Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic (NCT04931888), a non-randomized na study. The primary outcome is Change in Social Emotional Competence.

2. Clinical Question

3. Trial Design

This was a completed, parallel-group, nonrandomized behavioral pilot sponsored by Yale University. The registry lists enrollment as 31 and describes the study as an evaluation of EMPOWER, a social-emotional learning program adapted for refugee children during the COVID-19 pandemic. The study was intended to assess implementation outcomes as well as children’s social-emotional learning competence and COVID-19 knowledge among children and families.

Participants were assigned to an intervention arm or a waitlist arm. The intervention arm received the curriculum between pre- and post-evaluations. The waitlist arm was scheduled to receive the curriculum after its evaluations and to complete a second evaluation set timed with the control arm’s post-evaluations. This arrangement offers a comparison of the arms during the evaluation period, but the registry explicitly cautions that allocation was nonrandomized and the arms are not a like-for-like control comparison.

The registry lists no masking. The study is marked completed, with a start date of 2022-05-20 and primary completion date of 2022-08-15. The primary endpoint timeframe is Baseline to 4 Weeks. The record does not report the allocation procedure, the reasons participants entered each arm, or whether the timing and delivery of the curriculum were identical across participants. These details matter when judging whether differences between arms can be attributed to the program rather than to participant or implementation differences.

The enrollment figure describes the overall registry entry; it does not establish how many participants contributed data to the primary endpoint or each analysis. Arm-specific endpoint denominators and analysis populations are not reported in the registry record. A completed status indicates the study’s registry status, but does not by itself supply an outcome estimate or establish the strength of evidence.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Children were excluded if they or their parents were unsure how to answer. The question was only asked of and/or about child participants (not parents)

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: Participants include parents and children (3 of intervention and 3 of waitlist control are parents). The intervention group included 3 families. The waitlist control group also included 3 families.

6. Primary Endpoint

The registry lists the primary outcome as Change in Social Emotional Competence, measured over Baseline to 4 Weeks.

The primary endpoint is change in social-emotional competence, measured as the Attention to Feelings score from the Trait Meta Mood Scale. It is a continuous score reported in units on a scale. The subscale contains 7 questions on a 1-5 Likert scale, with a maximum score of 35 and a minimum score of 7. The stated assessment period is Baseline to 4 Weeks.

The measure targets children’s reported attention to their feelings. In general, a continuous scale can represent gradations in a measured characteristic rather than reducing responses to a binary category. A change score can describe how the measure differs between assessments, while a comparison between study arms can address whether the observed pattern differs by assignment. Neither type of estimate, on its own, resolves bias from nonrandom allocation.

The endpoint is relevant to the study’s stated focus on social-emotional learning competence. It is distinct from the implementation outcomes and from the listed secondary outcomes, Change in Quality of Life and Parent Afghan Symptom Checklist. The record says the primary question was asked of and/or about child participants, not parents, and excluded children if they or their parents were unsure how to answer. The registry does not report the numerical primary estimate, its 95% Confidence Interval, endpoint-specific participant counts, or the handling of incomplete responses. Therefore, the measure and intended timeframe can be described, but the direction, magnitude, and precision of any observed change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on the endpoint, the comparison being made, and the information available about how observations were collected and analyzed. For this study, the registry identifies a continuous primary measure, a baseline-to-follow-up timeframe, and nonrandomized parallel arms. It does not report a numerical primary result or analysis details. The following concepts explain what would ordinarily be relevant to interpreting such a design; they do not describe unreported procedures as if they were used.

What does a continuous mean measure describe?

The endpoint is a mean on the Attention to Feelings subscale. A mean summarizes the observed score distribution with a single central value. For a change endpoint, a mean change would summarize the average difference between assessments among the participants included in the analysis. A comparison of mean changes between arms could describe how the observed changes differed. These quantities answer different questions: change within an arm is not, by itself, a comparison of the intervention with the waitlist.

In general, a mean can be affected by unusually high or low observations, and it does not show the full spread of individual scores. A mean estimate is most informative when accompanied by a measure of uncertainty and clear information about which participants contributed data. The registry specifies a 95% Confidence Interval as the dispersion measure for the primary endpoint, but the numerical estimate and interval are not reported in the registry record.

How should a confidence interval be understood?

In general, a confidence interval gives a range of estimates compatible with the observed data under the statistical model and assumptions used. Its width conveys precision: a narrower interval indicates greater precision under that model, while a wider interval indicates less precision. The interval is not a guarantee that the true effect lies within its bounds, and it does not correct design limitations such as nonrandom allocation or selective availability of outcome data.

Because the registry does not report the primary estimate or its confidence interval, there is no basis in the record for assessing the precision of the primary result. The scale’s stated limits do not substitute for an observed estimate or its uncertainty. Nor can a confidence interval be reconstructed from the overall enrollment figure alone; it would require outcome data and the details of the analysis.

