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 The Effects of Executive Functions and Social Cognition on Mental Health (NCT06213194), a randomized na study. The primary outcome is Depression_1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06213194 |
| Phase | NA |
| Condition | Autism or Autistic Traits, Mental Health Disorder, Executive Dysfunction |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 178 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ibn Haldun University |
| Results posted | Yes |
2. Clinical Question
Population
Adults with and without elevated autistic traits. The study description gives an age range of 18-35. The registry enrollment is 178; further details about the enrolled population and its characteristics are not reported in the registry record.
Intervention
MindZone, an online training program combining executive-function and social-cognitive skills. The experimental group description specifies a 6-week program, with access to each week of training restricted until the preceding week is complete.
Comparator
The control group does not receive the training until the follow-up test. The description says the program will be offered to the control group after the study is done. Other details about contact, activities, or support in the control condition are not reported in the registry record.
Primary question
The primary outcome is depression symptoms measured with the Depression Anxiety Stress Scale 21. The study also asks whether executive functions and social-cognitive skills help account for associations between autistic traits and mental health symptoms, and whether training changes those skills and symptoms. Results for these questions are not reported in the registry record.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study sponsored by Ibn Haldun University. Its status is completed. The study start date is 2024-05-20, and the primary completion date is 2024-10-10. The registry enrollment is 178. The listed phase is NA.
Participants are assigned to an experimental group or a control group. The experimental group receives MindZone, an online program combining executive-function and social-cognition training. Its description specifies a 6-week program with sequential access to training weeks. The control group does not receive the program until the follow-up test; the registry says the program will be offered to that group after the study is done. Further details about how participants were recruited, how assignment was generated or concealed, and what masking involved are not reported in the registry record.
The primary measure is scheduled at pre-test, described as baseline, and post-test, described as immediately after the intervention. The record’s primary outcome is a mean score for depression symptoms, with standard deviation as the measure of dispersion. Although the study description includes hypotheses about executive functions, social cognition, anxiety, depression, and stress, the registry does not report the results for those hypotheses. The record also does not report group-specific enrollment, participant flow, adherence, or follow-up completion.
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: Participants are under the age of 18, and who have any record of psychiatric or physical conditions excluded from the study.
Overall Study
| Stage | Experimental Group | Control Group |
|---|---|---|
| STARTED | 89 | 89 |
| COMPLETED | 31 | 34 |
| NOT COMPLETED | 58 | 55 |
Analysis population for the primary outcome, as defined in the registry: Experimental and control groups
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.
| Characteristic | Unit | Experimental Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 89 | 89 | 178 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 89 | 89 | 178 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 27.58 (SD 5.95) | 27.24 (SD 6.13) | 27.41 (SD 6.02) |
| Sex: Female, Male: Female | Participants | 28 | 29 | 57 |
| Sex: Female, Male: Male | Participants | 3 | 5 | 8 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Turkey | Participants | 89 | 89 | 178 |
6. Primary Endpoint
The registry lists the primary outcome as Depression_1, measured over Pre-test (baseline), Post-test (immediately after the intervention).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome, titled Depression 1, measures depression symptoms using the Depression Anxiety Stress Scale 21. The score is described as ranging from 0-21, with higher scores indicating higher depressive symptoms. The registry specifies the outcome as a mean score on a scale, with standard deviation, and identifies the experimental and control groups as the population. Measurement is scheduled at baseline and immediately after the intervention.
A symptom scale gives a numerical measure that can be summarized across participants and compared between groups or across measurement occasions. The mean describes the group’s average score, while the standard deviation describes the spread of individual scores around that average. In general, a lower mean score indicates fewer reported symptoms on this scale, but interpretation of a study comparison also depends on the size and precision of the estimated difference and on the analysis used.
The registry record does not report the observed means, standard deviations, group-specific results, or an estimated contrast for this endpoint. It also does not report a clinically meaningful threshold for interpreting changes in the score. The endpoint’s measurement definition therefore clarifies what the study intended to assess, but does not establish what happened to participants’ scores.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and outcome schedule, but it does not provide numerical results for the primary depression outcome. No group means, standard deviations, between-group estimates, confidence intervals, or p-values are reported in the registry record. The record lists 0 analyses. As a result, the size, direction, and precision of any observed difference between the experimental and control groups cannot be described from this information.
The study’s primary measure is a mean score on the Depression Anxiety Stress Scale 21, assessed at baseline and immediately after the intervention. A statistical comparison could, in general, focus on differences at post-test, changes from baseline, or a model that accounts for both measurement occasions. These approaches answer related but not identical questions. The registry record does not report which approach was used, whether any adjustment was made, or whether the analysis followed the randomized assignment or another population definition.
The study description also proposes questions about whether executive functions and social-cognitive abilities help explain associations between autistic traits and depression, anxiety, and stress. It separately proposes testing whether online training develops executive-function and social-cognitive skills and reduces distress symptoms. These are stated hypotheses, not reported findings. No mediation estimates, cognitive outcome estimates, or mental-health results are reported in the registry record. The record identifies Cognitive Empathy and Self-Assessment Manikin for Affective Empathy as secondary outcomes, but provides no results for them.
