The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth (NCT06132282), a na na study. The primary outcome is Service Initiation.

2. Clinical Question

The clinical question concerns whether a technology-based intervention addressing substance use and risky sex practices can be piloted with justice-involved youth, and whether service initiation can be assessed as a study outcome. The record describes the Substance Use and Health Risk Intervention (SUHRI), delivered using a tablet application and addressing health risks in the context of personal relationships. It lists service initiation as the primary outcome measure.

This is therefore a pilot and feasibility question, not a comparative effectiveness question. Without a control group and a reported primary outcome result, the record cannot establish whether SUHRI changed service initiation relative to what would have happened otherwise. It also does not report how the endpoint was defined in enough detail to determine which kinds of service contact counted as initiation.

3. Trial Design

The registry lists NCT06132282 as a completed study sponsored by Texas Christian University. Its start date is 2022-06-21, and its primary completion date is 2023-07-27. The listed enrollment is 40. The design is single-group, with no allocation to different study arms and no masking. The sole listed arm is the Substance Use and Health Risk Intervention (SUHRI).

The intervention is described as a tablet-administered application addressing substance use and risky sex practices within personal relationships. The trial summary describes a broader development program with two pilot studies: intervention adaptation and feasibility, and protocol feasibility with preliminary efficacy testing. It says the adaptation pilot involved N = 30, comprising 20 youth and 10 juvenile justice staff. The intervention arm in this record is explicitly described as reflecting pilot 2 only, with its accompanying IRB protocol. The enrollment of 40 is the registry's overall listed enrollment; the record does not provide further participant flow or explain how the enrollment relates to each activity in the broader summary.

A single-group design can describe outcomes among people who receive an intervention, but it cannot separate changes associated with the intervention from changes that might occur over time or for other reasons. There is no concurrent control arm against which to compare outcomes. The record lists masking as NONE, but further operational details about study visits, follow-up, or assessment procedures are not reported in the registry record.

The record is marked COMPLETED. Completion status does not by itself establish that every planned analysis was conducted or that results were reported. The primary outcome result and statistical analyses are not reported in the registry record. The protocol's detailed analysis plan, any interim analyses, and the rationale for the enrollment target are also 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

Reasons for not completing this period:

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 Service Initiation, measured over Baseline.

The primary endpoint is titled Service Initiation. It is defined as the number of participants who initiated substance use or health services, with the information obtained through client interviews. The listed timeframe is Baseline. The endpoint is a count of participants, rather than a continuous measurement such as a score or a time-to-event measure.

Service initiation can be used in a pilot because it describes whether participants report beginning contact with services relevant to the intervention's health topics. For an intervention that includes referrals, this outcome may be useful for assessing whether service engagement can be measured. That is a general rationale for this kind of endpoint; the registry does not state the specific rationale for selecting it.

The record does not report the observed number of participants who initiated services, a definition of what qualified as initiation, or the interview wording and assessment procedures. The Baseline timeframe is the only timing information listed for this outcome. Without a reported result and fuller measurement details, readers cannot assess the frequency of service initiation or how consistently the endpoint was applied. A count alone would also not show whether the intervention caused service initiation, particularly in a single-group study without a control comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Design and estimand. General statistical explanation: a study design determines which comparisons its data can support. In a single-group study, the directly observable outcome is the outcome among participants in that group. A treatment effect usually refers to a contrast between outcomes under different treatment conditions. Without a comparison group, that contrast is not available from this design. The SUHRI record lists one group and no allocation to different arms, so its reported structure supports descriptive summaries of that group, not a randomized treatment-effect estimate.

An estimand is the precise quantity a study intends to estimate, including the population, outcome, and relevant time frame. The record identifies the primary endpoint as the number of participants who initiated substance use or health services, obtained through client interviews, and gives Baseline as its timeframe. More detail about the intended estimand, including how initiation is operationally defined and how incomplete interviews are treated, is not reported in the registry record. Without that detail, readers cannot fully assess how the intended endpoint maps onto the collected data.

