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 Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants (NCT03926247), a na na study. The primary outcome is Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03926247 |
| Phase | NA |
| Condition | Mental Health |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 56 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of New Mexico |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 56 Mexican immigrants who participated in the Immigrant Well-being Project intervention. The primary outcome description says an outcome analysis included participants with data at a minimum of two timepoints, with at least one of those timepoints being the first or second measurement. The record does not give further eligibility details in the information available for this analysis.
Intervention
The intervention was the Immigrant Well-being Project, a community-based approach intended to address social-structural determinants of mental health. It was administered by university students enrolled in a service-learning course and adapted into existing efforts at three community partner organizations. Its described activities include Learning Circles involving cultural exchange and one-on-one learning opportunities.
Comparator
There was no concurrent comparison group. The study is recorded as single-group, with allocation listed as not applicable. Its outcome assessment therefore concerns change over time among participants in the intervention, rather than a direct estimate of how outcomes differed from those in a control group.
Primary question
The primary question concerns linear change in depression/anxiety symptoms from baseline through follow-up, assessed with the Hopkins Symptom Checklist-25. Measurements used in the calculation were taken at baseline, 3 months, 6 months and 14 months. The registry record describes the measure and analysis population, but does not report a numerical estimate of change. The direction and magnitude of the observed change therefore cannot be established from the record information available for this analysis.
3. Trial Design
This is a completed, single-group behavioral intervention study sponsored by the University of New Mexico. The registry record lists enrollment as 56 and identifies the intervention as the Immigrant Well-being Project. Allocation is listed as not applicable, and masking is listed as none. There is no randomized or concurrent control group in the design described by the record, so the central statistical evidence is change over time within the intervention group, not a between-group treatment contrast.
The project adapted a transdisciplinary ecological intervention model for Mexican immigrants and integrated community-based advocacy, learning and social support into efforts at three community partner organizations working on mental health, education, legal and civil rights issues. University students enrolled in a service-learning course administered the intervention. The record describes Learning Circles as involving cultural exchange and one-on-one learning opportunities. It says the intervention has two elements, but the description of the second element is not reported in the registry record.
The primary outcome timeframe uses measurements at baseline, 3 months, 6 months and 14 months. The registry dates the study start to 2018-03-13 and primary completion to 2022-02-15, and lists the study status as completed. These dates describe the study record; they do not indicate the timing of individual participants’ measurements.
The record lists four secondary outcomes addressing social support, access to resources and quality of life, alongside the primary symptom outcome. It also lists seven outcome measures and seven analyses. Further details about recruitment procedures, implementation fidelity, follow-up completion and the statistical model beyond the reported summary measure are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Immigrant Well-being Project Intervention |
|---|---|
| STARTED | 56 |
| COMPLETED | 31 |
| NOT COMPLETED | 25 |
Analysis population for the primary outcome, as defined in the registry: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
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: A total of 56 participants enrolled in the study and completed the intervention. However, 2 of the participants did not complete the baseline interview (but completed interviews at subsequent time points).
| Characteristic | Unit | Immigrant Well-being Project Intervention |
|---|---|---|
| Participants analysed | 54 | |
| Age, Continuous | years | 39.06 (SD 9.89) |
| Sex: Female, Male: Female | Participants | 46 |
| Sex: Female, Male: Male | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 54 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 54 |
| Region of Enrollment: United States | participants | 54 |
| Perceived English Proficiency | units on a scale | 1.12 (SD 0.72) |
| Satisfaction with Resources | units on a scale | 3.18 (SD 1.00) |
| Difficulty Accessing Resources | units on a scale | 2.51 (SD 1.29) |
| Multisectoral Social Support Inventory | units on a scale | 2.14 (SD 0.76) |
| Collective Efficacy | units on a scale | 2.85 (SD 0.88) |
| Social Cohesion | units on a scale | 3.12 (SD 0.85) |
| WHO Psychological Wellbeing | units on a scale | 10.51 (SD 2.44) |
| WHO Physical Wellbeing | units on a scale | 8.60 (SD 2.75) |
| WHO Environmental Wellbeing | units on a scale | 10.21 (SD 2.87) |
6. Primary Endpoint
The registry lists the primary outcome as Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25, measured over Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is linear change in depression/anxiety symptom score assessed with the Hopkins Symptom Checklist-25 (HSC-25). The registry describes the score as ranging from 1.00 to 4.00 and states that lower scores indicate better outcomes, corresponding to lower levels of depression and anxiety symptoms. Measurements used for the analysis were taken at baseline, 3 months, 6 months and 14 months.
