Brief Suicide Intervention for Youth in Juvenile Detention Settings: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Brief Suicide Intervention for Youth in Juvenile Detention Settings (NCT05225103), a na na study. The primary outcome is Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS).

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group behavioral intervention study of suicide prevention in juvenile detention settings. It lists Duke University as sponsor, an enrollment of 8, no allocation, and no masking. The record does not specify a trial phase beyond listing it as not applicable. These design details describe the registered study; they do not establish that an efficacy comparison was conducted.

The brief description characterizes the work as intervention development and says it was not designed or powered to test hypotheses. It outlines an intended sequence involving development and refinement, an open trial at one juvenile detention facility with a stated planned enrollment of 20, and subsequent implementation across six sites, with sites assigned to an earlier or later wave. These statements describe the study plan in the brief summary. They should not be read as evidence that every planned stage took place. The registry record lists enrollment of 8 and a single-group model.

The described intervention is offered to youth in suicidal crises at implementation sites, with data collected only from youth who had prior assent or consent. The brief summary describes assessments at the crisis, at 2 and 4 weeks after initial intervention, and at a two-month follow-up. The primary outcome timeframe is listed as up to 2 month follow-up assessment. The record does not report how many assessments were completed at each time or whether the planned assessment schedule was followed.

Although the brief summary describes sites being assigned to implementation waves, the registry’s allocation field is not applicable and its model is single group. The record therefore does not present a randomized, like-for-like treatment comparison. The listed completion status and study dates do not fill in the missing outcome results or analysis details.

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.

Before assignment: Data were only collected from the 8 youth who were identified as being acutely suicidal and who then received the new intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Data not collected on one participant.

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 Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS), measured over Up to 2 month follow-up assessment.

The primary endpoint is the number of participants who reported a suicide attempt, measured with the Columbia Suicide Severity Rating Scale (C-SSRS) through up to the 2 month follow-up assessment. In the registry description, a participant is counted as reporting the endpoint after answering yes to question #6: whether they had done anything, started to do anything, or prepared to do anything to end their life.

This wording focuses on reported actions or preparation, rather than suicidal thoughts alone. It gives the endpoint a specific operational definition: the recorded response to the stated C-SSRS question determines whether a participant is counted. The record identifies the unit as participants and the measure as a count of participants, rather than a continuous score or an event rate.

As a general statistical point, a clearly defined endpoint helps readers understand which experiences count as an outcome and which do not. A participant count can describe how many people met the endpoint in the assessed group, but interpretation also depends on knowing who was assessed and how missing observations were handled. The registry notes that data were not collected on one participant, but does not report the observed primary outcome count or the analysis population. Thus, the endpoint definition is available, while its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What can a single-group design estimate?

In general, a single-group study can describe outcomes observed among participants who receive an intervention. If outcomes are measured at more than one time, it can also describe how recorded outcomes vary across assessments, provided the relevant results are reported. Such descriptions do not, on their own, establish what would have happened to the same participants without the intervention. A comparator group is needed for a direct between-group contrast, and a well-designed comparison must address whether groups are sufficiently comparable.

That distinction is especially important for a study described as intervention development. The brief summary says this work was not designed or powered to test hypotheses. The registry lists a single-group model and no allocation. The record therefore does not support interpreting it as a randomized efficacy comparison, even though its brief description discusses planned implementation waves. It does not report an estimated intervention effect against a separate control arm.

What does a count endpoint tell the reader?

The primary outcome is a count of participants who answered yes to a specified C-SSRS question about doing, starting, or preparing to do anything to end their life. In general, a count states how many participants met an endpoint under its definition. To interpret a count fully, readers also need to know the relevant assessed population, the denominator, the assessment period, and how missing observations were handled. The registry states the timeframe and notes data were not collected on one participant, but the primary result and analysis details are not reported.

A count is not interchangeable with a rate, a risk difference, or a treatment-effect estimate. Those quantities require additional information and, for a treatment comparison, an appropriate comparator. No such calculation should be inferred from the listed enrollment or safety counts. In particular, the record does not provide enough outcome information to derive a primary endpoint estimate.

Why do confidence intervals matter?

As a general statistical explanation, a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis method. A narrow interval indicates greater precision than a wide interval, while an interval that spans many plausible values signals substantial uncertainty. An interval does not correct weaknesses in study design, missing data, or measurement. Because no primary outcome estimate or interval is reported in the registry record, precision for the primary endpoint cannot be assessed.

