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 Social Workers Addressing Firearm Risk (NCT05784662), a randomized na study. The primary outcome is Change in Knowledge About Gun Violence.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05784662 |
| Phase | NA |
| Condition | Gun Violence Prevention |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 111 |
| Arms in the primary outcome | n/a |
| Lead sponsor | State University of New York at Buffalo |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns practicing social workers recruited for a pilot evaluation of the Social Workers Addressing Firearm Risk intervention. The brief summary describes recruiting an additional 100 practicing social workers, excluding participants from Aim 1, with n = 50 allocated to each arm. The registry lists enrollment as 111. The record does not explain how that enrollment figure relates to the recruitment description. Eligibility details beyond the stated population are not reported in the registry record.
Intervention
Participants assigned to the intervention arm were to receive the fully online SAFR intervention. It contains four modules, with expert interviews, didactic content, handouts, and brief quizzes. The quizzes are described as required for New York State continuing education credit.
Comparator
The control condition is a wait-list. Control participants were to receive invitations to surveys but not access to SAFR during the study, with access to the intervention at the conclusion of the study.
Primary question
The primary question is whether knowledge about gun violence changes over time in the study arms, as measured at baseline, 1 month later, and 3 months later. The registry record does not report numerical outcome results or a direct comparison between arms, so the direction and precision of any observed difference cannot be assessed from the posted results.
3. Trial Design
This is a randomized, parallel-group pilot study of the Social Workers Addressing Firearm Risk intervention. The registry identifies the allocation as randomized and the model as parallel. Masking is listed as none, so the study is open-label in the sense that masking was not used. The registry status is completed. The recorded study start is 2023-08-21 and primary completion is 2024-05-31.
The brief summary describes Aim 2 as a randomized controlled trial intended to evaluate preliminary efficacy. It says an additional 100 practicing social workers, excluding participants from Aim 1, would be recruited and allocated using block randomization, with n = 50 in each arm. Separately, the registry lists enrollment as 111. The record does not reconcile these statements, so they should be read as distinct registry entries rather than assumed to describe the same recruitment count in the same way.
One arm received the four-module online SAFR intervention. The comparator was a wait-list control: participants were invited to complete surveys but did not receive the intervention during the study, with access planned at its conclusion. The registry record does not report adherence to intervention modules or the timing of control participants' eventual access.
The brief summary says the study would use validated measures from Aim 1 to assess study variables and would focus on estimating parameters for planning a later comparative trial with a national sample. It also describes feedback on the intervention and tracking feasibility and acceptability indicators, including recruitment, intervention completion, and measurement-tool completion. Results for those process measures are not reported in the registry record. Details of concealment, the randomization sequence, and any implementation deviations 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
| Stage | SAFR Arm | WL Control Arm |
|---|---|---|
| STARTED | 63 | 48 |
| COMPLETED | 42 | 31 |
| NOT COMPLETED | 21 | 17 |
Reasons for not completing this period:
| Reason | SAFR Arm | WL Control Arm |
|---|---|---|
| Lost to Follow-up | 21 | 17 |
Analysis population for the primary outcome, as defined in the registry: Some participants lost to follow up and/or had missing data on outcomes measures.
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.
| Characteristic | Unit | Social Workers Addressing Firearm Risk | Control | Total |
|---|---|---|---|---|
| Participants analysed | 63 | 48 | 111 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 60 | 47 | 107 |
| Age, Categorical: >=65 years | Participants | 3 | 1 | 4 |
| Age, Continuous | years | 40.2 (SD 10.9) | 39.7 (SD 11.2) | 40.0 (SD 11.0) |
| Sex: Female, Male: Female | Participants | 17 | 14 | 31 |
| Sex: Female, Male: Male | Participants | 46 | 34 | 80 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 3 | 12 |
| Race (NIH/OMB): White | Participants | 52 | 41 | 93 |
| Race (NIH/OMB): More than one race | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 63 | 48 | 111 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Knowledge About Gun Violence, measured over Baseline, 1 month later, and 3 months later.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is change in knowledge about gun violence, measured with the Knowledge about gun violence measure. The registry describes this measure as novel and states that the theoretical minimum and maximum are 0.0 and 5.0. Higher scores indicate more knowledge about firearm safety. Scores are reported in principle as a mean with a standard deviation, so the endpoint is a continuous measure rather than a count of events or a time-to-event outcome.
Knowledge is relevant to the stated aim because SAFR is an educational intervention with expert interviews, didactic material, handouts, and quizzes. Measuring the score at baseline and at follow-up can describe how knowledge changes over time. Repeated measurements can also help distinguish a starting level from subsequent measured levels, although the registry record does not report the numerical scores or their changes.
