This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for School-Based Mental Health Effectiveness Study (NCT04383327), a randomized na study. The primary outcome is Teacher Knowledge of Evidence-Based Practice (Knowledge Score).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04383327 |
| Phase | NA |
| Condition | Child Development |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 2444 |
| Arms in the primary outcome | 3 |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
Teachers and parent-child pairs in urban and rural low-resource communities in Uganda. The registry describes schools in Kampala and Hoima.
Intervention
ParentCorps-Professional Development (PD), a behavioral intervention, delivered either alone or alongside the behavioral teacher stress management package T-Wellness.
Comparator
A control group. The registry record does not describe the control condition in further detail.
Primary question
What teacher knowledge of evidence-based practice scores were recorded at baseline across the three groups, and how do the posted group summaries compare? The primary measure is a teacher quiz score, not a reported post-intervention change.
The study addresses prevention and implementation in early childhood mental health in low-resource communities. Its stated aims include assessing the intervention’s effectiveness, practical implementation strategies, and underlying mechanisms. The comparison of ParentCorps-Professional Development with and without T-Wellness is intended to address the contribution of the additional teacher stress management package. The registry also lists child conduct problems as a secondary outcome.
The posted primary outcome is explicitly labeled Baseline. Consequently, the results describe baseline scores and unadjusted comparisons of those scores. They do not establish what happened after intervention delivery or whether scores changed over time. The registry record does not report a post-intervention primary outcome analysis.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study with an enrollment of 2444. Its status is Completed. The recorded study start date is 2021-08-01, and the primary completion date is 2024-06-30. The phase is listed as not applicable. The sponsor is NYU Langone Health.
The three groups are ParentCorps-Professional Development alone, ParentCorps-Professional Development with T-Wellness, and Control. The record describes schools in Kampala, Uganda, as urban, and schools in Hoima, Uganda, as rural. For PD alone, it lists 6 schools in Kampala with 89 teachers and 325 parent-child pairs, plus 10 schools in Hoima with 98 teachers and 344 parent-child pairs. For PD with T-Wellness, it lists 6 Kampala schools with 77 teachers and 300 parent-child pairs, plus 10 Hoima schools with 80 teachers and 329 parent-child pairs. For Control, it lists 6 Kampala schools with 73 teachers and 316 parent-child pairs, plus 9 Hoima schools with 92 teachers and 321 parent-child pairs.
The registry labels allocation as randomized, masking as single, and the model as parallel. It does not identify who was masked, describe allocation concealment, or specify the unit of randomization. Although the intervention descriptions are organized by school, that alone does not establish the randomization unit or the analysis approach. Details of implementation, adherence, and any variation between urban and rural results are not reported in the registry record.
The primary outcome is teacher knowledge of evidence-based practice at baseline. Child mental health conduct problems are listed among the secondary outcomes, also with a Baseline timeframe. The record gives no post-baseline outcome results in the material reported for these endpoints.
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: While parents + children were enrolled as dyads, only the parent participants provided consent. The participant flow information provides the total number of parents AND children. The baseline characteristic information provides data on parents only, as only parents had baseline characteristic data collected. Further, all child-related assessments were completed by the parent participants.
Only the first 6 of 12 groups are shown.
Overall Study
| Stage | ParentCorps-Professional Development (PD) - Parent + Child: Urban | ParentCorps-Professional Development (PD) - Teachers: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban | Control - Parent + Child: Urban | Control - Teacher: Urban |
|---|---|---|---|---|---|---|
| STARTED | 650 | 89 | 600 | 77 | 632 | 73 |
| COMPLETED | 538 | 75 | 522 | 64 | 522 | 60 |
| NOT COMPLETED | 112 | 14 | 78 | 13 | 110 | 13 |
Reasons for not completing this period:
| Reason | ParentCorps-Professional Development (PD) - Parent + Child: Urban | ParentCorps-Professional Development (PD) - Teachers: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban | Control - Parent + Child: Urban | Control - Teacher: Urban |
|---|---|---|---|---|---|---|
| Lost to Follow-up | 112 | 14 | 78 | 13 | 110 | 13 |
Analysis population for the primary outcome, as defined in the registry: All teacher participants were analyzed.
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: Note that only parent participants in the parent + child dyads were consented and had baseline characteristic data collected.
