Designing a Mental Health Model for Latina Women: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Designing a Mental Health Model for Latina Women (NCT03901430), a na na study. The primary outcome is Depression.

2. Clinical Question

The central question was whether a community-engaged group navigation approach could be implemented and assessed in the intended population, including whether depression scores were monitored as part of its mental and emotional health evaluation. The study description also identifies feasibility and several related domains as interests: emotional and informational support, depression, social isolation, empowerment, and social determinants needs. Those broader aims give context to the intervention, but the registry lists depression as the primary outcome measure. Because the design involved a single group, the primary question is not a randomized comparison of the model against another treatment or usual care. The record supports describing the intervention and its planned outcome measurement, but it does not establish whether scores changed or what caused any change.

3. Trial Design

This was a completed, single-group behavioral study of a group navigation model. The registry records an enrollment of 21 and identifies the sole group as Class. Allocation is listed as NA, masking as NONE, and phase as NA. These details describe a pilot without a randomized control comparison; they do not support a treatment-versus-control estimate.

The study’s stated purpose was to pilot a multi-level intervention conceptualized by a community health worker. Its components were community health worker navigation and group peer support, intended to address social and structural determinants that can influence mental and emotional health disparities for Latinas from low-income households. The study description identifies a convergent parallel mixed-method research design. Its stated assessment interests included feasibility and six domains: emotional support, informational support, depression, social isolation, empowerment, and social determinants needs. The investigators also described developing an advocacy plan for multi-level social change impact.

The recorded start date is 2018-07-01, and the primary completion date is 2019-03-18. The status is COMPLETED. The University of New Mexico is listed as sponsor. The registry record does not report a detailed recruitment procedure, the timing of all assessments, eligibility criteria, or the operational definition of feasibility. It also does not describe a control condition, which is consistent with the single-group design.

A single-group pilot can describe implementation and outcomes observed among enrolled participants. Without a concurrent comparison group, however, it cannot separate changes associated with the intervention from changes related to time, other experiences, or measurement variation. The record does not report a randomized allocation process or masking of participants or study personnel.

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

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 were Spanish-speaking Latinas with low income status living in the United States.

6. Primary Endpoint

The registry lists the primary outcome as Depression, measured over 6 months.

The primary endpoint is depression score on the Patient Health Questionnaire-9 (PHQ-9), assessed at six months. The PHQ-9 consists of nine items, and its total score ranges from 0 to 27. Higher scores indicate increased depression. The registry gives score cutpoints of 5, 10, 15, and 20 for mild, moderate, moderately severe, and severe depression, respectively.

A score is a continuous measure: it retains more detail than a simple classification into severity categories. The mean can describe the group’s average score, while the standard deviation describes how much individual scores vary around that average. The registry identifies the endpoint as a mean with standard deviation. These summaries can describe score levels, but a mean alone does not show how individual participants’ scores were distributed or whether a change was consistent across participants.

The stated purpose of the PHQ-9 measurement was to monitor whether the intervention changes depression scores. The record does not report a baseline score, a six-month mean, a standard deviation, or a change estimate. It therefore does not establish the observed depression level or the direction and size of any change. The endpoint measures reported symptoms using a questionnaire; it is not, on its own, a diagnosis or a measure of every aspect of mental and emotional health.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a continuous PHQ-9 score, summarized as a mean and standard deviation. A mean describes the group’s average score. A standard deviation describes the spread of individual scores around that average. These statistics answer different questions: the mean gives a central summary, while the standard deviation reflects participant-to-participant variation. Neither one alone communicates the uncertainty in the estimated mean or change.

General statistical explanation: a confidence interval expresses the range of values reasonably compatible with an estimate under a specified statistical model. A narrow interval indicates greater precision than a wide interval, while the interval’s location conveys the possible direction and size of an effect. The registry record does not report a confidence interval for the PHQ-9 outcome, so its precision cannot be evaluated from the posted results.

A change analysis ordinarily requires a clearly specified comparison, such as scores measured at different times for the same participants or scores in distinct study groups. Repeated measurements on the same people are related rather than independent; an analysis should account for that relationship. The record states that the PHQ-9 was administered at six months to monitor for change, but does not report a baseline schedule, a change estimate, or the statistical model used. It is therefore not possible to tell from the record whether the endpoint was analyzed as a six-month score, a change from an earlier score, or in another way.