The assessment schedule is baseline, 1 month later, and 3 months later. The registry notes that some participants were lost to follow-up and/or had missing outcome-measure data. It does not report the number with observed scores at each time point, the exact scoring rules for incomplete responses, or a numerical estimate of change. The primary outcome is therefore defined, but its observed magnitude and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the study as completed, but completion status is not itself evidence about the intervention's measured effects. The posted results do not include mean knowledge scores, standard deviations, changes from baseline, differences between arms, confidence intervals, or p-values. The registry also lists no analysis entries. As a result, the data available in the registry record do not establish the direction, size, or statistical precision of change in the primary outcome.
The outcome is measured at baseline, 1 month later, and 3 months later. In general, repeated measurements can describe both change within an arm and whether the pattern of change differs between arms. These are different questions. A change within the SAFR arm alone would not establish that change was attributable to the intervention, because change may also occur over time in the comparison arm. A between-arm contrast in change would address a comparative question, but no such estimate is reported in the registry record.
The registry's brief summary describes the aim as evaluating preliminary efficacy while emphasizing estimation for planning a later comparative study. In a pilot context, estimates can be informative even when they are uncertain. Their precision matters: a point estimate alone does not show how compatible the data are with a range of effects. A confidence interval, when reported, expresses uncertainty around an estimate under the statistical model. No confidence interval for the primary outcome is reported in the registry record.
Interpretation is also limited by incomplete follow-up or outcome data, which the registry acknowledges without quantifying. If observed outcomes differ systematically from missing outcomes, a complete-case estimate could be biased. The record does not state how missing values were handled, whether the analysis included all randomized participants, or whether sensitivity analyses were conducted. These omissions prevent assessment of how robust any estimated effect might be to missingness.
The enrollment entry and the recruitment description in the brief summary are not identical: the record lists enrollment as 111, while the summary describes an additional 100 practicing social workers and n = 50 per arm. The record does not explain the relationship between these figures. They should not be used to infer an unreported analysis population or outcome denominator. The adverse-event figures have their own at-risk counts and do not supply denominators for the primary outcome.
In general, a non-significant test, if one were reported, would not by itself demonstrate that there was no meaningful effect. Likewise, an apparent change would not by itself establish a reliable comparative effect. Because no numerical primary-outcome analysis is posted, neither type of conclusion can be drawn from this registry record. The available information supports description of the design and outcome definition, not a claim about the magnitude or certainty of the intervention's effect.
9. Statistical Methods Explained
The brief summary describes a planned randomized comparison and says results would be analyzed using mixed linear models or generalized estimating equations, as appropriate. It also says supportive analyses adjusting for participant covariates would be considered. These are descriptions of intended analytical approaches; the registry record does not report which method was ultimately used or provide a fitted model. No numerical analysis results are listed in the registry.
What do repeated-measures models address?
In general, a mixed linear model can represent repeated observations from the same participant while accounting for the fact that those observations are related. It can estimate patterns over time and compare those patterns across randomized arms. The model can also represent differences among participants through participant-level effects. The exact model depends on choices such as the time representation, the covariance structure, and the included terms. Those details are not reported in the registry record.
In general, generalized estimating equations estimate average relationships for a population while accounting for correlation among repeated observations from the same participant. They are another possible approach when outcomes are measured more than once. The choice between a mixed model and generalized estimating equations depends on the scientific target and assumptions about the data. Although the brief summary names both approaches, it does not say which was selected for the primary outcome, what link or covariance structure was used, or how model adequacy was evaluated.
What does randomization contribute?
Random allocation is intended to make the arms comparable, on average, with respect to measured and unmeasured characteristics at assignment. That supports interpretation of an arm contrast as a comparison of assigned strategies, subject to implementation, missing data, and analysis assumptions. Randomization does not guarantee that every characteristic will be balanced in a pilot study, and it does not remove uncertainty in estimates. The summary states that block randomization was planned, but sequence generation, allocation concealment, block details, and any departures from the planned procedure are not reported in the registry record.
Masking is listed as none. In general, lack of masking can affect behavior, reporting, or outcome assessment, particularly when an outcome is measured through a questionnaire. The registry describes the primary measure as a knowledge score, but does not report whether scoring was automated, whether assessors were involved, or whether participants knew the study hypotheses. These details are not reported in the registry record and should not be assumed.
How should uncertainty be understood?
In general, a point estimate summarizes the observed pattern under a chosen analysis, while a confidence interval shows the range of values reasonably compatible with the data and model at the stated confidence level. A narrow interval generally indicates greater precision than a wide interval, though precision is not the same as freedom from bias. No point estimate, confidence interval, or p-value for the primary outcome is reported in the registry record, so the precision of the estimated knowledge change cannot be evaluated.