Only the first 6 of 13 groups are shown.
| Characteristic | Unit | ParentCorps-Professional Development (PD) - Parents Urban | ParentCorps-Professional Development (PD) - Teachers: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban | ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban | Control - Parents: Urban | Control - Teacher: Urban |
|---|---|---|---|---|---|---|---|
| Participants analysed | 325 | 89 | 300 | 77 | 316 | 73 | |
| Age, Continuous | years | 36.04 (SD 9.65) | 40.9 (SD 11.8) | 36.54 (SD 10.17) | 40.2 (SD 12.3) | 35.83 (SD 8.86) | 42.7 (SD 11.3) |
| Sex: Female, Male: Female | Participants | 245 | 68 | 250 | 49 | 237 | 50 |
| Sex: Female, Male: Male | Participants | 80 | 21 | 50 | 28 | 79 | 23 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 325 | 89 | 300 | 77 | 316 | 73 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 325 | 89 | 300 | 77 | 316 | 73 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: Uganda | participants | 325 | 89 | 300 | 77 | 316 | 73 |
6. Primary Endpoint
The registry lists the primary outcome as Teacher Knowledge of Evidence-Based Practice (Knowledge Score), measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Teacher Knowledge of Evidence-Based Practice, measured as a score on a scale. Teachers complete a 10-item quiz assessing knowledge of evidence-based interventions. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge. The registry identifies the measure as a mean with standard deviation and labels its timeframe Baseline. It states that all teacher participants were analyzed.
A knowledge score is relevant to a professional development intervention because it describes teachers’ reported understanding of evidence-based practice. The score offers a continuous summary rather than a simple count of teachers who cross a stated threshold. Group means describe average scores, while standard deviations describe how spread out individual scores are around those averages. Those summaries help characterize the groups, but do not by themselves describe changes following training.
The registered measure is a quiz score, not a direct measure of classroom practice, implementation quality, or child mental health. Although the study’s stated aims include implementation and underlying mechanisms, this primary endpoint speaks specifically to knowledge. The registry record does not report evidence about the quiz’s validation, reliability, scoring rules beyond the stated range, or a threshold for a meaningful difference. Because the endpoint is posted at baseline, its group summaries cannot be interpreted as an intervention effect.
7. Results Posted in the Registry
- ParentCorps-Professional Development (PD) - Teachers: Urban and Rural: mean 36.68 versus 35.18 on control; difference 1.50 (95% CI -1.24 to 4.24), standardized effect d = 0.11; z-test p = 0.283.
- ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural: mean 36.41 versus 35.18 on control; difference 1.23 (95% CI -1.60 to 4.06), standardized effect d = 0.10; z-test p = 0.394.
Mean difference: ParentCorps-Professional Development (PD) - Teachers: Urban and Rural
95% CI: -1.24 to 4.24
Recalculated from the posted summary statistics
8. Secondary Efficacy Endpoints
The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Child Mental Health- Conduct Problem | Continuous Endpoint | Mean difference | -0.05 (-0.27 to 0.17) | 26,896 per arm |
Child Mental Health- Conduct Problem
- Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
- Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
- Result:
- ParentCorps-Professional Development (PD) - Parents: Urban and Rural: mean 2.39 versus 2.44 on control; difference -0.05 (95% CI -0.27 to 0.17), standardized effect d = -0.02; z-test p = 0.663.
- ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural: mean 2.41 versus 2.44 on control; difference -0.03 (95% CI -0.25 to 0.19), standardized effect d = -0.01; z-test p = 0.793.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ParentCorps-Professional Development (PD) - Parents: Urban and Rural and the control. The interval gives the range of effects that remain compatible with the data.
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural and the control. The interval gives the range of effects that remain compatible with the data.
The posted secondary outcome is child mental health conduct problem, with a Baseline timeframe. Its group means are close to one another, and the unadjusted recalculated comparisons versus Control are small in the outcome’s score units. The confidence intervals for both comparisons include zero. The registry lists the same conduct-problem label three times among the secondary outcomes, while the detailed results describe parent scores across the three study groups.
This overall pattern is consistent with the primary result in one limited respect: neither outcome’s baseline summaries show a clear separation between the intervention groups and Control. It does not corroborate or contradict an intervention effect, because these are baseline measurements rather than post-intervention results. The primary endpoint concerns teacher knowledge; the secondary measure concerns parent-reported child conduct problems, so the two outcomes represent different constructs and inform different parts of the study’s aims.
Secondary results generally carry less inferential weight when many outcomes or comparisons are considered without a stated multiplicity plan. General statistical principle: testing multiple outcomes increases the chance that at least one result appears notable by chance, unless the analysis accounts for that multiplicity or the findings are interpreted as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy of secondary outcomes, or sponsor-reported analyses for these results.
