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 Work Assistance and Stipends for Housing (SASH) (NCT05803603), a na na study. The primary outcome is Methadone Doses.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05803603 |
| Phase | NA |
| Condition | Opioid-Related Disorders, Housing Problems |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Maryland, Baltimore |
| Results posted | Yes |
2. Clinical Question
Population
Homeless patients receiving methadone for opioid use disorder. The record describes the study as a feasibility study involving this population; it does not provide further eligibility details in the information recorded for the primary measure.
Intervention
Participants were assigned to an intervention described as stipend and social work supports. The arm description specifies a $500 monthly housing stipend for the first months of the study and twelve months of social work support to help participants find permanent housing.
Comparator
No separate control group is recorded. This is a single-group study, and allocation is listed as NA. The intervention arm therefore should not be read as a like-for-like comparison against a concurrent untreated or alternative-treatment group.
Primary question
The primary measure is percentage of missed methadone doses during the 3 months prior to enrollment. The study summary also asks whether the stipend increases treatment retention, improves quality of life, and prevents homelessness. Those broader questions should be distinguished from the specified primary measure and its pre-enrollment timeframe.
The central statistical issue is what a single group receiving a combined intervention can establish. The record describes a feasibility study and includes no concurrent comparison group. A change observed during or after participation could be described, if results were reported, but it would not by itself separate intervention effects from other explanations such as changes over time or differences in participants' circumstances.
The listed primary measure is a percentage of missed doses, with lower percentages defined as better outcomes. Its measurement period is before enrollment, so it describes methadone attendance before the intervention period rather than a post-intervention outcome. The record does not report an outcome value for this measure or a result for the study's broader questions about retention, quality of life, and housing.
3. Trial Design
SASH is recorded as a completed clinical trial feasibility study sponsored by the University of Maryland, Baltimore. The study began on 2022-12-01, reached primary completion on 2024-01-01, and has a completed status. The recorded phase is NA. Enrollment is 8.
The design is listed as single group, with allocation recorded as NA and masking recorded as none. No separate control arm is described. As a result, the design does not provide a randomized or concurrent between-group contrast. The intervention arm is described as receiving a $500 monthly stipend for the first months of the study and twelve months of social work support to help participants find permanent housing. The stipend and social work supports form a combined intervention in the record, so their separate contributions cannot be distinguished from this design description.
The study concerns opioid-related disorders and housing problems. Its stated objective is to assess feasibility while seeking to improve opioid use disorder, quality of life, and housing outcomes for homeless patients receiving medication for opiate use disorder. The summary frames questions around retention, quality of life, and preventing homelessness. These are stated aims, not reported findings.
The record lists 24 outcome measures and 1 analysis. It does not explain how feasibility was defined, what procedures were used to assess it, or what statistical analysis was performed for the primary measure. A sample-size justification and a detailed statistical plan are not reported in the registry record. The described design therefore supports a cautious reading: the registry identifies the intervention, population, and primary measure, but the available details do not establish a comparative test of the intervention's effects.
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 | Intervention Arm |
|---|---|
| STARTED | 8 |
| COMPLETED | 5 |
| NOT COMPLETED | 3 |
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 | Intervention Arm |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 46.75 (SD 8.75) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Methadone Doses, measured over 3 months prior to enrollment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percent of missed doses |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Methadone Doses and is defined as the percentage of missed methadone doses. Its timeframe is the 3 months prior to enrollment. The record gives a range of 0–100% and states that lower percentages mean better outcomes. The measure is continuous, with the mean identified as the summary parameter and the standard deviation as its dispersion measure.
A missed-dose percentage can describe attendance at methadone treatment over a defined period. In a study concerned with treatment retention, it is relevant as an indicator of participation in dosing. A continuous measure also preserves degrees of variation across participants rather than reducing attendance to a simple yes-or-no category. In general, the mean describes the average value, while the standard deviation describes how spread out individual values are around that average.
The endpoint's timing is essential to interpretation. Because the specified period is before enrollment, the endpoint characterizes pre-intervention methadone attendance; it does not directly measure attendance after receiving the stipend and social work supports. It may provide baseline context, but the registry record does not report a post-intervention methadone-dose endpoint or a comparison of before-and-after values.
