Scaling Up Science-based Mental Health Interventions in Latin America: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Scaling Up Science-based Mental Health Interventions in Latin America (NCT03392883), a na na study. The primary outcome is The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument.

2. Clinical Question

In practical terms, the registry question is about implementation: how the intervention’s adoption, appropriateness, acceptability, feasibility, and reach or access are represented by the named measure over follow-up. That is distinct from asking whether the intervention outperforms a control group. The record includes secondary measures of depression, disability, anxiety, and, for the Full Implementation Study only, drinking. It does not report results for those measures. The central statistical reading is therefore limited: the registry identifies a measure and follow-up schedule, but does not give the estimates needed to describe the direction, size, or uncertainty of change.

3. Trial Design

This is a completed, single-group study with enrollment of 1348. The registry lists allocation as NA and masking as none. It does not report a randomized allocation or a separate control group; the record also cautions that the study is not a randomized comparison and that its arms are not a like-for-like control comparison. The study is titled Scaling Up Science-based Mental Health Interventions in Latin America and describes systematic, multi-site mental health implementation research in rural and urban primary care settings, involving stakeholders in the US and Latin America.

The intervention is Digital Health Assisted Mental Healthcare, based on the Laddr® mobile platform from Square2 Systems. Its type is recorded as behavioral. The registry lists depression and problematic alcohol use as conditions. It identifies the primary measure as an implementation context and outcomes instrument assessed at 6- and 12-month follow-up visits in a subsample. Other named measures include the PHQ-8, WHODAS, GAD-7, and the QDS for the Full Implementation Study only.

The registry records a start date of 2018-02-13, a primary completion date of 2021-03-18, and a status of completed. The phase is NA. Dartmouth-Hitchcock Medical Center is listed as the sponsor. These design details establish the setting and structure for interpreting the posted information, but they do not specify how participants were selected, how many sites or countries contributed, or how follow-up was managed. Those details are not reported in the registry record. In particular, the single-group structure means that changes over time, if reported, would not by themselves establish how outcomes would have changed without the intervention.

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:

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: Seventeen of the Baseline measures are not administered to providers and administrative staff. Therefore, there are zero participants analyzed among providers and administrative staff for those measures.

6. Primary Endpoint

The registry lists the primary outcome as The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument, measured over At 6- and 12-month follow-up visits with a sub-sample of participants.

The primary endpoint is the Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument. It is reported as a mean score with standard deviation, on a scale. Its stated timeframe is 6- and 12-month follow-up visits with a subsample of participants.

The measure is described as covering adoption, appropriateness, acceptability, feasibility, and reach or access. The registry description says the measure consists of 5 scales, then states that all four scales range from 1 to 4, with response descriptions from Not at all to A lot. That wording is internally unclear about how many scales have the stated range. The record does not provide further scoring or interpretation details.

As a general statistical point, an implementation measure can describe how an intervention is taken up and experienced in the settings where it is introduced; it addresses a different question from a clinical outcome measure. Repeated measurement can describe change over time, but interpretation depends on the reported scores, their variability, the number of participants contributing data at each visit, and the analysis method. The registry record does not report the primary endpoint estimates or those supporting details, so the observed direction and precision of change cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean with standard deviation describe?

The primary outcome is designated as a mean, with standard deviation as its dispersion measure. As a general statistical explanation, a mean summarizes the average score in the analyzed observations, while a standard deviation describes how spread out individual scores are around that average. The mean describes the group’s score level; the standard deviation describes variation among observations. Neither alone gives the uncertainty around the mean. That uncertainty depends on the amount and structure of the analyzed data, which are not reported for this endpoint in the registry record.

The listed measure is intended to be assessed over time. A change estimate would summarize how scores differ between assessment occasions, but the registry record does not provide those estimates. It also does not say whether the analysis uses paired observations, a repeated-measures model, or another approach. These methods can make different assumptions about the relationship between observations from the same participant and about incomplete follow-up. The specific analysis method is not reported in the registry record.

Why does the single-group design matter?

As a general statistical point, repeated observations can show how a measured outcome changes within a group. A control group can help distinguish intervention-associated changes from changes that might also occur without the intervention. Here the registry records a single-group model and no randomized allocation, and it explicitly cautions against treating arms as a like-for-like control comparison. Thus, the design does not supply the randomized between-group contrast that would support a direct estimate of the intervention’s effect relative to a control.

That distinction does not make descriptive change uninformative. It changes what the estimate can support. If change estimates were available, they could describe the recorded trajectory in the analyzed participants. They could not, on their own, establish that the intervention caused that trajectory. In this record, even the numerical trajectory is not reported, so interpretation cannot proceed to its magnitude or uncertainty.

