Optimizing Residential Treatment Gains for Adolescents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Optimizing Residential Treatment Gains for Adolescents (NCT05764369), a randomized na study. The primary outcome is Group Attendance (Feasibility).

2. Clinical Question

The broader trial aims to examine feasibility, acceptability, and preliminary effects of PWRT compared with TAU. The mechanisms and outcomes named in the registry description include family function, social support, parental self-efficacy, parenting practices, adolescent internalizing and externalizing behaviors, and placement restrictiveness. The attendance result alone addresses only one part of that broader aim: whether parents in the PWRT arm attended the facilitated groups. It cannot establish whether the program changed the listed family or adolescent outcomes.

3. Trial Design

The registry record describes NCT05764369 as a randomized, single-masked, parallel trial, with enrollment of 69. Its listed phase is NA, and its status is completed. The record names Ohio State University as sponsor. The listed study start date is 2023-08-31, and the primary completion date is 2025-06-02.

The study compares Parenting Wisely Residential Treatment (PWRT) with Treatment as Usual (TAU). The intervention description says PWRT parents complete ten online Parenting Wisely modules and attend a weekly 90-minute discussion group facilitated through Zoom. TAU is described as standard programming for parents in residential treatment settings, including family therapy offered weekly during the residential admission and discharge-planning meetings with caseworkers if assigned. The detailed arm descriptions in the registry are incomplete, so further procedural details are not reported in the registry record.

The primary attendance endpoint applies to parents assigned to PWRT. The registry states that TAU participants did not attend the intervention groups or complete the intervention modules, and that these attendance outcomes were not collected from them. It also states that neither adolescent group had data collected for this measure. Thus, randomization defines the broader trial design, but the posted attendance measure is not a two-arm outcome comparison.

Single masking is recorded, but which participants, staff, or assessors were masked is not reported in the registry record. The allocation procedure beyond its randomized designation, the planned analysis methods, and any sample-size justification are also not reported in the registry record. These gaps limit assessment of how design choices were implemented and how results for the broader trial were intended to be 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Treatment as Usual group did not attend the intervention groups nor complete the intervention modules. There was not data on these outcomes collected from them. Data was not collected on either adolescent group 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 Group Attendance (Feasibility), measured over Mean calculated at 6-weeks post-baseline.

The primary endpoint is the mean number of facilitated groups attended by parents in the PWRT arm, measured at 6-weeks post-baseline. Its unit is number of groups attended. The registry reports a mean of 3.0 and a standard deviation of 1.08 among 32 PWRT parent participants.

Attendance is used as a feasibility indicator because it records whether participants engage with a scheduled component of the intervention. A mean can describe the average attendance in the group, while the standard deviation describes how dispersed individual attendance values are around that average. In general, attendance can help characterize participation and implementation; it does not by itself establish acceptability, explain why people attended or missed sessions, or measure changes in family or adolescent outcomes.

The endpoint is not presented as a comparison with TAU. The registry explicitly says that TAU parents did not attend the intervention groups, did not complete the modules, and had no data collected for these outcomes. Attendance data were also not collected for either adolescent group. Therefore, the posted result describes attendance among PWRT parents only. A target level of attendance or a criterion for judging feasibility is not reported in the registry record, so the mean should be read descriptively rather than as meeting or failing a stated threshold.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as continuous and reports it as a mean with a standard deviation. General statistical explanations below describe how these summaries are usually read; they do not add analysis methods that the registry says were used. The specific analysis plan for this endpoint is not reported in the registry record.

What does the mean describe?

The mean is the arithmetic average of the recorded attendance values in the analyzed group. Here it is reported as 3.0 groups among 32 PWRT parent participants. The mean gives a compact description of the group’s average attendance, but it does not show the individual values or how many people attended each number of groups. Different attendance patterns can have the same mean, so the mean should be read alongside information about spread and, where available, the distribution of observations.

What does the standard deviation describe?

The standard deviation is a measure of how much observations tend to vary around their mean. The reported standard deviation is 1.08 groups. It describes spread among the observed attendance values, not uncertainty in the estimated mean. It also does not imply that every participant attended a number of groups within a particular distance of the mean. The registry does not post individual-level values, a range, or other distributional summaries for this endpoint.

Why is there no arm comparison?

A randomized design can support comparisons when outcomes are measured in the groups being compared. For this attendance measure, the registry says that TAU parents did not attend the intervention groups and that attendance data were not collected from them. It also says data were not collected from either adolescent group. Thus, the posted result is a one-group summary for PWRT parents, not a treatment-effect estimate comparing PWRT with TAU. The record’s comparator designation does not create a numerical comparison when comparator outcome data for this endpoint are absent.

How should uncertainty be understood?

