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 Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop (NCT03868930), a randomized na study. The primary outcome is Military to Civilian Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03868930 |
| Phase | NA |
| Condition | Post-traumatic Stress Disorder, Traumatic Brain Injury, Substance Related Disorders |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 221 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Post-9/11 Veterans with difficulties reintegrating into community life were the intended population. The description characterizes the approach as transdiagnostic: a mental health diagnosis was not required for enrollment, and Veterans could have multiple diagnoses. The listed conditions include post-traumatic stress disorder, traumatic brain injury, substance-related disorders, depression, anxiety disorders, suicide, and pain. The registry reports enrollment of 221 participants.
Intervention
STEP-Home is a behavioral skills workshop focused on emotional regulation, problem solving, and attention training. Its stated purpose is to support skills relevant to daily function and community participation. The registry describes this arm as a skills-based intervention.
Comparator
The comparison was Present Center Group Therapy, abbreviated PCGT in the registry. It is described as a nonspecific supportive intervention in which participants identify and discuss current life stressors.
Primary question
The primary measure was the Military to Civilian Questionnaire, assessing post-deployment community reintegration in post-9/11 Veterans. The registered measurement schedule includes baseline, post-treatment at 12 weeks, and post-treatment follow-up at 24 weeks. Higher scores indicate greater reintegration and functional difficulties. The registry record does not report numerical results for the comparison, so it does not establish how the groups’ scores changed relative to one another.
3. Trial Design
The registry describes a randomized, parallel-group trial comparing two behavioral interventions: STEP-Home and Present Center Group Therapy. It identifies the masking as single, but does not report who was masked. The trial is multisite according to its title. Its phase is listed as not applicable. Enrollment was 221, and the listed status is completed.
STEP-Home centers on emotional regulation, problem solving, and attention training strategies. PCGT provides a supportive group setting focused on current life stressors. This active comparison is relevant to interpretation: the registered question is not simply whether STEP-Home participants changed over time, but how outcomes in the STEP-Home group compare with outcomes under another group intervention. The registry does not report details of the allocation procedure beyond randomization, such as the method used to generate or conceal assignments.
The registry lists the start date as 2019-06-17 and the primary completion date as 2024-03-29. The sponsor is the VA Office of Research and Development. The trial description frames STEP-Home as a community reintegration workshop for a broad population of post-9/11 Veterans, rather than a program restricted to one diagnosis.
The primary outcome was scheduled for assessment at baseline, after the 12-week treatment period, and at a 24-week post-treatment follow-up. The registry says that the number analyzed at each time point indicates participants who completed survey questions at that time. Numerical outcome results and the analysis comparing the randomized groups are not reported in the registry record. Details such as the duration and frequency of individual sessions, the randomization ratio, and the identity of the person or people masked are also 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: 195 (138M/57F) post-9/11 U.S. military Veterans were randomized to either 12 sessions of SH or PCGT. Assessments were conducted at baseline, 12 and 24 weeks. Analyses were based on intention to treat.
Intervention & Post-Treatment Assessment
| Stage | STEP-Home | PCGT |
|---|---|---|
| STARTED | 100 | 95 |
| COMPLETED | 53 | 57 |
| NOT COMPLETED | 47 | 38 |
Reasons for not completing this period:
| Reason | STEP-Home | PCGT |
|---|---|---|
| Lost to Follow-up | 3 | 1 |
| Physician Decision | 1 | 4 |
| Did not start treatment | 18 | 16 |
| Withdrawal by Subject | 25 | 17 |
Follow-Up Assessment
| Stage | STEP-Home | PCGT |
|---|---|---|
| STARTED | 53 | 57 |
| COMPLETED | 44 | 45 |
| NOT COMPLETED | 9 | 12 |
Reasons for not completing this period:
| Reason | STEP-Home | PCGT |
|---|---|---|
| Lost to Follow-up | 9 | 12 |
Analysis population for the primary outcome, as defined in the registry: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Only participants with available baseline data are included in baseline demographic analyses
| Characteristic | Unit | STEP-Home | PCGT | Total |
|---|---|---|---|---|
| Participants analysed | 93 | 91 | 184 | |
| Age, Continuous | Years | 38.2 (SD 10.3) | 39.8 (SD 10.5) | 39.1 (SD 10.4) |
| Sex: Female, Male: Female | Participants | 25 | 20 | 45 |
| Sex: Female, Male: Male | Participants | 68 | 71 | 139 |
| Race/Ethnicity, Customized: White | Participants | 62 | 60 | 122 |
| Race/Ethnicity, Customized: Black | Participants | 19 | 21 | 40 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: American Indian/Alaskan Native | Participants | 4 | 4 | 8 |
| Race/Ethnicity, Customized: Other | Participants | 15 | 7 | 22 |
| Race/Ethnicity, Customized: Hispanic | Participants | 23 | 22 | 45 |
| Branch of Service: Army | Participants | 55 | 43 | 98 |
| Branch of Service: Navy | Participants | 10 | 12 | 22 |
| Branch of Service: Air Force | Participants | 5 | 9 | 14 |
| Branch of Service: Marines | Participants | 11 | 10 | 21 |
| Branch of Service: Coast Guard | Participants | 3 | 0 | 3 |
| Branch of Service: Missing Data | Participants | 6 | 9 | 15 |
| Branch of Service: Multiple Branches | Participants | 3 | 8 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Military to Civilian Questionnaire, measured over Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The registered primary endpoint is the Military to Civilian Questionnaire, a 16-item measure of post-deployment community reintegration in post-9/11 Veterans. The registry gives a score range from 0 to 64 and specifies that the outcome is summarized as a mean with a standard deviation. Higher scores indicate greater reintegration and functional difficulties, so the direction should not be read as a simple measure of improved functioning: the registry description explicitly includes both reintegration and difficulties.
