Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements (NCT02493088), a registered phase not stated study. The primary outcome is The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors..

2. Clinical Question

3. Trial Design

The registry record identifies this as a completed study sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Its title concerns conduct disorder in prison and the search for recurring prospective and retrospective contextual elements. The listed condition is mental disorders. The registry dates the study start to 2015-03 and primary completion to 2015-09.

The study description proposes following individuals diagnosed with antisocial personality disorder in prison during 6 months. The listed intervention is recording behavior and contextual elements. The stated aims include cataloguing conduct disorders and circumstances preceding misconduct, and studying contextual factors related to judicial steps in connection with aberrant driving behaviors.

The registry lists an enrollment of 11 and names an Antisocial Personality group, described as individuals diagnosed with antisocial personality disorder. It does not describe a comparator group, and allocation is not stated. The record therefore does not support interpreting the group as part of a randomized or otherwise controlled comparison.

The primary outcome is a count of individuals with aberrant driving behaviors. Secondary outcomes concern the percentage of aberrant driving behaviors preceded by an observed contextual element and the number of observed situations by type of behavior: auto-aggressive, aggressive, or other hetero transgression. The record lists 3 outcome measures, but does not report their observed results or analysis details.

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: Patient with a negative psychopathy score at PCL-R were excluded A patient was transfered before assignment

Overall Study

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 The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors., measured over 6 months.

The primary endpoint is the number of individuals diagnosed with antisocial personality disorder in Rochefort prison who have aberrant driving behaviors during 6 months. It is a participant-count endpoint: it asks how many participants meet the described behavioral criterion within the stated observation period. It does not, as written, measure the number of separate behaviors or the rate at which behaviors occur.

A participant count can describe how often the specified event was observed in the study group. Interpreting that count requires knowing the population observed, how the behavior was defined, how it was identified, and whether observation was complete for the stated period. The registry record supplies the endpoint wording and timeframe, but does not report an operational definition, ascertainment procedure, or observed count.

The endpoint is relevant to the stated aim of documenting aberrant driving behaviors in this prison population. It is distinct from the secondary outcomes, which address contextual elements preceding behaviors and counts of observed situations classified by behavior type. The primary endpoint result and its precision are not reported in the registry record, so the endpoint cannot be quantitatively interpreted from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is defined as a number of participants with an event, rather than a continuous measurement. For this type of outcome, an analysis may report the count and, when appropriate, the proportion of the observed group meeting the event definition. A count describes what was observed; a proportion relates that count to the group at risk. Neither should be inferred when the registry record does not report the endpoint result. Here, the primary endpoint count and a corresponding estimate are not reported in the registry record.

Uncertainty is important when interpreting an estimated event frequency. A confidence interval is a range calculated using a statistical procedure to express uncertainty around an estimate. It is not a guarantee that the true value lies within the range, and its interpretation depends on the method and assumptions used. The registry record does not report a confidence interval for the primary endpoint, or a statistical analysis of that endpoint. There is therefore no reported interval with which to judge precision.

The intervention description emphasizes recording behavior and context over 6 months. For an observational follow-up, the quality and completeness of event identification affect the interpretation of counts. Important information can include how aberrant driving behaviors were defined, how contextual elements were recorded, who performed the recording, and how missing observations were handled. These details are not reported in the registry record. Without them, readers cannot assess whether the outcome was ascertained consistently or whether the intended observation period was complete for participants.

The registry record states a planning-illustration framework using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. This is a planning framework, not evidence that the study itself had two arms, used equal allocation, or conducted a randomized comparison. The record does not report the calculated planning estimates, and it does not report the trial’s own sample-size justification. Such planning estimates, when available, are not observed power and do not replace an analysis of the collected outcomes.

General statistical planning often considers how much information is needed to estimate an effect with useful precision or to test a specified hypothesis. A calculation depends on the assumed event frequency or effect, the chosen significance level, the desired power, and the design. If the assumptions differ from the data-generating situation, the planning calculation may not describe the eventual precision. The registry record does not provide enough reported outcome information to assess those assumptions for this study.