A confidence interval is, in general, an interval estimated using a statistical procedure to convey uncertainty about an unknown quantity, such as a population mean. The registry does not report a confidence interval for attendance. It also does not report a hypothesis test, p-value, or other inferential analysis for this endpoint. The standard deviation cannot substitute for a confidence interval: the former describes variability among participants, whereas the latter would describe uncertainty about an estimate under a specified method. The method for estimating uncertainty is not reported in the registry record.

What does randomization contribute?

Randomization is a design method for assigning participants to trial groups. In general, it can help make groups comparable at the start of a study, but its value for an outcome comparison depends on having suitable outcome data and an analysis that accounts for the design. For this attendance measure, the registry does not report data for TAU or adolescent participants, so the posted attendance summary cannot use randomization to estimate a between-group effect. The method used to generate or implement allocation is not reported in the registry record.

What is not established by the posted analysis information?

The registry lists 0 analyses. The analysis population definition, any adjustments, handling of missing values, model choice, and assumptions are not reported in the registry record. For a continuous outcome, statistical models may rely on assumptions about the outcome distribution or the structure of variability; the actual assumptions and diagnostic procedures for this endpoint are not reported. No adjusted or unadjusted comparison is posted, and no recalculated comparison is available for the one-group attendance result.

The sample-size assumptions described in the record refer to planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations, in general, describe hypothetical planning under stated assumptions; they are not observed power and do not replace the trial’s own design justification. A sample-size justification for this trial is not reported in the registry record. Since the attendance result has no two-arm comparison, there is no posted treatment contrast for interpreting as an effect for this endpoint.

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("Parenting Wisely Residential Treatment (PWRT) - Pa")
n   <- c(32)
m   <- c(3)
sp  <- c(1.08)
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  Parenting Wisely Residential Treatment (PWRT) - Pa  32  3.000  1.080  2.611  3.389

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures and identifies 3 secondary outcomes: Brief Problem Monitor internalizing behaviors, externalizing behaviors, and total score. It lists 0 analyses. A prespecified statistical analysis plan, including any approach to multiple outcomes or multiple tests, is not reported in the registry record. Therefore, it is not possible to determine whether a multiplicity adjustment was planned or how the family of outcomes was intended to be interpreted. General statistical practice recognizes that considering many outcomes can increase the chance of at least one apparently notable result; the record does not state how this issue was addressed.

For the primary attendance measure, the registry reports data for 32 PWRT parents and no attendance data for TAU parents or either adolescent group. It explicitly explains that these outcomes were not collected from those groups because they did not participate in the intervention groups or modules, or because the measure was not collected from adolescents. Those entries are not evidence of zero attendance observations among participants in those groups; they are described as data not collected.

The record does not report the number of participants with missing attendance data within the PWRT parent group, reasons for missing values, imputation, or sensitivity analyses. It also does not describe the analysis population, such as whether it was defined by assigned group, participation, or availability of outcome data. Overall enrollment of 69 and the endpoint sample size of 32 do not, without participant-flow information, establish why the figures differ or how many observations are missing. No missing-data assumption or method is 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 reports serious adverse events and other adverse events separately for the PWRT and TAU parent groups and for the two adolescent groups. For each listed group, the reported number affected by serious adverse events is 0, the number affected by other adverse events is 0, and deaths are 0. The reported numbers at risk are 32 in each parent group, 1 in the PWRT adolescent group, and 4 in the TAU adolescent group.

These figures describe what was posted in the registry record for the groups and risk counts listed. They do not establish that no adverse events occurred outside the categories, participants, or observation procedures represented in those entries. The registry does not provide event descriptions in the posted serious-event terms, because no top serious-event terms are listed. The period and method of adverse-event collection are not reported in the registry record, so the scope of ascertainment cannot be assessed from these figures alone.

Because the adolescent risk counts differ between groups and are small as reported, the counts should not be treated as a reliable comparative safety estimate. More generally, a zero count in a registry entry is a report about recorded events in the listed group, not proof that an intervention carries no risk. These data do not support medical advice or a conclusion about comparative safety.

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

The posted result answers a limited feasibility question: how many facilitated groups PWRT parents attended on average at 6-weeks post-baseline. The reported mean is 3.0 groups, with a standard deviation of 1.08, among 32 parents. This gives a descriptive account of attendance in the PWRT parent group, and the spread indicates that individual attendance was not represented by the mean alone.

The result does not show whether attendance was high or low relative to an agreed feasibility target. No such target is reported in the registry record. Nor does it establish that parents found the program acceptable, that the web modules were completed, or that the program changed family processes or adolescent outcomes. Those are separate questions, and the attendance mean is not a substitute for measures of acceptability, parenting, family functioning, or adolescent behavior.

