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 Develop and Validation of Measurement-Based Transition Assistance (NCT05384171), a randomized na study. The primary outcome is Number of Participants Assessed for the Feasibility of Study Procedures.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05384171 |
| Phase | NA |
| Condition | Well-being |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 46 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Veterans invited to take part in a study about post-military readjustment and support seeking. The registry record describes 500 letters mailed; the number analyzed varies by feasibility measure according to the number eligible for that measure. The recorded enrollment is 46.
Intervention
Measurement-Based Transition Assistance (MBTA), a behavioral intervention intended to give individualized feedback about areas where a Veteran might benefit from additional support, with personalized recommendations for relevant programs, services, and supports. The intervention addresses health, vocational, financial, and social circumstances.
Comparator
An active control condition in which participants completed assessment measures only at baseline, then received MBTA along with other assessment measures at the three-month follow-up. The comparison therefore concerns the timing of access to MBTA within the study, not a comparison with no assessment at either time point.
Primary question
Can the study procedures be carried out feasibly, as assessed through enrollment, completion of both surveys, access to and completion of the MBTA assessment, and review of the personalized well-being report? The registry record does not report numerical results for these feasibility measures.
The study is framed around help-seeking: some Veterans may not know how severe a challenge must be to warrant support or what resources are available. MBTA is intended to address those barriers by linking assessment feedback with relevant supports. The primary question recorded for this trial, however, is about feasibility of the procedures rather than whether MBTA changes support-seeking or well-being.
Secondary outcomes include readiness to change, stages of change, theory of planned behavior constructs, attitudes toward seeking professional psychological help, and support-seeking actions to improve well-being. These outcomes describe several related aspects of readiness and behavior. Their presence in the registry does not, by itself, establish that the intervention changed any of them; numerical results for these outcomes are not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group study with no masking. The registry lists the phase as not applicable. The sponsor was the VA Office of Research and Development. The trial status is completed, and enrollment is recorded as 46. The study dates recorded are 2022-11-03 for the start and 2023-04-30 for primary completion.
The two groups differed in when MBTA was offered. The intervention group received MBTA and other assessment measures at baseline, as well as MBTA satisfaction measures; at the three-month follow-up, participants received MBTA and other assessment measures. The active control group completed assessment measures only at baseline, then received MBTA, MBTA satisfaction measures, and other assessment measures at the three-month follow-up.
Randomized allocation means assignment to study groups was intended to occur by chance. In general, this design can support a comparison between assigned groups, while a parallel-group structure means participants remain in their assigned study group rather than crossing over between conditions. The registry record does not describe the randomization sequence, how allocation was concealed, or any additional procedures used to implement assignment. It also does not report a masking procedure; the listed masking is none.
The planned primary outcome evaluates feasibility at baseline and the three-month follow-up. Its description specifies several separate measures, including enrollment among those invited, completion of both surveys, and engagement with the MBTA assessment and personalized report. Because these measures have different eligible groups and time points, the primary outcome is not represented by one simple two-group comparison in the posted results. Numerical results for the feasibility measures 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.
Before assignment: Potential participants were randomly assigned to a group prior to mailing (250 to Intervention Group arm and 250 to Active Control Group arm)
Overall Study
| Stage | Intervention Group | Active Control Group |
|---|---|---|
| STARTED | 27 | 19 |
| COMPLETED | 15 | 10 |
| NOT COMPLETED | 12 | 9 |
Reasons for not completing this period:
| Reason | Intervention Group | Active Control Group |
|---|---|---|
| Lost to Follow-up | 9 | 9 |
| Withdrawal by Subject | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: 500 letters mailed; number analyzed varies per row because of number of eligible participants within each category/row
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: Baseline participants are those that provided data in baseline. It does not include participants that consented to participate but then did not provide any data
| Characteristic | Unit | Intervention Group | Active Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 24 | 19 | 43 | |
| Age, Continuous | years | 41.71 (SD 11.12) | 35.16 (SD 8.73) | 38.25 (SD 10.33) |
| Sex/Gender, Customized: Male | Participants | 15 | 13 | 28 |
| Sex/Gender, Customized: Female | Participants | 5 | 6 | 11 |
| Sex/Gender, Customized: Other or prefer not to say | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 5 | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 | 14 | 34 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 9 |
| Race (NIH/OMB): White | Participants | 17 | 12 | 29 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | Participants | 24 | 19 | 43 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Assessed for the Feasibility of Study Procedures, measured over baseline (T1) and three-month follow-up (T2).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Number of Participants Assessed for the Feasibility of Study Procedures.” Its unit is participants, and its stated timeframe is baseline (T1) and three-month follow-up (T2). The endpoint description explains that feasibility was to be evaluated at the end of data collection using several measures: the proportion of invited Veterans who enrolled, the proportion who completed both surveys, and the proportions who accessed or completed the MBTA assessment or reviewed the personalized well-being report.
