CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention (NCT03584386), a randomized na study. The primary outcome is Change in Suicide Cognitions Scale (SCS).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. Its enrollment is recorded as 103, and its status is completed. The listed start date is 2018-10-01 and the primary completion date is 2021-03-31. The registry phase field is NA, while the brief summary calls the project Phase II. The project description includes formative usability and acceptability work as well as a summative clinical trial, so the overall enrollment figure should not be treated as the size of a single randomized comparison without further clarification. The brief summary describes a randomized controlled trial of emergency department patients, with Jaspr compared with Care-As-Usual. It gives planned arm counts for that component, but the record does not present a single reconciled account of those planned counts, the overall enrollment, and the analysis populations for the primary endpoint. The intervention listings include Jaspr and Jaspr-at-Home (JAH), and the arm descriptions refer to both an ED RCT and a Telehealth RCT. The primary outcome description specifically places the Suicide Cognitions Scale in the Telehealth RCT. Participants in the described emergency department study were assessed at baseline and again at 7, 30 and 90 days. For the primary scale, the stated timepoints are baseline, 30 days and 90 days. The number analyzed differs between primary-outcome rows because of attrition over different timepoints. The registry record does not report the sequence of allocation, concealment procedures, or detailed procedures for follow-up. These design details should not be inferred from the terms randomized or parallel-group.

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: Due to the COVID-19 pandemic, recruitment for the ED RCT was ended prematurely. We transitioned to the Teleheath RCT which recruited a different target population than the previous RCT. ED: 48 patients completed eligibility screening, 44 were eligible and 40 consented to participate. 26 patients completed all data collection points. Telehealth: 64 patients completed eligibility screening, 63 met eligibility criteria, and 63 provided consent. 44 patients completed all data collection points.

ED RCT (90 days)

Reasons for not completing this period:

Telehealth RCT (90 days)

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The number analyzed differs between rows because of attrition over different timepoints.

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: The periods listed in the Participant Flow reflect the total numbers started, completed, and not completed for each RCT, the ED RCT and the Telehealth RCT. The overall number of baseline participants combines the ED RCT and Telehealth RCT totals and differs from the enrollment number because of missing data and 1 participant was lost to follow-up before baseline data was collected

6. Primary Endpoint

The registry lists the primary outcome as Change in Suicide Cognitions Scale (SCS), measured over Baseline, 30 days, and 90 days..

The primary outcome is change in the Suicide Cognitions Scale (SCS), a self-report measure of suicidal schemas. The record describes an 18-item instrument with responses on a 5-point Likert scale. Item scores are summed to give a total from 18 to 90, with higher scores indicating worse outcomes. The measure is administered at baseline, 30 days and 90 days in the Telehealth RCT. A change outcome is intended to describe how a participant’s score differs over time from a reference assessment. Comparing changes between randomized groups can address whether their observed score trajectories differ, but interpretation depends on the timing of measurements, the participants included at each timepoint, and the statistical analysis used. Those analysis details and the numerical results for the primary outcome are not reported in the registry record. The scale is used to quantify a defined construct with a standardized scoring approach. Its score is not, by itself, a direct count of suicidal behaviors or emergency department visits. The brief summary lists predictions about several kinds of outcomes, but the stated primary endpoint is the SCS change measure. No conclusion about other outcomes should be substituted for a result on this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary outcome is continuous: it is a summed scale score, and the registry identifies the summary parameter as a mean with standard deviation. A mean describes the center of a group’s scores, while a standard deviation describes how spread out individual scores are around that center. These summaries can help characterize the observed scores, but neither alone expresses the uncertainty in a comparison between randomized groups. The registry record does not include the primary outcome values needed to interpret those summaries at each timepoint.

What does change over time mean?

For a repeated measure, change refers to how a score at follow-up relates to a participant’s baseline score. A comparison of change between groups would ask whether their measured trajectories differ, rather than merely whether one group’s score changed from baseline. The result can depend on which follow-up is examined and how repeated observations are handled. The record specifies baseline, 30 days and 90 days for the SCS, but does not report the model, contrast, or group estimates used to analyze these measurements. It therefore does not support reconstructing a single effect from the outcome description alone.

How should uncertainty be understood?