The endpoint also does not estimate a difference between PWRT and TAU. Although the trial is randomized, attendance data were not collected from TAU parents or adolescents for this measure. No treatment contrast, inferential test, or confidence interval is posted. The broader trial description states that researchers intend to examine mechanisms and adolescent outcomes, but no conclusion about those outcomes follows from this attendance result alone.

The record reports enrollment of 69, but does not provide participant-flow details explaining the endpoint count or the relation between enrollment and the reported attendance group. Accordingly, this summary cannot establish how representative the 32 participants are of all enrolled participants, whether any attendance values were missing within that group, or why. These limitations concern interpretation and precision; they do not change the basic descriptive meaning of the posted statistic.

The appropriate reading is therefore narrow and factual: the registry reports an average of 3.0 attended groups among 32 PWRT parents, with a standard deviation of 1.08. The result is evidence about attendance as recorded, not proof of efficacy, comparative benefit, acceptability, or a specific level of feasibility.

14. Why This Trial Matters Statistically

Feasibility outcomes answer a different statistical question from clinical-effect outcomes. Attendance measures whether participants engaged with a scheduled intervention component. For a program built around facilitated groups, such information can help describe implementation and participation, which are relevant when interpreting later outcome studies. It is important, however, to distinguish that descriptive role from evidence that the intervention changed family or adolescent outcomes.

This trial also illustrates why the endpoint and comparison structure need to be read together. The study is randomized, but the posted primary endpoint is only measured in the PWRT parent group. Because attendance data were not collected from TAU parents or adolescents, the endpoint does not produce a randomized between-group estimate. Randomization is a feature of the overall design, not a guarantee that every reported measure supports a comparative analysis.

The reported mean and standard deviation offer two distinct pieces of information: average attendance and participant-level spread. Neither is an uncertainty interval, and no confidence interval or inferential analysis is posted for this outcome. Readers therefore have a descriptive summary but limited information about how precisely it represents a wider population or how attendance relates to a benchmark.

The broader goals include mechanisms and adolescent outcomes, while the posted primary result addresses intervention attendance. Keeping these questions separate is statistically important. Participation can provide context for interpreting intervention delivery, but outcome effects require appropriate outcome data, a defined analysis, and uncertainty estimates. The registry record does not report those analyses for the attendance endpoint. This makes the record useful for understanding what was measured while also marking the boundary of what the posted result can establish.

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 primary endpoint is available only for PWRT parents. The registry states that TAU parents did not attend the intervention groups or complete the modules, and that attendance data were not collected from them; it also states that neither adolescent group had data collected for this measure. Consequently, the endpoint cannot provide a direct randomized comparison of attendance. The absent entries should not be read as observed zero values.

The result is a mean and standard deviation without a posted confidence interval, hypothesis test, or analysis. The registry lists 0 analyses, and the method for estimating uncertainty is not reported in the registry record. A feasibility threshold is also not reported, making it impossible to interpret the mean as meeting a stated criterion. Individual attendance distributions and the number of parents at each attendance level are not posted in the registry record for this result.

The record reports overall enrollment of 69 and an attendance sample of 32 PWRT parents, but no participant flow or explanation linking these counts. Reasons for any unobserved endpoint values, if any, are not reported in the registry record. The analysis population and handling of missing values are also not reported, so representativeness and missing-data concerns cannot be assessed.

The registry describes a randomized, single-masked, parallel study, but the masked party, allocation implementation, and detailed statistical plan are not reported in the registry record. The broader trial includes multiple outcomes, while the multiplicity approach is not reported. These limits apply to the interpretation of the posted record and do not establish that the study lacked procedures; the relevant details are simply not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Optimizing Residential Treatment Gains for Adolescents — NCT05764369.
• Registry record last updated 2026-08-31; status last verified 2026-06.
• Results first posted 2026-08-31.
• 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

NCT05764369, “Optimizing Residential Treatment Gains for Adolescents,” is listed as a completed randomized, single-masked, parallel trial sponsored by Ohio State University. Enrollment is 69. The registry lists the start date as 2023-08-31 and the primary completion date as 2025-06-02, with phase recorded as NA.

The trial compares Parenting Wisely Residential Treatment (PWRT) with Treatment as Usual (TAU). The primary measure is PWRT parent attendance at facilitated groups at 6-weeks post-baseline. The record reports a mean of 3.0 groups and a standard deviation of 1.08 among 32 PWRT parents. It states that attendance data were not collected from TAU parents or either adolescent group.

The record lists 7 outcome measures, 3 secondary outcomes, and 0 analyses. It does not report a comparison or inferential analysis for the attendance endpoint. Accordingly, the posted primary result is descriptive evidence about attendance among PWRT parents, not an estimate of comparative clinical effects.