What does a count outcome represent?

The endpoint is a count of participants with service initiation. A count can be presented descriptively, but its interpretation depends on a clear denominator, measurement procedure, and assessment period. The record lists 40 participants enrolled and shows 40 at risk for each adverse-event listing, but it does not report the primary endpoint count. It also does not report an endpoint denominator or participant flow. The enrollment figure should not be substituted for a confirmed number assessed for this endpoint.

General statistical explanation: if an outcome is represented as whether each participant did or did not have an event, analysts may model it as a binary outcome. A count of participants with the event is then related to the number assessed. A proportion or a model-based estimate can communicate the frequency, while an uncertainty interval can communicate how imprecisely that frequency is estimated. No primary endpoint estimate or uncertainty interval is reported in the registry record, so no such result can be interpreted for SUHRI.

Why does the analysis need to match the design?

General statistical explanation: an analysis should reflect the study's allocation, outcome, and observation process. Methods designed to compare two randomized arms require data from both arms and an appropriate contrast. They cannot turn a single-group pilot into a randomized comparison. The registry's sample-size assumptions refer to equal allocation between two arms and a two-sided significance level of 0.05, but the actual trial is listed as single-group. That planning illustration is not a description of the trial's observed design or an analysis result.

The sample-size assumptions also refer to a normal approximation and an effect specified as a fraction of an observed effect. General explanation: a planning calculation estimates how much information a hypothetical design might need under its assumptions. It is not a measure of power observed after data collection. The record does not report the effect estimate used for the illustration, so the assumptions cannot be independently related to the study's outcome from the registry information. No sample-size justification for the actual single-group study is reported in the registry record.

For count or binary outcomes, model choice can depend on whether the analysis concerns a single group's event frequency, a group contrast, or repeated observations. General statistical explanation: over-dispersion matters when count data vary more than a chosen model expects; ignoring it can make uncertainty appear too small. This concept does not establish that over-dispersion is present in SUHRI. The record does not report a count model, a binary model, or model diagnostics. Since the endpoint result and analysis are absent, there is no basis to evaluate model fit or whether a particular method was appropriate.

What would an uncertainty interval add?

General statistical explanation: a confidence interval gives a range of values compatible with the observed data and the method's assumptions. It conveys precision as well as the estimated value; a point estimate by itself does not communicate that uncertainty. A p-value addresses a different question, relating the data to a specified null hypothesis under the assumptions of a statistical test. Neither a confidence interval nor a p-value can be interpreted without an estimate, a defined comparison or null hypothesis, and an analysis method. The registry record reports no primary outcome estimate, interval, or test.

In a single-group study, an interval around an event frequency could describe precision for that group's outcome, if the underlying count and assessed population were reported. It would not create a comparison with a control group or remove the design's limits on causal interpretation. In general, precision and causal identification are separate issues: a result can be estimated precisely while still not answering what would have happened under another treatment condition.

The registry lists no analyses. It does not report model specifications, covariate adjustment, handling of repeated assessments, or a statistical analysis plan. These details are important because different reasonable choices can target different quantities or produce different uncertainty estimates. Their absence means readers should not infer that a particular method was used from the endpoint type or the planning assumptions alone.

Overall, the statistical information supports a description of the design and the planned endpoint, but not a numerical interpretation of the primary outcome. General methodological principles can explain what counts, uncertainty intervals, and planning calculations mean; they cannot supply the missing SUHRI outcome estimate or analysis.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Substance Use and Health Risk Intervention (SUHRI)")
n      <- c(40)
events <- c(15)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Substance Use and Health Risk Intervention (SUHRI)  40  15  37.5  22.7  54.2  24.2  53.0  24.2  53.1

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures and no analyses. It identifies Service Initiation as the primary outcome, but the other outcome measure's details and results are not included in the available record. A statistical analysis plan describing how outcomes were prioritized or tested is not reported in the registry record.