No mean, standard deviation, or other primary endpoint result is reported in the registry record. Consequently, the direction and precision of the observed primary measure cannot be assessed from the reported information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a small, single-group feasibility study, but it does not report the primary outcome value. The enrollment is 8, and the primary measure is the percentage of missed methadone doses in the 3 months before enrollment. Although the measure is described as a mean with standard deviation, neither a mean nor a standard deviation is reported. The posted results therefore do not show the level or variability of the primary measure.
Even if a value for the pre-enrollment measure were available, its timing would limit what it could say about the intervention: the measured period precedes enrollment and the intervention. It could describe participants' prior methadone attendance, but it could not, by itself, show whether attendance changed after participants received support. A post-intervention outcome and a suitable comparison would be needed to estimate an intervention-related difference more directly; neither is described for this primary endpoint in the record.
The lack of a concurrent comparator is also central. In a single-group study, a later outcome could reflect the intervention, but it could also reflect changes in circumstances, usual care, or other influences. Without a control group, those explanations cannot be separated by a between-group comparison. Because the stipend and social work support are delivered together, the design description also does not isolate the contribution of either component.
The registry summary asks about treatment retention, quality of life, and preventing homelessness, but no results for those questions are included in the reported information. The record lists 24 outcome measures and 1 analysis, but that alone does not indicate which measures were analyzed, how they were analyzed, or whether results were complete. These details are not reported in the registry record.
For safety, the intervention arm's reported counts include 0 participants affected by serious adverse events and 0 affected by other adverse events, with 0 deaths. Such counts describe what was recorded; they do not establish that risk is absent. The record does not provide event-term detail for serious adverse events.
Overall, the available record describes a feasibility study and its intervention, but offers insufficient outcome information to determine the observed primary endpoint or the results for the study's wider aims. No conclusion about efficacy or causal effect follows from the design description or the absence of reported outcome values.
9. Statistical Methods Explained
What does the mean represent?
The primary measure is continuous: each participant's methadone attendance is expressed as a percentage of missed doses over the stated period. The registry identifies the mean as the summary parameter. In general, a mean is an average that gives each measured value equal weight. The standard deviation, also specified in the record, describes the spread of values around that mean. A mean alone does not show whether participants had similar or widely varying values; the standard deviation provides complementary information about that variation.
The record defines the measure's range as 0–100% and states that lower percentages mean better outcomes. This direction helps interpret a reported value, but no mean or standard deviation is reported. Nor does the record provide a distribution of individual values. The endpoint's statistical description therefore cannot be used to infer the observed level of missed dosing or how consistent attendance was across participants.
Why does the endpoint timeframe matter?
The primary timeframe is the 3 months prior to enrollment. In general, outcome timing determines what a measure can represent. A measure taken before an intervention can describe participants' status before treatment exposure, but cannot directly register a change caused by that intervention. It could serve as baseline context for a later comparison, but the record does not report a later value for this endpoint or an analysis comparing pre- and post-intervention attendance.
Even a reported pre- and post-intervention difference would need careful interpretation in a single-group study. Without a concurrent comparator, a change over time cannot be attributed uniquely to the intervention. Secular changes, changes in care, and other events could also contribute. These are general considerations for single-group designs, not claims about what occurred among SASH participants.
What can a single-group design estimate?
The study is listed as single group, with allocation NA and no masking. The record does not describe a separate control arm. A single-group study can characterize the participants who enrolled and can document outcomes within that group if results are reported. It cannot create the same direct contrast as a randomized comparison between an intervention group and a concurrent control group. Any within-group change combines intervention exposure with the passage of time and any other changes occurring during the study.
The intervention combines stipend and social work support. General statistical interpretation of a combined intervention is that an observed outcome cannot identify which component contributed to it unless the design includes comparisons or analyses capable of separating those components. No such component comparison is described in the registry record.
What does a confidence interval tell readers?
In general, a confidence interval expresses uncertainty around an estimated quantity, such as a mean or a difference. A narrower interval indicates greater statistical precision under the method used; a wider interval indicates less precision. An interval does not correct limitations in study design, and an interval from a single group would not create a control-group comparison. The registry record does not report a confidence interval for the primary measure or state an interval method.
