This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Journey of Transformation Curriculum for Native American Adolescents (NCT05274217), a randomized na study. The primary outcome is Change in Patterns of 30 Day Substance Use Assessed by Self-report.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05274217 |
| Phase | NA |
| Condition | Alcohol Use, Tobacco Use, Substance Use |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Triple |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
Native American adolescents were the intended population. The registry record does not report the participants’ ages, locations, or other eligibility details.
Intervention
The Journey of Transformation-Native Youth Health Leadership Program curriculum, a behavioral intervention.
Comparator
A waitlist group assigned to begin the curriculum at the beginning of the winter trimester, compared with an immediate group assigned to begin at the beginning of the fall trimester.
Primary question
Whether patterns of self-reported 30-day substance use changed from baseline at post-intervention and follow-up assessments. The investigators also described goals involving substance-use intentions and sexual health.
The primary outcome covered self-reported tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs. Responses were planned on an ordinal scale, from no occasions to 40 or more occasions in the prior 30 days. The registry also describes secondary outcomes concerning intentions to use alcohol, cigarettes, and marijuana; confidence in refusing drugs and alcohol; and intentions for safer sex.
The registry record reports that the study was terminated at baseline. Outcome data are not available, and post-intervention and follow-up data were not collected. Consequently, the clinical question remains unanswered by the posted results: there is no recorded estimate of change in substance-use patterns or of differences between the immediate and waitlist groups.
3. Trial Design
NCT05274217, titled Journey of Transformation Curriculum for Native American Adolescents, was a randomized behavioral study sponsored by the University of Washington. Its registry classification lists the allocation as randomized, the masking as triple, and the model as crossover. The study phase is recorded as NA, and the study type is classified as other.
The intervention was the Journey of Transformation-Native Youth Health Leadership Program curriculum. The immediate group was assigned to begin at the start of the fall trimester, while the waitlist group was assigned to begin at the start of the winter trimester. This describes a planned difference in intervention timing. Further details about the crossover structure, treatment periods, sequence, or how the groups would contribute to each comparison are not reported in the registry record.
The recorded enrollment was 33. The study started on 2022-09-13, and the primary completion date is recorded as 2022-09-21. Its status is terminated. The registry states that termination occurred at baseline and that post-intervention and follow-up outcome data were not collected.
The primary outcome was intended to assess change in patterns of 30-day substance use from baseline to a 3-month post-intervention follow-up, from baseline to a 6-month follow-up, and from baseline to a 12-month follow-up for the immediate group only. These are planned assessment points, not completed observations. The registry lists five outcome measures, but the record does not contain outcome results or a reported analysis of those measures.
Details of the randomization procedure, allocation concealment, the masking procedures, and the planned statistical model are not reported in the registry record. The registry classifications identify design features but do not provide enough information to reconstruct how the study would have analyzed its crossover and waitlist components.
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
| Stage | Immediate Group | Waitlist Group |
|---|---|---|
| STARTED | 33 | 0 |
| COMPLETED | 22 | 0 |
| NOT COMPLETED | 11 | 0 |
Reasons for not completing this period:
| Reason | Immediate Group | Waitlist Group |
|---|---|---|
| Study terminated. | 11 | 0 |
Analysis population for the primary outcome, as defined in the registry: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
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: This study was terminated due to a significant revision of protocol.
| Characteristic | Unit | Immediate Group | Waitlist Group | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 0 | 22 | |
| Age, Continuous | years | 14.4 (13.0 to 16.0) | — | 14.4 (13.0 to 16.0) |
| Sex/Gender, Customized: Sex – Female | Participants | 13 | — | 13 |
| Sex/Gender, Customized: Sex – Male | Participants | 8 | — | 8 |
| Sex/Gender, Customized: Sex – Unknown | Participants | 1 | — | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 22 | — | 22 |
| Race (NIH/OMB): Asian | Participants | 0 | — | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | — | 0 |
| Race (NIH/OMB): White | Participants | 0 | — | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | 0 |
| Region of Enrollment: United States | Participants | 22 | — | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Patterns of 30 Day Substance Use Assessed by Self-report, measured over Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change in patterns of 30-day substance use assessed by self-report. Participants were to report occasions of use on an ordinal scale: 0 occasions, 1-2 occasions, 3-5 occasions, 6-9 occasions, 10-19 occasions, 20-39 occasions, or 40 or more occasions. The measure included tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs.