A symptom scale provides a structured way to quantify responses, making it possible to describe patterns in participants’ reported symptoms over time. In general, repeated assessments can distinguish a trajectory across follow-up from a comparison based on a single starting and ending measurement. A linear change summary represents the pattern using a straight-line trend over the assessment times; it may be a useful compact description, but it does not show every participant’s path or every change between visits.
The registry identifies the reported summary as a least-squares mean, with standard error as its measure of dispersion. In general, a least-squares mean is a model-based mean estimate, while a standard error describes its sampling precision. The numerical estimate and standard error are not reported in the registry record information available for this analysis. Consequently, neither the estimated direction nor the size or precision of the change can be described from that information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the outcome being assessed and the planned measurement schedule, but it does not report a numerical primary-outcome estimate in the information available for this analysis. In particular, a least-squares mean for linear change and its standard error are not reported in the registry record. Without the estimate, it is not possible to state whether the symptom score moved upward or downward, or how large the estimated change was. Because lower HSC-25 scores indicate better outcomes, the direction of any reported change would be important to interpretation, but no direction can be assigned without the result.
The study’s single-group structure is central to reading any change estimate. A within-group trend describes what happened across assessments among participants in the intervention group. It does not by itself isolate the intervention’s effect from other explanations for change over time. In general, changes in participants’ circumstances, concurrent services, familiarity with a questionnaire, or patterns of who completed follow-up can contribute to observed trends. The registry record does not report a concurrent control group that could help distinguish these possibilities through a between-group comparison.
The primary outcome description states that participants were included in a particular outcome analysis when they had data at a minimum of two timepoints, including either the first or second timepoint. This defines a minimum data condition for inclusion, but it does not specify how missing values were handled in the statistical model or how many participants contributed to the primary analysis. Those details are not reported in the registry record.
The record’s listed secondary outcomes cover social support, access to resources and quality of life. They address related but distinct aspects of the project’s aims and should not be treated as interchangeable with the primary symptom outcome. Numerical results for these outcomes are not reported in the registry record information available for this analysis. Nor are confidence intervals, p-values or detailed model results reported there. General statistical interpretation would use an estimate and its uncertainty together: a point estimate conveys the estimated change, while an interval or standard error conveys how precisely it was estimated. In their absence, the strength and precision of evidence about change cannot be assessed.
The study status is completed, but completion status is not itself an outcome finding. The record supports describing the design, measure and analysis-population rule; it does not support a conclusion about the observed symptom trajectory or the impact attributable to the intervention.
9. Statistical Methods Explained
The primary outcome is described as a linear change over repeated assessments and summarized as a least-squares mean. The measurements used were collected at baseline, 3 months, 6 months and 14 months. The registry also identifies the standard error as the dispersion measure. These labels describe the form of the outcome summary, but the detailed model specification and its numerical results are not reported in the registry record information available for this analysis.
What does a least-squares mean describe?
In general, a least-squares mean is an estimated mean derived from a statistical model. It can summarize the outcome while accounting for terms included in that model. The label alone does not reveal which covariates, covariance assumptions or other model terms were used. Those details are not reported in the registry record. A model-based estimate should therefore be interpreted using the specification and accompanying uncertainty information, rather than as a raw average unless the analysis explicitly establishes that equivalence.
What does a standard error tell the reader?
In general, a standard error describes the precision of an estimated quantity across repeated samples under the analysis assumptions. A smaller standard error indicates a more precise estimate in that framework; it is not a measure of variability among individual participants. A confidence interval, when reported, uses an estimate and its uncertainty to show a range of values compatible with the data under specified assumptions. The registry record information available for this analysis does not report a primary-outcome standard error value or confidence interval, so the precision of the estimated change cannot be judged.
Why can measurements over time be informative?
Repeated measures can describe the course of an outcome rather than only its value at one assessment. A linear summary condenses that course into a trend. As a general statistical concept, such a summary can be convenient, but it can obscure departures from a straight-line pattern. It also does not show whether changes were similar across participants. The record identifies the measurement times but does not report the fitted time-specific estimates or a detailed model specification that would clarify how the trajectory was represented.