Over-dispersion is a general concern when counts vary more than a simple model assumes. If present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for that extra variation. The endpoint is described as a participant count with an event, not as a repeated-event rate. The registry record does not report a count model, an over-dispersion assessment, or any other statistical model, so no model-based interpretation is available.

The secondary outcome concerning the percentage of aberrant driving behaviors with a contextual element observed beforehand differs from the primary participant count. It focuses on behaviors and their preceding context, rather than on the number of participants with any behavior. The other secondary outcome counts observed situations by behavior type. These outcomes require clear definitions of a behavior, a contextual element, and the time ordering between them. Their definitions and results are not reported in the registry record.

There are no analyses listed in the registry record. This does not establish whether analyses were performed outside the registry; it means the record does not provide analysis results or methods for evaluating them. In particular, no adjustment strategy, model specification, uncertainty estimate, or analysis population is described. Readers should distinguish the stated aims and planned outcome descriptions from analyzed results.

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("Antisocial Personality")
n      <- c(11)
events <- c(9)
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  Antisocial Personality  11  9  81.8  48.2  97.7  52.3  94.9  51.6  94.5

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 3 outcome measures: the primary participant count and secondary outcomes addressing preceding contextual elements and behavior types. When a study evaluates several outcomes or several analyses, multiplicity can arise because repeated statistical testing increases the chance of at least one apparently notable result under a collection of null hypotheses. General approaches include identifying a primary hypothesis in advance, adjusting inference across tests, or clearly treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or a detailed statistical analysis plan.

The record lists 0 analyses. It therefore provides no outcome-specific estimates, hypothesis tests, or analysis descriptions for the primary or secondary outcomes. It is not possible to determine whether all planned analyses were conducted, whether any outcomes were omitted, or whether results were selected for reporting. Those matters are not reported in the registry record.

Missing-data handling is also not reported in the registry record. The record does not describe whether every participant was observed throughout 6 months, how incomplete behavioral records were treated, or how missing contextual information was handled. Missing observations can affect a count or proportion if the chance of missingness is related to the outcome or participant circumstances. Without the amount and handling of missing data, readers cannot assess the extent of that concern.

The record does not define an analysis population, such as which enrolled participants were included in each outcome analysis. Nor does it describe exclusions or the treatment of participants with incomplete follow-up. The enrollment figure alone does not establish the denominator used for any endpoint analysis. Analysis populations, missingness, and multiplicity procedures are therefore not available for evaluation from the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry safety entries report serious adverse events affecting 0 among 11 at risk in the Antisocial Personality group. The entry for other adverse events reports 2 affected among 11 at risk. These are counts from the safety fields, not results for the primary endpoint concerning aberrant driving behaviors.

The serious adverse event terms are not reported in the registry record. Deaths are also not reported in the registry record. The record does not provide further descriptions, timing, severity categories beyond the serious/other distinction, or an account of how events were collected. The figures should therefore be read as limited registry safety summaries, not as a complete narrative of events.

A count of 0 serious adverse events in the listed group does not establish that serious events are impossible or that risk is absent. More generally, safety counts describe what was recorded in the study population and observation context. They do not, without a suitable comparison and fuller methods, identify a causal relationship with an intervention. No comparator is described in this record.

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

The registry record establishes that the study was designed to follow people diagnosed with antisocial personality disorder in prison for 6 months and to record conduct disorders and contextual elements. It gives an enrollment of 11, identifies the primary behavioral question, and lists secondary questions about preceding context and types of behavior. It also reports limited adverse-event counts.

It does not report the observed number of participants with aberrant driving behaviors, the secondary outcome findings, or statistical estimates of uncertainty. As a result, the record cannot establish the frequency of the behaviors in the study group or the consistency of any estimated frequency. It also cannot show whether contextual elements preceded behaviors, whether judicial steps were associated with behavior, or whether one behavior type was more common than another.