General explanation: an ordinal outcome places responses in an ordered set of categories without requiring that the distance between adjacent categories be equal. It can represent broad patterns of frequency while avoiding a claim that every response corresponds to a precise count. An analysis should respect that ordering and the scale’s categorical structure; the registry record does not report which analysis was planned.
The endpoint was intended to measure change over time, with assessments planned from baseline to post-intervention and later follow-up points. Repeated assessments can describe whether reported patterns change after an intervention and whether such changes persist. In a randomized comparison, differences in change between groups can help distinguish intervention timing from changes that occur over time in both groups.
That intended use cannot be assessed from the posted results. The registry states that the study ended at baseline and that the post-intervention and follow-up data were not collected. No endpoint values, category distributions, or estimates of change are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical fact is the absence of outcome data. The study was terminated at baseline, before the planned post-intervention and follow-up measurements were collected. There is therefore no reported estimate of change in 30-day substance-use patterns, no estimate comparing the immediate and waitlist groups, and no reported uncertainty interval or significance test for the primary outcome.
The planned assessments included baseline to 3-month post-intervention follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up for the immediate group only. These time points describe the intended measurement schedule. They should not be read as completed observations or as evidence that a change occurred at any follow-up.
The intervention’s stated aims included delaying or reducing tobacco and other substance use and improving sexual health. Those aims are not findings. The available record does not establish whether the curriculum changed substance-use behavior, substance-use intentions, refusal self-efficacy, or safer-sex intentions. It also does not establish that outcomes were unchanged: without post-baseline measurements, there is no outcome comparison with which to evaluate either direction of effect.
The registry lists 0 analyses. It does not report estimates, confidence intervals, p-values, or a statistical analysis plan. Accordingly, there is no basis in the posted results for judging the size, precision, or statistical significance of a treatment contrast. The study’s randomized designation describes the planned assignment, but randomization alone cannot supply the missing outcome information.
The record lists an enrollment of 33, but that count is not an outcome result and does not show how many participants completed follow-up. The safety record separately lists 33 participants at risk in the Immediate Group and 0 in the Waitlist Group. Those safety denominators do not provide evidence about efficacy or replace the absent outcome assessments.
General explanation: an estimate is most informative when read together with its uncertainty. A confidence interval describes a range of values compatible with the data under the method used; a narrow interval indicates greater precision than a wide one. Here, no effect estimate or interval is reported, so precision cannot be assessed. Neither a favorable nor an unfavorable treatment conclusion follows from the lack of results.
9. Statistical Methods Explained
The registry identifies randomized allocation, triple masking, and a crossover model. These are design labels rather than a complete statistical plan. The record does not explain the randomization procedure, who was masked, what information was masked, how the crossover was structured, or which model was intended for the primary endpoint. The design labels should therefore be interpreted narrowly and should not be treated as evidence that a particular analysis was performed.
What does randomization contribute?
General explanation: random assignment is intended to make groups comparable, on average, with respect to both measured and unmeasured characteristics at the time of assignment. It supports a comparison of outcomes between assigned groups when outcomes are collected and the analysis follows an appropriate plan. It does not guarantee that groups are identical, and it cannot address outcomes that were never measured. In this study, the randomized designation does not yield a treatment-effect estimate because the registry reports that the study ended at baseline.
How should an ordinal outcome be analyzed?
The primary endpoint used ordered categories of 30-day substance-use frequency. General explanation: ordinal analyses use the ordering of categories without necessarily treating the gaps between categories as equal. A model may estimate the association between group and the tendency to report higher or lower categories, while accounting for the outcome’s ordered form. Other valid approaches depend on the study question, data structure, and assumptions. The registry record does not report a chosen model, assumptions, or analysis details, so no specific method can be attributed to this trial.
Several substances were included in the endpoint, and the planned assessments covered more than one follow-up time. General explanation: multiple outcomes, time points, and comparisons create several opportunities to find an apparently notable result by chance. A prespecified primary comparison can help define the main question, while a multiplicity strategy can address the interpretation of additional tests. The registry record does not report how multiple substances, time points, or secondary outcomes would have been handled analytically.
What does the crossover label imply?
