Team-Focused Implementation in Child Advocacy Centers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Team-Focused Implementation in Child Advocacy Centers (NCT05679154), a randomized na study. The primary outcome is Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure.

2. Clinical Question

The broader study rationale is that CACs may identify children at risk for mental health problems and facilitate access to evidence-based treatment. The study also aimed to assess the effect of CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment. These aims describe the questions the trial set out to address; they do not establish that the registry record reports results for them. The listed outcome measures include team functioning, team performance, and CPM-PTS acceptability, appropriateness, and feasibility. Numerical findings for these outcomes are not reported in the registry record.

3. Trial Design

The registry record identifies a randomized, parallel-group pilot test comparing team-focused implementation with standard implementation. Its brief description states that CACs implementing CPM-PTS would be randomized to one of those two approaches. The record also identifies the design as cluster-randomized. In a cluster-randomized study, groups rather than individual participants are allocated to conditions; the trial description places the intervention in the context of CAC teams. The number of centers or clusters and the number allocated to each condition are not reported in the registry record.

The trial is marked completed, with enrollment of 147. The recorded start date is 2024-07-31, and the primary completion date is 2025-10-08. The record classifies the masking as none and the phase as NA. The two interventions are described as behavioral. Their arm descriptions are not reported in the registry record, so the precise implementation procedures cannot be compared from the available descriptions.

The primary endpoint is a Month 6 acceptability score for team-focused implementation. Only participants in that condition rated its acceptability, and the primary analysis included participants with complete data for the measure. Thus, this endpoint is not described as a direct comparison of acceptability scores between the two randomized conditions. The number of participants contributing complete data is not reported in the registry record.

Cluster allocation matters for statistical interpretation because participants within the same center or team may have more similar outcomes than participants from different clusters. Treating all individuals as independent observations can therefore misrepresent the uncertainty in an estimated effect. The record indicates that a simple individual-level re-analysis would be misleading and that only the sponsor’s own analysis is shown. Details of that analysis, including its model and handling of clustering, are not reported in the registry record. The sponsor is the University of Pittsburgh.

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: One center withdrew from the study during baseline data collection and before randomization. Participants affiliated with this center (n = 55) did not participate in any additional data collection. Outcome measures are not available for these participants. No caregivers were enrolled in this study.

Participants Entering at Baseline

Reasons for not completing this period:

Participants Entering at 6 Months

Analysis population for the primary outcome, as defined in the registry: Only participants in the team-focused implementation condition rated its acceptability. Analyses included participants with complete data for this measure.

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 Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure, measured over Month 6.

The primary endpoint is perceived acceptability of team-focused implementation at Month 6. It is assessed using items from the Acceptability of Intervention Measure. Each item uses a 1-5 Likert scale; the item scores are averaged, and higher scores indicate more positive perceptions. The resulting score has a stated range of 1-5.

Acceptability is an implementation outcome: it describes how acceptable an approach is perceived to be by those asked to rate it. This is relevant to a pilot study because an implementation strategy may need to be viewed favorably by the people involved in using it. As a general statistical point, a measure of acceptability answers a different question from whether an implementation strategy changes clinical outcomes. It should not be treated as a direct measure of caregiver understanding, treatment initiation, or children’s mental health.

The registry record specifies that only participants assigned to team-focused implementation rated its acceptability. It also specifies that analyses included participants with complete data for this measure. Accordingly, the primary endpoint as described does not supply a comparison of acceptability between the randomized arms, nor does it establish how the complete-data respondents differ from those without complete data. The Month 6 mean and standard deviation, and the number included in the endpoint analysis, are not reported in the registry record. Without those results, the level of acceptability and the precision of its estimate cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does random allocation contribute?

In a randomized trial, assignment to conditions is intended to reduce systematic differences between groups at the point of allocation. The registry describes a randomized, parallel-group comparison of team-focused and standard implementation. It also identifies the design as cluster-randomized. In this form of design, allocation occurs at the cluster level rather than independently for every person. The number and identity of clusters, and their allocation details, are not reported in the registry record.