How should the single-group design affect interpretation?
The study is recorded as single-group, and allocation is listed as not applicable. In general, within-group changes can reflect the intervention and other changes that occur during follow-up. A concurrent comparator can help estimate how outcomes would have changed over the same period without the intervention, subject to the design and analysis assumptions. No such comparison is part of the design recorded. Thus, even if a change estimate were available, it would describe the intervention group’s trajectory and would not alone establish that the intervention caused the change.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe planning illustrations based on the observed effect, not the study’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. In general, a planning calculation estimates the number of participants needed under chosen assumptions to reach a target level of power for a future comparison. It is not observed power and does not change the design of this single-group study. The planning assumptions do not establish that the trial used two arms, and the numerical planning results are not reported in the registry record information available for this analysis.
General concepts such as model-based estimation, standard errors and planning power help explain how statistical summaries are ordinarily read. They do not fill in absent trial results. The registry record does not report enough detail to reconstruct the primary analysis or independently verify its assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists seven outcome measures and seven analyses. The primary outcome is the HSC-25 depression/anxiety symptom score. The listed secondary outcomes concern change in social support, two measures of access to resources, and quality of life. Results for these outcomes are not reported in the registry record information available for this analysis.
When several outcomes or analyses are examined, the chance of obtaining at least one apparently notable result can increase if each is assessed separately. In general, multiplicity procedures can address this issue by adjusting significance thresholds or interpreting a family of estimates jointly. Whether any adjustment was planned or applied is not reported in the registry record. The record also does not report a statistical analysis plan detailing outcome hierarchy, prespecified contrasts or handling of multiple tests. Without those details and the outcome results, the relationship between the primary and secondary analyses cannot be evaluated statistically.
The primary outcome population rule says that a participant was included in a particular outcome analysis if data were available at a minimum of two timepoints, with one of those measurements required to be at the first or second timepoint. This specifies an eligibility condition for an outcome analysis, not a complete missing-data method. The registry record does not report the number included in the primary analysis, the amount or pattern of missing follow-up data, any imputation procedure, or sensitivity analyses for missing data.
In general, missing-data assumptions matter because people with incomplete follow-up may differ from those with observed measurements. Requiring some measurements does not, by itself, show that missingness was harmless or that the analysis included every enrolled participant. The registry record also does not report whether analyses followed an intention-to-treat approach, a per-protocol approach or another named analysis population. Interim analyses and their handling are not reported in the registry record.
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 |
|---|---|---|---|
| Immigrant Well-being Project Intervention | 0 | 56 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immigrant Well-being Project Intervention | 0 of 56 |
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 |
|---|---|
| Immigrant Well-being Project Intervention | 0 of 56 |
The registry safety figures list 56 participants at risk for serious adverse events and 0 affected. The other-adverse-event figures list 56 at risk and 0 affected, and deaths are listed as 0. No serious adverse-event terms are listed. These figures describe the event counts recorded for the intervention group; they are not comparative estimates because the study has no concurrent control group.
A zero count means that no events in that category were recorded in the registry safety figures. It should not be read as proof that the intervention carries no risk. In general, event counts are interpreted in relation to how events were defined, how actively they were collected, the period of observation and the completeness of reporting. Those details are not reported in the registry record information available for this analysis. The figures also do not describe the severity or timing of events beyond the categories presented.
The absence of listed serious-event terms is consistent with the reported zero serious adverse events; it does not supply additional detail about safety monitoring. These counts should be read as registry-recorded safety information, not as a complete assessment of all possible harms or as evidence that would establish comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a community-based intervention evaluation for Mexican immigrants, with depression/anxiety symptoms as the primary outcome and assessments extending from baseline to 14-month follow-up. It identifies a least-squares mean summary and standard error for the primary analysis, along with an analysis-population rule requiring data at a minimum of two timepoints and at least one early measurement. These details establish what the study set out to assess and how participation in the outcome analysis was bounded.
A numerical primary-outcome result is not reported in the registry record information available for this analysis. Therefore, the record cannot support a statement about whether symptoms improved or worsened, the magnitude of any change, or the precision of that change. The score’s direction is clear: lower HSC-25 scores indicate better outcomes. But the direction of an observed result cannot be inferred from the scale description or from the study’s aims.
