eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care (NCT03009539), a randomized na study. The primary outcome is Change in Drug Use.

2. Clinical Question

The clinical question is whether an eHealth version of Familias Unidas, delivered through primary care, changes reported adolescent drug use compared with the registry’s Treatment as Usual condition. The registry describes a Hispanic-specific intervention intended to prevent or reduce drug use, sexual risk behaviors, and sexually transmitted infections among Hispanic youth. The registered primary endpoint addressed drug use; the other stated concerns provide context for the intervention, not additional primary-endpoint results.

The record names baseline-to-follow-up periods through 36 months, but does not report group-level estimates or a numerical comparison. It therefore does not establish from the posted results whether the groups differed in drug-use change.

3. Trial Design

This was a randomized, parallel-group trial with no masking recorded. The registry lists enrollment of 921 and status as completed. The recorded start date is 2017-04-18, and the primary completion date is 2022-12-18. The phase entry is NA. The sponsor was the University of Miami.

Families were to be recruited through four pediatric primary care settings. The intervention, eHealth Familias Unidas Primary Care, was behavioral. Its description specifies eight 12 - 15 minute mock parent sessions in Spanish and four 30 - 45 minute online family sessions in Spanish and/or English. The comparator is titled Treatment as Usual and is described as receiving no intervention. The registry does not describe other services participants in either group might have received.

Random allocation supports a comparison of the assigned groups, but does not by itself establish how allocation was generated or concealed. Those procedural details are not reported in the registry record. Likewise, the record does not state whether outcome assessors or analysts were masked; the masking entry is NONE.

The primary outcome concerns adolescents’ reports of drug-use episodes during the previous 90 days. Although the participant count represents dyads, the registry explicitly says that parents were not included in the drug-use analyses. This distinction matters when interpreting the outcome population: the intervention involved families, but the registered primary drug-use endpoint was adolescent-only.

The registry names six outcome measures and describes secondary measures of family functioning. It lists zero analyses. No numerical endpoint estimates, treatment-effect estimates, or detailed statistical analysis plan are reported in the registry record. The design and endpoint descriptions therefore establish what comparison was intended, but they do not supply an estimate of the intervention’s effect.

4. Participant Flow and Accounting

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

Before assignment: Additional arms were added to include parent enrollments.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The number of participants represent dyads. However, drug use was not analyzed for parents, only for adolescents. Therefore, these analyses include adolescents only.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Drug Use, measured over Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months.

The primary endpoint is titled Change in Drug Use and is measured as episodes of drug use. The registry says drug use is reported for the previous 90 days using questions from Monitoring the Future. The measure is described as a continuous outcome summarized by a mean and standard deviation. The specified assessment schedule includes baseline, baseline to 6 months, baseline to 12 months, baseline to 24 months, and baseline to 36 months.

Change from baseline is used to describe how an outcome evolves relative to a participant’s starting measurement. In general, considering more than one follow-up can show whether a pattern is sustained or varies over time; that is a general statistical reason to collect repeated measurements, not a finding about this trial. The registry record does not report the observed means, standard deviations, or numerical changes at any of the listed times.

The record clarifies that participant counts represent dyads, but the drug-use endpoint was not analyzed for parents. The registered drug-use analyses included adolescents only. This makes the endpoint relevant to the adolescent part of the family intervention while distinguishing it from the family-functioning outcomes.

The outcome description identifies the construct, recall period, instrument source, and time points. It does not provide the exact scoring or coding rules, the handling of zero use or missing responses, or a clinically meaningful threshold. Those details are not reported in the registry record. Without posted group results, the endpoint description cannot establish the direction, size, or precision of any difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What the registered design tells us. The registry identifies random allocation and a parallel-group design. In general, randomization aims to make groups comparable at the time of assignment, on average, including with respect to factors that may not have been measured. A parallel-group comparison follows participants assigned to separate groups. The registry does not report the sequence-generation or allocation-concealment procedures, so those aspects cannot be evaluated from this record.

What a mean and standard deviation describe. The endpoint is continuous and is identified as a mean with a standard deviation. In general, a mean summarizes the average measured value in a group. A standard deviation describes the spread of individual observations around that group’s mean; it is not the uncertainty in the estimated mean and is not a treatment-effect estimate. The record provides no endpoint means or standard deviations, so these summaries cannot be compared for this trial.