What can a confidence interval or test add?

As a general explanation, a confidence interval expresses the uncertainty around an estimate under the assumptions of the analysis. It can show which values are reasonably compatible with the data and method, and it is usually more informative than a point estimate alone. A hypothesis test summarizes evidence against a specified null hypothesis, but a p-value does not describe the size or practical importance of an effect. The registry record does not report a confidence interval, p-value, or test for the primary endpoint. The statistical plan, including any chosen model or inferential procedure, is not reported in the registry record.

How should the sample-size illustrations be read?

The accompanying sample-size section is described as a planning illustration based on an observed effect, not as the study’s own design calculation. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated share of the observed effect. These are planning assumptions, not evidence that this single-group study used two arms or was designed with those assumptions. The record does not report a sample-size justification for the study itself.

As a general statistical point, planning calculations explore how much information a future study might need under specified assumptions. They do not show the probability that the completed study found a result, and they are not observed power. An illustration based on an observed effect can also depend strongly on that estimate, which may be uncertain. The planning entries should therefore be read as conditional scenarios rather than as observed study outcomes or evidence about the precision of the primary endpoint.

Why can over-dispersion matter?

As a general concept, over-dispersion occurs when observed variability is greater than a statistical model assumes. When that happens, model-based uncertainty can be understated if the extra variability is ignored. The primary measure is a continuous score summarized by a mean and standard deviation, but the registry record does not describe a model or report an over-dispersion assessment. There is no basis in this record for saying that over-dispersion was present or that any particular adjustment was used.

The posted record lists 21 outcome measures and 29 analyses. Those counts indicate that multiple outcomes and analyses are recorded, but they do not reveal the analysis hierarchy, which results were designated primary in each analysis, or how conclusions were adjusted for multiple testing. The methods needed to assess the numerical results—outcome estimates, uncertainty, analysis sample sizes, and the analysis plan—are not reported. Accordingly, the methods discussion can clarify the statistical concepts and design constraints, but cannot reconstruct an unreported analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 21 outcome measures and 29 analyses. With multiple measures or analyses, there can be more than one opportunity to observe an apparently notable result. As a general statistical point, multiplicity procedures can help control the risk of misleading conclusions when many hypotheses are tested. Whether such procedures are needed, and how they should be applied, depends on the prespecified questions and analysis structure. The registry record does not report a multiplicity plan, a testing hierarchy, or whether any adjustment was used.

The primary measure is assessed at 6- and 12-month follow-up visits in a subsample. The record does not state the number of participants assessed at either visit, how the subsample was defined, or whether the same participants contributed at both times. It also does not describe missing-data methods, reasons for missing observations, or any sensitivity analyses. These details are important for assessing whether the analyzed observations represent the intended population and how incomplete follow-up affects uncertainty.

The record gives enrollment of 1348, but does not identify the analysis population for the primary endpoint or give an outcome-specific denominator. Enrollment should therefore not be read as the number analyzed for every measure. The registry record also does not report a statistical analysis plan, the handling of protocol deviations, or which participants were included in each analysis. These are reporting gaps in the information; they do not establish that a method was or was not used outside the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: suicidality (2.2%), hospitalization due to covid-19 infection (1.7%), heart dysfunction (0.6%), cancer (0.5%), chest pain (0.4%).

For patients in the Digital Health Assisted Mental Healthcare intervention group, the registry reports 1264 at risk for serious adverse events and 107 affected. It reports 1264 at risk for other adverse events and 615 affected, along with 7 deaths. These are the posted figures; they should be read as counts in the reported group, not as evidence that the intervention caused any event. The record does not provide a comparison group suitable for a like-for-like safety contrast.

The listed serious-event terms and percentages are suicidality, 2.2%; hospitalization due to COVID-19 infection, 1.7%; heart dysfunction, 0.6%; cancer, 0.5%; chest pain, 0.4%; and removal of gallbladder, 0.3%. The record does not clarify whether these categories can overlap, how terms were attributed, or whether they represent unique participants. It also does not report event timing, follow-up duration for each participant, adjudication methods, or an assessment of causal relationship.

As a general statistical point, event counts without a suitable comparison and clear exposure time do not establish relative risk. The posted figures are useful for describing what was recorded, but they cannot by themselves determine whether an event was caused by the intervention or compare safety against another care approach.