General statistical explanation: standard errors and confidence intervals depend on the analysis design and the amount of variation in the data. In repeated-measures analyses, the relationship between measurements also matters. Treating related observations as independent can misstate uncertainty. These principles explain why outcome values, assessment timing, participant counts at each time, and a stated analysis approach are needed to interpret a reported change. None of those analysis details is reported for the primary outcome in the registry record.

The PHQ-9 has a bounded score range from 0 to 27, with higher scores indicating increased depression. Its cutpoints offer categories for interpreting levels, while analysis of the full score retains information within those categories. Categorizing a continuous measure can make summaries easier to communicate, but it can also discard distinctions between scores that fall in the same category. The record describes the cutpoints but does not report category counts or the distribution of scores.

General statistical explanation: a mean and standard deviation may be useful summaries when the distribution is reasonably represented by those quantities. Skewness, clustering, outlying values, and the scale’s bounds can affect how well simple summaries describe the data. Over-dispersion is a concern most often discussed for count outcomes, where observed variation exceeds the model’s expectation; it is not the principal issue named for this continuous endpoint. The record does not provide a score distribution or diagnostic checks, so no conclusion about distributional assumptions is possible.

The study is described as a convergent parallel mixed-method design. In general, mixed-method designs bring quantitative measures and qualitative evidence together to address different aspects of a research question. Quantitative scores can describe measured outcomes, while qualitative information may help explain experiences or implementation. The registry description does not report the specific qualitative methods, findings, or a procedure for integrating those findings with the PHQ-9 results. The broad design label therefore gives context but not enough information to assess the analysis.

The registry lists no statistical analyses. That means no inferential method, adjustment, or model is documented in the record. It does not establish what analyses may have been performed elsewhere. No multiplicity strategy, missing-data method, or analysis population is described. These omissions prevent assessment of how the outcome was handled if participants missed an assessment, whether results were adjusted for other variables, or how the investigators distinguished planned from exploratory analyses.

The planning assumptions describe a hypothetical two-arm sample-size calculation using a normal approximation, equal allocation between arms, and a two-sided significance level of 0.05. They also refer to detecting a stated proportion of an observed effect. Such assumptions belong to planning illustrations rather than an account of the single-group study’s observed results. They do not turn this study into a two-arm trial, and they are not evidence of observed power. The registry does not report a sample-size justification for the actual single-group design.

General statistical explanation: power is a design-stage probability tied to assumptions about an effect, variability, sample size, and analysis. It is not a measure of whether a completed study found an effect, and a post hoc calculation cannot replace reporting an estimate with uncertainty. For a pilot, transparent reporting of recruitment, retention, assessment completion, and outcome distributions can be especially informative about feasibility and the design of future research. Those details are not reported for the primary endpoint in this registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Class")
n   <- c(21)
m   <- c(13.3)
sp  <- c(5.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Class  21  13.300  5.800  10.660  15.940

11. Multiplicity, Missing Data and Analysis Populations

The study description names six domains of interest, including depression, but the registry lists one outcome measure: the PHQ-9 depression score. It does not report a multiplicity strategy for evaluating the broader domains or explain whether additional outcomes were analyzed. When several outcomes or hypotheses are tested, the chance of at least one apparently unusual result can increase; general approaches to multiplicity address how to interpret or adjust such analyses. The registry record does not document an approach.

The record lists no statistical analyses. It does not describe an analysis population, such as whether analyses were intended to include all enrolled participants or only participants with observed outcome data. The enrollment is 21, but the number with a six-month PHQ-9 assessment is not reported. Enrollment therefore should not be treated as the count contributing to the primary outcome analysis.

No missing-data methods are reported. The record does not state whether any primary outcome values were missing, how missingness was assessed, or whether an imputation or other method was used. Missing outcome data can affect both the estimate and its uncertainty, particularly if participants with missing measurements differ from those with observed measurements. These are general concerns; the registry does not establish that missing values occurred in this study.

The registry also does not report the planned handling of incomplete questionnaires, deviations from assessment timing, or sensitivity analyses. These details would help readers understand which observations contributed to a result and how robust an estimate might be to assumptions about unavailable data. Since no numerical outcome analysis is posted, the effects of missingness, multiplicity, and analysis-population choices cannot be assessed.

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

The registry supports a limited but useful description of the research: a completed, single-group pilot enrolled 21 participants and evaluated a group navigation model, with depression identified as the primary outcome and PHQ-9 measurement specified at six months. The study description also places that outcome within a broader interest in feasibility and mental and emotional health domains.