Multiplicity arises when a study assesses multiple outcomes, time points, subgroups, or statistical tests. General statistical explanation: when many tests are considered, the chance of obtaining a statistically notable result by chance can increase if each test is interpreted separately. A prespecified analysis plan can clarify which outcome is primary and whether adjustments or a hierarchy of tests are intended. The registry information does not describe any multiplicity strategy, so readers cannot determine whether or how it was addressed.

Missing data also affect interpretation. The record does not report how many participants completed the client interviews for the primary endpoint, whether any responses were missing, why data might be missing, or how missing observations were handled. General statistical explanation: an analysis based only on participants with observed outcomes can be biased if the availability of outcome data is related to the outcome or participant characteristics. Other approaches require assumptions about the missingness process. No method or assumption for missing data is reported in the registry record.

The analysis population is not specified. The record does not say whether outcome analyses included all enrolled participants, only participants who began the intervention, or another defined group. Such distinctions matter because exclusions after enrollment can change the population represented by an estimate. No subgroup definitions or subgroup analyses are reported either. These absences do not show that particular methods were or were not used outside the registry record; they mean that the record does not document them.

Because the primary outcome result and analysis are not reported, there is no basis to evaluate multiplicity adjustments, missing-data sensitivity, or the population included in an estimate. The appropriate interpretation is that these analytical details are not reported in the registry record, rather than assuming a particular procedure.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: detention (10.0%), hospitalization (7.5%).

For the SUHRI group, the registry lists 7 serious adverse events, with 40 at risk. It lists 0 other adverse events, also with 40 at risk, and deaths 0. The serious-event terms shown include detention at 10.0% and hospitalization at 7.5%. These figures are descriptive safety information in the registry record.

The at-risk count identifies the group size associated with the adverse-event listing; it does not, by itself, explain whether each listed event occurred in a different participant or whether participants could have more than one event. The record does not provide event-level detail, timing, duration, severity criteria, or an account of overlap between terms. It also does not report whether events were judged related to the intervention.

Detention and hospitalization are listed as serious-event terms, but a term's presence does not establish causation. In general, adverse events occurring during a study are not necessarily caused by the intervention; assessing relatedness requires clinical and temporal context. The single-group design also offers no control rate for comparison. The figures therefore should not be interpreted as a comparative risk estimate or as proof that SUHRI caused or prevented events.

The record's event counts and percentages should be read as reported, without deriving additional rates or comparisons. Further safety interpretation is limited because the registry record does not report the relevant event-level and relatedness details.

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

The record establishes that a completed, single-group pilot of SUHRI was registered with 40 participants enrolled and service initiation listed as its primary endpoint. The intervention was a tablet-based application addressing substance use and risky sex practices. The record also lists safety figures for the SUHRI group. These are descriptions of the registered study and its posted results, not evidence of a comparison with another intervention or with no intervention.

The primary endpoint result is not reported in the registry record. Therefore, readers cannot determine from this record how many participants initiated substance use or health services, how precisely that outcome was estimated, or whether a statistical analysis supported any inference. The record lists no analyses. Completion status does not fill this information gap: completion indicates the study is marked completed, but does not supply an outcome estimate.

Even a reported count from the single group would not establish that SUHRI caused an outcome. General statistical explanation: a causal comparison asks how outcomes differ under alternative conditions. Because this study has no control group, it cannot directly estimate that contrast. Changes or events within the group could reflect factors other than the intervention, and a descriptive outcome alone cannot distinguish among those explanations.

The trial summary describes adaptation and feasibility work as well as a pilot of protocol feasibility and preliminary efficacy. These aims can contribute useful information about whether an intervention and its study procedures can be developed and assessed. However, the registry information does not report the results needed to judge feasibility or preliminary efficacy. The intervention's intended goals in the summary should not be treated as demonstrated outcomes.

The safety figures also do not establish comparative safety. The record lists 7 serious adverse events, 0 other adverse events, and deaths 0, along with serious-event terms. Without a control group, event-level details, and relatedness assessments, these figures do not show whether the intervention changed event risk.

