Navigating Mental Health Treatment for Black Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Navigating Mental Health Treatment for Black Youth (NCT05334381), a randomized na study. The primary outcome is Mental Health Treatment Initiation.

2. Clinical Question

The trial asks whether a patient-navigation intervention adapted for Black youth and their caregivers can increase initiation of outpatient mental health treatment, compared with standard enhanced treatment as usual. Participants were Black youth presenting in an emergency department with suicide risk. The registry describes a randomized, parallel-group comparison and follow-up assessments at approximately 2 months and 6 months.

The trial was registered as completed, with enrollment of 54. Completion status indicates the registry’s status for the study; it does not establish that the primary outcome results are available in the registry. The posted record contains no reported effect estimate or uncertainty interval for treatment initiation, so the direction and precision of the group comparison cannot be determined from these results.

3. Trial Design

This was a randomized, parallel-group behavioral trial with no masking reported. Participants were assigned to adapted STAT-ED or standard enhanced treatment as usual. The study’s stated focus was systematic adaptation of Suicidal Teens Accessing Treatment for Black youth presenting in the emergency department with suicide risk, with caregivers also included in the intervention approach.

Adapted STAT-ED is described as patient navigation with caregivers and/or adolescents. The listed components include psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making and following up on mental health appointments. The description also refers to assistance with appointments, though the registry text ends before the full description is complete. The comparison condition consisted of telephone contacts to check in and assist or remind caregivers and/or adolescents about referrals and appointments; these contacts are described as consistent with current emergency department practice.

The primary outcome is mental health treatment initiation, expressed as a count of participants who received outpatient behavioral health treatment. The outcome description refers to follow-up assessments at approximately 2 months and 6 months after baseline. The registry says that the overall number analyzed reflects participants who provided data beyond baseline at either follow-up or both. It does not report the analysis population count for the primary outcome or explain how results across the follow-up assessments were combined.

The registry lists the study as phase not applicable and completed. Enrollment was 54. It does not report the randomization procedure, allocation ratio, concealment method, protocol deviations, or reasons for discontinuation. Masking is listed as none, but the registry does not specify which study roles, if any, were unmasked beyond that entry. The statistical analysis plan and a rationale for the planned enrollment 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.

Before assignment: Fifty-four individuals (31 families) were were randomized to conditions. Randomization occurred at the family level not the individual level.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This study included two follow-up assessments: 2- and 6-months post-baseline. The overall number of participants analyzed reflects the number of participants who provided data beyond baseline (either at the 2-month or 6-month assessment, or both). Numbers analyzed below reflect the number of participants who provided data at each assessment.

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 Mental Health Treatment Initiation, measured over at approximately 2 months and 6 months.

The primary endpoint is mental health treatment initiation, measured as the number of participants who received outpatient behavioral health treatment. The registry describes assessment at approximately 2 months and 6 months. It identifies the ED STARS mental health service-use interview as the measurement instrument. The interview has 8 items and records mental health services children receive as well as actions families take to obtain services. Caregivers complete the interview unless a youth participates without a parent.

This endpoint focuses on whether outpatient treatment was received, rather than only whether a referral was made or an appointment was discussed. That distinction is relevant to the intervention’s stated purpose: navigation includes assistance with logistical barriers and with making and following up on appointments. The interview’s coverage of family actions also reflects the role caregivers may have in accessing services. These are general measurement considerations; the registry does not report separate endpoint results for each interview item or family action.

The record notes that this measure was used with over 6000 adolescents from the Pediatric Emergency Care Applied Research Network across diverse geographic regions of the United States. That context describes prior use of the interview, but does not establish how complete the measure was in this trial or whether the same respondents completed it at every assessment.

The registry does not report the number of participants who initiated treatment in either arm, an effect estimate, a confidence interval, or a statistical test for this endpoint. It also does not report a single analysis contrasting the groups across the follow-up assessments. The endpoint is therefore defined, but its comparative result cannot be interpreted from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group trial, but does not report the statistical methods used to analyze the primary outcome. The explanations below are general statistical guidance for interpreting this kind of endpoint, not a description of an analysis confirmed by the registry.