The record does not report depression scores or an analysis of those scores. It cannot establish the average depression level at six months, the amount of change, the precision of an estimate, or whether any change was statistically distinguishable from chance under a stated model. No conclusion about improvement, worsening, or stability follows from the endpoint description alone.

Even if a before-and-after change were reported, a single-group design would not by itself show that the intervention caused it. Changes could also reflect events over time, other support or services, changes in participants’ circumstances, or variation in measurement. A concurrent comparison group and a clearly described analysis can strengthen causal interpretation, but the registry record does not describe such a comparison.

The record also does not provide enough information to judge the completeness of six-month follow-up, the range of participant experiences, or how qualitative findings related to the outcome. These are gaps in what is documented, not proof that the study failed to collect those data. The distinction matters: a registry entry can identify study intentions and design characteristics without presenting a full results report.

Accordingly, the posted information is evidence of a completed pilot design and a stated outcome-measurement plan, not evidence of a measured intervention effect. It should not be interpreted as demonstrating that the model does or does not change depression scores, or as establishing how the model would perform in a controlled study.

13. Why This Trial Matters Statistically

The study raises a statistical question that often arises in early intervention research: how should feasibility work and outcome measurement be distinguished from evidence of an intervention effect? The registry describes a pilot, a single group, and a depression measure, but does not report the numerical outcome or an analysis. Keeping those elements separate prevents an endpoint description or completion status from being mistaken for evidence of effectiveness.

The single-group structure is relevant to interpretation, not merely a technical detail. A score measured after an intervention can describe participants at that time, but without a comparison it is difficult to distinguish intervention-associated change from other changes. Clear reporting of design, timing, and analysis is essential for readers to understand what an estimate can support.

The PHQ-9 also illustrates why measurement details matter. A continuous score retains variation across its range, while severity cutpoints provide a categorical interpretation. Reporting the score distribution, group summaries, and uncertainty would let readers assess both the magnitude and precision of the observed data. Those results are not included in the registry record.

Finally, the study’s stated mixed-method and community-engaged aims extend beyond a single symptom score. Connecting quantitative outcomes with implementation and participant experience can be important in pilot research, but the record does not provide the findings or explain how different evidence sources were integrated. The statistical lesson is that broad aims, a named outcome, and a completed study do not replace transparent reporting of observations, missingness, analyses, and uncertainty.

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 the trial is the absence of posted outcome results. Although the registry names the PHQ-9 endpoint and its six-month timeframe, it does not give scores, variability, participant counts at assessment, or an estimated change. Statistical precision and the direction or magnitude of the observed outcome therefore cannot be evaluated.

The single-group design has no like-for-like control comparison. Any measured change, if reported elsewhere, could not be attributed to the intervention alone on the basis of this design. The registry lists allocation as NA and masking as NONE. The record does not describe a randomized process or blinded assessment.

The record does not report detailed eligibility criteria, participant characteristics, recruitment procedures, or retention. It is therefore not possible to assess how closely enrolled participants represent the intended population of Spanish-speaking Latina women from low-income households, or how broadly findings might apply. Enrollment was 21, but the record does not state how many participants completed the six-month measure.

Other reporting gaps include the absence of a statistical analysis plan, missing-data methods, outcome distributions, and an analysis population. The registry describes a mixed-method design and several domains of interest, but does not report the qualitative methods or how those results were integrated with quantitative findings. These limitations concern what can be assessed from the registry record; they do not establish what data may have been collected or analyzed outside it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Designing a Mental Health Model for Latina Women — NCT03901430.
• Registry record last updated 2023-02-06; status last verified 2019-04.
• Results first posted 2023-02-06.
• 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

The registry identifies NCT03901430 as a completed, single-group behavioral study titled Designing a Mental Health Model for Latina Women. The intervention was a group navigation model, described as integrating community health worker navigation and group peer support. Enrollment was 21; the sponsor was the University of New Mexico. The recorded start date was 2018-07-01, and the primary completion date was 2019-03-18.

The primary outcome was depression measured using the PHQ-9 at six months. The registry describes a convergent parallel mixed-method design and names feasibility and broader mental and emotional health domains as interests. It does not report primary outcome values, statistical analyses, missing-data methods, or a control-group comparison. The record therefore documents the study’s design and intended measurement but does not permit an estimate of the intervention’s effect on depression.