Adolescents' Well-being in Community-based Treatment Versus Residential Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adolescents' Well-being in Community-based Treatment Versus Residential Treatment (NCT06498427), a registered phase not stated study. The primary outcome is Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint.

2. Clinical Question

The study also proposed comparing cost and other well-being outcomes. The stated hypothesis was that Child ACTT would be associated with better outcomes and lower cost than PRTF. That is a hypothesis, not a result: the registry record lists no statistical analyses and does not report group outcome estimates. The registry identifies the study as quasi-experimental, not randomized, and does not state how participants were allocated. The groups therefore should not be treated as a like-for-like randomized comparison. Differences between them could reflect treatment setting, participant characteristics, or other factors; the available record does not describe an analysis that separates these possibilities.

3. Trial Design

This is a quasi-experimental longitudinal study of adolescents in community-based Child ACTT or PRTF. Its official title describes a comparison of well-being in those settings. The study is marked completed, with enrollment listed as 124. The registry gives a start date of 2022-01-04 and a primary completion date of 2025-06-20. Those dates describe the registered study timeline; they do not establish when any individual participant entered or completed follow-up.

Child ACTT is described as a team-based, multidisciplinary service for children in homes and other placements. The intervention description is an excerpt from a service definition and is incomplete in the registry record. PRTFs are described as non-hospital facilities intended to provide inpatient services to Medicaid-eligible individuals under the age of 21, with the aim of improving residents’ condition or preventing further regression so the need for that level of care can be removed. These are different service settings, rather than two versions of a treatment delivered under the same circumstances.

The primary endpoint is timed at the study intervention endpoint, defined as discharge or 6 months. The record also includes a post-discharge follow-up for a secondary outcome, but the timing and procedures for that follow-up are not reported in the registry record. The registry lists 10 outcome measures, including participant and legal-guardian reports, satisfaction measures, and individual clinical-scale domains. It does not list statistical analyses. Allocation procedures, eligibility details beyond those described in the treatment definitions, analytic populations, and the handling of departures from planned follow-up are not reported in the registry record. Because the study is quasi-experimental and allocation is not stated, interpretation must account for the possibility of baseline differences between groups.

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.

Study Intervention Period

Post-Discharge Follow-up

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 Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint, measured over Study intervention endpoint (discharge or 6 months).

The primary endpoint is the average z-score across participant-reported domains of the Adolescent Treatment Outcome Package Clinical Scale (TOP-CS) at the study intervention endpoint: discharge or 6 months. TOP is described as a comprehensive well-being assessment used in behavioral health and child welfare settings. The adolescent clinical scale contains 58 items and assesses experience over the past 2 weeks across 12 domains, including Depression, Attention Problems, Conduct Problems, and Suicidality. Responses range from All to None of the Time on a 6-point Likert scale.

The domain z-scores are averaged to create a single summary measure. The record states that summary scores range from -0.62 to 11.30, with 0 representing the general population mean. Higher average domain scores indicate higher severity and lower behavioral health well-being. This direction matters when interpreting any group contrast: a numerically higher score corresponds to greater measured severity, not better well-being.

A summary score offers a way to represent several clinical domains in a single endpoint, while retaining a defined interpretation relative to the general population mean. It can also conceal domain-specific patterns: the same overall average may arise from different combinations of domain scores. No group means, standard deviations, contrasts, confidence intervals, or tests for this primary endpoint are reported in the registry record. Consequently, the measure’s definition is available, but the observed endpoint comparison is not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record labels the study quasi-experimental and describes two treatment settings. In general, a quasi-experimental comparison evaluates groups without the protection of random allocation. Random assignment, when used, helps make groups comparable on average; without it, the groups may differ in prognostic characteristics before treatment begins. The registry says allocation is not stated and flags the arms as not a like-for-like control comparison. It does not report a method for accounting for baseline differences, so the causal meaning of a potential group contrast cannot be assessed from this record.

What does a mean represent?

The primary measure is continuous: it is an average of domain z-scores. A group mean describes the average observed score among the participants included in the calculation. It does not describe every participant, and it can conceal variation across individuals and across the domains making up the summary. The registry specifies standard deviation as the dispersion measure for this endpoint. In general, a standard deviation describes how spread out individual scores are around a mean; it is not the same as uncertainty in the estimated mean.

What would a confidence interval add?

In general, a confidence interval describes the precision of an estimate under the statistical model used to construct it. A narrower interval indicates greater precision than a wider interval, but an interval does not remove bias from non-random allocation or other design limitations. No confidence interval for the primary endpoint is reported in the registry record. Without an estimate and its interval, neither the magnitude nor the precision of a group difference can be evaluated.

What does the endpoint’s scale mean?