These measures address whether recruitment, follow-up, and use of the intervention’s components can be carried out in the study. They are process measures, not direct measures of whether MBTA improves health, well-being, or support-seeking. The distinction matters: a study can assess whether participants were recruited and engaged without establishing an effect on clinical or behavioral outcomes.
The record states that 500 letters were mailed and that the number analyzed varies by measure because eligibility differs across categories. It does not report the observed counts or rates for the endpoint’s individual feasibility measures. The primary outcome has multiple categories or time points and is not reduced in the posted results to one comparison. Therefore, no numerical conclusion about feasibility can be drawn from the endpoint information recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized evaluation of MBTA and specifies several feasibility measures, but it does not report numerical results for the primary outcome. In particular, the record does not give the number of invited Veterans who enrolled, the number who completed both surveys, or the counts accessing and completing the MBTA assessment or reviewing the personalized report. Without those results, the central feasibility question cannot be answered from the posted information.
Enrollment is recorded as 46, and the endpoint description notes that 500 letters were mailed. These figures provide context for the study’s recruitment process, but they do not supply the outcome-specific denominators or results. The description explicitly notes that the number analyzed varies by row because eligibility differs. It would therefore be inappropriate to treat the total enrollment as the denominator for every feasibility measure or to derive a recruitment rate from those two figures.
The record lists five kinds of secondary outcomes, including readiness to change, attitudes toward professional psychological help, and support-seeking actions. It also records 8 outcome measures and 6 analyses. The numerical results for the secondary outcomes are not reported in the registry record. Consequently, there is no posted estimate, uncertainty interval, or statistical test with which to describe the direction or precision of a secondary-outcome comparison.
For interpretation, the distinction between a planned outcome and a reported result is essential. The endpoint description tells readers what investigators intended to measure; it does not establish what was observed. Similarly, random allocation describes the study design, not the direction or size of any result. The available record therefore supports a description of the design and intended measures, but not a claim that MBTA altered feasibility, readiness, attitudes, or support-seeking.
The posted adverse-event figures are descriptive safety counts: the intervention group has 34 participants at risk, with 0 affected by serious adverse events, and the active control group has 9 participants at risk, also with 0 affected. Other adverse events are recorded as 0 affected in both groups, and deaths are recorded as 0 in both. These counts describe events recorded in the registry; they do not provide a full assessment of intervention effects or establish that no events occurred outside the recorded data.
Overall, the record documents a small completed study focused primarily on the feasibility of study procedures, but the key feasibility results are absent. The appropriate interpretation is therefore limited to what the registry lists: study structure, intended measures, enrollment, and recorded adverse-event counts. The effect of MBTA on the listed behavioral outcomes remains undetermined from the registry record.
9. Statistical Methods Explained
The registry identifies the allocation as randomized, the masking as none, and the model as parallel. These labels describe features of the study design. They do not specify every operational detail of how participants were assigned or how outcomes were analyzed. Details of the randomization method, allocation concealment, analysis model, and prespecified statistical procedures are not reported in the registry record.
What does random allocation contribute?
In general, random allocation uses chance to assign participants to groups. Its purpose is to reduce systematic differences between groups at assignment, so that a comparison can be interpreted more credibly as a comparison of the assigned study conditions. Randomization does not guarantee that groups will be identical, especially in a study with limited enrollment. It also cannot correct problems that arise after assignment, such as missing outcome data or differences in how outcomes are measured.
Here, the assigned conditions differed in the timing of MBTA. The intervention group received MBTA at baseline, while the active control group received it at the three-month follow-up. Both groups completed assessment measures, though the timing and contents differed. That design makes the timing of access an important part of interpreting any future group comparison. The registry record does not provide enough information to determine which statistical method was used to compare groups or how baseline values were handled.
Why is a parallel-group design relevant?
In a parallel design, participants are assigned to a study group and remain in that group for the study. In general, analyses can compare outcomes between those assigned groups, with the choice of method depending on the outcome type, measurement schedule, and analysis plan. This trial includes outcomes spanning feasibility, readiness, attitudes, and support-seeking. The primary outcome also comprises several separate feasibility categories and time points, rather than one uniform response. The registry record does not report a single analysis plan that explains how those different outcomes were modeled.
What can be concluded from the endpoint description?