For a single-group study, an interval around a participant count or proportion would describe uncertainty about the observed group’s outcome under a chosen statistical model. It would not create a comparison that the design does not contain. A precise description of an outcome in one group is still different from a causal estimate of what the intervention changed.

What does the sample-size planning illustration mean?

In general, a sample-size calculation describes the number of participants that a hypothetical study might require under specified assumptions, such as a target effect, allocation, significance level, and statistical approximation. It is a planning exercise, not evidence that an effect was detected. The sample-size assumptions associated with this record describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The listed assumptions say the target effect is a stated fraction of the observed effect.

Those assumptions do not describe the registered single-group study as a two-arm comparison, and the illustration should not be treated as observed power. The record states that the intervention development study was not designed or powered to test hypotheses. No result from a planning calculation can replace an outcome estimate, interval, or statistical analysis of the enrolled group.

How should sparse event counts be read?

For binary outcomes, each participant is classified according to whether the defined event was recorded. General statistical methods for such outcomes rely on the number of participants with and without the event, as well as the number assessed. When event counts are small, estimates can be imprecise, and common approximations may perform poorly. The suitable method depends on the design, data completeness, and the question being asked.

Here, the registry does not report the primary event count or an analysis method for that endpoint. It gives safety counts, but those counts are descriptive and do not identify a treatment effect. No additional inferential method, adjustment strategy, or model should be attributed to the study based on the posted record.

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("SAFETY-A Implementation Sites")
n      <- c(7)
events <- c(1)
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  SAFETY-A Implementation Sites  7  1  14.3  0.4  57.9  2.6  51.3  3.2  52.7

11. Multiplicity, Missing Data and Analysis Populations

The brief summary names several areas for preliminary examination, including suicidal thoughts and behavior, non-suicidal self-injury, linkage to care, and proposed mechanisms such as hopelessness, self-efficacy to remain safe, urgency to act on suicidal thoughts, and acceptance. The registry also lists secondary outcomes concerning urgency to act, hope and reasons for living after leaving the facility, acceptance, self-efficacy in keeping safe, and emergency mental health services.

When a study examines multiple outcomes, general statistical practice distinguishes outcomes that are central from those that are exploratory. Testing many outcomes can increase the chance of at least one apparently unusual result under a null model. Researchers may address this through prespecified outcome hierarchies or multiplicity adjustments, or they may clearly label analyses as exploratory. The registry record does not report a multiplicity strategy, an outcome hierarchy, or a statistical analysis plan. It lists 0 analyses, so no posted analysis results are available for assessing how multiple outcomes were handled.

The record says data were not collected on one participant. It does not report why data were unavailable, which outcomes or assessment times were affected, or how missing data were handled. It also does not report an analysis population, such as whether analyses were based on all enrolled participants or only those with available outcome data. Missingness should not be assumed to be random, nor should an imputation method or exclusion rule be inferred.

The brief description specifies prior assent or consent as a condition for data collection, but the registry does not report participant flow or the number assessed at each follow-up. Thus, the completeness of observations over time cannot be evaluated. These gaps limit interpretation of both the primary endpoint and the planned secondary outcomes.

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 non-serious adverse event terms

The registry lists the SAFETY-A Implementation Sites group with 8 participants at risk for serious adverse events and 0 participants affected. For other adverse events, it lists 8 at risk and 1 affected. Deaths are listed as 0. These are the safety figures in the record; they are counts, not comparative estimates.

The record provides no terms for the other adverse event in the list of top serious-event terms, and the serious-event terms list is empty. It therefore does not describe the nature, timing, or circumstances of the reported other adverse event. The record also does not provide further information on how adverse events were collected or attributed. Those details are not reported in the registry record.

In general, an observed count of zero does not establish that the underlying risk is absent; it means no affected participants were recorded in the listed group. Sparse safety counts also offer limited precision. Since the study is single group and has no like-for-like control comparison, these counts cannot establish whether the intervention caused, prevented, or changed the occurrence of adverse events.

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

The registry record documents a completed intervention development study for a brief, trauma-informed intervention based on SAFETY-A in juvenile detention settings. It identifies the intended population, intervention description, assessment schedule, primary endpoint definition, enrollment, and selected safety counts. It also states that the work was not designed or powered to test hypotheses.

