Practice Experiences for School Reintegration: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Practice Experiences for School Reintegration (NCT05934396), a randomized na study. The primary outcome is Proportion of Participants Who Complete All Study Procedures.

2. Clinical Question

3. Trial Design

NCT05934396, titled Practice Experiences for School Reintegration, is a randomized pilot optimization trial of a virtual-reality program for hospitalized adolescents with suicidal-related admissions. The registry lists the study as completed, with enrollment of 54. The recorded start date is 2023-08-01 and the primary completion date is 2024-12-20. The listed phase is NA.

The study follows a Multiphase Optimization Strategy, or MOST, to refine the PrESR program and examine feasibility and acceptability. The registry describes the aims as informing clinician training, recruitment of adolescent inpatients, and management of experimental conditions. It also says the pilot will assess candidate intermediary and outcome measures, while not being powered to test hypotheses.

The randomized Optimization Trial has eight intervention conditions. Enhanced Control consists of Cognitive Behavioral Therapy worksheets. The other conditions combine worksheets, Safety Planning, and one or more virtual-reality modules: Affect Regulation, Cognitive Restructuring, and Problem Solving. The registry labels the model factorial. In general, factorial designs allow combinations of intervention components to be assessed within a shared study structure; the registry record does not report a detailed statistical analysis plan explaining how component effects or interactions were to be estimated.

Masking is listed as none. The registry also includes Hospital Professionals and Adolescent Patients Selected by Hospital Professionals as groups associated with the Open Trial Period; the primary outcome description says data were not collected for those groups. The record does not report further details about allocation procedures, concealment, or the conduct of the open trial.

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: 125 parents/guardians were called based on chart review and 94 were successfully contacted; out of those, 54 provided permission for their adolescent to participate. Of 54 adolescents contacted, 48 provided assent, of whom 1 was screened out due to risk for cybersickness. Of the remaining 47 adolescents, 5 were in the open trial and 42 were in the optimization trial. 7 hospital professionals consented to participate in the open trial, of whom 4 delivered the intervention to at least one patient.

Only the first 6 of 10 groups are shown.

Optimization Trial

Open Trial Period

Analysis population for the primary outcome, as defined in the registry: Analysis population includes adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians, including those considered for the Optimization Trial and the Open Trial.

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.

Population: Data pertaining to Adolescent Patients Selected by Hospital Professionals are only analyzed for the outcomes related to overall patient recruitment and screening: "Proportion of Patients in the Target Population Who Agree to Participate \[Time Frame: Baseline\]" and "Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening \[Time Frame: Baseline\]".

Only the first 6 of 11 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Proportion of Participants Who Complete All Study Procedures, measured over up to 3-months following school re-entry.

The primary endpoint is the proportion of participants who complete all study procedures. Completion is based on procedures at Baseline, 2-week follow-up, 3-month follow-up, and journals kept over the two weeks of return to school. The endpoint is defined relative to the participants taking part in the relevant condition.

This measure is used to assess whether the study procedures can be carried out and whether participants can remain engaged through the planned follow-up and journaling activities. For a pilot optimization trial, procedural completion can inform feasibility alongside acceptability and recruitment. It does not directly measure symptom change, school functioning, or the effectiveness of a clinical intervention.

The registry says the outcome applies to participants in the Optimization Trial. It also specifies that data were not collected for Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. The posted arm results are proportions, with no confidence intervals or other measures of uncertainty included in the registry record. The record does not describe how partial completion was handled beyond the definition that participants must complete all listed procedures.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the study randomized and factorial, and lists masking as none. Randomization is a method for assigning participants to study conditions using a chance-based process. In general, random assignment can reduce systematic differences between groups, although it does not ensure that small groups will be alike in every respect. The registry record does not report the sequence-generation method, allocation concealment, or other implementation details.

What does the factorial label mean?

In general, a factorial design evaluates combinations of intervention components within a common study. Here, the intervention conditions combine virtual-reality modules for Affect Regulation, Cognitive Restructuring, and Problem Solving, with Cognitive Behavioral Therapy worksheets and, in most conditions, Safety Planning. The set of conditions includes single modules and combinations of modules. A factorial structure can support questions about component contributions and combinations, but valid estimates depend on the planned model and analysis. The registry record does not report which component contrasts, interactions, or other effects were prespecified or analyzed.

What does the primary outcome estimate?

The endpoint is a proportion: participants completing all the listed study procedures relative to participants taking part in that condition. A proportion is a descriptive summary of the frequency of an outcome within a group. Because the endpoint requires completion of every specified procedure, it combines information about baseline participation, follow-up, and journaling rather than isolating any one step. The registry provides arm-level proportions but does not post confidence intervals or a formal model for comparing them.

Why does uncertainty matter?

