Strengthening Healthy Relationships Among Apsaalooke Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Strengthening Healthy Relationships Among Apsaalooke Youth (NCT05734014), a na na study. The primary outcome is Crow Knowledge.

2. Clinical Question

The research question is therefore descriptive and feasibility-oriented: what did youth express in response to the activity and prompt, and did their responses include the cultural concepts identified in the outcome description? The posted design does not estimate a treatment contrast against a control group. It cannot, on its own, separate changes associated with the sessions from other influences or describe what would have happened without them. The record characterizes the work as a pilot project developed with community participation; it does not report a formal causal hypothesis or a prespecified threshold for judging feasibility.

3. Trial Design

This is a completed, single-group behavioral pilot sponsored by Montana State University. The registry lists the intervention as Connectedness Activities and describes youth sessions focused on respect, communication, and relationality. Its summary says the project used community-based participatory research principles and worked closely with Community Advisory Board members to develop the project’s stages. The board identified 5th grade as an important age to focus on; the record does not establish that every participant was in that grade.

The record gives a start date of 2024-05-01 and a primary completion date of 2024-06-30. Enrollment is listed as 10. The phase is listed as NA, allocation as NA, and masking as NONE. The study model is SINGLE GROUP. These labels describe a pilot without a reported randomized allocation or masking procedure. The record explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. There is no separate control group described for interpreting the outcome.

The project aims to develop pilot activities related to intergenerational, family, community, and land connectedness among Crow youth. The listed primary outcome, Crow Knowledge, is assessed at a timeframe of 2 week. The registry lists 1 outcome measure and 1 analysis, but it does not report the analytic procedure, participant flow, adherence, or detailed eligibility criteria. The outcome’s numerical findings are also not reported in the registry record. Consequently, the design can be described from its registry labels and narrative, but the implementation and statistical analysis cannot be reconstructed in detail.

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 Crow Knowledge, measured over 2 week.

The primary endpoint is titled Crow Knowledge and is expressed as a count of participants. Its description refers to an arts-based open-ended question asking youth to describe what they liked, what was challenging, or what they learned. The project examined whether responses mentioned the clan system, identified in the record as Crow Relationally, or the Creation Story. The outcome timeframe is listed as 2 week.

This kind of open-ended prompt can capture youth perspectives in their own words and allow the project to consider whether culturally meaningful ideas appear in their responses. It differs from a fixed-response scale: responses need interpretation or coding before a participant can be classified according to the concepts being examined. As a general measurement issue, clear coding rules and consistent application matter because different interpretations of an answer could change whether it is counted as mentioning a concept.

The registry identifies the measure as a participant count, but does not give the result, coding rules, or clarify whether mentions of the clan system and Creation Story were combined into one outcome or handled separately. It also does not report a validated scoring instrument or a threshold for what would count as a successful result. The endpoint’s stated purpose can therefore be described, but its operational definition and observed value are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry gives enough information to identify the broad study structure and outcome type, but not enough to reproduce the analysis. The study model is single group, the outcome is described as a participant count, and the record lists 1 analysis. It does not report the statistical method, a model specification, a confidence interval, a hypothesis test, or an analysis population. The explanations below describe general statistical concepts, not methods confirmed as used in this study.

What does a participant count represent?

In general, a participant count records how many people meet a stated condition. For an outcome based on open-ended answers, the condition must be operationalized: the analyst needs a rule for deciding whether a response contains a relevant mention. If the count is intended to represent participants who mention a concept, the interpretation depends on the definition of a mention and on which responses are eligible for coding. The registry identifies the measure as a count of participants but does not report the coding rules or the observed count.

A count can be presented by itself, or alongside a denominator to convey the share of eligible participants meeting the condition. Those descriptions answer different questions: a count gives the number meeting the definition, while a proportion relates that count to the number assessed. Neither value can be recovered from the registry description alone. Enrollment is listed as 10, but the record does not say whether all enrolled participants posted an evaluable response. It would therefore be inappropriate to treat enrollment automatically as the endpoint denominator.

Why do coding rules matter?

General measurement principles are especially relevant when responses are open-ended. A coding guide can specify what qualifies as a mention, how ambiguous wording is handled, and whether the clan system and Creation Story are coded as separate concepts or under a combined rule. Independent review or a process for resolving disagreements can help evaluate consistency. The registry record does not report whether any such procedures were used. Their absence from the record does not establish that they were absent from the project; it means they cannot be assessed from the registry description.

When coding is not described, readers cannot determine how sensitive the result may be to judgment calls. A response might communicate a concept without using an expected phrase, or use similar language in a different sense. Consistent, transparent rules help make the resulting count interpretable and reproducible. For a culturally grounded outcome, those rules also need to reflect the intended meaning of the concepts rather than treating words as context-free markers. The record’s community-participatory description provides important context, but it does not specify the endpoint coding process.