What change from baseline represents. In general, a change score expresses a follow-up measurement relative to a participant’s baseline measurement. A between-group analysis of change would compare those changes across assigned groups. Such an analysis is only one possible approach: a model could instead use follow-up values while accounting for baseline, or use repeated observations together. The registry record does not report which approach was used, or whether any such analysis was conducted. It is therefore not appropriate to attribute a particular model or adjustment to this trial.

The listed time points include multiple follow-up periods. In general, repeated observations on the same participant are related rather than independent. A method designed for repeated measurements can account for that relationship and may use available observations across time, depending on its specification. The analysis model, assumptions, and handling of within-participant correlation are not reported in the registry record. No conclusion about those choices can be made from the schedule alone.

Uncertainty and statistical significance. In general, a confidence interval gives a range of effect values compatible with the data and the method used, and conveys uncertainty around an estimate. A p-value measures how unusual data at least as extreme as the observed data would be under a specified null hypothesis and model. Neither measure describes the probability that the intervention works, and neither replaces examination of the estimated effect. The registry record does not report a primary-outcome estimate, confidence interval, or p-value. There is therefore no trial-specific inferential result to interpret.

Multiple outcomes and times. The registry names six outcome measures and the primary drug-use outcome has several time points. When many outcomes or time points are tested, the chance of at least one apparently notable result can increase if no adjustment or prespecified hierarchy is used. In general, multiplicity can be addressed through prespecified primary comparisons, adjustment procedures, or careful distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity strategy or identify a single numerical comparison among the listed periods. The primary endpoint has several categories or time points and is not reduced to one comparison in the posted record.

Planning illustrations. The registry describes a planning approach based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, a sample-size calculation asks how many participants would be needed under specified assumptions to detect a target effect at a chosen significance level and power. A planning illustration is not an observed outcome and is not observed power. The record does not state the resulting participant counts for the planning scenarios. It also does not report the trial’s own sample-size justification, so the planning description should not be taken as that justification.

Limits of statistical interpretation. The registry lists zero analyses. It does not report an analysis population for each outcome, the statistical model, covariate adjustments, missing-data methods, or sensitivity analyses. These are important because analytic choices can affect estimates and their uncertainty. General statistical explanations do not fill in those trial-specific details. The posted record supports description of the design and intended measurement, but not reconstruction of an unreported analysis or calculation.

10. Multiplicity, Missing Data and Analysis Populations

The record names six outcome measures and describes the primary drug-use endpoint across baseline and several follow-up periods through 36 months. Assessing multiple outcomes or time points raises a general multiplicity issue: without a prespecified strategy, repeated testing can make chance findings more likely. The registry record does not report an adjustment method, a hierarchy among comparisons, or which time point was intended as the decisive primary comparison. It states that the primary outcome has several categories or time points and is not reduced to one comparison.

Missing-data methods are also not reported. The record does not state how many adolescents had measurements at each follow-up, why measurements might be missing, or how incomplete observations were handled. In general, these details matter because estimates based on observed follow-up data can be affected if the participants with available measurements differ systematically from those without them. No claim about the extent or pattern of missingness can be made from the record.

The outcome population is described as adolescents only, although participant counts represent dyads. The registry does not explain the analysis population rules, whether all randomized adolescents were included in each analysis, or how the family pairing was reflected in statistical models. The record lists zero analyses, so no specific population or model can be attributed to the results.

These absences limit assessment of robustness and precision. They do not establish that data were missing or that multiplicity adjustments were omitted in the conduct of the study; they mean those details are not reported in 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.

The registry lists two groups for adverse events. For eHealth Familias Unidas Primary Care, 225 participants are listed as at risk, with zero serious adverse events, zero other adverse events, and zero deaths. For Treatment as Usual, 231 participants are listed as at risk, with zero serious adverse events, zero other adverse events, and zero deaths.

These are counts as posted in the registry record. They should be read as the reported entries, not as proof that no events occurred outside the record’s definitions, observation period, or reporting process. The registry does not provide further definitions of serious or other events, the event-collection procedures, or an explanation of how the at-risk populations were determined. The listed at-risk counts also differ from the overall enrollment entry; the record does not explain that distinction.

Zero reported events do not quantify the likelihood of an event beyond the period and population captured by the record. These safety entries do not provide information about changes in drug use, which is the primary endpoint. The registry does not report a separate narrative safety analysis or comparisons with uncertainty estimates.