Accordingly, the secondary baseline summaries are useful as descriptions of the parent groups and as context for the range of outcomes the study addresses. They do not establish a change in child conduct, a mechanism of action, or a difference in implementation effectiveness. The registry record does not report post-baseline secondary results or an analysis linking teacher knowledge with child outcomes.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Child Mental Health- Conduct Problem
- Child Mental Health- Conduct Problem
- Child Mental Health- Conduct Problem
9. Statistical Interpretation
At baseline, the posted mean teacher knowledge score was 36.68 for ParentCorps-Professional Development, 36.41 for ParentCorps-Professional Development with T-Wellness, and 35.18 for Control. The reported standard deviations were 14.46, 13.96, and 11.75, respectively. These are baseline descriptions of the teachers in each group, not estimates of change after training.
Unadjusted comparisons recalculated from the posted summary statistics estimate a mean difference of 1.5 points for PD alone versus Control, with a 95% confidence interval from -1.24 to 4.24 and p = 0.283. For PD with T-Wellness versus Control, the recalculated mean difference is 1.23 points, with a 95% confidence interval from -1.595 to 4.055 and p = 0.394. Both intervals include zero, so the posted summaries are compatible with no baseline difference as well as with differences in either direction. These results are descriptive comparisons at baseline and should not be read as treatment effects.
The recalculations are simple, unadjusted comparisons based on posted group summaries. The registry record lists no reported analyses for the outcomes discussed, and the sponsor’s own analysis results are not reported in the registry record. No discrepancy is flagged between the posted summaries and these recalculations. The recalculated results therefore help describe the summary data, but they are not a substitute for a prespecified, sponsor-reported analysis.
The record identifies a randomized design, but randomization does not make baseline group differences evidence of an intervention effect. Nor does a nonsignificant unadjusted p-value establish that groups are equivalent. The confidence intervals express uncertainty around the recalculated differences, and their breadth leaves a range of baseline contrasts compatible with the data. The registry record does not provide a prespecified equivalence margin or a threshold for a meaningful knowledge-score difference.
The central interpretive limitation is timing: the primary and secondary outcome timeframes are both labeled Baseline. No change from baseline, later assessment, or intervention-versus-control outcome after delivery is reported for these results. They therefore describe group composition and baseline measurement, rather than effectiveness. Any claim about post-intervention knowledge or child conduct would require results not reported in the registry record.
10. Statistical Methods Explained
The primary endpoint is continuous: each teacher has a score, and the registry reports group means and standard deviations. A mean gives the group’s average score, while a standard deviation describes variation among scores within that group. A larger standard deviation indicates more spread around the average; it does not indicate uncertainty in the group mean itself. The group sample sizes and standard deviations both affect how precisely a mean or difference in means can be estimated.
The registry lists the comparison measure as a mean difference. A difference in means expresses how far one group’s average is from the control group’s average, in the original score units. The posted comparisons are unadjusted recalculations from group-level summary statistics. They are not adjusted for other participant characteristics, location, school, or any other covariates. No adjusted primary analysis is reported in the registry record.
A confidence interval gives a range of values compatible with the data under the calculation’s assumptions. For a mean difference, an interval that crosses zero includes no difference as one possibility. The interval’s width communicates precision: a narrower interval indicates more precision, and a wider interval indicates greater uncertainty. An interval should be interpreted alongside the estimated difference and the study design, not as a range guaranteed to contain the true value.
A p-value measures how unusual the observed data, or data more extreme, would be under a specified null model. The unadjusted p-values reported for the recalculated primary comparisons are not probabilities that the null hypothesis is true, nor do they measure the size or importance of a difference. Since the record does not report a full analysis plan or sponsor analysis, the assumptions underlying these recalculations cannot be checked against a prespecified model.
The posted intervention is described at the school level, while the primary outcome is measured for teachers. If teachers within a school have correlated scores, analyses that treat every teacher as fully independent can understate uncertainty. General statistical principle: when observations are clustered, a suitable analysis accounts for within-cluster similarity, because teachers in the same school may share experiences or context. The registry record does not report whether clustering was accounted for, how schools were incorporated into the analysis, or whether the randomization unit was the school.
Over-dispersion is relevant when observed variability is greater than a model assumes. General statistical principle: a model that understates variation can produce confidence intervals that are too narrow and p-values that are too small. The posted summaries include standard deviations, but the registry record does not report a model-based variance assessment or an over-dispersion adjustment. It is therefore not possible to determine whether such considerations affected a sponsor analysis.