General explanation: crossover designs commonly involve participants receiving different interventions or conditions in sequence, allowing within-participant comparisons. Such designs require attention to period effects, sequence effects, and whether effects from an earlier period could persist into a later one. The record’s model classification and its descriptions of immediate and waitlist start times do not explain the study’s intended periods or analytical handling of these issues. It would be inappropriate to infer a specific crossover analysis from the label alone.
Can the registry support a power or sample-size conclusion?
The record describes a planning illustration based on a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect expressed as a stated fraction of an observed effect. It distinguishes participants per arm for most outcomes from total events for time-to-event outcomes. No numerical planning results or observed effect are reported in the registry record. The planning assumptions are not a record of the trial’s own sample-size justification, and the illustration cannot be interpreted as observed power.
General explanation: a sample-size calculation is a planning exercise that depends on assumptions about the outcome, effect to detect, variability, allocation, and statistical procedure. If those assumptions differ from the study’s actual circumstances, the calculation may not describe the precision ultimately achieved. Power is a design quantity, not a substitute for an effect estimate or its confidence interval. Without reported outcome data, none of these calculations can establish how large or precise an effect this study observed.
What can be said about analysis and uncertainty?
The registry reports 0 analyses and no numerical primary-outcome results. No standard errors, confidence intervals, test statistics, or p-values are reported. General explanation: statistical inference ordinarily combines an estimated effect with a measure of uncertainty, so readers can distinguish a well-estimated result from a result with substantial uncertainty. Since this record contains no effect estimate, the uncertainty around a treatment comparison cannot be described. The appropriate statistical interpretation is that the intended analyses cannot be evaluated from the posted results.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covered multiple substances and planned assessments at several follow-up points. The registry also lists secondary outcomes involving intentions to use alcohol, cigarettes, and marijuana; drug and alcohol refusal self-efficacy; and intentions for safer sex. Considering several outcomes or time points can raise multiplicity questions: when many comparisons are tested, the chance of at least one apparently positive result by chance can increase. General explanation: investigators may address this through prespecified primary comparisons, adjustment methods, or a clear distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity strategy or a statistical analysis plan.
There are no outcome results to evaluate for selective reporting, consistency across time points, or agreement between primary and secondary measures. The record lists 0 analyses. It does not report whether any analyses were planned before termination or whether any interim analyses were intended. Interim-analysis plans are not reported in the registry record.
Missingness is unusually consequential for interpretation because the registry states that termination occurred at baseline and that post-intervention and follow-up data were not collected. The record does not describe participant-level missingness patterns, reasons for missing assessments, or a missing-data method. In particular, it does not support distinguishing noncollection after termination from other forms of missingness at later visits.
The analysis population is not reported in the registry record. There is no reported intention-to-treat analysis, per-protocol analysis, or other analysis population. General explanation: an intention-to-treat approach typically analyzes participants according to their randomized assignment, while other approaches may use different inclusion rules. Such choices matter when outcomes are observed, but no analysis population can be inferred from a registry entry alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Immediate Group | 0 | 33 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immediate Group | 0 of 33 |
| Waitlist Group | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Immediate Group | 0 of 33 |
| Waitlist Group | 0 of 0 |
The serious adverse event record lists the Immediate Group with 33 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. The Waitlist Group is listed with 0 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse event terms are listed.
These figures should be read in relation to the reported denominators. The Waitlist Group has 0 participants at risk in this safety record, so its zero event counts do not describe an observed group of participants at risk. The record does not explain this denominator or provide details about the safety observation period, event collection procedures, or reasons for the group-specific counts.
General explanation: a reported count of zero means that no events were recorded in the stated reporting context; it does not, by itself, establish that an intervention has no safety risks. Interpretation depends on how many people were observed, for how long, and how events were collected. Here, those additional details are not reported in the registry record. The safety figures are not a comparison of event rates and do not address the missing primary outcome data.
12. What the Result Does, and Does Not, Mean
The registry record establishes that NCT05274217 was planned as a randomized study of the Journey of Transformation-Native Youth Health Leadership Program curriculum, with immediate and waitlist start groups. It also establishes that the study was terminated at baseline and that post-intervention and follow-up data were not collected. These registry entries describe the study’s status and the limits of its posted results; they do not describe an intervention effect.