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to make the groups comparable, on average, with respect to measured and unmeasured characteristics at assignment. Randomization does not guarantee that every characteristic is balanced in a particular trial, especially when enrollment is limited. The registry identifies the study as randomized but does not describe the procedure, allocation ratio, or concealment method. Those details are not reported in the registry record.

A parallel-group design compares participants assigned to one intervention with participants assigned to another, rather than having the same participants receive both conditions. Here, the two named conditions are adapted STAT-ED and standard enhanced treatment as usual. Masking is listed as none. In general, lack of masking can matter when outcomes depend on participant or caregiver reports, because expectations may influence reporting or behavior. The registry does not report whether outcome interviewers were masked or how potential reporting effects were addressed.

What does a participant count represent?

The primary endpoint is described as a count of participants who received outpatient behavioral health treatment. For a binary endpoint at a defined assessment, each participant is classified according to whether the event occurred. A group count alone does not express the probability of treatment initiation or the contrast between groups; interpretation also depends on the number assessed, the definition of the assessment window, and the comparison method. These quantities and methods are not reported for the primary endpoint.

The registry describes follow-up at approximately 2 months and 6 months, and states that the overall number analyzed includes participants with data at either assessment or both. Repeated assessments raise an analysis question: the same participant may contribute information at more than one time. General methods must account for that dependence if observations from multiple assessments are analyzed together. Treating repeated observations as independent can make uncertainty appear too small. The registry does not report whether assessments were analyzed separately or jointly, or how within-participant dependence was handled.

How should uncertainty be assessed?

In general, an effect estimate gives the direction and scale of a comparison, while a confidence interval conveys the uncertainty around that estimate under a specified statistical model. A narrow interval indicates greater precision than a wide interval, though precision does not by itself establish clinical importance. A p-value, when used, addresses how compatible the observed data are with a specified null hypothesis under the model; it does not measure the probability that the null hypothesis is true. The registry record does not report an effect estimate, confidence interval, or p-value for treatment initiation.

For a binary outcome, analysts may compare group proportions or use a regression model, but the appropriate choice depends on the estimand, follow-up structure, missingness, and analysis plan. Adjustment for baseline characteristics may also be specified in advance. These are general possibilities, not methods attributed to this trial. The statistical model, any covariate adjustment, and the decision rules for the primary analysis are not reported in the registry record.

What does a planning illustration mean?

In general, a sample-size planning illustration asks how much information a future study might need to detect a chosen effect under stated assumptions. It is not an estimate of what the completed trial found, and it is not observed power. The registry describes planning assumptions based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also distinguishes participants per arm from total events for time-to-event outcomes. These are planning conventions described in the record, not evidence that the trial’s own design used them.

A planning illustration depends on the effect chosen, outcome variability, significance threshold, and analysis assumptions. If the observed effect itself is unavailable in the registry results, the illustration cannot be used to recover the trial’s primary comparison. The trial’s own sample-size justification and any formal power calculation are not reported in the registry record. Planning values, where displayed, should therefore be read as conditional illustrations rather than as proof that the completed study had a particular probability of detecting an effect.

What is not known about the analysis?

The registry lists two outcome measures and no reported analyses. It does not report a statistical analysis plan, an interim-analysis plan, handling of missing outcome data, prespecified covariates, or methods for multiplicity. It also does not report whether the primary comparison followed assignment regardless of intervention uptake. Each of these decisions can affect how a result should be interpreted. Without the methods and comparative outcome estimate, readers cannot verify whether the analysis matched a prespecified plan or assess the sensitivity of the findings to alternative assumptions.

General statistical interpretation should distinguish the randomized assignment from actual intervention receipt, the measurement schedule from the analysis schedule, and descriptive counts from comparative estimates. The registry provides some design and measurement information, but the missing analysis details prevent a full assessment of the trial’s statistical evidence.

