Suicide Prevention Integration Into Task-shifted Mental Health Interventions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Suicide Prevention Integration Into Task-shifted Mental Health Interventions (NCT06208293), a randomized na study. The primary outcome is Mean Score Beck's Scale for Suicidal Ideation (BSI).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group behavioral trial with no masking. Its status is completed, and enrollment is recorded as 73. The phase is listed as NA. The record gives a start date of 2024-11-28 and a primary completion date of 2025-06-25.

The two named interventions are KPZ and EUC. Participants assigned to KPZ were to receive the package in addition to EUC. The package is described as culturally adapted and delivered by trained Peers, with a co-designed safety plan. EUC is described as usual care enhanced by trained Lady Health Workers, who link at-risk women with a primary-care facility medical officer. The full details of intervention delivery are not reported in the registry record.

The trial is described as cluster-randomized in the analysis note. The specific unit of randomization, the number and size of clusters, and the method used to account for clustering are not reported in the registry record. Those details matter because outcomes from people in the same cluster may be more alike than outcomes from people in different clusters. A simple analysis that treats every participant as independently randomized could therefore misstate uncertainty.

The trial is presented as a pilot assessing feasibility and acceptability of integrating a suicide-prevention package into an existing task-shifted depression intervention. The record also lists secondary measures concerning implementation, Peer knowledge and practice, mental health and social support, and qualitative interviews. Protocol details, including the sample-size justification and any interim analyses, are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Data presented here is for participants that completed the assessment at each time point.

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: Data is for all eligible participants.

6. Primary Endpoint

The registry lists the primary outcome as Mean Score Beck's Scale for Suicidal Ideation (BSI), measured over baseline, 3 months and 6 months.

The primary endpoint is the mean score on Beck's Scale for Suicidal Ideation (BSI) at baseline, 3 months and 6 months. The BSI is described as a 19-item self-report measure of the current intensity of attitudes, behaviors and plans related to suicide during the past week. Its first 19 items use response options graded from 0 to 2, and the items are summed to produce a total score from 0 to 38. Higher scores indicate greater suicidal-ideation severity.

A continuous score preserves gradations in reported severity rather than reducing responses to a yes-or-no outcome. Comparing mean scores can describe average differences between groups or time points, while the standard deviation describes variation among observed scores. Neither summary fully describes the distribution of individual responses.

The registry says the primary-outcome data are for participants who completed the assessment at each time point. That means the reported means are tied to observed assessments; the record does not say how missing assessments were handled in the analyses. The clinical interpretation of a score also depends on the instrument and study context. The registry does not report a threshold for a clinically important change or a responder definition.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is continuous: it is a numerical score summarized by a mean and standard deviation. The registry lists mean differences as the analysis measure and confidence intervals at the 95% level. The results are not accompanied by p-values, detailed model descriptions or a complete explanation of the contrasts. Those elements should not be inferred from the outcome type alone.

What does a mean difference represent?

In general, a mean difference subtracts one group or condition's mean from another according to a specified ordering. Its sign depends on that ordering. For a measure where higher scores indicate greater severity, a negative value could indicate a lower mean in the first group only if the registry clearly identifies which mean is subtracted from which. Here, the arm mapping and contrast direction for the listed identifiers are not reported in the registry record. It is therefore safest to describe the estimates and intervals without assigning their signs to a named arm.

The registry distinguishes final-value mean differences from net mean differences, but does not provide enough detail to establish how the net estimates were constructed. In general, a net contrast may account for a baseline value or a change over time, but the precise definition varies by analysis. No such construction should be assumed for these results. The time point represented by each estimate, the adjustment variables and the statistical model are not reported in the registry record.

How should confidence intervals be read?

In general, a confidence interval expresses the uncertainty around an estimated quantity under a statistical model and its assumptions. It is not an interval containing a stated proportion of individual scores, and it does not guarantee that the true value lies within its endpoints. The posted 95% intervals give readers a sense of the estimates' precision. For the net estimate of -1.00, the interval runs from -2.00 to 0.00; for the net estimate of 0.56, it runs from -4.92 to 3.80. The latter spans values on either side of zero. The registry provides no p-values, so significance tests should not be reconstructed or asserted from the record.

Statistical uncertainty and practical importance are separate questions. Even a precisely estimated difference may be too small to matter in a particular setting, while an uncertain estimate may include differences that could be important. The registry does not report a threshold for a meaningful BSI change, so the clinical importance of the posted estimates cannot be determined from a threshold-based interpretation.

Why does cluster randomization affect analysis?

General statistical explanation: in a cluster-randomized study, groups of participants rather than each participant individually are assigned to conditions. Participants in the same cluster may share context, providers or other influences, so their outcomes may be correlated. Treating such observations as independent can make standard errors too small and confidence intervals too narrow. An analysis should account for the clustering, for example through a suitable model or variance adjustment, but the registry does not report which approach was used or the clustering details needed to evaluate it.

The analysis note specifically warns that a simple individual-level re-analysis would be misleading and says only the sponsor's own analysis is shown. This is why a straightforward recalculation from group summaries is not an appropriate substitute for the reported analysis. Without the cluster structure and model specification, an independent participant-level calculation could not reproduce the design-based uncertainty reliably.