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

This registry record describes a completed implementation study of digital health-assisted mental healthcare in rural and urban primary care settings, with a primary measure intended to track implementation context and outcomes over time. It identifies the measure’s named domains, follow-up occasions, and the fact that only a subsample was scheduled for those visits. It also lists secondary measures and reports adverse-event counts for patients in the intervention group.

What the record does not show is the primary endpoint’s numerical result. There is no reported mean, change estimate, standard deviation, confidence interval, or test result. Therefore, this page cannot state whether the primary measure changed, how large a change was observed, or how precisely it was estimated. The secondary outcome names likewise do not establish any particular result.

The single-group design also shapes what any observed change could mean. As a general statistical point, a change over time in one group is not the same as a randomized comparison with a control group. Without a like-for-like comparator, it is difficult to separate intervention-associated change from other influences on outcomes. The registry itself warns against treating the study as a randomized comparison.

The safety figures describe reported events in the intervention group, not causal effects. No suitable comparative safety estimate is given. Nor does the enrollment figure show how many participants contributed to each outcome analysis: outcome-specific denominators and missing-data details are not reported in the registry record.

Thus, the posted information supports a careful account of study design, selected measures, and reported event counts. It does not establish a clinical effect, a causal effect, or a comparative safety conclusion. Those boundaries reflect what is reported, rather than a judgment that unreported results were necessarily absent from all study materials.

13. Why This Trial Matters Statistically

This study is statistically notable for the distinction between implementation outcomes and clinical outcomes. Its primary measure concerns adoption, appropriateness, acceptability, feasibility, and reach or access, while the registry also names measures of depression, disability, anxiety, and drinking. Those questions are related but not interchangeable: a measure of implementation context does not by itself quantify a clinical outcome.

The single-group design is also central to interpretation. The registry describes implementation research across rural and urban primary care settings and explicitly cautions that this is not a randomized comparison. In implementation research, describing how an intervention is introduced and assessed across settings can be informative, but causal conclusions require a design and analysis that address what would have happened in the absence of the intervention. The posted record does not offer a randomized control comparison.

The primary endpoint’s follow-up in a subsample highlights the importance of reporting who contributed data at each assessment. The registry record does not give those numbers or the handling of incomplete observations. Without them, readers cannot assess the reach of the endpoint analysis or how representative it is of all enrolled participants.

Finally, the record’s multiple outcomes and analyses make transparent reporting of the analysis plan important. It lists 21 outcome measures and 29 analyses, but does not report a multiplicity strategy or numerical primary outcome results. The statistical lesson is not that these features invalidate the study; it is that design, outcome definition, analysis populations, and uncertainty must be considered together before interpreting findings.

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 main limitation for interpreting results from this record is that numerical findings for the primary endpoint are not reported. Without outcome estimates and measures of uncertainty, the direction, magnitude, and precision of change cannot be evaluated. The record likewise names secondary measures without reporting their numerical results.

The study is single-group, with allocation recorded as NA and masking as none. The registry cautions that its arms are not a like-for-like control comparison. Consequently, the design does not support a randomized contrast with a concurrent control group. Any change over time, if observed, would require cautious interpretation as a description of the analyzed group rather than proof of a causal effect.

The primary endpoint is assessed at follow-up in a subsample, but the record does not explain how that subsample was formed or report the number assessed at each visit. It does not describe missing observations, outcome-specific analysis populations, or sensitivity analyses. The enrollment figure alone cannot answer these questions.

The endpoint description also has a scoring ambiguity: it refers to 5 scales and then states that all four scales have a range of 1 to 4. The registry does not resolve this wording. It does not report a detailed scoring procedure or the statistical model used for change over time. The counts of outcomes and analyses are available, but a multiplicity plan is not. These limitations concern the detail available in the registry record; they do not establish what may have been documented elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Scaling Up Science-based Mental Health Interventions in Latin America — NCT03392883.
• Registry record last updated 2022-11-09; status last verified 2022-10.
• Results first posted 2022-05-17.
• 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 record describes a completed, single-group study of Digital Health Assisted Mental Healthcare based on the Laddr® mobile platform. It lists enrollment of 1348, a start date of 2018-02-13, and a primary completion date of 2021-03-18. The primary outcome is a mean score on an implementation context and outcomes measure, assessed at 6- and 12-month follow-up visits in a subsample.

The record names secondary measures of depression, disability, anxiety, and drinking, and reports adverse-event counts for patients in the intervention group. It does not report numerical primary outcome results, outcome-specific analysis populations, missing-data methods, or a multiplicity plan. The single-group design does not provide a randomized, like-for-like control comparison. Interpretation should therefore remain limited to the design and information posted in the registry record.