Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI (NCT02057081), a randomized na study. The primary outcome is Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT).

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel-group clinical trial. The registry lists enrollment of 249 participants and identifies the study as completed. It lists the phase as not applicable. The sponsor was the VA Office of Research and Development. The record gives a study start date of 2014-10-09 and a primary completion date of 2019-03-12.

Participants were assigned to one of two behavioral interventions: the Multifamily Group for mTBI for Couples or Group Health Education. The treatment is described as a 14-session psychoeducational rehabilitation and skills-building program for couples. The control is described as a 14-session didactic educational group for families. The trial summary characterizes the comparison as a skills-based group versus supportive health education without skills training. The registry record does not report the method used to generate or conceal the allocation sequence.

The design is parallel-group, meaning participants were assigned to a group rather than described as crossing between interventions. Although the record labels masking as double, it does not state which people were masked or how masking was maintained in a behavioral group study. The exact analysis population and the statistical model used for the primary outcome are not reported in the registry record.

The primary endpoint was a continuous score measured at baseline, after treatment, and six months after treatment. The registry describes the post-treatment assessment as occurring in study month 38 after 12 bimonthly sessions and the later assessment as occurring in study month 44. The intervention descriptions separately specify 14 sessions. The record does not explain the relationship between the stated number of sessions and the assessment wording. Enrollment and completion status describe the trial record, but do not establish how many participants contributed data at each follow-up assessment.

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: One participant was consented but their partner did not consent.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only veteran participants were administered and evaluated on this outcome (not their partners). Two participants from the treatment group and 3 participants from the control group were missing data for this outcome at baseline.

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: Reflects demographic characteristics of those participants who consent, were randomized and completed the baseline assessment (does not include those that were enrolled and did not complete or who were ineligible)

6. Primary Endpoint

The registry lists the primary outcome as Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT), measured over baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44.

The primary outcome was change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT), a measure of community reintegration. The registry describes three subscales: Extent of Participation, Perceived Limitations, and Satisfaction. Each subscale has a total score calculated by summing item responses, with a stated range of 10 to 140. Higher scores indicate more frequent community participation for Extent of Participation, greater perceived limitations for Perceived Limitations, and greater satisfaction with community participation for Satisfaction. The direction of a higher score therefore differs across the subscales and should be interpreted by subscale rather than as a single uniform benefit direction.

Community reintegration is relevant to the trial’s focus on Veterans’ participation in community life after injury or combat-related stress. A structured score makes it possible to describe the measure at baseline and at later assessments. The registry record lists baseline, post-treatment, and six-month post-treatment assessment times. Only Veteran participants were evaluated for this outcome; partners were not. The registry record does not report a single combined primary estimate, a clinically important difference, or the results for the individual subscales and times. Consequently, the measure’s role can be described, but the magnitude and precision of any observed change cannot be assessed from the reported information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is identified as randomized, double-masked, and parallel-group. Randomization is intended, in general, to make assigned groups comparable on average at the start of a trial, including on factors that are measured and those that are not. It does not guarantee identical groups in a particular trial. The record does not report the randomization sequence method, allocation concealment procedures, or whether assignment was stratified. It labels masking as double, but the identities of the masked parties and the practical masking procedures are not reported.

What a parallel-group comparison means

In a parallel-group design, participants are assigned to one intervention group and followed in that group. Here the two behavioral conditions were the multifamily group for couples and Group Health Education. The registry describes each as a 14-session program, with the former emphasizing rehabilitation and skills-building and the latter didactic education. In general, an active comparison can help distinguish the contrast between intervention approaches from the effects of simply receiving group contact or education. The registry record does not report attendance, fidelity to the intervention, or differences in exposure between groups.

What the continuous endpoint represents

The primary measure is continuous: it yields numerical scores rather than a simple yes-or-no outcome. The registry identifies the mean as the summary parameter and standard deviation as the dispersion measure. In general, a mean describes the center of a set of scores, while a standard deviation describes how spread out individual scores are around that center. The record does not report the group means or standard deviations at the assessment times, nor does it report a mean change or between-group contrast.

The three CRIS-CAT subscales should be kept distinct. They concern extent of participation, perceived limitations, and satisfaction, and higher scores have different interpretations across them. The stated range for each total score is 10 to 140. The registry record does not report a single summary that combines these subscales. Nor does it specify whether the primary analysis focused on change from baseline, a comparison at a particular follow-up, or a model using multiple assessment times.