The measure is scheduled at baseline, after 12 weeks of treatment, and at the 24-week post-treatment follow-up. Repeated assessment is useful because a group comparison can address both the treatment-period pattern and whether differences persist at follow-up. That is a general feature of longitudinal outcome measurement; it does not establish which statistical model was used in this trial. The registry record does not report the observed means, standard deviations, changes, between-group estimates, or uncertainty intervals.
The registry states that the number of participants analyzed at each time point refers to enrolled participants who completed the survey questions at that time. This defines the reported time-point count, but does not explain how incomplete questionnaires or missing follow-up assessments were handled in the analysis. The rationale for selecting this instrument over other possible measures is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of STEP-Home with PCGT and names the Military to Civilian Questionnaire as the primary outcome. However, it does not report numerical findings for that outcome. There are no posted group means, standard deviations, changes from baseline, between-group estimates, confidence intervals, or p-values in the record. Consequently, the direction, size, and precision of any difference between the groups cannot be assessed from the registry record.
The endpoint description requires care. The questionnaire concerns community reintegration, but its higher scores are described as indicating greater reintegration and functional difficulties. These two aspects should not be collapsed into a claim that a higher score is uniformly better or uniformly worse. Interpretation needs to follow the instrument’s scoring and the actual analysis definition; that definition beyond the description is not reported in the registry record.
The planned assessments span baseline, the end of the 12-week treatment period, and the 24-week follow-up. In general, measurements at multiple time points can distinguish change during treatment from patterns at follow-up. A within-group change alone, however, would not establish a treatment contrast. Randomized comparisons are interpreted by comparing groups, with an analysis that accounts for the design and the relevant measurements. The analysis method used for this trial is not reported in the registry record.
The registry lists 221 enrolled participants, but that enrollment figure does not tell how many contributed primary-outcome data at each assessment. The registry’s definition of the time-point analyzed count refers to survey completion, yet the actual counts are not reported in the record. The disposition of participants after randomization, reasons for missing assessments, and treatment adherence are not reported in the registry record.
Other registered measures cover attention-related cognitive errors, problem solving, emotion regulation, PTSD symptoms, depression, anxiety and stress, neurobehavioral symptoms, disability, and life satisfaction. These outcomes describe a broad range of domains, but the existence of a measure is not itself evidence of a result. Numerical results for these outcomes are not reported in the registry record. No conclusion about relative benefit, lack of benefit, or clinical importance can be drawn from the available record alone.
9. Statistical Methods Explained
The registry describes the primary outcome as continuous and summarizes it using a mean and standard deviation. The mean represents the average score among the participants included in a particular summary. The standard deviation describes how dispersed individual scores are around that mean. In general, a standard deviation describes variation among observations; it is not the same as the uncertainty in an estimated mean or group difference.
What does a group comparison estimate?
In a randomized parallel-group trial, the central statistical question is ordinarily a contrast between outcomes in the assigned groups. For a continuous measure, such a contrast may be expressed as a difference in means or as a model-based estimate. The registry record names the randomized groups and the primary measure, but does not report the exact primary comparison, the estimated effect, or the statistical model. It therefore does not support a numerical description of the treatment contrast.
In general, a confidence interval describes a range of values compatible with the data and the assumptions of an analysis. Its width conveys precision: a narrower interval indicates more precise estimation than a wider interval, all else equal. A p-value addresses compatibility of the data with a specified null hypothesis under a statistical model; it does not measure the size or importance of an effect. The registry record does not report confidence intervals or p-values for the primary outcome, so no such interpretation can be made for this trial’s observed results.