The endpoint averages z-scores across TOP-CS domains. The registry states that 0 is the general population mean and that higher average scores indicate higher severity and lower behavioral health well-being. A z-score expresses a value relative to a reference distribution, but the record does not describe the exact reference data or further scoring procedures. Statistical interpretation should follow the stated direction of the summary measure rather than assuming that a higher score is favorable.

Why does the study design matter?

In general, an unadjusted comparison of group means describes the observed groups, but it does not establish that the setting caused any difference. Adjustment may address measured differences, depending on what was measured and how the model was specified; it cannot automatically address unmeasured differences. The registry does not report allocation, baseline characteristics, adjustment variables, or a model for the primary endpoint. It also lists no analyses. Thus, it is not possible to determine whether the posted results use an unadjusted comparison, an adjusted model, or another method.

What is the role of the planning illustrations?

The study’s design rationale and sample-size justification are not reported in the registry record. The associated planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. Such values are planning illustrations, not observed power and not evidence that a planned sample size was adequate. The record does not state that these assumptions were used to design the trial. In general, sample-size planning depends on assumptions about the target effect, variability, significance level, allocation, and analysis. A planning calculation cannot replace reporting the estimate and uncertainty actually observed.

For a continuous endpoint, uncertainty depends on the amount of information and variability, as well as the analysis method. The registry lists an enrollment of 124 and separate adverse-event risk sets, but it does not report the number of participants with an evaluable primary endpoint or the sample size used in any outcome analysis. Enrollment alone is not enough to determine the precision of an endpoint estimate when endpoint completion and analysis populations are not described. The record also does not report whether the longitudinal structure was modeled or whether the endpoint was analyzed only at the specified intervention endpoint.

General statistical practice distinguishes a prespecified primary endpoint from secondary outcomes, and often considers multiplicity when testing many outcomes. Here, the registry identifies the primary endpoint and lists secondary measures, but does not state a testing hierarchy, multiplicity adjustment, or analysis plan. Without that information and without reported analyses, there is no basis to interpret any nominal statistical significance across outcomes.

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("Child ACTT - Experimental", "PRTF - Treatment as Usual")
n   <- c(59, 57)
m   <- c(0.42, 0.63)
sp  <- c(1.39, 1.19)
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  Child ACTT - Experimental  59  0.420  1.390  0.058  0.782
CARM  PRTF - Treatment as Usual  57  0.630  1.190  0.314  0.946

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and lists 10 outcome measures overall, including several secondary measures. Testing multiple outcomes can increase the chance of at least one apparently notable result arising by chance. In general, investigators may address this through a prespecified hierarchy, adjustment procedures, or a clearly limited set of confirmatory tests. Which approach was used is not reported in the registry record. Because no analyses are listed, there are no reported test results to evaluate for multiplicity or to distinguish as confirmatory versus exploratory.

The registry record does not describe missing-data rates for the primary or secondary outcomes, reasons for missing assessments, or methods used to handle missing observations. It also does not report the analysis population for the primary endpoint, such as whether the analysis included all enrolled participants or only those with endpoint measurements. These details are important because participants without endpoint data may differ from participants with observed scores. If missingness is related to treatment setting or well-being, an analysis limited to observed scores may not represent all enrolled participants. This is a general concern, not a claim about what occurred in this study.

The primary endpoint is assessed at discharge or 6 months, and the registry includes a secondary post-discharge follow-up measure. The procedures for determining the endpoint visit, accommodating different discharge timing, and handling incomplete follow-up are not reported in the registry record. Without a stated statistical analysis plan or outcome estimates, it is not possible to assess whether missing data, multiple outcomes, or different assessment timing affected the results.

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 adverse-event record lists Child ACTT with 59 participants at risk for serious adverse events and 59 at risk for other adverse events. It reports 0 affected for both categories and 0 deaths. For PRTF, it lists 58 participants at risk for serious adverse events and 58 at risk for other adverse events, again with 0 affected in both categories and 0 deaths. These figures describe what is recorded for the listed groups; they are not comparative estimates of safety.

The registry does not list serious-event terms. The absence of recorded affected participants in these fields should not be read as proof that no adverse events occurred under any definition or outside the reporting captured by this record. The record does not provide event definitions, ascertainment procedures, observation time by participant, or explanations for the difference between listed risk sets and the overall enrollment. It also does not report statistical comparisons of adverse events. Accordingly, the figures can be described as reported counts, but they do not support a broader conclusion about relative safety or rare events.

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

The record establishes that a completed quasi-experimental study was registered to compare adolescents receiving Child ACTT with adolescents receiving PRTF. It defines a participant-reported clinical outcome based on average TOP-CS domain z-scores and specifies the endpoint as discharge or 6 months. The outcome’s direction is clear: a higher score indicates higher severity and lower behavioral health well-being. The record also describes a hypothesis about better outcomes and lower cost for Child ACTT, and lists a wider set of secondary measures.