What the record does not establish is whether participants who received the intervention had fewer or more suicide attempts than they would have had without it. The registered model is single group, and no separate randomized comparison is reported. The primary outcome count itself is not reported, and there is no posted estimate or confidence interval to show the result’s precision. The study’s completed status does not resolve those gaps.

The safety figures show that the registry recorded 0 participants with serious adverse events among 8 at risk, 1 participant with other adverse events among 8 at risk, and 0 deaths. These descriptions do not establish that the intervention caused or prevented any event. The registry does not provide the event term for the other adverse event or a comparator group for interpreting the counts.

The brief summary frames the work as preliminary examination of feasibility and patterns in outcomes and proposed mechanisms. However, those results are not reported in the registry record. Readers can identify what the study planned to assess, but cannot determine from this record whether the intervention was feasible, whether outcomes changed, or how complete follow-up was. Any claim about effectiveness, mechanism, or outcome frequency would go beyond the results posted in the registry.

14. Why This Trial Matters Statistically

This study raises statistical issues that are important in early intervention development. A development study can help define an intervention, refine its delivery, and identify which outcomes may be practical to measure. Its aims differ from those of a trial designed to estimate a treatment effect. The brief summary makes that distinction explicit by describing the study as not designed or powered to test hypotheses.

The registered single-group model also clarifies the limits of the questions the record can answer. Descriptive observations may help characterize participants’ experiences, but without a like-for-like comparator they cannot isolate the intervention’s effect from other influences. This distinction remains important even when the intended intervention is delivered alongside Enhanced Usual Care.

Outcome reporting is another central statistical issue. The registry defines a specific primary endpoint, but does not report its observed count. Without the result, denominator details, and an account of missing observations, readers cannot assess the frequency or precision of the endpoint. A clear endpoint definition is useful, but it is not a substitute for reporting the data and analysis.

The study description also includes multiple planned outcomes and proposed mechanisms. This makes transparent reporting of which outcomes were assessed, how missing data were handled, and whether analyses were exploratory especially important. The registry lists no analyses, so these details are not available. The record is therefore useful for understanding the study’s stated aims and design, while also illustrating why design, outcome reporting, and analysis reporting must be considered together.

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 principal limitation for statistical interpretation is that the primary endpoint result is not reported in the registry record. The endpoint is defined, but no event count, estimate, confidence interval, or hypothesis test is presented. The registry lists 0 analyses, so there are no posted statistical results to evaluate.

The record describes a single-group study with no allocation and no like-for-like control comparison. Consequently, it does not provide a controlled estimate of an intervention effect. The brief summary discusses a planned sequence of development, an open trial, and site implementation waves, but the registry’s listed model and enrollment do not establish which planned stages were completed.

Enrollment is listed as 8, and the primary outcome description notes that data were not collected on one participant. The record does not explain the missing data, specify affected assessments, describe follow-up completeness, or state how missing observations were handled. These omissions make it difficult to assess the analysis population or the possible influence of missing outcome data.

The record also does not report participant characteristics, outcome distributions, intervention adherence, or statistical methods used for any completed analysis. It lists several intended secondary outcomes, but does not provide their results or explain how multiple outcomes were handled. Safety information is limited to aggregate counts, with no recorded serious-event terms and no term reported for the other adverse event. These limitations mean the posted record supports a description of the registered aims and selected counts, not a broad conclusion about intervention effects or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Brief Suicide Intervention for Youth in Juvenile Detention Settings — NCT05225103.
• Registry record last updated 2025-08-19; status last verified 2025-07.
• Results first posted 2025-08-19.
• 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 intervention development study sponsored by Duke University. It lists enrollment of 8, no allocation, and no masking. The intervention is a brief, trauma-informed intervention based on SAFETY-A, described as being delivered with Enhanced Usual Care in implementation sites.

The primary endpoint is the number of participants reporting suicide attempts by a specified C-SSRS question, up to 2 month follow-up assessment. The registry notes that data were not collected on one participant, but does not report the primary endpoint result or any statistical analyses. The brief summary states that the study was not designed or powered to test hypotheses.

For safety, the record lists 0 serious adverse events among 8 at risk, 1 other adverse event among 8 at risk, and 0 deaths. The primary outcome and further statistical results are not reported in the registry record.