The registry’s adverse-event fields record 0 for serious and other events and deaths in both groups. Those entries describe what is recorded in the registry; they do not provide further detail about how adverse events were collected or assessed. In the absence of participant-flow information and outcome data, it is not possible to judge the completeness of follow-up, the amount of missing data, or how well the analysis represents the randomized groups.
Accordingly, the statistical conclusion is limited: the registry describes a completed randomized study and its intended questions, but it does not report the estimates needed to evaluate those questions. A direction of effect, magnitude, or degree of statistical uncertainty cannot be inferred from the design description alone.
9. Statistical Methods Explained
What does randomization contribute?
In general, random assignment is intended to make the groups comparable, on average, with respect to factors measured and unmeasured before the intervention. This helps support an interpretation of a between-group contrast as an intervention effect, provided that assignment is preserved in the analysis and important sources of bias are addressed. Randomization does not ensure that every characteristic is balanced in a particular study, nor does it resolve problems caused by missing outcomes, non-adherence, or selective analysis. The record says allocation was randomized, but the sequence-generation and concealment procedures are not reported in the registry record.
What does a parallel design mean?
In a parallel-group design, participants are assigned to a group and the groups are compared over the study period. The record identifies an experimental group and a control group, with MindZone training planned for the experimental group and delayed access for the control group. This differs from a crossover design, in which participants receive different conditions in sequence. The registry does not report whether the primary analysis compared post-test scores, modeled both scheduled measurements, or used another method.
How should a mean and standard deviation be read?
General statistical interpretation: the mean is a measure of the center of a set of numerical scores. The standard deviation describes variability among those scores. Reporting both can help readers understand the group’s average and how dispersed individual scores are, but the two summaries alone do not show the uncertainty in a between-group comparison. That uncertainty is usually conveyed with a confidence interval or a test statistic, neither of which is reported for the primary outcome in the registry record.
A confidence interval is a statistical range expressing uncertainty about an estimated quantity under a specified analysis. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. The range must be interpreted in relation to the question and scale; it does not by itself establish clinical importance. No primary-outcome confidence interval or estimate is reported in the registry record, so precision cannot be evaluated.
What comparisons could address the outcome?
General statistical explanation: an analysis might compare post-test means between randomized groups, compare changes from baseline, or use a model that incorporates baseline and post-test measurements. A model can account for the correlation between measurements on the same participant. Choices among these approaches should be prespecified and described, because the estimate and its uncertainty depend on the analysis. The registry record reports the measurement occasions but does not report the chosen model, covariates, assumptions, or analysis population. The record also notes that the primary outcome has several categories or time points and is not reduced to one comparison.
What do the planning assumptions say?
The registry describes sample-size illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations: they describe the sample size that would be needed under specified assumptions, not the probability that a completed study has demonstrated an effect. They are not observed power. The effect estimate and resulting planning counts are not reported in the registry record, and the record does not provide a separate sample-size justification for the trial’s design.
Why can variability matter?
General statistical explanation: a mean-based comparison is more difficult to estimate precisely when scores vary substantially among participants, especially when the available information is limited. If a statistical model assumes that variability is similar across groups or follows a particular distribution, departures from those assumptions can affect standard errors and tests. Over-dispersion, meaning variability greater than the model anticipates, can make uncertainty appear smaller than it should if not addressed. The registry record gives standard deviation as the descriptive measure for the primary endpoint but does not report observed variability or model diagnostics. There is therefore no basis in the record for assessing these assumptions.
These concepts explain how results would ordinarily be interpreted; they do not substitute for the missing study estimates. The registry’s design description and outcome definitions alone cannot establish an intervention effect.
10. Multiplicity, Missing Data and Analysis Populations
The study description sets out several related questions: whether executive functions mediate associations between autistic traits and mental-health symptoms; whether social-cognitive skills mediate those associations; and whether training changes cognitive skills and mental-health symptoms. The proposed constructs include cognitive flexibility, inhibitory control, working memory, cognitive empathy, affective empathy, anxiety, depression, and stress. The registry lists eight outcome measures and names Cognitive Empathy and Self-Assessment Manikin for Affective Empathy as secondary outcomes.
When a study assesses multiple outcomes, relationships, or time points, the chance of finding at least one apparently notable result can increase if each is tested separately. General statistical approaches may define a primary comparison in advance, control the family-wise error rate, use a false-discovery approach, or distinguish confirmatory from exploratory analyses. These approaches involve trade-offs. The registry record does not report a multiplicity strategy, a hierarchy of secondary hypotheses, or which analyses were designated confirmatory. It lists 0 analyses, and does not report outcome estimates or p-values.
Missing-data procedures are also not reported in the registry record. The record does not state how missing baseline or post-test measures would be handled, whether imputation was planned, or how departures from assumptions about missingness would be examined. Participant flow, exclusions, adherence, and completion by group are not reported. The analysis populations are not described, so it is unclear whether analyses were planned according to randomized assignment, receipt of training, or another definition.