What do the planning illustrations mean?

General statistical explanation: sample-size planning asks how many participants might be needed to detect a chosen effect with a target probability of rejecting a null hypothesis under specified assumptions. Such calculations depend on the anticipated effect, variability, significance level, allocation, design and analysis. They are planning illustrations, not evidence about the probability that the completed trial detected an effect. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms and a normal approximation, with the effect defined as a stated fraction of the observed effect. The illustrations are not the trial's original design justification, and the registry record does not report that justification. No observed-power conclusion should be drawn from a planning calculation.

What is not established by the summaries?

The record lists 17 outcome measures and 20 analyses. Multiple outcomes and analyses can raise multiplicity concerns because repeated testing may increase the chance of at least one apparently unusual result. General statistical explanation: adjustment methods can address some forms of multiplicity, but may also change the interpretation of estimates and tests. The registry does not report a multiplicity strategy, a hierarchy of outcomes, or which analyses were prespecified. It is not possible to tell from the counts alone whether or how multiplicity was addressed.

The analysis population is described for the primary endpoint as participants completing assessments at each time point. The record does not report a full analysis-population definition, participant flow, missing-data method, or sensitivity analysis. These omissions restrict evaluation of both precision and potential selection effects in the observed results.

10. Analyses Reported by the Sponsor

The analysis note states that the trial is cluster-randomized and that a simple individual-level re-analysis would be misleading; it therefore presents only the sponsor's own analysis. This is important because a recalculation that treats every participant as independently assigned would fail to reflect the cluster structure and could give an unreliable measure of uncertainty. The posted mean differences and confidence intervals should consequently be read as the registry's reported analyses, not replaced by a basic recalculation from participant-level-independent assumptions.

The registry does not provide enough model or cluster detail to independently reproduce those estimates. It also does not map the group identifiers for the final-value entries to named arms, fully define the net contrasts, or report p-values. The two net estimates are -1.00 with a 95% confidence interval from -2.00 to 0.00, and 0.56 with a 95% confidence interval from -4.92 to 3.80. The final-value entries are -14.80 with a 95% confidence interval from -17.90 to -11.80, and -14.30 with a 95% confidence interval from -17.40 to -11.20. These figures can be quoted as posted, but the record does not support a more specific reconstruction of their meaning.

No independent recalculated estimate is reported for comparison. Accordingly, there is no numerical recalculation to use to challenge or confirm the sponsor's analysis. The analysis note's caution about the design is the basis for relying on the posted sponsor analysis rather than presenting a simple unadjusted participant-level result.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 17 outcome measures and 20 analyses. With multiple outcomes, time points and analyses, the chance of at least one result appearing unusual can increase if many statistical tests are considered together. General statistical explanation: a prespecified hierarchy or multiplicity adjustment can help clarify how a family of results should be interpreted. The registry record does not report whether such a plan was used, which outcomes were designated as primary beyond the listed BSI endpoint, or whether the analyses were prespecified.

The primary endpoint description states that the data are for participants who completed the assessment at each time point. That describes the observed-data population for the reported measure, but it does not explain how many assessments were missing, why they were missing, or whether participants with incomplete follow-up were included in other analyses. The number of completed assessments at each time point and the method used to address missing outcomes are not reported in the registry record. No imputation or sensitivity-analysis procedure is reported.

The record does not give a full analysis-population definition, such as whether participants were analyzed according to their assigned group regardless of intervention received. Participant flow between randomization and assessment is also not reported in the registry record. These gaps limit the ability to assess whether the observed means represent the randomized groups or a subset shaped by completion of follow-up.

Cluster randomization adds a further analysis consideration. The registry's analysis note cautions against simple individual-level re-analysis, but details of cluster count, cluster sizes and the model used are not reported. Without those details, the treatment of within-cluster dependence and its effect on uncertainty cannot be evaluated. The record also does not report interim analyses or a sample-size justification. These missing details do not invalidate the posted results, but they constrain independent assessment of the analysis and the certainty of its conclusions.

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 5% reporting threshold.

The registry lists no serious adverse events, other adverse events or deaths in the reported groups. For KPZ, the serious-event and other-event risk groups each list 25 at risk and 0 affected, with 0 deaths. For EUC, each lists 25 at risk and 0 affected, with 0 deaths. Separate workforce entries list 11 Peers at risk for each event category and 0 affected, with 0 deaths; the Lady Health Worker entry lists 12 at risk for each event category and 0 affected, with 0 deaths.

These are the counts recorded for the listed groups; they do not establish that no event of any kind occurred outside the registry's reporting definitions or observation period. The registry record does not report the event ascertainment window, detailed definitions, or further information on monitoring and reporting. The listed workforce entries are distinct group listings and should not be combined with participant-arm counts to infer an overall total. Zero reported events in these entries is a description of the registry data, not a general statement about safety.