Why does nonrandom allocation matter?

In general, random allocation is intended to make study arms comparable, on average, with respect to measured and unmeasured baseline characteristics. Nonrandom allocation does not provide that protection. Participants who receive the curriculum during the initial evaluation period may differ from those placed on the waitlist for reasons related to enrollment, availability, preferences, or other factors. These are general possibilities, not explanations reported for this study.

Statistical adjustment can sometimes address measured differences, but it cannot ensure balance on factors that were not measured or were measured poorly. The registry does not report baseline characteristics, allocation details, or an adjusted analysis. Its explicit warning that the arms are not a like-for-like control comparison should therefore guide interpretation. Even if an arm contrast had been reported, it would need to be read as an association in this nonrandomized pilot rather than as an unqualified causal effect.

What do the planning assumptions mean?

The registry describes planning illustrations based on a stated fraction of an observed effect, equal allocation between arms, a two-sided significance level of 0.05, and a normal approximation. These are planning assumptions, not reported features of the trial’s original design. The planning illustrations are not observed power and do not show how likely this completed study was to detect an effect. The registry record does not report the original sample-size justification or indicate that these illustrations governed enrollment.

In general, a sample-size illustration asks how much information a future study might need under stated assumptions. It depends on the effect size chosen, variability, allocation, statistical model, and decision threshold. If the assumed effect is derived from a small pilot estimate, that estimate can be unstable; using a fraction of it is a planning scenario, not confirmation that such an effect is real. No sample-size figures or observed endpoint estimate are reported in the registry record, so no numerical planning conclusion can be drawn from the record.

What can be inferred from the available analysis record?

The registry lists zero analyses. It does not report a test statistic, p-value, adjusted estimate, model specification, handling of repeated measurements, or approach to missing outcome data. These absences prevent a detailed review of the statistical analysis. In general, model choice should reflect the outcome’s scale, the repeated assessment structure, and the intended comparison, but the record does not identify a model to evaluate.

The scale is bounded, with values from 7 to 35. General considerations for a bounded continuous score include checking whether the observed distribution is compatible with the assumptions of the chosen model and whether extreme values or clustering affect uncertainty. The registry does not report observed score distributions or diagnostics, so it is not possible to judge these matters for this study. No additional calculations can be justified without the endpoint results and analysis details.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint alongside secondary outcomes and describes additional study aims related to implementation, social-emotional learning, and COVID-19 knowledge. It does not report how the analysis handled the possibility of testing multiple outcomes or multiple comparisons. A multiplicity plan is not reported in the registry record. In general, when many outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase; a prespecified strategy can clarify how such results should be interpreted. No particular strategy should be assumed for this study.

Missing-data methods are also not reported. The registry states that children were excluded from the primary question if they or their parents were unsure how to answer, but it does not give the number affected or describe whether incomplete assessments were otherwise present. It does not report whether the analysis used complete cases, imputation, or another approach. In general, missingness can affect both the representativeness of the analyzed participants and the precision of estimates, especially if the reasons for missingness are related to the outcome.

The analysis population is not reported in the registry record. The stated enrollment of 31 does not establish how many participants posted primary endpoint data, how many were included in each arm’s analysis, or whether all enrolled participants were analyzed. Baseline characteristics by arm and participant flow are also not reported. These gaps make it difficult to assess attrition, comparability, and the relationship between enrollment and the endpoint results. The registry’s listing of zero analyses leaves no reported analysis population or missing-data method to evaluate.

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 safety record lists four groups: Intervention - Child, Intervention - Parent, Waitlist - Child, and Waitlist - Parent. For serious adverse events, the number at risk is 13, 3, 6, and 3 respectively, and the number affected is 0 for each listed group. Deaths are recorded as 0 in each group. For other adverse events, the number at risk is 13, 3, 6, and 3 respectively, and the number affected is 0 for each listed group.

These figures describe what the registry record reports for the listed groups; they should not be combined into an overall count. The group-specific denominators differ, and the registry does not report further detail about the duration or completeness of safety surveillance, how events were solicited, or whether the listed at-risk counts represent all participants exposed to the program. The record lists no serious adverse event terms.

In general, a zero count in a registry safety field means that no affected participants are recorded in that field. It does not establish that an event is impossible or that the intervention has no safety concerns, particularly when the study is a pilot and the record does not provide detailed surveillance methods. The figures should be interpreted as registry reporting, not as a broad safety conclusion.

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

The registry record establishes that EMPOWER was evaluated in a completed, nonrandomized pilot involving refugee children and families during the COVID-19 pandemic. It identifies the intervention, a waitlist arrangement, the primary Attention to Feelings endpoint, and the intended baseline-to-4-weeks assessment. It also documents the overall enrollment figure and the specific child response eligibility condition for the primary measure. These registry entries describe the study’s purpose and design.