What would uncertainty quantify?

As a general statistical concept, a confidence interval describes the uncertainty around an estimate under a specified statistical model and its assumptions. For a participant proportion, an interval can show how much sampling uncertainty remains, particularly when the number assessed is limited. A count alone does not express this uncertainty. An interval also does not account automatically for measurement error, selective missingness, or differences between the study participants and a wider population.

No confidence interval or other uncertainty estimate is reported for Crow Knowledge. Because the numerical endpoint result is not reported either, there is no estimate whose precision can be evaluated. Readers should not infer that a result is precise or imprecise solely from the enrollment listing.

What can a single-group design estimate?

In general, a single-group study can describe what was observed among participants who took part, provided the outcome and denominator are clearly reported. It does not supply a concurrent counterfactual: there is no comparable group showing what might have happened over the same period without the intervention. A change observed over time, if measured, could reflect the activity as well as other influences. In this record, a baseline outcome or pre-post analysis is not reported.

The registry labels allocation as NA, masking as NONE, and the model as SINGLE GROUP. The record also states that this is not a randomized comparison and that arms are not a like-for-like control comparison. These design details make a causal contrast unavailable from the described study. They do not prevent a descriptive account of the pilot, but they limit claims about intervention effects.

How should planning calculations be read?

Generally, sample-size planning asks how many participants a future study might need under specified assumptions about an effect, variability, significance level, allocation, and statistical model. Such calculations are planning illustrations, not evidence about the precision or power of a completed study. The registry’s planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. Those assumptions do not describe the design of this single-group pilot, and no numerical planning results or observed endpoint value are reported in the registry record. They should not be read as observed power or as a justification for the enrollment in this study.

These planning assumptions also cannot establish what effect is meaningful for the community or whether the outcome’s coding is reliable. Statistical planning is conditional on a defined outcome and assumptions; it cannot substitute for clear outcome reporting, a suitable comparison design, or culturally appropriate interpretation. The registry record does not report a sample-size justification for the pilot, an interim analysis plan, or further statistical methods.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 1 outcome measure and 1 analysis. This is useful descriptive information, but it does not fully establish how many statistical comparisons or coding decisions were considered. The outcome description refers to mentions of the clan system and the Creation Story, and the record does not clarify whether these were assessed separately or combined. It also does not report a prespecified hierarchy among outcomes, an adjustment for multiple testing, or an analysis plan defining which result would be primary if several comparisons were made. These details are not reported in the registry record; no multiplicity procedure should be assumed.

Missing-data handling is also not described. The record lists enrollment of 10, but does not report participant flow, how many youth completed the sessions, how many answered the open-ended prompt, or whether any responses could not be coded. Thus, the number of participants contributing to the endpoint and the denominator used for any reported result are not available. It is not possible to assess whether missing responses might differ systematically from available responses.

The analysis population is not reported in the registry record. The record does not say whether analysis included all enrolled participants, only those who attended or completed activities, or those with an interpretable response. These distinctions can matter for a pilot: an analysis restricted to participants who completed activities can describe their responses, while a broader analysis may address participation across the enrolled group. No conclusion about the analysis population or missing-data method can be drawn from the listed outcome and analysis counts alone.

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’s adverse-event figures list 0 serious adverse events among 10 participants at risk in the intervention group, 0 other adverse events among 10 participants at risk, and 0 deaths. These are the reported counts in the record. They indicate that no events in those categories are listed for this study; they do not establish that all possible harms were assessed or that no unrecorded events occurred.

Safety counts should be interpreted in light of the study design and the information recorded. This is a single-group pilot, not a controlled comparison, so the figures do not provide a relative safety comparison with a control group. The registry record does not provide event definitions, collection procedures, observation time for safety outcomes, or additional detail about how adverse events were assessed. It also does not list serious adverse-event terms.

A zero count is a description of reported events, not proof that the underlying risk is zero. With no event count beyond what the record reports and no accompanying uncertainty estimate, the precision of the safety information cannot be assessed. These figures are best read as a registry summary of reported events in the enrolled intervention group, rather than as a comprehensive estimate of safety.

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

The study is described as a community-engaged pilot to develop activities that promote relationality and connectedness among Apsáalooke youth. The intervention involved youth sessions focused on respect, communication, and relationality, and the primary outcome concerned cultural concepts expressed in open-ended responses. The Community Advisory Board contributed to development of the project, and the board identified 5th grade as an important age to focus on. These details explain the project’s context and intent.