Random allocation is intended to create comparable groups on average, but it does not ensure identical baseline measurements in a particular trial. Baseline summaries are useful for describing the groups and identifying observed differences. In a randomized study, baseline adjustment may be part of an analysis plan, but whether and how to adjust depends on the prespecified methods. The registry record does not report whether baseline scores were used as covariates in a later outcome model, and no later primary score is posted in these results.
The outcome population is described as all teacher participants analyzed. The baseline arm summaries list 187 teachers for PD, 157 for PD with T-Wellness, and 165 for Control. These analysis counts are not a report of a longitudinal analysis population. The registry record does not describe missing outcome handling, exclusions, imputation, or whether all randomized participants contributed to each outcome. These details matter because complete-case summaries can represent a selected subset if outcome availability is related to participant characteristics or outcomes.
The reported secondary conduct-problem outcome is also continuous and summarized using means and standard deviations. The same general principles apply: differences in means retain the outcome’s score units, confidence intervals describe uncertainty, and unadjusted p-values do not address the number of outcomes tested. The registry lists three secondary outcome entries with the same conduct-problem label, but does not report sponsor analyses for them. The statistical interpretation is therefore limited to the posted baseline summaries and simple unadjusted recalculations.
These general methods explain how to read the posted statistics, not the trial’s own prespecified statistical plan. Details of that plan, including covariate adjustment, clustering, missing-data handling, multiplicity procedures, and interim analyses, are not reported in the registry record.
11. Confidence Intervals and Precision
The recalculated primary comparison for PD alone versus Control is 1.5 points, with a 95% confidence interval from -1.24 to 4.24. For PD with T-Wellness versus Control, the recalculated difference is 1.23 points, with a 95% confidence interval from -1.595 to 4.055. Each interval crosses zero. Thus, neither comparison precisely distinguishes a baseline difference from no difference using these unadjusted summaries.
The intervals also show that the estimates are uncertain: values on both sides of zero remain compatible with the data under the calculation assumptions. The upper and lower limits are not predictions for individual teachers, and the confidence level does not mean that a particular interval has a 95% probability of containing the true value. In general, a confidence interval is a method that, over repeated use under its assumptions, produces intervals that cover the target parameter at the stated rate.
These intervals do not establish equivalence. Equivalence requires a prespecified margin defining which differences would be considered sufficiently small, along with an analysis designed to evaluate that margin. Neither such margin nor an equivalence analysis is reported in the registry record. Likewise, the intervals are not intervals for an intervention effect, because the relevant outcomes are labeled Baseline.
Precision is also conditional on the analysis assumptions. The recalculated intervals use posted summary statistics and do not account for any school-level clustering or covariate adjustment. Whether the sponsor’s analysis used different methods is not reported in the registry record. The intervals should therefore be read as uncertainty estimates for the unadjusted baseline contrasts, rather than as a complete account of uncertainty under a fully specified trial analysis.
12. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 1,227 | 1,643 |
| 75% of the observed effect | 2,181 | 2,920 |
| 50% of the observed effect | 4,907 | 6,569 |
The planning figures are participants per arm for the continuous outcomes, not total event counts. They are illustrative calculations based on the observed effect and are not the trial’s original design justification. The planning assumptions listed for these figures are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect.
The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one. The 90% column expresses the corresponding planning target for a 90% chance. These are planning probabilities conditional on the assumed effect and model; they are not measures of what the completed study achieved.
The rows scale the assumed effect to 100%, 75%, or 50% of the observed effect. Smaller target effects are harder to distinguish from random variation, so the calculations require more participants per arm. The figures are not a reconstruction of the trial’s enrollment plan, and the registry record does not report the original sample-size assumptions or justification. This is not observed power: observed power is not a useful substitute for interpreting the effect estimate and its confidence interval after results are available.
The calculations use equal allocation and a normal approximation. They do not, in the stated assumptions, describe adjustments for school clustering, loss to follow-up, multiple comparisons, or other design features. The registry record does not report whether those considerations informed the trial’s original design.
13. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.
Worked calculation for this trial
- Observed difference Δ = 1.500; pooled standard deviation σ = 13.259.
