Increasing Teen Access to Sexual and Mental Health Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Increasing Teen Access to Sexual and Mental Health Care (NCT05444855), a na na study. The primary outcome is Number of Participants With Any Healthcare Utilization From Baseline to 6 Months.

2. Clinical Question

3. Trial Design

NCT05444855, titled “Increasing Teen Access to Sexual and Mental Health Care,” is listed as completed. The listed sponsor is Children’s Mercy Hospital Kansas City. The study start date is 2022-06-08, and the primary completion date is 2023-04-30. The registry lists enrollment as 51. Phase is recorded as NA.

The design is identified as single group, with allocation listed as NA and masking listed as none. The intervention is named Peer Leader Model and categorized as other. The study description centers on community partnerships, outreach events, peer leaders, and access to information and services through the Children’s Mercy Mobile Unit. The brief summary says investigators planned to engage up to 40 teen peer leaders to encourage healthcare-seeking and mobilize their social networks.

The registry describes two participant labels: Peer Leader Participants and Friend Network Participants. The latter are adolescents enrolled as friends of peer leaders and are described as having access to activities and materials shared by the peer leaders. These labels do not create a randomized comparison. The registry itself cautions that the arms are not a like-for-like control comparison, so differences between them should not be interpreted as the effect of the peer leader model.

Participants were asked to complete eligibility screening and baseline surveys online or in person. The study description also identifies short follow-up surveys at 2, 4, and 6 months. The registry record does not report further details about implementation, participation in outreach, or how the completed follow-up data were analyzed.

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: In the protocol, we use the target enrollment number of 100 participants. However, our actual participants were 51 enrolled, which is reflected in our results section.

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Any Healthcare Utilization From Baseline to 6 Months, measured over Baseline to 6 months.

The primary endpoint is titled “Number of Participants With Any Healthcare Utilization From Baseline to 6 Months.” It is expressed in participants and is described as measuring any use of healthcare utilization through the trial. Surveys at baseline, 2 months, 4 months, and 6 months were specified as the measurement approach.

A participant-level count can describe how many people met an outcome definition, rather than how many separate visits or services occurred. The registry record does not give a more detailed definition of what qualified as healthcare utilization, whether different types of services were counted alike, or how survey responses were combined into the endpoint. Those details matter for interpreting what the count represents.

In general, tracking utilization over follow-up can describe whether participants report accessing care during the observation period. It does not by itself establish why care was accessed, whether the intervention caused a change, or whether access was timely or appropriate. In this record, the primary endpoint’s observed count and any estimate of uncertainty are not reported in the registry record. The endpoint is listed, but the posted results do not supply the numerical result needed to describe its observed value.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the study as single group and reports zero analyses. It does not report a statistical analysis plan, a model used for the primary endpoint, or an estimate of the outcome. The concepts below are general explanations of how such statistics are commonly interpreted; they are not claims about methods used in this study.

What does a participant count represent?

For a binary outcome, each participant is classified according to whether the specified event occurred or did not occur. A count of participants with any healthcare utilization therefore depends on the outcome definition and the available participant-level information. The registry describes the outcome as any use from baseline to 6 months and identifies surveys at baseline, 2 months, 4 months, and 6 months. It does not report the rule used to combine responses across those survey times or the number with an observed outcome.

A count alone is a descriptive quantity. To understand how common an event is in a study population, analysts may also report a proportion with an appropriate denominator. To compare populations, they may report a difference or another contrast and an uncertainty interval. These quantities require defined analysis populations and observed data. The registry record does not report them for this endpoint, so none can be interpreted from the posted results.

What would an uncertainty interval tell a reader?

In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the statistical method. It communicates precision as well as the estimate itself: a wider interval indicates less precision, while a narrower interval indicates greater precision. An interval does not remove potential bias from a non-comparable group, incomplete follow-up, or measurement limitations. No confidence interval for the primary outcome is reported in the registry record.

Why does the study structure matter?

