FMBI With War-affected Families: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for FMBI With War-affected Families (NCT05241314), a non-randomized na study. The primary outcome is Youth Adjustment.

2. Clinical Question

The study’s stated focus is both implementation and preliminary outcomes. Those aims need to be kept distinct: evidence that an intervention can be adapted and delivered is not itself evidence of change in an outcome, while an outcome estimate would not by itself establish feasibility or acceptability. The registry describes optional post-intervention focus groups as a way to examine the feasibility of the community-based participatory research approach. It does not report their findings.

3. Trial Design

The registry identifies this as a completed, non-randomized study with no masking and a sequential model. The recorded enrollment is 25. The listed start date is 2022-01-01, and the primary completion date is 2023-01-01. The study is sponsored by the University of Minnesota. Its phase is listed as NA.

The study concerns Karen refugee families affected by war and living post-resettlement in the United States. Community health worker interventionists were to provide a 7-week home-based intervention. The listed behavioral interventions are Learning to BREATHE and After Deployment Adaptive Parenting Tools (ADAPT). The registry describes a youth group, with one randomly selected index youth per participating family, and a caregiver group consisting of maternal and paternal caregivers if present. It also mentions optional post-intervention focus groups.

Random selection of an index youth within a family should not be confused with random assignment of participants to interventions. The study’s allocation is explicitly recorded as non-randomized. The registry record does not describe a randomized allocation process, a masked assessment process, or a control comparison that would support a like-for-like estimate of intervention effect. The term sequential is recorded as the study model, but the stages, order of intervention delivery, and relationship between the named interventions are not reported in the registry record.

The stated objectives include assessing feasibility and acceptability and exploring preliminary improvements in social and behavioral health. Intervention adaptation, training and evaluating community health worker interventionists, and establishing fidelity-monitoring and quality-improvement procedures are also described as priorities for this pilot phase. The registry record does not report detailed fidelity results, recruitment or retention results, or findings from focus groups. It reports 10 outcome measures, but no analyses are listed. As a result, the design and aims can be described, but the posted information does not establish whether implementation targets were met or whether measured outcomes changed.

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: Phase 1 described in the IRB protocol was for intervention adaptation only and not human subjects research. We did not record individual outcomes or baseline information but used the information to inform implementation in phase 2. This record is for phase 2 part of the study and not phase 1.

Overall Study

Analysis population for the primary outcome, as defined in the registry: This outcome measure only pertains to the youth group

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.

6. Primary Endpoint

The registry lists the primary outcome as Youth Adjustment, measured over 3 months.

The primary outcome is titled Youth Adjustment and applies only to the youth group. It uses the Strengths and Difficulties Questionnaire (SDQ I/S), a 25-item youth behavioral screening questionnaire. The registered score is the Total difficulties score, formed by summing the scores from all scales except the prosocial scale. Its stated range is 0-40, and higher scores indicate higher adjustment challenges. The outcome is specified at 3 months and summarized as a mean with a 95% confidence interval.

A behavioral screening score provides a defined way to quantify difficulties across the measured domains. Using a continuous score preserves variation across the scale rather than reducing participants to categories. The mean describes the group’s average score, while the confidence interval conveys uncertainty around that estimate. Those interpretations are general statistical context; the registry record does not report the observed mean or interval, so the actual level of youth adjustment challenges and the precision of its estimate cannot be assessed from the posted results.

The direction of the scale matters when interpreting any estimate: a higher Total difficulties score corresponds to greater adjustment challenges, not better adjustment. The outcome’s title alone should therefore not be read as indicating that higher scores are favorable. The registry record does not report a baseline value, a comparison estimate, or an outcome change. The primary endpoint definition is available, but a result for that endpoint is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized by a mean and a 95% confidence interval. These choices describe how an outcome would be presented; they do not provide the result itself. No analysis is listed, and the primary outcome estimate is not reported in the registry record. The following is general statistical context for interpreting these methods, not a description of unreported analyses.

What does a mean describe?

A mean is a measure of the center of a set of numeric observations. For the registered youth outcome, it would describe the average SDQ Total difficulties score among the youth included in the analysis. Because this is a continuous scale with a stated range of 0-40, the mean can retain more gradation than a simple count of participants above or below a threshold. The registry does not specify a threshold, and no mean is reported. The mean alone would not show how scores are distributed across individuals: different distributions can have the same mean. Measures of spread or participant-level data would be needed to describe that variation, and those details are not reported in the registry record.

How should a confidence interval be read?

General statistical context: a confidence interval communicates uncertainty in an estimated quantity under the statistical method used. A narrower interval generally indicates greater precision for that estimate, while a wider interval indicates less precision. A 95% confidence interval is not a statement that 95% of participants’ scores lie inside the interval, and it is not a probability statement about the fixed true value after the interval has been calculated. Its interpretation depends on the method and assumptions used to construct it. The registry specifies a 95% confidence interval for the mean, but does not report its limits or the method used to calculate it. Precision therefore cannot be judged from the endpoint definition alone.