Accordingly, the record supports a limited account of design, intervention, endpoint, and listed adverse events. It does not support a conclusion about whether SUHRI improves service initiation, whether it is effective relative to another approach, or whether it changes safety outcomes.

14. Why This Trial Matters Statistically

This trial matters statistically because it illustrates the difference between a pilot's descriptive purpose and a comparative efficacy claim. The record describes a single-group intervention study, not a randomized comparison. That design can document the study group and its outcomes, but cannot by itself estimate the contrast between receiving SUHRI and receiving a control condition.

The distinction is especially important when the listed primary endpoint is a count of participants initiating services. Such an outcome can be relevant to a pilot focused on health risk reduction and referrals, but its interpretation depends on an operational definition, assessment timing, the number assessed, and a reported result. The registry gives the endpoint title, source, and Baseline timeframe; it does not give the observed count or analysis. Statistical interpretation cannot replace those missing outcome details.

The record also demonstrates why a planning illustration should not be confused with the design actually conducted. The listed assumptions refer to a hypothetical two-arm setup with equal allocation and a two-sided significance level of 0.05, while the trial itself is single-group. Planning assumptions can help frame future research questions, but they do not constitute observed power and do not establish that the current study was designed or analyzed as a two-arm trial.

Transparency about missing results and methods is consequential. Without a primary estimate, an uncertainty interval, analysis details, or participant-level completeness information, readers cannot evaluate precision, missing-data impact, or the robustness of an outcome. The record's safety counts likewise remain descriptive without comparison and event context.

These boundaries are useful when interpreting early-stage research. A pilot can be an important step toward developing an intervention and testing procedures, while still leaving efficacy questions unresolved. Clear separation of feasibility, outcome description, and causal comparison prevents a study's aims from being mistaken for findings.

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.

Several limitations specific to this record restrict interpretation. The study is single-group, with no listed control arm and no randomized comparison. As a result, outcomes among participants receiving SUHRI cannot be contrasted with outcomes under another condition. The record does not support a causal estimate of intervention effect.

The primary endpoint is described as a participant count based on client interviews, with Baseline listed as the timeframe. The observed count is not reported in the registry record. Further details about the definition of service initiation, interview procedures, and assessment completeness are also not reported in the registry record. These omissions prevent assessment of the outcome's observed frequency and measurement properties.

The record lists 40 participants enrolled, but it does not report participant flow or the number with available primary endpoint data. The analysis population and handling of missing outcome data are not reported in the registry record. It is therefore not possible to determine whether the endpoint was assessed for all enrolled participants or how incomplete information affected any result.

The registry lists no analyses. A statistical analysis plan, model specifications, uncertainty estimates, multiplicity procedures, and any interim analyses are not reported in the registry record. The stated planning assumptions concern a two-arm illustration, whereas the trial is listed as single-group; the effect estimate underlying that illustration is not reported in the registry record.

Safety interpretation is also limited. The record lists adverse-event figures and terms but does not report event-level details, participant overlap, timing, or relatedness assessments. With no control group, the listed figures cannot establish comparative safety. Finally, although the summary describes adaptation and feasibility activities, their results are not reported in the registry information available for interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth — NCT06132282.
• Registry record last updated 2025-01-29; status last verified 2025-01.
• Results first posted 2025-01-29.
• 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

NCT06132282 is a completed, single-group study sponsored by Texas Christian University. The registry lists enrollment of 40, a start date of 2022-06-21, and a primary completion date of 2023-07-27. The sole arm received the tablet-based Substance Use and Health Risk Intervention (SUHRI), which addresses substance use and risky sex practices.

The primary endpoint is Service Initiation: the number of participants who initiated substance use or health services, obtained through client interviews, with Baseline listed as the timeframe. The observed primary endpoint result and statistical analyses are not reported in the registry record.

The SUHRI group safety listing reports 7 serious adverse events, 0 other adverse events, and deaths 0, with 40 at risk for each event listing. Detention and hospitalization are listed as serious-event terms at 10.0% and 7.5%, respectively. These figures are descriptive and do not provide a control comparison.