The registry record does not report a numerical primary endpoint result, a confidence interval, a p-value, or an analysis population. It therefore does not show whether the measured score changed, how large any change was, or how precise an estimate might be. A completed study status is not a substitute for results. Nor does the stated enrollment determine how many participants contributed to the endpoint analysis.

Even if an outcome estimate were available, the nonrandomized allocation would limit causal interpretation. Differences between arms could reflect differences that existed before the evaluation period or other factors related to how participants entered the arms. The registry explicitly cautions that the arms are not a like-for-like control comparison. Without reported baseline characteristics and analysis methods, the extent to which such differences were addressed cannot be assessed.

The study’s pilot and implementation focus is important: it was designed to evaluate adoption, acceptability, feasibility, and attrition as well as child outcomes and family COVID-19 knowledge. However, numerical results for those measures are not reported in the registry record. The record consequently supports describing the questions the study set out to examine, but not claiming that the program improved or failed to improve social-emotional competence, quality of life, symptoms, or COVID-19 knowledge. The safety fields record zero affected participants for the listed serious and other adverse-event categories, but the record does not provide enough surveillance detail to turn those entries into a definitive safety assessment.

13. Why This Trial Matters Statistically

This study is statistically notable for the distinction between a pilot’s implementation aims and the evidence needed to estimate an intervention effect. EMPOWER was intended to be adapted for a resettled refugee community, with trauma-informed and culturally specific wellness and COVID-19 safety components. Evaluating feasibility, acceptability, adoption, and attrition can help characterize whether a program can be delivered and assessed in its intended setting. Those questions are different from establishing a causal effect on a child outcome.

The nonrandomized parallel design makes that distinction especially important. An arm comparison may be informative descriptively, but without random allocation, observed differences can be entangled with differences in who entered each arm or how participation unfolded. The registry itself warns against treating the arms as a like-for-like control comparison. Recognizing that limitation is necessary before interpreting any outcome contrast.

The primary measure is a defined child-focused scale with a stated assessment window and score range, which makes the intended endpoint clear. At the same time, the registry does not report the numerical endpoint result, uncertainty interval, or analysis population. Without those elements, readers cannot judge magnitude, precision, or the relationship between enrollment and observed data. The record also does not describe the statistical plan, missing-data handling, or multiplicity approach.

These features make the registry useful for understanding the study question and design while leaving substantial uncertainty about the outcome evidence. A careful statistical reading separates what the study planned to measure from what the record documents as an observed result. It also keeps implementation evidence, safety reporting, and causal inference as distinct questions rather than treating them as interchangeable signs of effectiveness.

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 registry record has limited information for assessing the primary result. It identifies the endpoint and its timeframe but does not report the mean change, 95% Confidence Interval, arm-specific results, or endpoint-specific denominators. It also lists zero analyses. As a result, the direction, magnitude, and precision of the primary outcome cannot be evaluated from the record.

The nonrandomized allocation is a substantive design limitation. The registry cautions that the arms are not a like-for-like control comparison, and it does not describe how participants were allocated or report baseline characteristics by arm. This makes it difficult to assess whether the groups differed before the intervention period or whether any adjustment addressed such differences. The absence of masking is recorded; the registry does not explain how outcome assessments were conducted or whether knowledge of arm assignment could have influenced responses.

The primary question excluded children if they or their parents were unsure how to answer. The registry does not report how many children met this condition, how incomplete assessments were handled, or the analysis population. This limits assessment of selection and missing-data concerns. Additional details about intervention delivery, participation, attrition, and fidelity are not reported in the registry record, despite the study’s implementation focus.

The record lists secondary outcomes and broader study aims but does not report numerical results or a multiplicity strategy. It also does not report the original sample-size justification or the analysis model. Safety entries are available by group, but surveillance duration and ascertainment methods are not described. Together, these gaps mean the record can support a design-level account, but not a detailed evaluation of outcome reliability, completeness, or causal interpretation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic — NCT04931888.
• Registry record last updated 2023-11-30; status last verified 2023-11.
• Results first posted 2023-11-30.
• 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.

18. Record Summary

NCT04931888 is a completed, nonrandomized, parallel behavioral pilot of EMPOWER, a social-emotional learning and wellness program for refugee children and families during the COVID-19 pandemic. The registry lists enrollment of 31, no masking, a start date of 2022-05-20, and primary completion on 2022-08-15.

The primary endpoint is change in the Attention to Feelings subscale of the Trait Meta Mood Scale from baseline to 4 Weeks. Its score ranges from 7 to 35. The intervention arm received EMPOWER between pre- and post-evaluations; the waitlist arm was scheduled to receive it after evaluations. The registry cautions that nonrandomized allocation means the arms are not a like-for-like control comparison.

The numerical primary result, confidence interval, analysis population, and statistical analysis details are not reported in the registry record. The listed safety groups have zero serious and other adverse events affected, and zero deaths recorded. These registry entries do not establish a broader safety conclusion.