These omissions limit assessment of selective reporting, the sensitivity of conclusions to missing observations, and the comparability of analyzed groups. They do not establish that any particular problem occurred; they identify information that is not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The study addresses a relevant statistical distinction: an association between autistic traits and mental-health symptoms is not the same question as whether an intervention changes symptoms. The description proposes examining executive functions and social cognition as possible mediators of associations, and separately evaluating online training. These are distinct aims that require different analyses and interpretations.
In general, mediation analysis asks whether an intermediate measure helps account for an association between an exposure and an outcome. Evidence of mediation depends on the measures, timing, model, and assumptions used; an association alone does not establish a causal pathway. The registry record does not report mediation estimates or the analysis methods needed to evaluate those assumptions. The training hypotheses likewise require reported outcome comparisons to determine whether cognitive measures or mental-health scores changed in relation to group assignment.
The primary outcome definition indicates that higher Depression Anxiety Stress Scale 21 scores correspond to higher depressive symptoms. But without observed scores or a comparison estimate, the record does not show whether scores rose, fell, or differed between groups. It also does not show how precise any comparison was or whether a difference was clinically important. The record contains no basis for concluding that MindZone did or did not change depression, anxiety, stress, executive function, or social cognition.
A completed status means the registry marks the study as completed; it is not itself evidence of a particular outcome. Similarly, the adverse-event entries recorded as 0 do not provide detailed information about event ascertainment or follow-up. Interpretation should remain tied to the information actually recorded, with outcome conclusions reserved until suitable results and analysis details are available.
12. Why This Trial Matters Statistically
This study brings together questions that are often treated separately: the relationship between autistic traits and mental-health symptoms, the possible explanatory roles of executive functions and social cognition, and the effects of an online skills-training program. Statistically, those questions require distinct estimands. A group comparison of depression scores, a mediation analysis, and a test of cognitive skill development are not interchangeable, even if they draw on overlapping participants or measures.
The randomized parallel design is relevant to evaluating the training comparison because it creates an experimental contrast between a group offered training and a control group scheduled to receive it later. The pre-test and immediate post-test schedule also makes change over time relevant. Clear reporting of the target comparison, model, analysis population, and uncertainty would be needed to show how the design was translated into an estimate.
The registry record is useful for identifying the planned primary measure and the breadth of the study’s hypotheses. It also shows why transparent reporting matters when a study has multiple outcomes and proposed pathways: readers need to know which results answer the central question and how uncertainty and multiplicity were handled. Since the record does not report results or analysis methods, it can frame the statistical questions but cannot resolve them.
For biostatistical interpretation, the key contribution of this record is therefore the design and measurement context, not evidence about the direction or size of an effect. Outcome estimates, their precision, and fuller analytic reporting would be necessary to assess the study’s findings.
13. 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 interpreting this trial from the registry record is the absence of reported outcome results. Although the primary endpoint, measurement schedule, and group descriptions are specified, group means, standard deviations, comparison estimates, confidence intervals, and p-values are not reported. The record lists 0 analyses. No conclusion about the direction, magnitude, or precision of an effect can be drawn.
Important design and analysis details are also not reported in the registry record. The meaning of single masking, randomization procedures, allocation concealment, statistical models, covariate adjustment, analysis populations, and missing-data handling are not described. Participant flow, baseline characteristics, adherence to the online program, and follow-up completion by group are also not reported. These details would help readers assess bias, comparability, and the interpretation of any estimates.
The primary measure is scheduled at baseline and immediately after the intervention, but results at these occasions and any longer-term follow-up are not reported. The record does not provide an effect estimate for planning calculations, a trial-specific sample-size justification, or the resulting sample-size illustrations. The multiplicity approach for the several proposed cognitive and mental-health questions is also not reported.
These are limitations of the information available in the registry record, not evidence that the study necessarily had poor conduct or that a particular bias occurred. They constrain independent statistical appraisal and prevent evaluation of whether the stated hypotheses were supported.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: The Effects of Executive Functions and Social Cognition on Mental Health — NCT06213194.
- Registry record last updated 2025-03-17; status last verified 2025-03.
- Results first posted 2025-03-17.
- 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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17. Record Summary
NCT06213194, titled “The Effects of Executive Functions and Social Cognition on Mental Health,” is listed as a completed, randomized, single-masked, parallel-group study sponsored by Ibn Haldun University. The registry enrollment is 178. The study dates are 2024-05-20 to 2024-10-10, and the listed phase is NA.
The experimental group receives MindZone, an online program combining executive-function and social-cognitive skills, described as a 6-week training program. The control group receives training after the follow-up test. The primary outcome is a mean Depression Anxiety Stress Scale 21 depression score, measured at baseline and immediately after the intervention; higher scores indicate higher depressive symptoms, on a 0-21 scale.
The study description proposes questions about mediation and training effects across cognitive and mental-health measures. The registry record lists 0 analyses and does not report outcome estimates, uncertainty intervals, or a statistical analysis plan. The record therefore documents the study design and intended measures but does not support conclusions about its results.