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

The registered study asks a focused question about adolescent drug-use change in a randomized comparison of an online family intervention with a condition described as receiving no intervention. Its endpoint, recall period, and follow-up schedule are specified. These details help define what the trial was intended to measure and in whom.

However, the registry record does not report numerical results for the primary outcome. There are no posted group means, changes, treatment-effect estimates, confidence intervals, or p-values for drug use. Accordingly, the record cannot show whether reported drug-use episodes were higher, lower, or similar between groups at any follow-up, or how precisely a difference was estimated.

This absence is not a null result. A null result would require reported data and an analysis that did not show evidence of a difference under its stated method; no such analysis is listed. Nor can a favorable or unfavorable effect be inferred from the study’s aim, intervention description, enrollment, or safety counts.

The record also does not provide the analysis plan, missing-data handling, multiplicity strategy, or detailed analysis populations. These omissions prevent a full appraisal of how the intended comparison was carried out. The safety entries report zero serious and zero other adverse events in both groups, but they do not resolve the unanswered efficacy question and are limited to the registry’s listed counts.

The appropriate interpretation is therefore about reporting, not treatment effect: the record documents a completed randomized trial and identifies its intended primary endpoint, but does not provide the numerical primary-outcome evidence needed to assess the size, direction, or precision of the comparison.

13. Why This Trial Matters Statistically

Statistically, this trial illustrates why an endpoint description and a result are different kinds of evidence. The record specifies drug-use episodes during the previous 90 days, the source of the questions, the change-from-baseline framing, and several follow-up periods. That information defines the intended measurement, but it does not quantify the effect of assignment to either group.

The family-based setting also makes population definitions important. The intervention was delivered to families, and enrollment is described in terms of dyads, yet the primary drug-use outcome was analyzed for adolescents only. Distinguishing the intervention unit, participant count, and outcome population is necessary for understanding what a reported estimate would represent. The record does not describe how dyad structure was handled in analysis.

The listed multiple time points raise a further statistical consideration. Results across follow-up may not all answer the same inferential question, and a prespecified approach can help distinguish a primary comparison from additional analyses. The registry does not report such a strategy or numerical analyses. This makes it especially important not to select or imply a favorable time point from an outcome schedule alone.

Finally, the posted safety counts and overall enrollment do not supply the missing endpoint analysis. A completed study can still have an incomplete registry record for statistical interpretation. This record is useful for identifying the planned comparison and the reporting gaps that would need to be resolved before drawing conclusions about the primary outcome.

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.

Several limitations specific to this registry record constrain interpretation. Most importantly, it does not report numerical results for the primary drug-use endpoint. The record lists six outcome measures and zero analyses, leaving no estimate of change, between-group difference, or uncertainty to evaluate. Although multiple assessment periods are specified, the record does not identify a single numerical comparison.

The endpoint is described through reported episodes during the previous 90 days and questions from Monitoring the Future, but the precise scoring rules and treatment of responses are not stated. The registry does not report the analysis model, covariate adjustment, missing-data approach, sensitivity analyses, or analysis-specific sample sizes. It also does not explain how the dyad-based participant count relates to the adolescent-only outcome analyses.

The record names four pediatric primary care settings but does not give their characteristics or the recruitment distribution across them. It does not describe allocation procedures beyond randomized assignment, or report details about masking beyond NONE. The comparator is described as receiving no intervention, with no further account of usual-care services.

The safety record contains zero reported events in each category, but does not provide event definitions or ascertainment details. The at-risk counts are not reconciled with the enrollment entry. These limitations concern what the registry reports; they do not establish that the study lacked these procedures or analyses outside the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care — NCT03009539.
• Registry record last updated 2024-06-13; status last verified 2024-05.
• Results first posted 2024-06-13.
• 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

NCT03009539 is a completed randomized, parallel-group trial sponsored by the University of Miami, with no masking recorded and enrollment of 921. Its recorded start date is 2017-04-18 and its primary completion date is 2022-12-18. The phase entry is NA.

The study compared eHealth Familias Unidas Primary Care with Treatment as Usual. The primary outcome was change in adolescent drug-use episodes reported for the previous 90 days, assessed from baseline through follow-up periods ending at 36 months. The registry says drug-use analyses included adolescents only, although participant counts represent dyads.

The record does not report numerical primary-outcome results or analyses. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in both groups. Details of the statistical analysis plan, missing-data handling, and multiplicity strategy are not reported in the registry record.