Why repeated assessments require an analysis plan

Baseline, post-treatment, and six-month post-treatment measurements create several possible ways to define a treatment contrast. General statistical practice would specify which time point or change measure is primary and how the repeated observations are modeled. Such choices affect the interpretation of an estimate and its uncertainty. The registry record does not report the prespecified contrast, covariance structure, model assumptions, or method for handling repeated observations. The record’s note that the outcome has several categories or time points and was not reduced to one comparison means that no single effect estimate can be interpreted as the definitive primary contrast from this entry.

Uncertainty and statistical evidence

General explanation: a confidence interval expresses uncertainty around an estimated quantity and indicates which values remain compatible with the observed data under specified assumptions. A narrower interval generally indicates greater precision than a wider interval, but precision is not the same as clinical importance. A p-value evaluates compatibility between data and a specified null model; it does not measure the size of an effect or the probability that a treatment is effective. The registry record does not report primary-outcome confidence intervals or p-values, and it lists zero analyses. Thus, there is no reported inferential analysis to interpret for the primary endpoint.

Planning assumptions are not trial results

The registry’s sample-size assumptions describe planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event illustrations, the convention is total events, while other illustrations concern participants per arm. These are planning assumptions, not observed trial outcomes and not observed power. The registry record does not report a sample-size justification from the original trial protocol, and the primary outcome information is not reduced to a single comparison. Accordingly, those assumptions do not supply a primary effect estimate or a basis for judging the trial’s achieved precision.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies change in caregiver burden as a secondary outcome. The primary CRIS-CAT outcome itself has three subscales and multiple assessment times. This creates several possible outcome comparisons. In general, when many outcomes or time points are tested, the chance of at least one apparently notable result can increase unless the analysis plan defines priorities or adjusts for multiplicity. The registry record does not report a multiplicity strategy, a hierarchy among subscales or time points, or a primary contrast that resolves these choices. It also lists zero analyses, so no analysis results or adjustment procedures are available to assess.

For the primary outcome, two treatment participants and three control participants were missing baseline data. The registry record does not report how those missing baseline values were handled. It also does not report the extent or pattern of missing data after treatment or at the six-month assessment, reasons for missingness, or any sensitivity analyses.

In general, missing-data methods rely on assumptions about why observations are missing. If follow-up availability differs according to participants’ outcomes or other characteristics, an analysis based only on observed measurements may not represent the full randomized groups. The registry record does not report whether the primary analysis used all randomized participants, only participants with observed data, or another analysis population. The handling of departures from assigned intervention and the use of imputation are also not reported. These gaps limit assessment of how representative any potential result would be of the randomized participants.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: self-reported interpersonal violence (2.2%), psychiatric hospitalization (0.9%), medical hospitalization (0.9%), medical hospitalization (0.7%).

The adverse-event record reports serious events for six of 136 participants at risk in the treatment group and four of 112 at risk in the control group. It reports zero other events in both groups and zero deaths in both groups. These are the registry’s event counts and at-risk counts; they do not provide a complete account of event timing, duration, severity beyond the serious classification, or individual participants’ histories.

The listed serious-event terms include self-reported interpersonal violence at 2.2%, psychiatric hospitalization at 0.9%, Medical hospitalization at 0.9%, and medical hospitalization at 0.7%. The record lists the two hospitalization terms with different capitalization and percentages. It does not explain whether these entries refer to distinct categories or how the percentages were calculated, so they should be read as separate reported entries rather than combined or reinterpreted.

In general, adverse-event counts describe events recorded during the monitoring period; they do not by themselves show that an intervention caused an event. The registry record does not provide enough detail to assess attribution, comparative risk, or the circumstances of each event. The figures should therefore be understood as reported safety information, not as a causal comparison or a complete characterization of safety.

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

The registry record establishes that a randomized, parallel-group trial compared a skills-based multifamily program with group health education for couples affected by mild traumatic brain injury or combat-related stress. It describes the primary measure, its subscales, assessment schedule, and the distinction between the two interventions. Those design details clarify what the trial intended to study.

The posted results do not, however, include a single primary-outcome comparison. No group estimates, changes, confidence intervals, or inferential tests for the CRIS-CAT outcome are reported in the registry record. The record also does not give the results for its secondary caregiver-burden outcome. Consequently, it cannot establish how the groups differed on community reintegration or caregiver burden, how large any difference was, or how precise an estimate might be.