In general, a confidence interval describes a range of values compatible with the data and the method used to calculate it. A narrower interval indicates greater precision under that method; a wider interval indicates less precision. A point estimate without an interval can conceal substantial uncertainty, while an interval does not by itself establish the importance of an effect. The registry record does not report an SCS estimate or confidence interval for a between-group comparison. A p-value, if reported, would address a different question about compatibility with a specified null model and would not replace an estimate and its interval.

What can randomization contribute?

In general, random allocation aims to make assigned groups comparable on average at the point of assignment, reducing the risk that treatment assignment is systematically related to participants’ characteristics. It does not guarantee that every group is identical, prevent differences arising by chance, or address problems caused by missing follow-up data or deviations after assignment. The record identifies the study as randomized and parallel-group, but does not report the allocation sequence or concealment procedures. No additional safeguards should be assumed.

What does the record say about analysis choices?

The registry record lists no analyses. It does not report a statistical model for the primary endpoint, a rule for selecting among the multiple timepoints, an adjustment strategy, or a defined analysis population. Nor does it report whether results were analyzed according to randomized assignment or according to another population definition. These omissions prevent detailed evaluation of how the reported outcome structure would have been translated into an inferential comparison. Because the primary outcome spans multiple assessments and is not reduced to one comparison, choosing a single summary without a stated analysis plan would impose an assumption not documented in the record.

Why can over-dispersion matter?

In general, over-dispersion occurs when variability in data is greater than a statistical model assumes. If a model understates that variability, its uncertainty estimates may be too small and its intervals too narrow. The primary SCS outcome is described as continuous and summarized using a mean and standard deviation; the registry does not report an over-dispersion assessment or identify a model for which that issue was evaluated. This general concept should not be taken to mean over-dispersion occurred in this trial.

How should planning calculations be read?

General sample-size illustrations describe how many participants per arm might be needed under specified assumptions, such as a target power, significance level, allocation pattern, and effect to detect. They are planning tools, not measurements of the trial’s achieved power and not observed evidence of benefit. The record’s stated illustration assumptions refer to a two-sided significance level of 0.05, equal allocation, a normal approximation and fractions of the observed effect. The record does not report a trial-specific design justification or sample-size calculation. Any planning illustration based on an observed effect should be interpreted cautiously, since the observed estimate may be uncertain and may not be a reliable effect to plan around.

Overall, the statistical methods that generated a primary group comparison are not reported in the registry record. The outcome definition and measurement schedule are available, but the analysis specification, numerical results and uncertainty estimates needed to assess the primary comparison are not.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is measured at more than one follow-up timepoint, and the registry record says the number analyzed differs between rows because of attrition over time. Multiple outcomes are also named in the project description, including the SCS, the Optimism & Hope Scale, suicidal behaviors, admissions, coping skills and self-efficacy. The record does not report how these outcomes or timepoints were prioritized in the analysis, or whether any adjustment for multiple comparisons was used. In general, testing multiple outcomes or timepoints can increase the chance that at least one result appears unusual by chance. Multiplicity methods can address that concern, but the appropriate approach depends on which comparisons were planned and how they relate to one another. The registry record does not report a multiplicity strategy or a detailed statistical analysis plan. The brief summary’s predictions should not be treated as a prespecified testing hierarchy. Missing-data methods, reasons for attrition and the amount of missingness at each timepoint are not reported in the registry record. The analysis population is also not reported. In general, handling missing repeated measurements requires assumptions about why observations are missing and how the analysis uses available information. Without those details, readers cannot assess whether the timepoint-specific analyzed participants may differ from those not analyzed, or how that could affect estimates. No particular missing-data assumption or analysis population should be inferred.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

For the Jaspr group, the registry reports 0 participants with a serious adverse event among 52 at risk and 17 with other adverse events among 52 at risk. For Care As Usual, it reports 0 participants with a serious adverse event among 50 at risk and 17 with other adverse events among 50 at risk. Deaths are recorded as 0 in each group, and no serious adverse event terms are listed. These are recorded counts, not estimates of comparative risk. The record does not describe the other adverse events, their severity, timing, relationship to the intervention, or how events were collected. The serious-event counts therefore indicate only what was entered in this registry outcome record; they do not establish that no unrecorded events occurred. The at-risk figures also do not align transparently with the enrollment and trial-component descriptions elsewhere in the record. The registry does not explain the relationship between these safety denominators and the enrollment figures. No additional totals or rates can be inferred from the record.