In general, a confidence interval conveys the range of values compatible with the data under a statistical procedure and its assumptions. It helps readers distinguish an estimate from its precision. The registry record does not report confidence intervals for the primary outcome. With the small arm sizes posted, the observed proportions may be sensitive to individual outcomes, so the values should be treated as preliminary descriptions rather than stable estimates.

What can a hypothesis test establish?

In general, a hypothesis test evaluates how compatible observed data are with a stated statistical model or null hypothesis. A p-value does not measure the size or clinical importance of an effect, and it does not establish that an intervention works. The registry describes this pilot as not powered to test hypotheses, and the posted results include no analyses. There are consequently no posted p-values or model-based comparisons to interpret. The registry record does not report the statistical plan, test choices, covariate adjustments, or any interim analyses.

How should planning calculations be read?

In general, sample-size planning calculations use assumptions about the effect to detect, the significance level, allocation, and statistical method. Such figures are planning illustrations, not evidence that a study had a particular probability of detecting an effect after it was completed. The stated assumptions for planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of the observed effect. The record does not report the trial’s own sample-size justification. The registry describes the pilot as not powered to test hypotheses, so any planning illustration should not be mistaken for observed power or a confirmatory analysis.

For binary outcomes, general statistical methods may model either event counts or proportions. Choice of method depends on the design, the amount of data, and the intended estimand. The record identifies the primary outcome as a proportion but does not report a model or a method for estimating uncertainty. No recalculated two-arm comparison is posted for this outcome. Without a specified analysis and adequate detail about the underlying observations, the arm-level summaries are best read descriptively.

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("Enhanced Control", "Affect Regulation", "Problem Solving", "Affect Regulation + Problem Solving", "Cognitive Restructuring", "Affect Regulation + Cognitive Restructuring")
n      <- c(6, 5, 6, 5, 5, 5)
events <- c(0, 0, 0, 0, 0, 0)
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  Enhanced Control  6  0  0.0  0.0  45.9  0.0  39.0  0.4  41.0
ARM  Affect Regulation  5  0  0.0  0.0  52.2  0.0  43.4  0.4  45.9
ARM  Problem Solving  6  0  0.0  0.0  45.9  0.0  39.0  0.4  41.0
ARM  Affect Regulation + Problem Solving  5  0  0.0  0.0  52.2  0.0  43.4  0.4  45.9
ARM  Cognitive Restructuring  5  0  0.0  0.0  52.2  0.0  43.4  0.4  45.9
ARM  Affect Regulation + Cognitive Restructuring  5  0  0.0  0.0  52.2  0.0  43.4  0.4  45.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, but reports 0 secondary outcomes posted and 0 analyses. It does not report a multiplicity strategy, such as how the statistical plan would account for examining multiple outcomes, intervention components, or combinations. In general, multiplicity matters because examining many comparisons can increase the chance of apparently notable findings arising by chance. Without posted analyses or a stated plan, readers cannot determine which comparisons were intended to be primary beyond the listed primary endpoint.

The record does not report a statistical analysis plan, prespecified model, p-values, confidence intervals, or handling rules for missing data. The primary endpoint requires completion of all study procedures, but the registry does not say whether participants with incomplete procedures were handled in any particular way beyond the endpoint definition. It also does not provide procedure-level missingness or reasons for noncompletion.

The endpoint description limits the applicable population to the Optimization Trial and states that data were not collected for Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. The record does not provide further details about analysis populations, such as intention-to-treat or per-protocol definitions, or whether participants were analyzed according to their randomized condition. Those details 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospitalization for suicide-related risk or associated symptoms (40.0%), emergency department visit for suicide-related risk or associated symptoms (33.3%), hospitalization for medical procedure: gi (16.7%), hospitalization for medical procedure: skin (16.7%), parent distress related to adolescent risk behaviors (16.7%).

The adverse-event figures are reported by group as participants at risk and participants affected, with serious events and other events listed separately. For serious adverse events, the registry reports 3 affected among 6 at risk in Enhanced Control; 1 among 5 in Affect Regulation; 1 among 6 in Problem Solving; 1 among 5 in Affect Regulation + Problem Solving; 1 among 5 in Cognitive Restructuring; 1 among 5 in Affect Regulation + Cognitive Restructuring; 0 among 5 in Cognitive Restructuring + Problem Solving; and 3 among 5 in Affect Regulation + Cognitive Restructuring + Problem Solving. It reports no serious adverse events among the 5 adolescent patients selected by hospital professionals. The Hospital Professionals group has 0 at risk.

For other adverse events, the reported affected counts range from 0 to 1 in the Optimization Trial conditions; the registry also reports 0 among 5 in the adolescent-patient group. Deaths are reported as 0 in each listed group. These figures describe reports in this pilot, not comparative safety estimates. The record does not provide uncertainty intervals or a statistical comparison, and small group sizes limit interpretation.