The numerical result for Crow Knowledge is not reported in the registry record. Therefore, the record does not establish how many participants mentioned the clan system or the Creation Story, how the responses were coded, or how precise an estimate might be. It cannot show whether the activities changed knowledge or connectedness, and the single-group design does not provide a randomized comparison against which to estimate an intervention effect. The completed status does not fill those reporting gaps.

The record does support a description of the project’s design and stated aims. It documents a behavioral intervention, single-group model, enrollment of 10, and a 2 week outcome timeframe. It also records 0 serious adverse events, 0 other adverse events, and 0 deaths. These safety figures remain limited to the registry’s reported categories and do not establish absence of all harms.

More broadly, statistical evidence is shaped by both design and measurement. A count derived from open-ended responses needs a transparent definition, and a causal claim needs a suitable comparison. The registry information does not report enough about either endpoint coding or analysis to assess the strength of an outcome finding. The appropriate conclusion is therefore limited: the record describes a completed pilot and its intended cultural focus, but does not report the primary numerical result needed to judge what responses were observed.

13. Why This Trial Matters Statistically

This trial is statistically notable because its central outcome is not a conventional fixed-response score. Crow Knowledge is described through an open-ended, arts-based prompt and attention to whether youth mention culturally meaningful concepts. Such measures can be well suited to exploratory work and community-defined questions, but statistical interpretation depends on a clear bridge between narrative responses and the participant count recorded as the endpoint.

The project’s community-based participatory approach is relevant to that bridge. The registry says Community Advisory Board members worked closely with the project to develop its stages and identified 5th grade as an important focus. This context matters because the meaning of relationality and connectedness is not captured solely by a generic numerical scale. At the same time, statistical transparency remains important: readers need to know how responses became an outcome and what denominator was used. Those details are not reported in the registry record.

The single-group structure also illustrates the difference between feasibility-oriented description and causal evaluation. A pilot can contribute information about developing an intervention and eliciting participant responses, while a randomized or otherwise suitable comparison is needed for a controlled estimate of an intervention contrast. This record does not report such a comparator and explicitly cautions that its arms are not a like-for-like control comparison.

Finally, a completed registry entry and an identified outcome do not by themselves make a result interpretable. Numerical findings, coding procedures, missing-data information, and analysis methods are needed to assess magnitude and precision. The record’s gaps make those limitations visible and show why statistical conclusions should match the evidence actually reported.

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.

The main limitation for interpreting the outcome is that the registry record does not report its numerical result. No count of participants meeting the outcome definition, endpoint denominator, uncertainty estimate, or statistical test is available. Enrollment of 10 cannot be substituted for the number assessed because participant flow is not reported.

The endpoint is based on open-ended responses, but the record does not describe coding rules, coder training, review procedures, or how ambiguous answers were handled. It does not clarify whether mentions of the clan system and Creation Story were combined or assessed separately. These omissions prevent assessment of measurement reliability and reproducibility.

The design is single group, with no reported randomized control. The record states that it is not a randomized comparison and that arms are not a like-for-like control comparison. It does not report baseline outcome measurement or a pre-post analysis, so change over time cannot be assessed from the available information. The record also does not report participant eligibility details, ages, adherence, analysis population, or missing-data methods. Although the Community Advisory Board identified 5th grade as an important age to focus on, the record does not establish that all enrolled youth were in that grade.

Further statistical limitations include the absence of a reported analysis method, multiplicity approach, and sample-size justification. The record does not report interim analyses or a detailed statistical plan. The safety figures are limited to the adverse-event categories listed and lack additional collection or follow-up detail. These limitations concern what can be assessed from the registry record; they do not establish that unreported procedures or information were absent from the project itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Strengthening Healthy Relationships Among Apsaalooke Youth — NCT05734014.
• Registry record last updated 2025-11-21; status last verified 2025-11.
• Results first posted 2025-11-21.
• 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

NCT05734014, titled Strengthening Healthy Relationships Among Apsaalooke Youth, is listed as completed. Montana State University is the sponsor. The record describes a behavioral intervention called Connectedness Activities in a single-group study, with enrollment of 10. Allocation is listed as NA, masking as NONE, and phase as NA.

The project used community-based participatory research principles and worked with Community Advisory Board members. Its activities focus on respect, communication, relationality, and connectedness across generations, family, community, and land. The primary outcome is Crow Knowledge, an arts-based open-ended response measure concerning whether youth mention the clan system or the Creation Story. Its timeframe is 2 week.

The record lists 1 outcome measure and 1 analysis, but does not report the primary numerical result, endpoint coding procedure, or statistical method. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths. These details support a description of the registered pilot, but not an estimate of the outcome’s magnitude or precision.