativeness of any outcome estimate cannot be assessed from 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 lists 0 participants with a serious adverse event among 72 at risk in the Elders' Resilience Curriculum Recipients group. It also lists 0 participants with other adverse events among 72 at risk, and 0 deaths. These are the recorded figures for the group; they are counts, not comparative estimates of risk.

A zero count means no events of the listed type were recorded for the stated at-risk group in the registry entry. It does not prove that the true event risk is zero, and it does not establish how the figures compare with what would have occurred without the intervention. There is no separate control group in the listed design.

The registry record does not report the safety-monitoring procedures, the definitions used to classify events, the follow-up period for adverse-event collection, or whether all participants were monitored throughout that period. The primary outcome timeframe is baseline and 26 weeks, but the safety reporting timeframe is not specified. These limitations restrict how much can be inferred from the zero counts. The figures should be read as the registry's reported event counts, not as evidence that risk was absent.

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

The record establishes that the study evaluated a behavioral, culturally grounded curriculum in a single group of youth aged 9-14. Its primary outcome was change in Reasons for Life Scale scores from baseline to 26 weeks. The measure is intended to capture beliefs and experiences that make life feel enjoyable, worthwhile, and meaningful; higher scores indicate more reasons for life.

What the record does not establish is whether scores increased or decreased, how large any change was, or how precise an estimate may have been. The primary outcome result is not reported in the registry record. Without an estimate and its uncertainty, a statistical conclusion about change cannot be drawn from this entry.

Even if a within-group change were available, the single-group design would not establish that the curriculum caused it. Changes over time can have multiple explanations, and the record does not include a concurrent comparison group to help distinguish them. This is a limitation of causal interpretation, not a judgment about the cultural relevance or importance of the program.

The study's stated aims include connectedness and cultural strengths as well as reasons for living. The registry identifies awareness of connectedness as a secondary outcome, but does not report its result or details about the other listed outcomes. The available record therefore does not permit a full assessment of those broader aims.

The adverse-event entry reports zero serious adverse events, other adverse events, and deaths in the listed intervention group. Those counts describe what was recorded, not proof of no risk. Taken together, the registry record is informative about the study's design and measurement focus, but it does not provide the outcome findings needed to assess whether participants' scores changed.

14. Why This Trial Matters Statistically

This study raises statistical questions that are important when evaluating behavioral interventions in specific cultural and community settings. The registry describes a program taught by White Mountain Apache Tribe Elders and intended to promote connectedness, cultural strengths, and reasons for living among American Indian youth. Its primary measure focuses on reasons for life, an outcome aligned with part of that stated goal.

Statistically, the distinction between describing change and estimating a causal effect is central. Repeated measurement can show how scores among participants vary over time. A single-group design, however, does not provide a concurrent counterfactual comparison. That means the interpretation of any change must remain descriptive unless stronger design or analysis information is available. The registry record does not report such additional information.

The record also highlights the importance of transparent outcome reporting. A scale definition, measurement timeframe, and stated summary parameter explain what was intended to be assessed, but they cannot substitute for an estimate, uncertainty measure, and account of the analysis population. Those primary outcome results are not reported in the registry record.

Finally, the registry identifies multiple outcomes and analyses while leaving multiplicity methods, missing-data handling, and analysis populations unspecified. These are not minor technical details: they shape how precisely and credibly findings can be interpreted. Clear reporting of these choices would help readers assess both the evidence and its limits without overclaiming what a single-group evaluation can show.

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.

The main trial-specific limitation is the single-group design. The registry describes curriculum recipients but no concurrent control group, and allocation is recorded as NA. Any outcome change can therefore be described over time but cannot be attributed uniquely to the curriculum from this design alone. The absence of masking, recorded as none, is another feature to consider when interpreting self-reported outcomes; the record does not describe procedures intended to reduce reporting or measurement influences.

The primary endpoint relies on youth self-report. The record describes the scale's items and scoring direction but does not report administration procedures, evidence about measurement performance in this study population, or how missing item responses were handled. The primary outcome estimate itself is not reported in the registry record, preventing assessment of its size and precision.

The registry lists 3 outcome measures and 3 analyses but does not report the full outcome set, analysis methods, multiplicity procedures, or analysis populations. Missing-data amounts and handling are also not reported in the registry record. Without those details, readers cannot determine how closely the analyzed observations correspond to the enrolled group or how sensitive results might be to incomplete follow-up.

The enrollment is listed as 72, but the record does not report outcome-specific sample counts at baseline and 26 weeks. It also does not report the basis for the study's sample size or protocol-level statistical planning. Any planning illustrations based on an observed effect should be viewed as hypothetical calculations, not evidence of design adequacy or observed power.

Safety interpretation is limited by the lack of reported monitoring procedures and a specified adverse-event follow-up period. The recorded zero counts should not be interpreted as proof of no risk. These limitations concern what can be concluded from the registry record; they do not establish that unreported procedures or analyses were absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Elders' Resilience Curriculum — NCT06045273.
• Registry record last updated 2025-06-04; status last verified 2025-05.
• Results first posted 2025-06-04.
• 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

The registry record describes a completed, single-group behavioral study of the Elders' Resilience Curriculum, with enrollment listed as 72 and participants described as youth aged 9-14. The study started on 2023-11-15, reached primary completion on 2024-05-16, and is listed as completed. Masking is recorded as none, and allocation is recorded as NA.

The primary outcome is change in Reasons for Life Scale score from baseline to 26 weeks. The scale uses 11 self-report items, with total scores ranging from 11-33 and higher scores indicating more reasons for life. The primary outcome result is not reported in the registry record. The registry lists 3 outcome measures and 3 analyses, but does not report the methods, missing-data handling, or analysis populations.

The adverse-event entry lists 0 serious adverse events, 0 other adverse events, and 0 deaths in the intervention group. The single-group design limits causal interpretation, and the registry does not provide outcome estimates needed to assess the primary result.