The most frequently listed serious-event terms include hospitalization or emergency department visits for suicide-related risk or associated symptoms. The registry lists their percentages, along with other terms, but does not provide enough context to interpret those percentages as comparative risks. Serious adverse events should be read as safety reporting, not as a primary outcome or a causal assessment of the interventions.

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

The posted completion proportions describe how often participants in each Optimization Trial condition completed all specified study procedures. They provide an initial indication of participation through follow-up and school-return journaling in this pilot. The different values across conditions can help identify feasibility questions for further refinement, but the registry does not report statistical analyses that establish whether the observed variation reflects reliable differences between intervention combinations.

The values do not show whether PrESR improves clinical outcomes, reduces suicidal risk, changes symptoms, or supports school reintegration. The primary endpoint measures procedure completion, not those clinical outcomes. Although the registry describes candidate intermediary and outcome measures as part of the pilot, it does not post secondary outcome results.

The results also do not establish that any one virtual-reality component is responsible for a particular completion pattern. Conditions combine components, and no component-level estimates or interaction analyses are posted. The registry record does not report the intended analysis model or uncertainty estimates. In general, a factorial label alone does not tell readers which effects were estimated or how those effects were interpreted.

The study description says the pilot was not powered to test hypotheses. Accordingly, the arm-level values are most appropriately understood as exploratory, descriptive information for feasibility and program refinement. They should not be treated as proof of a treatment effect, proof of no effect, or a basis for ranking the conditions. The registry record also does not report a sample-size justification or detailed analysis populations, which further limits conclusions about the strength and scope of the evidence.

14. Why This Trial Matters Statistically

This trial is statistically notable because it evaluates a set of intervention combinations in a randomized factorial pilot rather than focusing only on a single treatment-versus-control contrast. The conditions include virtual-reality modules for Affect Regulation, Cognitive Restructuring, and Problem Solving, allowing the study to explore how skill-practice elements might be combined during inpatient care. The feasibility endpoint focuses on whether participants complete the planned study procedures, an important question for a program that includes follow-up and journaling after school re-entry.

The registry frames the work as a pilot optimization trial under MOST. That framing matters: the stated aims include refining the program and informing clinician training, recruitment, and experimental-condition management. Those aims differ from confirming clinical effectiveness. The study description explicitly says that it is not powered to test hypotheses, so descriptive feasibility findings are the appropriate focus of the posted primary results.

At the same time, the small posted arm sizes and absence of analyses make the estimates uncertain. The variation in completion proportions can inform future questions, but it cannot independently identify an optimal combination or establish a clinical benefit. The registry record does not provide a statistical analysis plan or component-level results. This limits what readers can learn about the factorial structure from the posted results, while underscoring the importance of distinguishing an optimization pilot from a confirmatory trial.

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 a combined completion measure. A participant must complete all specified procedures to count as completing the endpoint, so the arm-level proportion does not identify which follow-up or journal procedure was missed. Procedure-specific completion and reasons for noncompletion are not reported in the registry record.

The Optimization Trial conditions have small posted arm sizes, and no confidence intervals or analyses are reported. The arm-level proportions therefore have limited precision, and small changes in observed outcomes could shift them. The record describes the trial as not powered to test hypotheses. It also does not report a sample-size justification or the planned statistical methods for assessing component effects or combinations.

The record lists 10 outcome measures but posts 0 secondary outcomes and 0 analyses. It does not report multiplicity handling, a missing-data strategy, detailed analysis populations, or an intention-to-treat definition. Masking is listed as none, and the record does not report allocation concealment or sequence-generation details. These omissions limit assessment of potential bias and of how the reported summaries relate to the randomized design.

The primary endpoint applies to the Optimization Trial, not to the Hospital Professionals or Adolescent Patients Selected by Hospital Professionals in the Open Trial Period. Those groups therefore do not add information to the primary outcome. Finally, completion of procedures is a feasibility measure rather than a clinical endpoint; the posted primary results cannot establish effects on symptoms, suicidal risk, or school reintegration.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Practice Experiences for School Reintegration — NCT05934396.
• Registry record last updated 2025-09-25; status last verified 2025-01.
• Results first posted 2025-09-25.
• 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

NCT05934396 is a completed randomized pilot optimization trial of Practice Experiences for School Reintegration, an immersive virtual-reality supplement for hospitalized adolescents with suicidal-related admissions. It is listed as factorial, with no masking. The registry reports enrollment of 54 and dates of 2023-08-01 for study start and 2024-12-20 for primary completion.

The primary endpoint is the proportion completing Baseline, 2-week follow-up, 3-month follow-up, and journals during the two weeks of return to school. Results are posted for eight Optimization Trial conditions, with arm sizes from 5.0 to 6.0 and proportions from 0.0 to 0.8. The registry describes the pilot as not powered to test hypotheses. It posts no analyses or secondary outcomes, and does not report uncertainty estimates or a detailed statistical analysis plan.