The record describes sample-size planning illustrations based on a stated fraction of the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. It specifies that non-time-to-event illustrations are expressed as participants per arm. Those illustrations are planning exercises, not observed power and not evidence that the pilot was designed to detect a particular effect. Numerical illustration results and the effect fractions are not reported in the registry record. The record does not report a sample-size justification for the original study design.
Why can over-dispersion matter?
In general, over-dispersion occurs when outcome variability is greater than a statistical model assumes. If it is ignored, standard errors can be too small and confidence intervals too narrow, making uncertainty look less than it is. The primary outcome in this study is described as a continuous score summarized with a mean and standard deviation; the registry does not report an over-dispersion assessment or say that this issue was relevant to the fitted analysis. This is a general statistical consideration, not a reported finding about this trial.
Covariate adjustment can sometimes improve precision or account for chance imbalances, but its effect depends on the covariates and model specification. The brief summary says supportive analyses adjusting for participant covariates would be considered. It does not identify the covariates, indicate whether adjustment was performed, or report adjusted estimates. No conclusion about the presence or consequences of covariate adjustment can be drawn from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed at baseline, 1 month later, and 3 months later, and the registry lists five outcome measures. Multiple outcomes or multiple time-point comparisons can create multiplicity: the more questions examined, the greater the chance that at least one result may appear unusual by chance if tests are interpreted without regard to the number of comparisons. In general, investigators may specify a primary contrast, use a testing hierarchy, or adjust for multiple testing. The registry record does not report a multiplicity strategy, a hierarchy among all outcomes, or the planned primary time-point contrast.
The registry indicates that some participants were lost to follow-up and/or had missing outcome-measure data. It does not quantify missingness at each visit or by arm, state why data were missing, or describe the handling of missing values. In general, missing-data methods rely on assumptions about the relationship between observed and unobserved outcomes. A method that is suitable under one missingness mechanism may be biased under another. Because the analysis method and assumptions are not reported, the effect of missing data on the primary estimate cannot be assessed.
The analysis population is also not specified. The record does not state whether analyses followed intention-to-treat principles, included participants with available measurements only, or used another definition. The enrollment listing of 111 and the recruitment plan described as an additional 100 do not establish the denominator for any outcome analysis. No participant flow or time-point-specific outcome denominators are reported in the registry record. These gaps make it impossible to determine the extent to which missingness, multiplicity, or analysis-population choices could affect interpretation.
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 |
|---|---|---|---|
| SAFR Arm | 0 | 63 | 0.0% |
| WL Control Arm | 0 | 48 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SAFR Arm | 0 of 63 |
| WL Control Arm | 0 of 48 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SAFR Arm | 0 of 63 |
| WL Control Arm | 0 of 48 |
The registry lists serious adverse events and other adverse events separately for the SAFR Arm and WL Control Arm. For the SAFR Arm, the at-risk count is 63 for each category, and the reported number affected is 0 for serious events and 0 for other events. For the WL Control Arm, the at-risk count is 48 for each category, and the reported number affected is 0 for serious events and 0 for other events. The deaths entry is 0 in both arms. No serious-event terms are listed.
These figures describe the adverse-event entries in the registry record; they are not a measure of the primary knowledge outcome. The at-risk counts are the denominators associated with the safety entries and should not be treated as the number of participants with primary outcome data. The record does not explain the relationship between these safety denominators, the enrollment entry, or the planned recruitment description.
In general, zero reported events means that no events were recorded in the listed safety data; it does not establish that risk is absent. The interpretation depends on how events were defined, collected, and monitored, and on the observation period. Those details are not reported in the registry record. The safety entries therefore support a narrow description of what was reported, rather than a broad conclusion about safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized pilot study testing an online educational intervention against a wait-list control. It specifies a continuous primary measure of knowledge about gun violence and identifies assessments at baseline, 1 month later, and 3 months later. It also describes a plan to gather feedback and track feasibility and acceptability indicators. These details establish what the study was intended to examine.
They do not establish what the primary outcome showed. No numerical knowledge scores, changes, arm contrasts, uncertainty intervals, or hypothesis-test results are reported in the registry record. Consequently, the record does not support a conclusion about whether knowledge increased, how large any change was, whether the arms differed, or how precise an estimate might be. The study's completed status does not fill this results gap.