Why do the repeated measurements matter?
The primary measure is scheduled at baseline, after 12 weeks of treatment, and at 24-week follow-up. Repeated measurements on the same participant are generally correlated rather than independent. A longitudinal analysis can account for that correlation and estimate patterns over time, but different model choices answer different questions and rely on different assumptions. The statistical model, covariance structure, and whether the primary comparison focused on a specific follow-up time or a pattern over time are not reported in the registry record.
Baseline measurements can describe the groups before treatment and may be incorporated into an analysis, but the registry record does not say whether baseline adjustment was used. In general, adjustment can improve precision when appropriately specified; it does not replace reporting the randomized-group comparison. The handling of baseline imbalances, if any, is not reported in the registry record.
How should dispersion and uncertainty be distinguished?
The registered standard deviation describes participant-to-participant variability in questionnaire scores. A standard error or confidence interval, by contrast, describes uncertainty in an estimated quantity. These concepts are not interchangeable. An observed mean and standard deviation alone would not fully communicate the precision of a between-group estimate; a group contrast and an uncertainty measure would also be needed. Those numerical results are not reported in the registry record.
For continuous outcomes, skewness, outliers, or unequal variability can affect how well a model’s assumptions fit the data. General diagnostic approaches may examine distributions and residual patterns, while robust methods may be considered if assumptions are not well supported. These are general statistical considerations, not statements about analyses performed in this trial. Diagnostic procedures and any alternative analyses are not reported in the registry record.
What do the planning illustrations mean?
Sample-size planning illustrations use assumptions about the target effect, significance level, allocation, and statistical model to estimate how many participants may be needed for a chosen power. The stated assumptions for the illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect expressed as a fraction of the observed effect. These are planning assumptions, not a report of the trial’s original design justification. The illustrations do not establish observed power, and the registry record does not report the trial’s own sample-size justification.
In general, power is a design quantity describing the chance of detecting a specified effect under stated assumptions. It is not a measure of whether a result is true, nor a substitute for an effect estimate and its precision. The registry record does not report the numerical effect estimates needed to assess the illustrations or any original power calculation. It also does not report an interim-analysis plan or statistical stopping boundaries.
10. Multiplicity, Missing Data and Analysis Populations
The registry includes a primary measure assessed at multiple time points, lists 15 outcome measures, and records 20 analyses. It also identifies multiple secondary measures covering cognitive errors, problem solving, emotion regulation, PTSD symptoms, depression, anxiety and stress, neurobehavioral symptoms, disability, and life satisfaction. A large set of outcomes and assessment times creates multiple opportunities for apparently notable findings. In general, multiplicity procedures can limit the chance of false-positive conclusions across a defined family of tests, but their relevance depends on which comparisons were planned and which were designated primary.
The record does not specify a multiplicity adjustment, a hierarchy of outcomes, or a plan identifying which time-point comparisons were confirmatory. The primary outcome’s several time points are not reduced to one comparison in the registry record. The statistical analysis plan, including any prespecified treatment of multiple comparisons, is not reported in the registry record. Without those details and the numerical results, the evidence across outcomes cannot be evaluated for multiplicity.
The registry says time-point analyzed counts represent enrolled participants who completed survey questions at each time. It does not report those counts, the amount or pattern of missing data, reasons for missingness, or methods for handling missing outcomes. Approaches such as complete-case analysis, imputation, or likelihood-based models are general possibilities, not methods that can be attributed to this trial. The primary analysis population and any sensitivity analyses are not reported in the registry record. A participant-flow account and a clear distinction between assigned, treated, and analyzed populations would help readers judge how missing information 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 |
|---|---|---|---|
| STEP-Home | 0 | 100 | 0.0% |
| PCGT | 0 | 95 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| STEP-Home | 0 of 100 |
| PCGT | 0 of 95 |
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 |
|---|---|
| STEP-Home | 0 of 100 |
| PCGT | 0 of 95 |
The registry lists serious adverse event counts for 100 participants at risk in the STEP-Home group and 95 participants at risk in the PCGT group. It reports zero affected participants for serious adverse events in each group. For other adverse events, it likewise lists 100 and 95 participants at risk, respectively, and zero affected participants in both groups. Deaths are listed as zero in each group. These are the recorded counts; they are not percentages and should not be converted into rates without additional information.
The record lists no serious adverse event terms. A zero count in the registry means that no affected participants were recorded for those categories in this entry; it does not establish that no adverse experiences of any kind occurred. The registry does not provide further detail about collection procedures, event definitions, duration of surveillance, or whether all events were assessed in the same way across groups. The number enrolled was 221, while the listed at-risk counts differ by group; the registry record does not explain the relationship between those figures. These safety entries should be interpreted as registry reporting, not as a comprehensive characterization of risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that STEP-Home was studied in a randomized comparison with a supportive group intervention and identifies community reintegration as the focus of the primary outcome. It also describes the intended population, the intervention content, the comparison condition, and the timing of outcome assessments. Those details clarify the research question and the outcomes the trial was designed to measure.