A randomized comparison is designed to make groups comparable, on average, through assignment. This record does not describe randomized allocation; it identifies a single-group model and labels peer leader and friend network participants. The record specifically warns that those arms are not a like-for-like control comparison. In general, observed differences between nonrandomized groups can reflect differences in who joined each group, as well as differences in intervention exposure or outcome measurement. Statistical adjustment can sometimes address measured differences, but it cannot guarantee removal of bias from unmeasured factors. No adjusted analysis is reported.

Repeated surveys can provide information at multiple times, but their interpretation depends on how repeated responses are handled. General methods may use only a prespecified time point, define an outcome over the full follow-up period, or model the pattern of responses over time. These approaches answer different questions and can make different assumptions. The registry record does not report which approach, if any, was used to analyze repeated responses.

How should the planning illustration be read?

The record describes sample-size planning assumptions using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect stated as a fraction of the observed effect. These are assumptions for a planning illustration, not the reported design of the study. The actual design is listed as single group. The record does not report an observed effect, and the illustration should not be read as observed power. In general, power is a property of a planned design under assumed conditions; it is not a measure of whether a completed study has demonstrated an effect.

The record does not report a sponsor analysis for the primary outcome or recalculated estimates. There is therefore no estimate or uncertainty interval to compare, and no basis in the registry record for assessing whether an analysis agrees with a recalculation. The posted information is insufficient to evaluate model assumptions, precision, or the statistical significance of the primary endpoint.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Peer Leader Participants", "Friend Network Participants")
n      <- c(18, 33)
events <- c(9, 7)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Peer Leader Participants  18  9  50.0  26.0  74.0  29.0  71.0  28.9  71.1
ARM  Friend Network Participants  33  7  21.2  9.0  38.9  10.7  37.8  10.7  37.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and zero analyses. It does not report a statistical analysis plan, a prespecified hierarchy of outcomes, or whether any interim analyses were planned or conducted. The absence of reported analyses means that the registry record does not provide a set of inferential results in which to evaluate multiplicity adjustments.

In general, multiplicity arises when several outcomes, time points, groups, or statistical tests are examined. Testing many questions can increase the chance of finding an apparently notable result by chance. A prespecified analysis plan can identify the primary question and explain how other tests will be interpreted. The presence of one listed outcome measure does not establish that only one analysis was considered; the record does not report enough detail to determine the full analysis strategy.

The endpoint uses surveys at baseline, 2 months, 4 months, and 6 months. The registry record does not report how missing survey responses were handled, whether participants with incomplete follow-up were included, or whether any imputation or sensitivity analysis was used. It also does not report outcome denominators at each time point or define an analysis population. These details are important because missingness can affect both the number of participants represented and the interpretation of the observed responses.

In general, missing data are not automatically equivalent to a negative response or to absence of healthcare utilization. The implications depend on why responses are missing and on the analysis approach. With no reported missing-data methods or primary outcome results, the effect of incomplete follow-up cannot be assessed from the registry record.

12. 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 Peer Leader Participants and Friend Network Participants as the safety groups. For Peer Leader Participants, 18 are listed as at risk for serious adverse events and 0 as affected; 18 are listed as at risk for other adverse events and 0 as affected. For Friend Network Participants, 33 are listed as at risk for serious adverse events and 0 as affected; 33 are listed as at risk for other adverse events and 0 as affected. Deaths are recorded as 0 in each group.

These figures are reported counts, not estimates of comparative risk. The record does not identify a control group suitable for a like-for-like safety comparison, and it lists no serious adverse-event terms. Zero recorded events should be read as zero events in these registry entries, not as proof that no event occurred or that the intervention cannot cause harm. The record does not describe event-collection procedures or provide further detail about the safety assessment.

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

The registry record documents a study of a peer leader model intended to encourage healthcare-seeking and mobilize teens’ social networks. It specifies healthcare utilization from baseline to 6 months as the primary endpoint and describes surveys at baseline, 2 months, 4 months, and 6 months. It also describes outreach activities, educational information, and access to the Children’s Mercy Mobile Unit. These details establish what the study set out to examine, not what the outcome was.