Randomization does not guarantee that groups will be identical, particularly when there are few clusters, and it does not remove the need to define the analysis population or address missing observations. It also does not by itself make an outcome a between-group comparison. The primary endpoint is described as acceptability rated only by participants in the team-focused condition. That endpoint can describe perceptions in that condition, but it is not described as a direct comparison of acceptability across both conditions.

Why does clustering affect analysis?

As a general statistical principle, members of the same cluster may share context, staff, and implementation practices. Their measurements can consequently be correlated. An analysis that treats every participant as statistically independent can understate uncertainty when within-cluster similarity is present. Methods for cluster-randomized trials account for that dependence, for example by modeling clusters or adjusting uncertainty estimates for clustering. The registry record does not identify the specific method used by the sponsor.

The record explicitly warns that a simple individual-level re-analysis would be misleading and states that only the sponsor’s own analysis is shown. This makes it especially important not to interpret a hypothetical calculation that ignores clusters as if it were the trial’s result. The cluster count, cluster sizes, intracluster correlation, and analysis model are not reported in the registry record. Without those details, readers cannot independently assess how clustering affected the precision of the posted estimate.

What does the primary score represent?

The primary outcome is a mean score on the Acceptability of Intervention Measure at Month 6. Items are rated on a 1-5 Likert scale, averaged, and interpreted so that higher scores indicate more positive perceptions. A mean is a measure of the center of a set of scores. The standard deviation, if reported, would describe variation among individual scores around that mean. Neither the Month 6 mean nor its standard deviation is reported in the registry record.

Acceptability is an implementation construct. It is distinct from feasibility, appropriateness, team functioning, team performance, and clinical outcomes, even though the registry lists measures in several of those areas. As a general measurement principle, a score should be interpreted according to what its items assess and who completed them. In this trial, only participants in the team-focused implementation condition rated acceptability, and the analysis used complete data for that measure. The number of complete records is not reported in the registry record.

How should uncertainty be understood?

A point estimate, such as a mean score, summarizes the observed data but does not by itself indicate how uncertain that estimate is. A confidence interval is a general statistical tool for communicating uncertainty: under the analysis assumptions, it identifies a range of values compatible with the data. A narrow interval indicates greater precision than a wide interval, while neither interval alone determines whether an outcome is important in practice. No interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated from the record.

Statistical significance, when used in a suitable comparative analysis, addresses compatibility with a null hypothesis under a particular model. It does not measure the size or practical importance of an effect. The registry record does not report a primary-endpoint hypothesis test or its result. It would therefore be inappropriate to infer significance or lack of significance from the design, enrollment, or outcome definition.

What is the role of the planning illustration?

The registry record describes sample-size assumptions for a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For outcomes other than time-to-event outcomes, such illustrations are expressed as participants per arm; time-to-event illustrations use a total event count. Such calculations are planning aids, not observed trial results and not measures of achieved power. The effect estimate and the numerical planning outputs are not reported in the registry record.

In general, a planning calculation asks how much information might be needed to detect a specified effect under chosen assumptions. It cannot establish that a completed study had a particular probability of detecting an effect after the fact. The record characterizes the illustration as based on the observed effect, but does not report the numerical effect or the resulting planning values. Those assumptions do not substitute for the trial’s own design justification, which is not reported in the registry record.

What can be concluded from the analysis information?

The record reports that four analyses are listed and that there are 19 outcome measures. Those counts do not identify which analyses correspond to which outcomes, what model was fitted, or how repeated measurements were handled. The analysis plan, interim analyses, adjustment for multiple comparisons, and treatment of missing values beyond the stated complete-data restriction for the primary measure are not reported in the registry record. Statistical interpretation should therefore remain limited to the stated design and endpoint definitions, without assuming unreported modeling choices.