Even with a numerical within-group change estimate, this design would not by itself establish that the intervention caused the change. The recorded design has one intervention group and no concurrent comparator. In general, a before-and-after pattern can be influenced by circumstances beyond the intervention, and the registry record does not provide a controlled estimate that separates those explanations.
The recorded safety figures show zero serious adverse events, zero other adverse events and zero deaths in the categories listed. Those counts are informative as registry entries, but do not establish that no harm occurred or provide a comparative safety assessment. The record also does not report detail about event ascertainment.
The appropriate conclusion is limited: the registry describes a completed single-group study, its intervention, outcome schedule, primary measure and analysis-population criterion. Numerical efficacy results and detailed statistical methods are not reported in the registry record information available for this analysis, so no conclusion about the observed outcome effect or its certainty is warranted.
13. Why This Trial Matters Statistically
This study is statistically notable for evaluating a multilevel, community-based intervention in a population and setting addressed through partnerships with community organizations. The intervention was adapted for Mexican immigrants and integrated into existing organizational efforts concerning mental health, education, legal issues and civil rights. Its stated approach includes community-based advocacy, learning and social support, with university students in a service-learning course administering the intervention.
The primary outcome connects that broader intervention model to a defined symptom measure: the Hopkins Symptom Checklist-25, for which lower scores indicate lower depression/anxiety symptoms. Measurements at baseline, 3 months, 6 months and 14 months allow the registry to define a longitudinal question rather than a single post-intervention snapshot. A linear change summary is one way to express a trajectory, although it does not capture every possible pattern across time.
The design also makes a useful statistical distinction visible. A single-group evaluation can describe change among participants, while a controlled comparison is needed to estimate how that change differs from what might have happened without the intervention. The record explicitly identifies no randomized comparator, so conclusions must remain within-group and descriptive unless additional evidence is available.
Finally, the registry record highlights questions that matter when interpreting longitudinal community research: who contributed outcome data, how missing assessments were handled, how multiple outcomes were interpreted, and what uncertainty accompanied estimates. The record specifies a minimum-data rule but does not report those further analytic details or numerical outcome results. This makes careful separation of the intervention’s rationale, the study design and the evidence actually recorded especially important.
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 principal limitation for interpreting outcomes is that the registry record information available for this analysis does not report numerical estimates for the primary or secondary outcomes. Without those estimates and their uncertainty, the direction, magnitude and precision of change cannot be assessed. The record identifies the primary measure and its scale properties, but the measure description is not a substitute for the observed result.
The single-group design limits causal interpretation. There is no concurrent control group, and allocation is listed as not applicable. Any within-group change could reflect the intervention, other events during follow-up, or differences in who provided data at each assessment. The record does not provide a between-group contrast that would address those explanations.
The minimum-data inclusion rule for outcome analyses does not fully describe missing-data handling. The number contributing to the primary analysis, the pattern of missing measurements, imputation methods and sensitivity analyses are not reported in the registry record. The model specification is also not reported beyond the least-squares mean summary and standard error label. Covariates and assumptions about correlations among repeated measurements therefore cannot be assessed.
The record lists seven outcome measures and seven analyses, but does not report whether multiplicity was addressed or how outcomes were prioritized in a statistical analysis plan. Intervention implementation details, including the second element mentioned in the brief intervention description, are not reported in the registry record information available for this analysis. Safety counts are recorded, but details of adverse-event definitions and ascertainment are also not reported. These gaps restrict interpretation of both outcome evidence and safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants — NCT03926247.
- Registry record last updated 2024-10-15; status last verified 2024-10.
- Results first posted 2024-10-15.
- 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
The University of New Mexico sponsored the completed study NCT03926247, a single-group behavioral intervention evaluation of the Immigrant Well-being Project for Mexican immigrants. Enrollment was 56; allocation was listed as not applicable and masking as none. The study started on 2018-03-13, with primary completion on 2022-02-15.
The primary outcome was linear change in HSC-25 depression/anxiety symptom score, measured at baseline, 3 months, 6 months and 14 months. Lower scores indicate better outcomes. An outcome analysis required data at a minimum of two timepoints, including one of the first or second timepoints. Numerical outcome estimates and detailed model specifications are not reported in the registry record information available for this analysis.
The safety figures list 0 serious adverse events, 0 other adverse events and 0 deaths. The record describes a community-based intervention administered by university students in a service-learning course and integrated with three community partner organizations.