The primary endpoint is a count of participants assessed for feasibility, but the accompanying description defines several distinct process measures. Some concern recruitment, some concern survey completion, and others concern access to or engagement with MBTA materials. In general, process outcomes require clearly defined eligible populations and denominators. The record states that the number analyzed varies by measure because of the number eligible in each category. The actual category-specific counts and results are not reported in the registry record, so neither a rate nor an uncertainty interval can be interpreted from the endpoint description alone.
How should sample-size planning illustrations be read?
General sample-size calculations ask how many participants or events would be needed under stated assumptions to detect a specified effect with a chosen statistical approach. The planning assumptions associated with the posted illustrations specify a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event illustrations, totals refer to events; for other outcomes, they refer to participants per arm.
Such illustrations are planning exercises, not observed findings and not evidence of observed power. They do not establish that the trial was designed using those assumptions. The registry record does not report the trial’s sample-size justification or say that the illustration was the protocol’s basis for enrollment. Moreover, the primary endpoint has multiple categories or time points and is not reduced to one comparison in the posted results. No single reported primary-outcome effect is available to interpret as the observed effect underlying a planning calculation.
What does statistical uncertainty mean?
In general, a confidence interval describes a range of values compatible with the data under a specified statistical model and procedure. Its width reflects precision: wider intervals indicate greater uncertainty about the estimated effect. A point estimate alone does not show how precisely an effect was estimated. Neither a confidence interval nor a point estimate for the primary or secondary outcomes is reported in the registry record.
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model does not account for that extra variability, standard errors and uncertainty intervals may be too small. Whether over-dispersion is relevant depends on the outcome and the analysis model. The registry record does not report a model or diagnostics that would allow readers to assess this issue for the trial’s outcomes.
Finally, statistical tests and uncertainty intervals are only interpretable in context: the outcome definition, analysis population, missing-data approach, and multiplicity strategy all matter. Those details are not reported in the registry record. The design labels and planned outcome descriptions should therefore not be mistaken for a complete statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five secondary-outcome domains: readiness to change measured with the University of Rhode Island Change Assessment Scale (URICA), stages algorithm, theory of planned behavior constructs, attitudes toward seeking professional psychological help measured with a short form, and support-seeking actions to improve well-being. It also records 8 outcome measures and 6 analyses. Numerical findings for these outcomes are not reported in the registry record.
When a study examines multiple outcomes, time points, or comparisons, the chance of obtaining at least one apparently notable result can increase. In general, a multiplicity strategy may define a primary comparison, adjust statistical tests, or otherwise distinguish confirmatory outcomes from exploratory ones. The registry record does not report whether any adjustment or prioritization strategy was used. The primary outcome itself is described through several feasibility measures, and the posted results do not reduce those measures to a single comparison.
Missing-data methods are also not reported in the registry record. The primary outcome description notes that the number analyzed varies by measure because eligibility differs by category, but that is not a description of how missing observations were handled. The record does not state whether analyses used complete cases, imputation, or another approach, nor does it report missingness by group or outcome.
The analysis population is not reported in the registry record. The enrollment count is 46, but the record does not specify whether each outcome analysis included all randomized participants, only participants who completed follow-up, or another defined group. Without that information and the outcome-specific denominators, readers cannot determine how the analysis population relates to random assignment or assess the possible impact of missing data. These omissions limit interpretation even if numerical outcome estimates were available.
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 |
|---|---|---|---|
| Intervention Group | 0 | 34 | 0.0% |
| Active Control Group | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention Group | 0 of 34 |
| Active Control Group | 0 of 9 |
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 Group | 0 of 34 |
| Active Control Group | 0 of 9 |
The registry records 34 participants at risk in the intervention group and 9 in the active control group. In both groups, 0 participants are recorded as affected by serious adverse events, and 0 are recorded as affected by other adverse events. Deaths are recorded as 0 in each group. No serious adverse-event terms are listed.
These are counts in the posted safety record, not evidence that the risk of events was identical between groups or that an event could not occur. A zero count means that no affected participants are recorded in that category for the group shown. The registry record does not report the safety observation period, event definitions, event ascertainment procedures, or further details that would allow a fuller safety assessment.
The at-risk counts are safety denominators and should not be assumed to represent the number enrolled in the entire trial or the denominator for each efficacy or feasibility outcome. The record does not explain how these safety populations were defined. These descriptive counts should be read as limited registry information, not as a comprehensive comparison of safety.
12. What the Result Does, and Does Not, Mean
The study’s primary question concerns whether its procedures are feasible, including recruitment, survey completion, and participants’ engagement with MBTA. The registry record describes how these aspects were intended to be assessed, but does not report numerical results for them. It is therefore not possible to determine from the posted record how many participants completed each step or how feasible the procedures were.