The outcome’s separate subscales are important to interpretation because their higher scores do not all indicate the same direction of experience. Extent of Participation concerns frequency of participation, Perceived Limitations concerns limitations, and Satisfaction concerns satisfaction. Without results by subscale and assessment time, a broad statement about improvement or decline would not be supported by the posted information.

General statistical meaning: a randomized design can support a causal comparison when the analysis appropriately follows the assignment process and handles missing data and other design features. Randomization alone does not reveal the size or certainty of an effect. Here, the registry record does not report the primary analysis or enough outcome data to evaluate its assumptions and uncertainty. The information supports a description of the trial question and design, but not a conclusion that either intervention produced a particular clinical result.

13. Why This Trial Matters Statistically

This trial addresses a statistical challenge common in behavioral and rehabilitation research: the primary outcome is measured repeatedly and contains multiple subscales. A trial can be randomized and still leave readers without a clear treatment contrast if results are not reported for a specified outcome, time, and analysis. The registry record describes baseline, post-treatment, and six-month post-treatment assessments, but does not reduce the primary outcome to one comparison.

The outcome also illustrates why measurement direction matters. A higher score on Extent of Participation represents more frequent community participation, whereas a higher score on Perceived Limitations represents greater perceived limitations. Satisfaction has its own interpretation. Combining or narrating these measures as if a higher score always has the same meaning could obscure the clinical question.

The comparison is between two group interventions rather than between an intervention and no contact. That design is relevant for interpreting what a future reported estimate would represent: the contrast between a skills-building approach and an educational group. The record describes both arms but does not report intervention attendance, fidelity, or a primary comparative result.

The registry also makes clear why a trial’s enrollment number is not a substitute for outcome reporting. The enrolled total does not indicate how many observations contributed to each assessment or what uncertainty surrounds an estimated effect. Baseline missingness is noted for the primary outcome, but follow-up missingness and the analysis population are not reported. Clear reporting of the primary contrast, its uncertainty, and missing-data handling would be needed to assess the statistical evidence. In the current record, the design can be understood more fully than the outcome evidence.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation for interpreting this trial record is the absence of a reported primary-outcome estimate and inferential analysis. The endpoint includes three subscales and several assessment times, but the registry does not identify a single reduced comparison. As a result, the magnitude, direction, and precision of the treatment contrast cannot be evaluated from the posted information.

The record reports baseline missingness for five Veteran participants on the primary outcome, but does not describe missingness at post-treatment or six-month follow-up. It does not state how incomplete data were handled, whether all randomized participants were included in an analysis, or whether sensitivity analyses were conducted. These omissions prevent assessment of potential bias related to incomplete follow-up.

Other trial details that could inform interpretation are not reported in the registry record. These include the allocation-generation and concealment procedures, who was masked, the primary statistical model, the prespecified primary contrast, intervention attendance and fidelity, and the handling of multiplicity across subscales and time points. The relationship between the described 14-session interventions and the assessment wording referring to 12 bimonthly sessions is also not explained.

The primary outcome was assessed only in Veterans, not their partners, so it does not directly describe partner outcomes. The record’s adverse-event entries provide counts and listed terms but do not report attribution or enough detail to interpret causes. Finally, the registry does not provide the results for the secondary caregiver-burden outcome. These limitations concern what can be learned from the registry record and do not establish that the underlying trial did not collect additional information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI — NCT02057081.
• Registry record last updated 2020-06-04; status last verified 2020-05.
• Results first posted 2020-06-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT02057081 is a completed randomized, double-masked, parallel-group trial sponsored by the VA Office of Research and Development, with enrollment of 249 participants. It compared a 14-session skills-based multifamily program for couples affected by mTBI with a 14-session Group Health Education intervention. The primary outcome was Veteran-only change in CRIS-CAT community-reintegration scores, assessed at baseline, post-treatment, and six months after treatment. Its subscales measured extent of participation, perceived limitations, and satisfaction. The registry lists caregiver burden as a secondary outcome and identifies baseline missing data for two treatment participants and three control participants on the primary measure. It does not report a single primary-outcome comparison, outcome estimates, confidence intervals, inferential tests, the analysis population, or follow-up missing-data handling. Serious-event counts and terms are recorded, but attribution and further event details are not reported in the registry record.