The aim is described as a preliminary evaluation and as a source of estimates for planning a subsequent comparative trial with a national sample. In general, pilot estimates can be uncertain and are often useful for assessing procedures and informing future study planning. They should not automatically be treated as definitive estimates of an intervention effect. The record does not report results for recruitment, completion, acceptability, or participant feedback, so those aims cannot be evaluated from the posted results either.
The registry also identifies missing or unavailable outcome data for some participants, without describing the amount or analytical handling. This limits what could be inferred even if a summary estimate were available, because the estimate's reliability can depend on who contributed outcome data and why other measurements were absent. The record does not describe the final analysis population or sensitivity analyses.
The appropriate reading is therefore descriptive: the registry documents the randomized pilot design, intervention and comparator, intended measurement schedule, and safety counts. It does not provide enough outcome information to characterize an effect or its uncertainty. Any claims about effectiveness, absence of effect, or generalizability beyond the described study would go beyond what is reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized pilot with repeated measurement of a continuous knowledge outcome. Its stated purpose includes estimating parameters that could inform planning for a subsequent comparative trial. That makes the distinction between an estimate and a definitive test especially important: pilot findings may guide future design, but their precision and transportability need to be considered rather than assumed.
The design also highlights the importance of defining the comparison over time. A baseline score and follow-up scores can describe trajectories, while an arm-by-time contrast can address whether the trajectories differ. Those estimands are not interchangeable. The registry provides the measurement schedule and mentions mixed linear models or generalized estimating equations, but it does not report the selected estimand or fitted analysis. The absence of numerical results leaves the key comparative statistical question unanswered in the posted record.
Several practical statistical issues are visible from the record even without outcome estimates. Some participants had missing or unavailable measurements, while the handling of those data is not reported. The intervention is unmasked, and multiple outcome measures and assessment times are recorded, but a multiplicity strategy is not reported. These features make clear why transparent analysis details and participant-flow information matter when interpreting a pilot study.
The record's recruitment statements also call for careful reading: enrollment is listed as 111, while the brief summary describes an additional 100 practicing social workers and n = 50 per arm. Since the registry does not reconcile these entries, neither should be used to infer outcome denominators. Statistically, that distinction matters because the amount and pattern of data available for analysis affect precision and interpretation.
Most importantly, the registry record separates a clearly described study question from an unreported result. It can inform readers about design and measurement, but does not permit estimation of the primary outcome's magnitude or precision. That boundary is central to responsible statistical interpretation.
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.
Outcome reporting is the central limitation for interpreting this trial from the registry record. The primary endpoint is defined, but no observed means, standard deviations, change estimates, between-arm contrasts, confidence intervals, or p-values are reported. The record lists no analysis entries. The outcome's direction, magnitude, and precision therefore remain unavailable.
The registry notes that some participants were lost to follow-up and/or had missing outcome-measure data, but it does not report the amount of missingness at each assessment or in each arm. It also does not describe imputation, model-based handling, sensitivity analyses, or the analysis population. The potential effect of missing data on the findings cannot be evaluated.
Several design and analysis details are not reported in the registry record. These include the randomization-sequence and concealment procedures, the final choice and specification of the repeated-measures model, any covariates used, the primary time-point contrast, and the approach to multiplicity across outcome measures and time points. Masking is listed as none, but the record does not detail outcome administration or scoring procedures.
The record gives different recruitment-related statements without explaining their relationship: enrollment is listed as 111, while the brief summary describes recruitment of an additional 100 practicing social workers and n = 50 per arm. The final number randomized, participant flow, and outcome denominators are not reported in a way that resolves this difference.
The primary measure is described as novel, with a theoretical scale range of 0.0 to 5.0, but the registry does not report its scoring details or measurement properties. Results for feasibility, acceptability, and participant feedback are also not reported. Together, these gaps restrict assessment of both the outcome findings and the practical conduct of the pilot.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Social Workers Addressing Firearm Risk — NCT05784662.
- Registry record last updated 2025-02-10; status last verified 2025-02.
- Results first posted 2025-02-10.
- 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.
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18. Record Summary
NCT05784662 is a completed randomized, parallel-group, unmasked pilot study of the Social Workers Addressing Firearm Risk intervention. It compares a fully online four-module intervention with a wait-list control. The primary outcome is change in knowledge about gun violence, assessed at baseline, 1 month later, and 3 months later with a continuous score whose theoretical range is 0.0 to 5.0.
The registry describes planned use of mixed linear models or generalized estimating equations and states that parameter estimation would inform a later comparative trial. It also acknowledges missing outcome data for some participants. Numerical primary-outcome results, analysis details, and results for feasibility or acceptability are not reported in the registry record. Safety entries list 0 serious events, 0 other events, and 0 deaths in both arms, using the arm-specific at-risk counts recorded for those entries.