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

The record establishes that a randomized parallel-group study was completed and that the SCS was designated as a primary outcome for assessment at baseline, 30 days and 90 days in the Telehealth RCT. It also states that the number analyzed varied across timepoints because of attrition. These registry entries describe the planned measurement and an issue relevant to interpretation, but they do not provide the actual primary-outcome comparison. The registry record does not report a numerical between-group estimate, its confidence interval, or a p-value for change in SCS. It therefore does not show how large any difference was, which direction it took, or how precisely it was estimated. The absence of a reported comparison is not evidence that the groups were the same, and it is not evidence that they differed. It means that the listed registry information does not permit that judgment. The intervention names and project description indicate that the work involved Jaspr and Jaspr-at-Home, alongside formative development and usability activities. The record’s descriptions of different trial components make it important not to conflate the overall enrollment figure, the emergency department RCT description and the telehealth outcome population. It does not fully reconcile those elements. The primary scale outcome should not be attributed to a particular intervention comparison beyond what the record states. The adverse event counts provide a separate, limited description of recorded safety outcomes. They do not substitute for efficacy results or clarify the missing primary comparison. Likewise, hypotheses in the brief summary are not trial findings. The registry record supports describing the study’s design labels, endpoint definition and recorded adverse-event counts, while leaving the magnitude and precision of the primary outcome unresolved.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registry record combines a development and usability project with descriptions of randomized clinical trial components. The record identifies randomized parallel allocation and describes both an emergency department comparison and a telehealth component. The primary SCS outcome is specifically associated with the Telehealth RCT, while overall enrollment is recorded separately. Care is needed to keep these populations and descriptions distinct rather than treating every count as belonging to one analysis. The endpoint is measured repeatedly, and the record explicitly notes that the number analyzed varies over time because of attrition. This illustrates why repeated-measure outcomes require clear reporting of timepoints, analysis populations and missing-data handling. Without those details, even a well-defined scale and assessment schedule are not enough to reconstruct how much change occurred or how certain a comparison may be. The record also illustrates the distinction between a research hypothesis and an observed result. The brief summary states predictions about several outcomes, while the registry information does not provide a single primary SCS comparison. The hypothesis is useful context for the study’s aims, but it cannot be interpreted as a finding. Similarly, a completed status and listed safety counts do not convey the size or precision of an efficacy result. For readers assessing trial evidence, the key statistical contribution of the record is therefore its documentation of the outcome construct and study framework, alongside visible gaps in result reporting and analysis detail. Clear separation of planned aims, measured outcomes, analyzed populations and numerical estimates is essential for interpretable clinical-trial evidence.

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 registry record does not report numerical primary-outcome estimates or a single comparison across the SCS follow-up times. It also does not report confidence intervals, p-values, a statistical model, or a detailed analysis plan. As a result, the direction, size and precision of the primary outcome cannot be assessed from this record. The number analyzed differs between primary-outcome rows because of attrition, but the amount and reasons for missingness are not reported. The record does not describe how missing values were handled or identify the analysis population. This limits assessment of whether observed follow-up scores could be affected by who remained under observation. The trial descriptions are not fully reconciled. Overall enrollment is recorded as 103, while the brief summary separately describes a planned emergency department RCT and the primary outcome description refers to a Telehealth RCT. The record does not explain how these components and their populations relate to the adverse-event denominators. They should not be combined or treated as interchangeable. The record does not report allocation concealment, detailed intervention delivery, a multiplicity approach, or a sample-size justification for the trial itself. It lists no analyses. The safety record gives counts but not descriptions or event-specific context for other adverse events. These limitations concern what the registry record documents; they do not establish that the underlying study lacked methods or results that were not entered in the record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention — NCT03584386.
• Registry record last updated 2026-10-14; status last verified 2022-04.
• Results first posted 2026-10-14.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT03584386 is listed as a completed randomized, parallel-group study with no masking. The registry records enrollment of 103, a start date of 2018-10-01 and primary completion on 2021-03-31. The project description includes formative usability and acceptability work and randomized clinical trial components. Jaspr and Jaspr-at-Home (JAH) are listed interventions, and Care As Usual is described as a comparator for the emergency department RCT. The primary outcome is change in the Suicide Cognitions Scale, assessed at baseline, 30 days and 90 days in the Telehealth RCT. The record notes attrition-related variation in the number analyzed across rows, but does not report a single primary comparison or its numerical estimates. Serious adverse events and deaths are recorded as 0 in both listed groups; other adverse events are recorded as 17 in each. The registry record does not provide detailed analyses, missing-data methods or a statistical plan.