- n = 2 × (1.96 + 0.842)2 × 13.2592 / 1.5002 = 1,226.6, rounded up to 1,227 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
delta <- 1.5 # observed difference in means
sigma <- 13.2593134491518 # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")
# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4383327)
n <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n)) # difference in sample means
s2 <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1)) # pooled sample variance
tstat <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))
Output from running the code
100% of observed effect: n per arm = 1,227 (80% power), 1,643 (90% power)
75% of observed effect: n per arm = 2,181 (80% power), 2,920 (90% power)
50% of observed effect: n per arm = 4,907 (80% power), 6,569 (90% power)
power.t.test: 1227.5
Simulated power at n = 1,227 per arm: 0.797 (20000 replicates)
The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
14. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan detailing how the primary and secondary outcomes were to be tested. It lists 17 outcome measures and 0 analyses, and identifies three secondary outcome entries under the conduct-problem label. The record does not report which outcomes, comparisons, or timepoints were designated for confirmatory inference beyond the stated primary endpoint.
Multiplicity arises when several outcomes, timepoints, or group comparisons are examined. General statistical principle: as the number of statistical tests grows, the chance of at least one apparently unusual result under a null model can increase. Common approaches include prespecifying a hierarchy, adjusting significance thresholds, or treating secondary analyses as exploratory. The registry record does not report whether any such approach was used. The unadjusted p-values should therefore not be read as if they necessarily account for all analyses that may have been considered.
Missing-data procedures are also not reported. The primary outcome description says all teacher participants were analyzed, but the record does not explain the handling of incomplete quiz scores, exclusions, or unavailable measurements. It does not describe imputation or compare participants with and without outcome data. The reported analysis counts therefore do not establish how missingness was addressed.
The registry does not identify an intention-to-treat population, a per-protocol population, or another prespecified analysis population for the outcomes. The primary description specifies that all teacher participants were analyzed, but does not say whether this means all randomized teachers or all teachers with an observed score. Details of the masking process and the trial’s own interim analyses are not reported in the registry record.
Finally, the record does not report whether the analysis accounted for school-level clustering, baseline covariates, or urban and rural location. It is not possible to infer these methods from the randomized designation or from the school descriptions. These gaps limit assessment of the prespecified inferential framework and of how closely the posted recalculated results correspond to the trial’s intended analysis.
15. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| ParentCorps-Professional Development (PD) | 0 | 1525 | 0.0% |
| ParentCorps-Professional Development (PD) + T-Wellness | 0 | 1415 | 0.0% |
| Control | 0 | 1439 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ParentCorps-Professional Development (PD) | 0 of 1525 |
| ParentCorps-Professional Development (PD) + T-Wellness | 0 of 1415 |
| Control | 0 of 1439 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ParentCorps-Professional Development (PD) | 0 of 1525 |
| ParentCorps-Professional Development (PD) + T-Wellness | 0 of 1415 |
| Control | 0 of 1439 |
The registry reports serious adverse events as zero affected in each group: PD, PD with T-Wellness, and Control. The corresponding numbers at risk are 1525, 1415, and 1439. Other adverse events are also reported as zero affected in each group, with the same respective numbers at risk. Deaths are reported as zero in all three groups, and no serious adverse event terms are listed.
These figures describe what is recorded in the registry, not a comprehensive assessment of safety. The adverse-event denominators differ from the teacher and parent-child counts described for the intervention groups, and the record does not explain their relationship to those counts. It does not report event-collection methods, follow-up duration for adverse events, definitions, or whether events were assessed systematically.
A zero in the registry means no affected participants were reported in that category; it does not prove that no event occurred or that risk is absent. The registry record also does not report a comparative safety analysis. The figures should be read as a record of reported events and denominators, not as evidence establishing that the interventions are risk-free.
16. What the Result Does, and Does Not, Mean
The posted findings describe baseline teacher knowledge and child conduct-problem scores across the three groups. The teacher means are similar in the descriptive sense that the group averages are near one another, and the recalculated unadjusted confidence intervals include zero for both intervention-versus-control contrasts. These results help characterize the baseline groups; they do not measure the effect of intervention delivery.
The word “randomized” describes the trial’s allocation design, not the meaning of a baseline difference. A baseline comparison cannot show that training changed knowledge, because it does not compare outcomes after training with an appropriate counterfactual. The registry record does not report post-intervention primary results, change scores, or later child conduct results for the outcomes discussed. It therefore does not support conclusions about effectiveness, implementation success, or underlying mechanisms.
Nor do the baseline estimates show that the groups are equivalent. No equivalence margin is reported, and the confidence intervals span possible differences in both directions. Failure to obtain a small p-value is not proof that groups are identical, just as a numerical difference at baseline is not evidence that an intervention caused that difference.