The registry record does not report numerical results for the primary outcome or the listed secondary outcomes. Therefore, it does not show whether average scores differed between groups, how large any difference was, how precise an estimate might be, or whether a pattern continued at follow-up. It also does not support a conclusion that either intervention did or did not improve outcomes. Absence of numerical results in this record is not evidence that the trial found no effect.
Even when numerical differences are available, statistical interpretation considers both magnitude and precision, as well as the meaning of the measure and the comparison being made. A statistically detectable difference need not be important to participants, and an imprecise estimate may leave substantial uncertainty. These are general principles. The record does not supply estimates with which to apply them to this trial.
The breadth of the registered outcomes reflects interest in several dimensions of functioning and symptoms, but each listed outcome requires its own result and appropriate context. The trial’s stated enrollment and completed status do not by themselves establish the completeness of outcome data or the strength of evidence for any particular comparison. Interpretation of efficacy, durability, and generalizability requires the numerical results, analysis details, and information on missing data, which are not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, the trial addresses a challenge common in clinical research: evaluating a broad intervention in a population with varied needs using outcomes that span multiple aspects of functioning. STEP-Home is described as transdiagnostic and focuses on emotional regulation, problem solving, and attention training. The comparison group also receives a behavioral group intervention, so the research question concerns the relative outcomes of two approaches rather than an intervention versus no group contact.
The primary measure is assessed across baseline, the end of 12-week treatment, and a 24-week follow-up. This schedule makes the distinction between short-term change and later patterns relevant. Proper interpretation depends on a clearly defined group contrast, appropriate handling of repeated observations, and transparent reporting of uncertainty. The registry record identifies the assessment schedule but does not report the analysis method or numerical outcome estimates.
The range of registered secondary outcomes also illustrates why prespecification and multiplicity matter. Measures cover cognitive errors, problem solving, emotion regulation, symptoms, disability, and life satisfaction. Without a reported hierarchy or adjustment plan, readers cannot determine how the analysis controlled for the many potential comparisons. This is a reporting limitation, not evidence that any particular result is misleading.
Finally, the registry’s description of survey completion as the basis for participant counts at each time point highlights the importance of reporting data availability over time. Enrollment alone does not convey how much outcome information contributed to each estimate. Numerical results, participant flow, missing-data methods, and the analysis plan would be needed for a fuller statistical assessment.
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.
A central limitation for interpretation is that the registry record does not report numerical primary or secondary outcome results. Without estimates and uncertainty measures, the size, direction, and precision of group differences cannot be assessed. The record also does not report numerical participant counts analyzed at each primary-outcome time point, despite defining those counts by survey completion.
Important design and analysis details are not reported in the registry record. These include who was masked, the allocation procedure beyond randomization, the exact primary comparison, the statistical model, baseline adjustment, handling of repeated measurements, and the prespecified approach to multiple outcomes and time points. Missing-data patterns, reasons for missingness, sensitivity analyses, and the primary analysis population are also not reported.
The outcome description notes that higher Military to Civilian Questionnaire scores indicate greater reintegration and functional difficulties. That wording combines concepts that may not have a single simple direction of interpretation. The registry does not provide further scoring guidance or explain how the endpoint was operationalized in the reported analysis.
The adverse-event entry reports zero affected participants in the serious and other adverse-event categories for the listed groups, but the registry record does not describe the ascertainment methods, event definitions, or monitoring period. The relationship between enrolled participants and the listed at-risk counts is not explained. These limitations restrict assessment of both outcome completeness and safety reporting. They do not establish that the trial lacked results; they identify information not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop — NCT03868930.
- Registry record last updated 2025-10-30; status last verified 2025-10.
- Results first posted 2025-05-30.
- 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
NCT03868930 is a completed, randomized, single-masked, parallel-group multisite trial sponsored by the VA Office of Research and Development. The registry lists enrollment of 221 and compares STEP-Home, a skills-based behavioral intervention, with Present Center Group Therapy, a supportive group intervention focused on current life stressors.
The primary outcome is the Military to Civilian Questionnaire, scheduled at baseline, after 12 weeks of treatment, and at 24-week follow-up. It is a 16-item measure on a scale from 0 to 64, with higher scores indicating greater reintegration and functional difficulties. The registry also lists a range of secondary measures. Numerical outcome results and key statistical analysis details are not reported in the registry record, limiting assessment of the treatment comparison.