The central intended outcome was change in self-reported 30-day patterns of use across several substance categories. The planned assessments included post-intervention and later follow-up measurements, with the longest listed follow-up applying to the immediate group only. Because those measurements were not collected, the record contains no observed change to interpret and no group contrast from which to assess the curriculum’s effects.
The study’s stated aims also included substance-use intentions and sexual health. These are research objectives, not evidence of a change in behavior or intentions. No outcome estimates are reported for the primary or secondary measures. The registry record therefore cannot show whether the intervention’s effects were beneficial, harmful, absent, or uncertain.
General explanation: absence of a reported result is not the same as a result showing no effect. A conclusion of no meaningful difference would require an observed estimate and enough precision to assess what differences remain plausible. Neither is available in the posted results. Likewise, an enrollment count and a randomized design do not resolve the absence of post-baseline observations.
The appropriate interpretation is limited but clear: the planned outcome question remains unanswered in this record. The available information supports description of the design, intervention timing, endpoint, termination, and recorded safety counts. It does not support a causal conclusion about substance use or sexual health.
13. Why This Trial Matters Statistically
This study raises an important statistical distinction between a research question and an answer to that question. A trial may specify a population, intervention, comparator, outcome, and follow-up schedule, but those design elements do not establish an effect. For NCT05274217, the primary question concerned change in 30-day substance-use patterns among Native American adolescents assigned to immediate or waitlist intervention timing. The registry reports that outcome data were not collected after baseline.
That distinction matters when interpreting randomized studies. Randomization can support a fair comparison when outcome information is available, but it cannot replace follow-up measurement. Without post-baseline outcomes, there is no estimate to compare, no uncertainty interval to evaluate, and no basis for claims about the direction or size of a treatment effect.
The endpoint also illustrates a common analytical challenge: an ordered response scale spanning several substance categories and multiple follow-up times. General explanation: researchers must define how such outcomes will be analyzed and how multiple comparisons will be interpreted. The registry record does not report those analysis decisions. This limits statistical interpretation even apart from the absence of collected outcomes.
Finally, the record shows why enrollment and safety counts should not be mistaken for efficacy evidence. The enrollment count describes the study, while safety counts describe reported events and their denominators. Neither provides the missing outcome contrast. The useful statistical conclusion is not that the intervention succeeded or failed, but that the planned comparison cannot be evaluated from the posted results.
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 primary limitation for interpreting this trial is that it was terminated at baseline. The registry explicitly states that outcome data are unavailable and that post-intervention and follow-up data were not collected. As a result, no change in the primary endpoint or comparison between groups can be estimated from the posted results.
The registry describes the study as randomized, triple masked, and crossover, and describes immediate and waitlist start timing. However, the randomization procedure, masking details, crossover periods, and planned handling of sequence or period effects are not reported in the registry record. The design cannot be reconstructed in enough detail to assess those features.
The primary endpoint was a self-reported ordinal measure covering several substances and several planned follow-up points. The registry does not report an analysis plan, a method for handling multiple outcomes or time points, a missing-data method, or an analysis population. It also does not report a sample-size justification. A planning illustration is described, but no numerical planning result or observed effect is reported.
The safety record lists 0 participants at risk in the Waitlist Group and does not explain that denominator. Details about safety monitoring duration and event ascertainment are not reported in the registry record. These limitations mean that the safety counts should not be used as a comparative estimate.
The listed enrollment is 33, but the record does not provide post-baseline completion information because the planned follow-up data were not collected. No conclusion about the magnitude, precision, or statistical significance of the intended intervention effect is supported by the available record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Journey of Transformation Curriculum for Native American Adolescents — NCT05274217.
- Registry record last updated 2023-10-04; status last verified 2023-09.
- Results first posted 2023-10-04.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05274217 studied the Journey of Transformation-Native Youth Health Leadership Program curriculum in a planned randomized waitlist-control design for Native American adolescents. The registry describes immediate and waitlist start groups and identifies change in self-reported 30-day substance-use patterns as the primary outcome.
The recorded enrollment was 33. The study started on 2022-09-13, had a primary completion date of 2022-09-21, and is listed as terminated. The registry states that termination occurred at baseline and that post-intervention and follow-up outcome data were not collected.
No primary or secondary outcome estimates are reported, and the registry lists 0 analyses. The available record describes the intended study question and design but does not provide evidence to estimate an intervention effect.