The absence of a comparator and the fact that allocation is not stated mean that the record does not support a controlled treatment-effect interpretation. Recording behavior and context is not described as a therapeutic intervention. The study’s stated aims concern observation and characterization; they should not be converted into claims about treatment effects or causes.

Even if outcome counts were available, findings from a prison group described in this record would not automatically apply to people in other settings or to groups not described. The record does not report participant characteristics beyond the diagnosis and prison setting, or enough detail about outcome ascertainment to assess broader applicability. The appropriate interpretation is therefore limited: the registry documents the planned observational questions and some safety entries, but does not provide the primary or secondary results needed to answer those questions.

14. Why This Trial Matters Statistically

This study raises a statistically important distinction between a research question and an answer. The registry describes an aim to identify contextual elements preceding misconduct and to examine judicial-step context in relation to aberrant driving behaviors. It also defines a participant-count primary endpoint and secondary outcomes about context and behavior types. However, the registry record does not report the outcome analyses. A stated aim cannot be treated as evidence that an association was observed.

The design information also matters for interpretation. The record describes an Antisocial Personality group, does not state allocation, and does not describe a comparator. These features limit the kinds of statistical claims that can be drawn from the record: it does not provide a controlled group contrast or support attribution of outcomes to an assigned treatment. Clear separation between descriptive observation and causal inference is essential.

Outcome definitions and follow-up completeness are especially important for behavioral research. Counts depend on how events are defined and captured, while questions about preceding context require reliable ordering of contextual observations and behaviors. The registry does not report these operational details or missing-data procedures. Without them, even a numerical result could be difficult to evaluate for measurement quality and precision.

Finally, the record illustrates why outcome reporting and uncertainty estimates matter. Enrollment and endpoint descriptions identify the scope of the study, but they do not show what was observed or how precisely it was estimated. The absent primary and secondary findings leave the central statistical questions unanswered in the registry record.

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 registry record gives limited detail about participant selection. It identifies individuals diagnosed with antisocial personality disorder in prison and names Rochefort prison in the primary endpoint, but does not report further eligibility criteria, baseline characteristics, or the process used to identify participants. The setting and diagnosis define the stated population, but do not by themselves establish how representative the enrolled group may be.

Outcome ascertainment is not described in operational detail. The record does not explain how aberrant driving behaviors, conduct disorders, or contextual elements were defined or recorded. It also does not specify how the temporal relationship between a contextual element and a behavior was established. These omissions make it difficult to assess measurement consistency, classification, and the possibility of incomplete recording.

The registry lists a 6-month timeframe but does not report individual follow-up completeness, missing-data handling, or analysis populations. The primary endpoint count and secondary outcome results are not reported. No analysis methods, uncertainty estimates, or adjustment procedures are described, and the record lists 0 analyses. As a result, neither the magnitude nor the precision of the behavioral findings can be evaluated.

No comparator is described and allocation is not stated. The record therefore does not establish a controlled comparison or support causal attribution. It also does not report whether the stated study aims were all addressed in analyses. These limitations are specific to the information available in the registry record; they do not establish what may or may not have been documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements — NCT02493088.
• Registry record last updated 2017-04-14; status last verified 2017-03.
• Results first posted 2017-04-14.
• 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

The registry record describes a completed study sponsored by Groupe Hospitalier de la Rochelle Ré Aunis, with start in 2015-03 and primary completion in 2015-09. Enrollment is 11. The study concerns individuals diagnosed with antisocial personality disorder in prison and proposes 6 months of recording behavior and contextual elements.

The primary endpoint is the number of individuals in Rochefort prison with aberrant driving behaviors. Secondary outcomes concern preceding contextual elements and observed situations by behavior type. The record does not report results for these outcomes or analysis methods; it lists 0 analyses. No comparator is described, and allocation is not stated.

Safety entries report serious adverse events affecting 0 among 11 at risk and other adverse events affecting 2 among 11 at risk. Serious event terms and deaths are not reported in the registry record.