Likewise, a p-value is not a measure of the size or importance of an effect. It relates the observed data to a specified statistical model and null hypothesis. The registry record does not report a primary-outcome p-value or identify a hypothesis test for that endpoint. No inferential result should therefore be inferred from the stated design or the number of analyses.
How should planning illustrations be understood?
Any sample-size planning figures associated with the reported results are illustrations based on an observed effect, not the trial's own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustration counts total events; for other outcomes, it expresses participants per arm.
These assumptions describe hypothetical planning, not what happened in this single-group feasibility study. They do not establish that the study was designed with a two-arm allocation, and they are not observed power. Sample-size illustrations based on an observed effect are also sensitive to uncertainty in that effect. The registry record does not report a sample-size justification for the trial itself or provide a primary endpoint result from which to judge the precision of an estimate.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. If a model underestimates variability, standard errors may be too small and uncertainty may appear narrower than it is. For a continuous percentage measure, the appropriate analysis depends on the data distribution and the planned model. The record does not report the distribution of values or the statistical model used, so it is not possible to assess whether over-dispersion was relevant or how variability was handled.
What analysis details are not reported?
The record lists 1 analysis, but does not specify the primary endpoint's analysis method, any adjustment variables, an analysis population, or handling of missing observations. Those choices matter because they affect which participants contribute information and how estimates and uncertainty are calculated. In general, the number of analyses alone does not identify the statistical approach or demonstrate that all planned analyses were reported. The interpretation must remain limited to the measures, design information, and results actually recorded.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Intervention Arm | 8 | 4.580 | 4.580 | 0.751 to 8.409 |
R code and output
arm <- c("Intervention Arm")
n <- c(8)
m <- c(4.58)
sp <- c(4.58)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Intervention Arm 8 4.580 4.580 0.751 8.40911. Multiplicity, Missing Data and Analysis Populations
The registry record lists 24 outcome measures and 1 analysis. It does not explain how the outcomes were organized into primary and secondary families, whether multiple hypotheses were tested, or whether an adjustment for multiplicity was planned. With many outcomes, repeated testing can increase the chance of finding apparently notable results by chance. General methods for addressing this issue include prespecifying a primary outcome, controlling error across a family of tests, or treating secondary findings as exploratory. No such strategy is reported in the registry record, so none should be assumed.
The primary endpoint is identified, but the record does not describe an analysis population or state how participants with incomplete measurements were handled. It does not report missing-data counts for the primary endpoint, reasons for missingness, or an imputation method. Missingness can affect both the estimate and how representative it is of all enrolled participants. In general, conclusions from an analysis of observed values depend on whether missingness is related to outcomes or participant characteristics; the record does not provide enough information to evaluate that possibility.
The study lists a single analysis, but no detailed statistical plan, interim-analysis description, or analysis timing is reported in the registry record. The endpoint's pre-enrollment measurement period also means that the record does not identify a post-intervention primary endpoint analysis. The available information cannot establish whether planned and completed analyses matched or whether all outcome data were available.
These gaps are reasons to limit interpretation, not evidence that a particular analysis or data-handling choice was made. No multiplicity adjustment, missing-data method, or analysis population can be inferred from the number of outcomes or from the study's feasibility label.
12. 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 |
|---|---|---|---|
| Intervention Arm | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention Arm | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention Arm | 0 of 8 |
For the intervention arm, the registry record reports 8 participants at risk for serious adverse events and 0 affected. It also reports 8 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed among the top terms.
These figures should be read as recorded counts, not as proof that no safety concerns are possible. A count of 0 affected means that no affected participants are reported in that category in this record; it does not establish that an event could never occur, nor does it describe risk outside the recorded study. The record does not provide further information about event definitions, surveillance procedures, timing, severity grading, or how adverse-event data were collected.
The listed at-risk and affected counts are confined to this intervention arm. There is no separate comparator arm in the study design to support a comparative safety assessment. With enrollment of 8, the counts are also a description of the reported study experience rather than a precise estimate of uncommon risks. The record's zero counts should not be interpreted as evidence that the intervention is free of risk.
13. What the Result Does, and Does Not, Mean
The record establishes that SASH was a completed, single-group feasibility study of a stipend and social work support intervention for homeless patients receiving methadone for opioid use disorder. It identifies the primary measure as percentage of missed methadone doses over the 3 months before enrollment, and specifies that lower percentages indicate better outcomes. It also records the intervention's stipend and social work components and the study's broader interests in retention, quality of life, and housing.