The study’s stated focus is important to distinguish from what these posted outcomes establish. It aims to advance prevention research in early childhood mental health in low-resource communities, and its design compares implementation approaches with and without T-Wellness. Yet the primary outcome available for interpretation is a teacher knowledge quiz at baseline. Evidence about practical implementation, child outcomes after delivery, or the added contribution of T-Wellness would require analyses and timepoints not reported in the registry record.
The appropriate conclusion is therefore narrow: the registry contains baseline group summaries and unadjusted recalculated comparisons, with uncertainty that remains substantial enough to include no baseline difference. These statistics are descriptive and do not determine whether either intervention approach changes teacher knowledge or child mental health.
17. Why This Trial Matters Statistically
This trial is statistically noteworthy because it brings together multiple levels of measurement: schools, teachers, and parent-child pairs. The intervention descriptions are organized by urban and rural schools, while the primary endpoint is measured for teachers and the secondary conduct-problem results are reported for parents. That structure makes it important to distinguish the participant who supplies a measurement from the unit at which allocation may have occurred. The registry record does not specify the randomization unit or report how the analysis addressed school clustering.
The study also compares two active implementation approaches with a control group: PD alone and PD with T-Wellness. That design reflects a question about implementation strategy as well as an intervention comparison. However, the posted primary endpoint is baseline teacher knowledge. It illustrates why a trial’s stated aims, design, and available results must be read separately: baseline summaries can describe starting measurements, but do not answer whether an approach later changes outcomes.
Statistically, the reported confidence intervals add useful information beyond the p-values. They show the range of baseline mean differences compatible with the unadjusted calculations and make uncertainty visible. They also caution against treating a nonsignificant comparison as evidence of equivalence. The sample-size illustrations demonstrate how planning requirements depend on the effect targeted, while remaining distinct from the trial’s original design calculations.
Finally, the record highlights the limits of registry outcome reporting. The absence of sponsor-reported analyses, missing-data methods, multiplicity procedures, and details about clustering leaves important questions about inference unanswered. Clear distinction between posted descriptive results and unreported trial analyses is essential when interpreting a complex school-based study.
18. 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.
A central limitation is that both the primary teacher knowledge endpoint and the listed child conduct-problem outcome are labeled Baseline. The registry results discussed do not provide post-intervention measurements or changes over time. This prevents evaluation of effectiveness from these statistics, even though effectiveness is part of the study’s stated aim.
The registry record does not describe the control condition beyond naming it, identify who was masked, or specify the randomization unit. It does not report whether analyses accounted for school clustering, urban-rural differences, or other covariates. Since schools are described as intervention settings and teachers are the primary analysis population, the missing detail about clustering is particularly relevant to judging uncertainty.
The primary outcome is a 10-item knowledge quiz scaled from 0-100, but the record does not report its validation, reliability, or a threshold for a practically meaningful score difference. This limits interpretation of the numerical scale beyond the stated direction that higher scores indicate greater knowledge. The registry also does not report the intervention exposure, adherence, or implementation fidelity for these results.
The recalculated comparisons are unadjusted and do not replace a sponsor analysis. No sponsor-reported analyses are listed for the outcomes, and the registry record does not report how missing scores, exclusions, multiplicity, or interim analyses were handled. The adverse-event denominators are not reconciled with the intervention-group participant descriptions, and event ascertainment details are not reported. These limitations restrict what can be concluded from the posted record.
19. Related Tutorials
20. Related Statistical Calculators
21. Sources
- ClinicalTrials.gov: School-Based Mental Health Effectiveness Study — NCT04383327.
- Registry record last updated 2026-09-14; status last verified 2026-08.
- Results first posted 2025-08-08.
- 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.
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22. Record Summary
NCT04383327 is a completed randomized, single-masked, parallel-group study sponsored by NYU Langone Health. It compares ParentCorps-Professional Development alone, PD with T-Wellness, and Control in urban and rural Uganda. The registry records an enrollment of 2444.
The primary outcome is baseline teacher knowledge of evidence-based practice, assessed with a 10-item quiz and reported as a mean score with standard deviation. The posted summaries show group means of 36.68, 36.41, and 35.18. Unadjusted recalculated comparisons versus Control have confidence intervals that include zero. Child conduct problems are listed as a secondary baseline outcome.
The registry record does not report post-intervention results or sponsor analyses for these outcomes. The available statistics therefore describe baseline groups and do not establish intervention effects.