The study also includes measures related to readiness to change, attitudes toward professional psychological help, and support-seeking behavior. Those are relevant to the intervention’s stated aims, but the record does not report numerical results for these outcomes. No estimate of an intervention effect, confidence interval, or statistical test is available in the registry record. Accordingly, the record does not establish whether MBTA changed any of these measures.
The design was randomized, parallel-group, and unmasked, with MBTA offered at different study times in the intervention and active control groups. These design features describe the intended comparison; they do not substitute for outcome results. Even when results are available, statistical interpretation depends on the analysis population, missing data, outcome definitions, and analysis plan. Those details are not reported in the registry record.
The adverse-event information records zero participants affected by serious or other adverse events and zero deaths in both groups, alongside the listed at-risk counts. These are descriptive counts for the registry record and do not establish a broad safety conclusion. The record does not give the observation period or event-collection details.
Thus, the strongest warranted reading is descriptive: the registry documents a completed randomized study of MBTA, an enrollment of 46, a set of planned feasibility and behavioral outcomes, and the recorded adverse-event counts. It does not provide the primary or secondary outcome results needed to judge the observed feasibility or estimate effects on support-seeking and related measures.
13. Why This Trial Matters Statistically
This trial is statistically notable because its stated primary outcome is feasibility, while its rationale describes a behavioral intervention intended to address barriers to help-seeking. Those questions are connected but not interchangeable. Feasibility measures can indicate whether recruitment, assessments, and intervention materials can be implemented; they do not by themselves estimate effects on attitudes, support-seeking, or well-being.
The endpoint description includes several process measures with different eligible populations and time points. The registry notes that the number analyzed varies by measure. That structure makes the denominators central to interpretation: a count without the relevant eligible population cannot show the proportion completing a step. The record does not report the category-specific results or denominators needed to evaluate those measures.
The trial also illustrates why design details and findings must be distinguished. Randomized allocation and a parallel-group structure identify the broad comparison, but the registry record does not report outcome estimates, uncertainty intervals, or the analysis plan. Without those, readers cannot assess the magnitude or precision of any between-group difference. Multiple secondary outcome domains also make information about outcome prioritization and multiplicity relevant, but those methods are not reported.
Finally, the recorded safety counts are descriptive and do not replace outcome reporting. The record allows readers to identify what event counts were entered, but not to evaluate the observation period or how events were collected. Taken together, the available information supports an assessment of the trial’s stated aims and design, while leaving its principal feasibility findings and behavioral outcomes unresolved.
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 primary limitation for interpretation is that numerical results for the stated feasibility endpoint are not reported in the registry record. The endpoint includes several separate measures, but their observed counts and rates are absent. The record gives the number of letters mailed and total enrollment, yet does not report the outcome-specific eligible denominators or the number completing each step. A recruitment rate or completion rate cannot be established from the information recorded.
The registry record also does not report numerical results for the secondary outcomes, despite listing several behavioral and attitudinal measures. No effect estimates, uncertainty intervals, or statistical tests are available for those outcomes. As a result, the posted information cannot show the direction, size, or precision of a group comparison.
Further limitations arise from missing methodological details. The randomization procedure, allocation concealment, analysis model, analysis population, missing-data handling, and multiplicity strategy are not reported in the registry record. The record also does not give the trial’s sample-size justification. These omissions prevent readers from evaluating whether the analyses followed a prespecified plan or how incomplete observations may have affected results.
The registry describes the intervention and active control as receiving MBTA at different times, which is important context for interpreting the comparison. However, no outcome findings are available to clarify how that timing related to engagement or later measures. Safety reporting is also limited: the event counts are recorded, but the observation period and event-collection procedures are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Develop and Validation of Measurement-Based Transition Assistance — NCT05384171.
- Registry record last updated 2024-10-09; status last verified 2024-09.
- Results first posted 2024-09-19.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05384171 is a completed, randomized, parallel-group study with no masking, sponsored by the VA Office of Research and Development. The registry records enrollment of 46 and lists the study dates as 2022-11-03 to 2023-04-30. Its primary outcome concerns feasibility of study procedures, assessed through recruitment, survey completion, and engagement with MBTA materials at baseline and three-month follow-up.
The intervention group received MBTA at baseline, while the active control group received it at follow-up. Secondary outcomes cover readiness to change, stages of change, theory of planned behavior constructs, attitudes toward professional psychological help, and support-seeking actions. Numerical primary and secondary outcome results are not reported in the registry record. The safety record lists zero participants affected by serious or other adverse events and zero deaths in both groups, with 34 at risk in the intervention group and 9 in the active control group.