It does not report the primary endpoint's mean or standard deviation, a post-intervention value for this measure, or results for the broader stated aims. Therefore, the posted information cannot show the observed primary outcome, its variability, or whether methadone attendance changed. The pre-enrollment timeframe further means that the named primary measure is not itself a post-intervention measure.
The design also does not support a direct causal comparison with usual care or another intervention: there is no separate control group recorded. If outcomes had been reported for the single group, they could describe what was observed among participants, but could not alone establish that the intervention caused those outcomes. Because the stipend and social work supports are combined, the design description does not isolate their individual effects.
The reported adverse-event figures are counts for the intervention arm and should be understood as such. They do not establish absence of risk. The appropriate conclusion is limited: the registry record documents a feasibility study and its design, but does not include enough outcome information to determine the primary result or answer the study's wider effectiveness questions.
14. Why This Trial Matters Statistically
Feasibility studies can help establish whether an intervention and its evaluation can be carried out in a specified setting and population. SASH addresses a population described as homeless patients receiving methadone for opioid use disorder and combines housing-related financial support with social work support. Those features make clear outcome definitions and careful attention to timing especially important: measures should correspond to the intervention period and to the questions researchers intend to answer.
The primary endpoint illustrates that point. Percentage of missed methadone doses is relevant to treatment attendance, but the stated timeframe is before enrollment. That timing makes the measure a description of pre-intervention experience rather than direct evidence of a subsequent intervention outcome. Aligning measurement periods with study aims helps readers distinguish baseline context from outcome change.
The single-group design also demonstrates a central interpretive distinction. Describing outcomes among participants is different from estimating what the intervention changed compared with what would have happened without it. A concurrent comparator can help address that difference; no such group is recorded for this study. The combined stipend and social work supports further mean that an outcome cannot be assigned to one component based on the design description alone.
Finally, a registry record is most informative when it reports the planned analysis, outcome estimates, uncertainty, missing-data handling, and safety details alongside design features. Here, the available record identifies important study aims and an endpoint, but the primary result and analysis details are not reported. That makes transparent separation of design information from outcome evidence essential to sound statistical interpretation.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this study restrict interpretation. The registry record describes a single-group design with no separate control arm. Consequently, the design description does not support a direct comparison with participants receiving usual care or an alternative intervention. Any outcomes observed within the group could not, on their own, distinguish intervention-related change from other influences over time.
The primary measure is defined over the 3 months prior to enrollment. It therefore reflects a period before participants entered the study, rather than a stated post-intervention period. The record does not report a corresponding later measure or a before-and-after analysis for this endpoint. This temporal mismatch limits its value for answering whether the intervention changed missed-dose percentage.
The intervention includes both a stipend and social work supports. No component-specific comparison is described, so the separate contribution of each element cannot be determined from the design information. The stipend duration is described only as the first months of the study; a more specific duration is not reported in the registry record.
Enrollment is 8, and the primary outcome estimate and its standard deviation are not reported. The record also does not describe missing data, the analysis population, the statistical method, or a sample-size justification. Although 24 outcome measures and 1 analysis are listed, details about outcome-level analyses and multiplicity are not reported. These omissions prevent assessment of precision, completeness, and analysis choices. The adverse-event counts are reported, but event definitions and surveillance details are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Social Work Assistance and Stipends for Housing (SASH) — NCT05803603.
- Registry record last updated 2025-04-18; status last verified 2025-03.
- Results first posted 2025-04-18.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
SASH is a completed, single-group feasibility study sponsored by the University of Maryland, Baltimore. It enrolled 8 participants and studied stipend and social work supports for homeless patients receiving methadone for opioid use disorder. The intervention description specifies a $500 monthly stipend for the first months of the study and twelve months of social work support to help participants find permanent housing.
The primary measure is percentage of missed methadone doses during the 3 months before enrollment, summarized as a mean with standard deviation; lower percentages are defined as better. The registry record does not report its outcome value or a post-intervention result. It lists 24 outcome measures and 1 analysis, without details of the statistical methods or missing-data handling.
No comparator group is recorded. The adverse-event counts report 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These counts are descriptive and do not establish absence of risk.