Why does the study design affect interpretation?

In a randomized comparison, random allocation is used to create groups whose differences at the outset are expected to be unrelated to treatment assignment, aside from chance. This registry record lists the allocation as non-randomized, so that design-based protection against confounding is not present. General statistical context: in non-randomized research, differences between groups or across time can reflect factors other than the intervention. Interpretation depends on the comparison and analysis actually conducted, as well as on the assumptions used to address such factors. The registry does not report a control comparison or an adjusted analysis. The record’s statement that one index youth was randomly selected within each participating family concerns selection of a youth; it does not change the non-randomized allocation of the study.

What does sequential mean?

The registry records a sequential model. That label alone does not describe the order of participant enrollment, intervention delivery, or outcome assessment. It does not establish whether participants received one intervention after another or whether distinct phases were compared. Those details are not reported in the registry record. A statistical interpretation should therefore not infer a particular sequence or assume that one stage served as a control for another.

What can the planning assumptions tell readers?

The stated sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. Such calculations concern sample sizes under assumptions; they are not results from participants and are not observed power. The registry record does not report that these assumptions were used to design the trial or give a trial-specific sample-size justification. The displayed planning values, if consulted, should not be treated as proof that the completed study had adequate power or that an effect was present. Any estimate derived from an observed effect can also be uncertain, especially when the underlying estimate is imprecise; the registry does not report a primary effect estimate with which to assess that issue.

General statistical context: over-dispersion occurs when observed variability is greater than a model assumes. When a model understates variability, standard errors may be too small and confidence intervals may be too narrow. Model choice should reflect the outcome’s distribution and the study design. The registry’s primary outcome is a bounded continuous score, but it does not report a fitted model or any assessment of distributional assumptions. This explanation does not imply that over-dispersion was present or that a particular model was used in this study.

In short, the registry describes the outcome scale, its summary format, and planning assumptions, but does not report an analysis that could be evaluated. Statistical methods can only be judged in relation to the actual estimand, data, model, and assumptions. The estimand, handling of repeated measurements if any, covariate adjustment, and method for calculating the confidence interval are not reported in the registry record. No conclusions about statistical significance, effect size, or the precision of an observed intervention effect can be drawn from the endpoint definition alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including Youth Adjustment as the primary outcome and secondary outcomes of physical health status, family functioning, emotion regulation, mindfulness, and physical symptom burden. It lists zero analyses. No outcome estimates or analysis results are reported in the registry record.

Multiplicity arises when several outcomes, time points, groups, or statistical tests are considered. General statistical context: the more tests conducted, the greater the chance that at least one result may appear statistically notable by chance if no adjustment or prespecified interpretation is used. Whether an adjustment is needed depends on the research questions and analysis plan. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or which outcomes were analyzed. It is therefore not possible to assess whether multiplicity was addressed or how any findings were selected or interpreted.

The registry record also does not report a missing-data strategy, the number of participants with endpoint data, or the analysis population. These details matter because outcome estimates can depend on which participants have observed measurements and how missing observations are handled. The enrollment count alone does not establish how many youth contributed primary outcome data. The record does not describe an intention-to-treat analysis, a per-protocol analysis, or another population definition.

These omissions do not establish that the study lacked an analysis plan or that data were missing. They mean that the relevant procedures and results are not reported in the registry record. Without them, readers cannot assess the effect of missingness, the completeness of follow-up, or the role of secondary analyses in the study’s conclusions.

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.

The registry lists separate safety figures for caregivers and youth. For caregivers, 14 were recorded as at risk for serious events and 0 as affected; 14 were recorded as at risk for other events and 0 as affected. For youth, 11 were recorded as at risk for serious events and 0 as affected; 11 were recorded as at risk for other events and 0 as affected. The registry reports 0 deaths in each group and lists no top serious-event terms.

These are counts in the registry’s safety categories, not estimates of comparative risk. The record does not report a control group, exposure-adjusted rates, event follow-up details, or a definition of how events were collected. The zero affected counts mean that the registry reports no affected participants in those listed categories; they do not establish that no symptoms or other events of any kind occurred. The safety figures should be read alongside the limits of the reported information, rather than as a comprehensive assessment of safety.

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

The registry record establishes that a completed, non-randomized study was conducted with an enrollment of 25 and that its stated aims included intervention feasibility, acceptability, and preliminary social and behavioral health outcomes. It identifies a youth adjustment endpoint measured with the SDQ Total difficulties score at 3 months, and it describes the intended home-based delivery by community health worker interventionists over 7 weeks. These details clarify the study question and its context.