10. Multiplicity, Missing Data and Analysis Populations

The registry names mental health treatment initiation as the primary outcome and suicidal ideation and behavior as a secondary outcome. It also describes primary-outcome follow-up at approximately 2 months and 6 months. The record does not report how many hypotheses were tested, whether each outcome and assessment time was treated as a separate comparison, or whether a multiplicity adjustment was planned.

In general, testing multiple outcomes or time points can increase the chance of obtaining at least one result that appears statistically notable by chance. A prespecified hierarchy or adjustment can help control that risk, but the appropriate approach depends on the study question and analysis plan. No such plan is reported in the registry record. The record also does not report a single primary contrast that combines or prioritizes the follow-up assessments.

Missing data are another unresolved issue. The outcome description says the overall number analyzed includes participants with data beyond baseline at either follow-up or both. It does not state how many participants contributed at each assessment, why data were unavailable, or how missing measurements were handled. In general, complete-case analyses may be biased when the likelihood of missing data is related to participant characteristics or outcome status. Other approaches require assumptions that should be made explicit and assessed where possible.

The registry does not report an analysis population definition, a missing-data strategy, or sensitivity analyses. It is therefore not possible to determine from the posted results whether the comparison included all randomized participants, only participants with follow-up data, or another group. These omissions limit interpretation of both the primary outcome and the secondary outcome.

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: hospitalization (41.7%).

The registry lists serious adverse event counts for both groups. For adapted STAT-ED, serious adverse events affected 5 of 12 participants at risk; for standard enhanced treatment as usual, they affected 3 of 14 participants at risk. Other adverse events affected 1 of 12 and 3 of 14 participants, respectively. Deaths are listed as 0 in both groups. These are descriptive safety counts in the registry, not a reported test of a difference between groups.

The registry lists hospitalization as the top serious adverse event term, with 41.7%. It does not provide the denominator or further context for that percentage in the available record. The term should not be taken as an explanation of all serious events or as evidence about whether events were related to the intervention.

In general, adverse-event counts need context about event definitions, observation periods, severity, relatedness, recurrence, and participant follow-up. The registry does not report those details for these counts. A difference in descriptive counts alone does not establish a causal safety effect, particularly without information about timing, exposure, and the analysis method. The figures describe what the registry records and should not be interpreted as a complete clinical characterization of risk.

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

The registry supports a clear description of the question and design: adapted STAT-ED patient navigation was compared with standard enhanced treatment as usual in a randomized, parallel-group study of Black youth presenting to an emergency department with suicide risk. The primary outcome concerns receipt of outpatient behavioral health treatment, assessed at approximately 2 months and 6 months. The trial is listed as completed, with enrollment of 54.

What the registry does not support is a conclusion about whether the adapted intervention changed treatment initiation. No arm-specific primary-outcome counts, comparative effect estimate, confidence interval, or test result are reported. Without these results, the magnitude and precision of any difference are unknown. The absence of a reported comparison is not evidence of no difference, and completion status does not fill that information gap.

The endpoint measures treatment receipt, an outcome relevant to the intervention’s stated goal of helping families navigate access to services. It does not, on its own, describe the quality, appropriateness, duration, or clinical benefit of treatment. The registry lists suicidal ideation and behavior as a secondary outcome, but does not report a numerical result or analysis for it. Consequently, the posted record does not establish an effect on that outcome either.

The serious and other adverse-event counts offer a limited descriptive account. They do not identify event causes or establish whether group differences are attributable to assignment. The registry’s listing of hospitalization as a serious-event term does not supply enough context to interpret its meaning for participants or compare event patterns.

In general, a trial result is most informative when it reports the outcome definition, analyzed population, group-level data, comparative estimate, uncertainty, and analysis methods. The registry record contains some design and measurement details but not this complete result set. Interpretation should remain restricted to the documented design, outcome definition, and adverse-event counts. No claim about treatment effectiveness or lack of effectiveness follows from the information reported.