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

The posted results give mean-difference estimates for a continuous measure of suicidal-ideation severity, with 95% confidence intervals. The BSI measures reported intensity over the past week, and higher scores indicate greater severity. The record also describes the trial as a pilot focused on the feasibility and acceptability of integrating a suicide-prevention package into an existing task-shifted intervention. This context matters: a pilot's purpose can include learning about implementation, not only estimating a clinical effect.

The results do not establish a clear arm-specific interpretation because the final-value group identifiers are not mapped to named arms and the net contrasts are not fully described. No p-values or threshold for a meaningful change are reported. The estimates and intervals can be read as the quantities posted, but they cannot support a definite claim about which named arm had lower scores or whether any difference was practically important.

The registry lists secondary measures involving implementation acceptability, appropriateness and feasibility, Peer knowledge and practice, depression and anxiety symptom scores, perceived social support, maternal suicide cognitions and qualitative interviews. Their presence indicates broader areas of assessment, but their results are not included in the registry record for this analysis. No conclusion about those secondary outcomes should be inferred from the primary-outcome estimates.

The reported safety counts show zero events in the listed categories and groups. They are limited to the registry's recorded counts and do not, on their own, characterize all possible safety outcomes or the adequacy of event monitoring. Likewise, enrollment and completion of the trial do not by themselves demonstrate that the intervention was feasible or acceptable; the relevant outcome results and their methods are needed for that assessment.

Overall, the record supports a cautious account of a completed pilot with posted BSI mean-difference estimates and no listed adverse events in the specified groups. It does not provide enough analysis detail to reconstruct the contrasts or independently assess the cluster-adjusted uncertainty. The results should not be expanded into a claim about treatment effectiveness.

14. Why This Trial Matters Statistically

This trial raises an important statistical issue: the randomization is described as cluster-based, while the primary endpoint is recorded for individual participants. The analysis must respect the level at which assignment occurred. If participants within clusters have correlated outcomes, treating all observations as independent can overstate the effective information and understate uncertainty. The registry explicitly cautions that a simple individual-level re-analysis would be misleading, making the design detail central to interpretation rather than a technical footnote.

The trial also illustrates the difference between a pilot's implementation aims and a definitive estimate of clinical effect. Its stated purpose is to assess feasibility and acceptability of integrating a culturally adapted suicide-prevention package into a task-shifted depression intervention in a low-resourced context. The listed secondary measures span implementation and participant outcomes. Interpreting such a broad set of measures requires clarity about which questions were primary, how outcomes were selected and whether multiple analyses were accounted for. Those plans are not reported in the registry record.

Finally, the registry's primary-outcome population is limited to participants who completed assessment at each time point, while the missing-data approach is not described. Incomplete follow-up can affect both the observed means and the precision of comparisons, especially if completion is related to outcomes. Clear reporting of participant flow, cluster structure, analysis models, contrast definitions and missing-data handling would make the estimates easier to interpret and reproduce. These are statistical reporting needs, not grounds to infer unreported results.

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 registry does not map the final-value analysis identifiers to named study arms. It also does not fully define the net mean differences, their direction, or the time-point contrast represented by each estimate. As a result, the signs and magnitudes cannot be confidently attributed to KPZ versus EUC from the record alone. The listed estimates are reported without p-values.

Although the analysis note identifies a cluster-randomized design, the randomization unit, cluster count, cluster sizes, and the method used to account for within-cluster correlation are not reported in the registry record. This prevents independent evaluation of the uncertainty estimates and means a simple participant-level recalculation would not be suitable.

The primary-outcome data are described as coming from participants who completed assessments at each time point, but the record does not give completion counts by time point, reasons for missingness, a missing-data method, or sensitivity analyses. A complete analysis-population definition and participant flow are also not reported. The relationship between the reported final-value and net estimates is unclear.

The registry lists 17 outcome measures and 20 analyses, but does not report a multiplicity plan, analysis hierarchy, or which analyses were prespecified. It does not report a sample-size justification or interim-analysis plan. The trial is described as a pilot, and the registry summary indicates an aim to assess feasibility and acceptability; the primary BSI results alone do not resolve those implementation questions. Details of eligibility, intervention fidelity and the full intervention content are also not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Suicide Prevention Integration Into Task-shifted Mental Health Interventions — NCT06208293.
• Registry record last updated 2026-10-20; status last verified 2026-09.
• Results first posted 2026-10-20.
• 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

NCT06208293 is a completed randomized, parallel-group behavioral pilot with no masking. Enrollment is recorded as 73, and the phase is listed as NA. The registry gives a start date of 2024-11-28 and a primary completion date of 2025-06-25. The two interventions are KPZ, a culturally adapted suicide-prevention package added to enhanced usual care, and EUC.

The primary outcome is mean BSI score at baseline, 3 months and 6 months. The posted analyses include final-value and net mean differences with 95% confidence intervals, but their group mapping and precise contrast definitions are not fully reported. The analysis note identifies cluster randomization and cautions against a simple individual-level re-analysis. The listed safety groups report zero serious adverse events, other adverse events and deaths. Important details about missing data, multiplicity, cluster-adjusted methods and analysis populations are not reported in the registry record.