The record does not report the number of participants with any healthcare utilization, an effect estimate, a confidence interval, or an analysis of the primary outcome. It is therefore not possible from the posted results to say whether reported utilization increased, decreased, or remained unchanged. Nor can the precision of any effect be judged.

The study’s single-group classification and the warning that the participant groups are not like-for-like control arms also limit causal interpretation. Even if group-specific outcome results were available, an unadjusted difference would not by itself show that the peer leader model produced that difference. Other group differences and patterns of participation could contribute.

More generally, healthcare utilization is one measure of contact with care. A utilization count does not by itself describe the content, quality, timeliness, or appropriateness of care, and it does not establish effects on health outcomes. Those distinctions matter when interpreting the study’s stated objective of improving access.

The registry’s completed status and its safety counts do not substitute for missing efficacy results. The results available in the record are limited to study description and reported adverse-event entries. The result that can be responsibly stated is that the primary endpoint’s observed value and statistical analysis are not reported in the registry record.

14. Why This Trial Matters Statistically

This study raises a practical statistical question: how should healthcare use be measured when an intervention works through peer relationships and community outreach? The registry identifies a participant-level utilization endpoint and repeated survey times, making the definition of the outcome, the handling of repeated responses, and the follow-up denominator central to interpretation. Those details determine what a reported count would mean.

It also illustrates why study structure must be considered before interpreting group labels. Peer leader participants and friend network participants are described, but the record says the arms are not a like-for-like control comparison. This distinction prevents descriptive group labels from being mistaken for randomized assignments. Statistical comparisons cannot, by themselves, remove the interpretive problems created by groups that may differ in important ways.

Transparent reporting of the observed endpoint count, the analysis population, missing follow-up, and uncertainty would help readers assess the strength and limits of the evidence. The registry record does not report those primary outcome details, and it lists zero analyses. As a result, the intervention’s utilization outcome cannot be evaluated statistically from this record.

The safety entries also show why counts need context. Recorded zeros describe what appears in the listed event fields; without more information about event ascertainment and follow-up, they do not establish an absence of risk. Taken together, the record is useful for understanding the study’s intended question and design, while also demonstrating that a completed status alone does not provide the results needed for an outcome interpretation.

15. 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 record constrain interpretation. The primary outcome is named, but its observed count and any statistical analysis are not reported in the registry record. The record lists zero analyses, so there is no reported effect estimate or precision measure to assess.

The design is identified as single group, and allocation is listed as NA. The two participant labels do not represent a randomized control comparison; the registry explicitly cautions that the arms are not like-for-like. This limits the ability to attribute any potential difference in utilization to the peer leader model. No adjustment strategy or other analytic approach is reported.

The endpoint is based on healthcare utilization surveys over baseline to 6 months, but the record does not define the qualifying services or explain how responses at multiple survey times were combined. It does not report follow-up completion, outcome denominators, the handling of missing responses, or the analysis population. These omissions leave uncertainty about what data would contribute to the endpoint and how representative the observed responses might be.

The brief summary describes intended outreach and access to education and services; the record does not report implementation or exposure results. The safety entries report no adverse events in the listed categories, but do not provide event-collection details or additional serious adverse-event terms. Finally, the planning illustration’s two-arm assumptions do not describe the stated single-group design and are not a substitute for observed outcome results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Increasing Teen Access to Sexual and Mental Health Care — NCT05444855.
• Registry record last updated 2024-09-19; status last verified 2024-09.
• Results first posted 2024-09-19.
• 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.

19. Record Summary

NCT05444855, “Increasing Teen Access to Sexual and Mental Health Care,” is listed as completed and sponsored by Children’s Mercy Hospital Kansas City. The record identifies a single-group study of the Peer Leader Model, with enrollment listed as 51. Its primary endpoint is the number of participants with any healthcare utilization from baseline to 6 months, measured through surveys.

The record describes peer leaders, their friend networks, community outreach, and the Children’s Mercy Mobile Unit. It also lists safety counts for Peer Leader Participants and Friend Network Participants. The observed primary outcome, its analysis, missing-data handling, and analysis population are not reported in the registry record. The listed participant groups are not a like-for-like control comparison.