13. Why This Trial Matters Statistically

This trial addresses a statistical question about access to care, not merely whether an intervention was delivered. Its primary outcome is treatment initiation, defined as participants receiving outpatient behavioral health treatment. That focus makes the outcome a comparison of a concrete service-use event, while the intervention itself includes navigation, appointment assistance, and efforts to address logistical barriers.

The design also raises practical analysis questions common to trials with follow-up measurements. The registry describes assessment at approximately 2 months and 6 months, and an overall analysis population that includes participants with data at either time or both. A reader needs to know whether the analysis compares each assessment separately or summarizes follow-up in another way, and how repeated observations from the same participant are handled. Those details are not reported in the registry record.

The study is randomized, which is an important design feature for a comparative question, but randomization alone does not make an unreported outcome interpretable. An effect estimate and its uncertainty are needed to assess what the observed data say. The registry record lists enrollment of 54 but does not report primary-outcome group counts or a statistical comparison. This illustrates why design information and outcome reporting serve different purposes.

There is also a distinction between a planning illustration and a completed-trial result. Planning assumptions can describe what a future study might require under selected conditions, but they cannot replace the actual comparison or establish observed power. The record’s stated planning conventions do not resolve the missing primary-outcome analysis.

For biostatistical interpretation, the central lesson is that a well-defined question and outcome do not by themselves yield an answer. Readers need transparent reporting of the estimand, analysis population, missing-data approach, model, and uncertainty. The registry provides context for the question, but its missing comparative results place a firm limit on the statistical conclusions that can be drawn.

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 trial-specific limitation of the registry record is the absence of reported primary-outcome results. Although treatment initiation is defined and the trial is listed as completed, arm-specific counts and comparative statistics are not reported. The record therefore does not permit an assessment of the direction, magnitude, or precision of the primary comparison.

The follow-up description leaves important details unresolved. Assessments are described at approximately 2 months and 6 months, and participants with data at either assessment or both contribute to the overall number analyzed. The record does not report the number assessed at each time, the outcome results by assessment, or how repeated measurements were combined. It also does not specify how missing outcome data were handled.

The registry does not report the statistical analysis plan, analysis population, model, covariate adjustment, multiplicity approach, or interim-analysis plan. The randomization procedure and allocation ratio are not described. These details are necessary to assess how the reported outcomes were analyzed and whether the analysis followed prespecified methods. No protocol deviations or reasons for missing follow-up are reported in the record.

Interpretation of safety is also constrained. The record provides serious and other adverse-event counts, deaths, and a top serious-event term, but does not describe the events’ timing, relatedness, recurrence, or clinical context. The denominator for the hospitalization percentage is not reported in the available safety description.

Finally, the registry describes an interview measure and its prior use with over 6000 adolescents, but does not report trial-specific completion, measurement quality, or respondent patterns. These limitations do not establish that the study was conducted improperly; they identify information absent from the registry record that is needed for a fuller statistical assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Navigating Mental Health Treatment for Black Youth — NCT05334381.
• Registry record last updated 2026-05-01; status last verified 2026-04.
• Results first posted 2026-05-01.
• 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

NCT05334381 is a completed, randomized, parallel-group behavioral trial titled “Navigating Mental Health Treatment for Black Youth.” It enrolled 54 participants and compared adapted STAT-ED patient navigation with standard enhanced treatment as usual. The study focused on Black youth presenting in an emergency department with suicide risk and included caregivers in the intervention approach.

The primary outcome is the number of participants receiving outpatient behavioral health treatment, assessed at approximately 2 months and 6 months using the ED STARS mental health service-use interview. Suicidal ideation and behavior is listed as a secondary outcome. The registry record does not report a statistical analysis of the primary outcome or comparative outcome estimates.

Safety counts include serious adverse events affecting 5 of 12 participants in the adapted STAT-ED group and 3 of 14 in the standard enhanced treatment as usual group. Deaths are listed as 0 in both groups. The record does not report enough analysis detail to support conclusions about comparative treatment effects or safety.