What the record does not establish is the result of the comparison. No statistical analyses are listed, and no primary or secondary outcome estimates are reported. There is no reported group difference, uncertainty interval, or test result to use in judging how large or precise an observed contrast may be. The registered hypothesis cannot be converted into a conclusion about the outcome, and completion status alone does not show whether the hypothesis was supported.

The design also limits causal interpretation. This was not a randomized comparison, allocation is not stated, and the registry identifies the arms as not a like-for-like control comparison. If outcome differences were available, they could reflect pre-existing differences between participants as well as differences in care settings. The record does not provide the information needed to assess adjustment for such differences.

Therefore, the sound interpretation is limited to the study question, design, endpoint definition, and registered safety counts. Claims about comparative effectiveness, cost, participant satisfaction, or treatment-related change are not supported by the results reported in the registry record. Further interpretation would require posted outcome data and methods detailed enough to evaluate the analysis and its limitations.

14. Why This Trial Matters Statistically

This study addresses a statistically challenging comparison because the two groups receive care in different settings and assignment is not described as random. Comparisons of community-based treatment and residential treatment can be difficult to interpret when the pathways into each setting may differ. The registry itself flags the arms as not a like-for-like control comparison. That makes design transparency, participant characteristics, and analytic methods central to interpreting any observed contrast.

The primary measure also illustrates the balance between a summary outcome and detail. Averaging TOP-CS z-scores across domains produces one endpoint for the stated comparison. A single endpoint can be easier to summarize than a collection of domain results, but it may hide whether domains move in similar or different directions. The registry’s inclusion of individual-domain outcomes suggests that these distinctions were relevant to the planned assessment, although no results are listed.

The record’s outcome set spans participant and guardian reports, clinical domains, and satisfaction. Different respondents and measures capture different perspectives; they should not automatically be treated as interchangeable evidence. A clear analysis plan would help readers understand which outcome is primary, how secondary outcomes are interpreted, and how uncertainty and multiple comparisons are handled. The registry does not report those analysis details.

Finally, this record demonstrates the difference between a completed study and an interpretable comparative result. Enrollment, an endpoint definition, and a stated hypothesis describe the study, but conclusions require outcome estimates and their precision. In a quasi-experimental study, readers also need to know how group differences were addressed. Without those elements, the study question is identifiable while its statistical answer remains unreported.

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 main limitation for statistical interpretation is that the registry record lists no analyses or outcome estimates. The primary endpoint’s definition is detailed, but group means, standard deviations, contrasts, and uncertainty are not reported. The same applies to secondary outcomes and the stated cost hypothesis. As a result, the magnitude, direction, and precision of any comparison cannot be evaluated.

The study is quasi-experimental, allocation is not stated, and the record warns that the arms are not a like-for-like control comparison. The registry does not report baseline characteristics or an adjustment strategy. Potential differences between groups before treatment therefore cannot be assessed from this information. The intervention description for Child ACTT is an excerpt and is incomplete, which also limits detailed understanding of what was delivered.

Several further analytic details are not reported in the registry record: the analysis population, outcome completion, missing-data handling, the statistical model, multiplicity procedures, and the sample-size justification used for the study. The timing is described as discharge or 6 months for the primary endpoint, but the handling of differing assessment timing is not stated. A post-discharge follow-up is identified for a secondary measure, while its procedures are not described.

The adverse-event entries report zero affected participants in the listed categories, but do not give event definitions, ascertainment details, or observation duration. These entries cannot establish the absence of unrecorded events or support a comparative safety conclusion. Together, these limitations mean that the registry supports a description of the study’s question and measurements, not a determination of treatment effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Adolescents' Well-being in Community-based Treatment Versus Residential Treatment — NCT06498427.
• Registry record last updated 2026-06-02; status last verified 2026-05.
• Results first posted 2026-06-02.
• 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

NCT06498427 is a completed quasi-experimental longitudinal study titled Adolescents’ Well-being in Community-based Treatment Versus Residential Treatment. It compares Child ACTT with PRTF and lists an enrollment of 124. The primary endpoint is the average participant-reported TOP-CS domain z-score at discharge or 6 months; higher scores indicate higher severity and lower behavioral health well-being. The registry lists 10 outcome measures and a hypothesis concerning outcomes and cost. It does not state allocation procedures or list statistical analyses, and it reports no primary or secondary outcome estimates. The registered adverse-event entries list zero affected participants in the serious and other adverse-event categories for both groups, with zero deaths. Given the unreported results and the non-randomized comparison, comparative outcome conclusions cannot be drawn from the registry record.