They do not establish whether the intervention improved youth adjustment, whether caregivers or youth experienced changes in the secondary outcomes, or whether families and interventionists found the approach feasible or acceptable. The primary outcome estimate, confidence interval, and analysis are not reported in the registry record. No analyses are listed. There is therefore no reported effect size or precision to use in judging the direction or magnitude of change.

The study’s non-randomized allocation also limits what could be concluded from a simple before-and-after or between-group difference, if one were reported: other influences may contribute to observed differences. The record does not report a control comparison or an adjusted analysis that would clarify this issue. A planning illustration based on an observed effect is not a substitute for the outcome estimate, and it should not be described as observed power or evidence that an effect occurred.

The appropriate interpretation is consequently limited. The posted information documents the design, intervention aims, outcome definition, and safety counts. It does not provide the outcome findings needed to characterize effects or their uncertainty. This is a distinction between what the registry describes and what its posted results establish; it is not evidence for either benefit or lack of benefit.

13. Why This Trial Matters Statistically

This study is statistically notable for the gap between a clearly stated pilot purpose and the absence of posted outcome analyses. Feasibility and acceptability are central aims, alongside preliminary questions about social and behavioral health. For a pilot, implementation information can be important in its own right, particularly when the intervention is being adapted and procedures for fidelity monitoring and quality improvement are being established. But those aims require reported findings to be evaluated, and the registry record does not report them.

The outcome definition is specific enough to explain what a future result would mean: the SDQ Total difficulties score ranges from 0-40, with higher values indicating higher adjustment challenges. Its mean and 95% confidence interval are identified as the planned summary. Yet the absence of the estimate and interval prevents assessment of either direction or precision. This highlights a general statistical point: a prespecified measure and summary method support interpretation only when the corresponding results are available.

The non-randomized design is another important feature. The study’s question concerns an intervention in a particular community context, but the record does not describe a randomized control comparison. This means causal attribution cannot be inferred from the design label or from the intervention’s stated objectives. The record also describes randomly selecting an index youth within participating families; that procedure addresses which youth is selected, not assignment to an intervention.

Finally, the study lists multiple outcomes but no analyses. Without estimates, analysis populations, missing-data methods, or a multiplicity approach, readers cannot evaluate how outcome findings would be supported or qualified. These limits make transparent reporting especially relevant: feasibility results and endpoint analyses could address different parts of the research question. The registry record provides useful design context, but not enough statistical results to resolve either question.

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 no outcome analyses are listed and no primary outcome estimate is reported in the registry record. The primary endpoint is defined, but its observed mean and 95% confidence interval are not reported. Without those results, the direction, size, and precision of any change in youth adjustment cannot be assessed. The registry also lists 10 outcome measures, making the absence of outcome-specific findings relevant to both the primary and secondary questions.

The allocation is non-randomized, and no like-for-like control comparison is reported. The registry record therefore does not describe a design that would support attributing differences to the intervention through randomized assignment. It does not report an adjusted comparison or details sufficient to assess potential confounding. The fact that one index youth was randomly selected within each family does not address intervention allocation.

Enrollment was 25, but the number of participants with primary endpoint data is not reported. The registry does not describe retention, completeness of follow-up, or how missing data were handled. The analysis population and any covariate adjustment are also not reported. These omissions prevent assessment of whether the outcome summary, if calculated, would represent all enrolled participants or a subset.

The intervention details are limited for statistical interpretation. The registry names Learning to BREATHE and ADAPT and describes 7 weeks of home-based delivery, but the mapping and sequence of the named interventions are not reported. The details of the sequential model and the findings from optional focus groups are also not reported. Finally, the record does not report a trial-specific sample-size justification, analysis plan, or multiplicity strategy. These limitations constrain conclusions about implementation, estimation, and generalizability; they do not by themselves show that the intervention did or did not have an effect.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: FMBI With War-affected Families — NCT05241314.
• Registry record last updated 2025-04-02; status last verified 2025-03.
• Results first posted 2025-04-02.
• 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

NCT05241314, titled FMBI With War-affected Families, is listed as completed and sponsored by the University of Minnesota. The registry records a non-randomized allocation, no masking, a sequential model, and enrollment of 25. Its listed start date is 2022-01-01, and its primary completion date is 2023-01-01.

The study concerns Karen refugee families living post-resettlement in the United States. The behavioral interventions listed are Learning to BREATHE and After Deployment Adaptive Parenting Tools (ADAPT). The registry describes 7 weeks of home-based intervention delivered by community health worker interventionists, with optional post-intervention focus groups.

The primary outcome is youth adjustment, measured using the SDQ Total difficulties score at 3 months and summarized as a mean with a 95% confidence interval. The registry lists 10 outcome measures and zero analyses. It reports safety counts for caregiver and youth groups, including zero serious events, zero other affected participants, and zero deaths in each group. Primary and secondary outcome results are not reported in the registry record.