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("Team-focused Implementation")
n   <- c(43)
m   <- c(4.31)
sp  <- c(0.69)
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  Team-focused Implementation  43  4.310  0.690  4.098  4.522

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 19 outcome measures and four analyses. It includes outcome descriptions covering team functioning at follow-up, team performance, and measures of CPM-PTS acceptability, appropriateness, and feasibility. Listing several outcomes raises a general multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase if every test is treated separately at the same threshold. Researchers may address this with a prespecified primary outcome, adjustment procedures, or an explicitly exploratory interpretation. The multiplicity strategy is not reported in the registry record, so it is not possible to determine how the listed outcomes were handled.

For the primary acceptability endpoint, the record states that analyses included participants with complete data for the measure. This identifies a complete-data restriction, but does not say how many participants had complete data, how many lacked data, or why data were missing. The missing-data methods and any sensitivity analyses are not reported in the registry record. As a general statistical point, complete-case results describe the participants with the necessary measurements; if those participants differ systematically from those without complete data, the result may not represent the full group originally assigned.

The overall enrollment of 147 should not be treated as the primary analysis sample size. The number contributing to the primary endpoint and the number of clusters represented in that analysis are not reported in the registry record. The record also does not report an intention-to-treat analysis population, a per-protocol population, or how participants were handled when follow-up measurements were unavailable. In a cluster-randomized trial, interpretation also depends on which clusters and participants contribute data and on how clustering is incorporated. Further details about these populations and procedures are not reported in 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 record reports serious adverse event figures separately for team-focused implementation and standard implementation. In the team-focused condition, 55 participants were at risk for serious adverse events, and 0 were affected. In the standard implementation condition, 37 were at risk, and 0 were affected. The record also reports 0 deaths in each condition. The counts for participants at risk for other adverse events are 55 and 37, respectively, and the number affected by other adverse events is 0 in both groups.

These are reported event counts, not evidence that an event was impossible or that the approaches have no risk. A zero count means that no affected participants were recorded in the specified categories in the registry record. The record does not report the observation period used for these safety figures, definitions or ascertainment procedures for adverse events, or uncertainty intervals. The counts at risk also differ between the two conditions, so the raw counts alone are not a complete comparison of safety.

The registry record gives no serious adverse event terms to describe. These figures should be read as the safety information recorded for this trial, rather than as a broad conclusion about all possible harms or about use outside the study context.

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

The trial record describes a pilot evaluation of team-focused implementation compared with standard implementation for CACs implementing CPM-PTS. Its primary endpoint concerns perceived acceptability of the team-focused approach at Month 6. This is a meaningful implementation question because the study rationale identifies teamwork as potentially relevant in team-based settings. The record also states broader aims involving feasibility, caregiver understanding, and intentions to initiate treatment.

The numerical primary outcome is not reported in the registry record. Therefore, the record does not establish the observed mean acceptability score, the variability of responses, or the precision of the estimate. It does not support a conclusion about whether participants generally viewed team-focused implementation favorably. The endpoint description explains how acceptability was measured, but measurement instructions are not the same as findings.

The primary outcome is not presented as a comparison of the two randomized conditions: only participants in the team-focused condition rated its acceptability. Consequently, the endpoint as described cannot establish that team-focused implementation was more acceptable than standard implementation. Nor does an acceptability score, by itself, establish that CPM-PTS improved children’s mental health, increased treatment initiation, or changed caregiver understanding. Those are distinct questions and require results from corresponding outcomes.

The study’s cluster-randomized design also shapes what can be inferred. Participants within the same center or team may have related outcomes, so a valid comparative analysis must account for that structure. The record says a simple individual-level re-analysis would be misleading and that only the sponsor’s own analysis is shown, but does not report the analysis details or numerical findings. It is therefore not possible to independently assess the comparative effects or their uncertainty from the registry record.

The appropriate reading is limited: the record identifies a completed pilot study, its implementation conditions, outcome definitions, and some safety counts. It does not report the primary endpoint result or numerical findings for the other stated outcomes. Absence of a result in the registry record should not be interpreted as a finding of no effect, just as the study aims should not be mistaken for evidence of benefit.

14. Why This Trial Matters Statistically

This trial is statistically notable because its implementation strategy is evaluated in a cluster-randomized setting. In such studies, the unit of allocation and the unit of measurement may differ: centers or teams can be assigned, while outcomes are collected from individuals. That structure requires analysis methods that respect the grouping. The registry record expressly cautions that a simple individual-level re-analysis would be misleading, highlighting why the design cannot be interpreted as an ordinary trial of independent individual assignments.

The primary outcome also illustrates the importance of matching a question to its measure. Acceptability of team-focused implementation is a relevant implementation outcome, but it is not equivalent to feasibility, appropriateness, team performance, or a clinical outcome. Keeping these constructs separate prevents an interpretation from stretching a score beyond what it measures. The registry lists multiple implementation outcomes as well as broader study aims, but numerical findings are not reported in the registry record.

There is also a useful distinction between evaluating an approach within one arm and comparing randomized arms. Only participants in the team-focused condition rated the primary acceptability endpoint. That endpoint may describe perceptions in that condition, but cannot alone estimate a between-condition contrast. The existence of a standard implementation comparator does not make every outcome a comparative endpoint.

Finally, the record illustrates how incomplete reporting constrains statistical interpretation. Enrollment and outcome definitions do not reveal the number analyzed, the estimate, its uncertainty, or the handling of clustering and missing data. Without the primary result, readers cannot assess its magnitude or precision. For a pilot study, feasibility and implementation outcomes can be informative, but their interpretation still depends on transparent numerical reporting and clear analysis methods.

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.

The most direct limitation for interpreting results is that the numerical findings are not reported in the registry record. This includes the Month 6 primary acceptability result and the results for the other listed outcomes. Without estimates and measures of uncertainty, the direction, magnitude, and precision of observed outcomes cannot be assessed. The record’s completed status does not itself supply those findings.

The primary endpoint is limited to participants in the team-focused implementation condition and to those with complete data for that measure. The number of complete responses is not reported in the registry record. The endpoint therefore does not provide the stated between-arm comparison, and the extent to which missing observations could affect its description cannot be evaluated.

Cluster randomization requires attention to the dependence of observations within centers or teams. The registry record notes that a simple individual-level re-analysis would be misleading and that only the sponsor’s own analysis is shown. The specific analysis method, cluster count, cluster sizes, and numerical uncertainty estimates are not reported in the registry record. This limits independent assessment of the analysis.

The intervention descriptions are also sparse: the registry record names team-focused and standard implementation but does not describe their components. The number of centers, allocation details, and the precise standard implementation procedures are not reported in the registry record. As a result, the approaches cannot be characterized in operational detail from the record.

The record lists multiple outcomes but does not report the multiplicity approach, missing-data methods beyond the primary complete-data restriction, interim analyses, or the statistical analysis plan. The safety figures have no reported observation period or event-ascertainment details. These limitations restrict interpretation; they do not establish that the approaches did or did not produce particular outcomes.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Team-Focused Implementation in Child Advocacy Centers — NCT05679154.
• Registry record last updated 2026-10-06; status last verified 2026-10.
• Results first posted 2026-10-06.
• 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.

19. Record Summary

NCT05679154 is a completed, randomized, parallel-group, cluster-randomized pilot test of team-focused versus standard implementation of CPM-PTS in rural CACs. The sponsor is the University of Pittsburgh. The recorded start date is 2024-07-31, the primary completion date is 2025-10-08, and enrollment is 147. The registry classifies the interventions as behavioral and masking as none.

The primary endpoint is Month 6 acceptability of team-focused implementation, assessed with averaged Acceptability of Intervention Measure items on a 1-5 scale. Only participants in that condition rated the measure, and the analysis included participants with complete data. Its numerical result is not reported in the registry record. The record also lists team functioning, team performance, acceptability, appropriateness, and feasibility outcomes, but numerical results for these are not reported in the registry record.

Serious adverse events and deaths are recorded as 0 in both conditions. The record cautions that a simple individual-level re-analysis would be misleading because of cluster randomization and states that only the sponsor’s own analysis is shown.