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 Behavioral Economics and Communication (NCT05918393), a na na study. The primary outcome is Averge of Aappropriate Communication Responses.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05918393 |
| Phase | NA |
| Condition | Problem Behavior |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | State University of New York - Upstate Medical University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns individuals with autism and comorbid severe destructive behavior, as described in the registry summary. The listed condition is problem behavior. Enrollment is 9. The registry record does not report further participant characteristics in the material available, so the population cannot be described more narrowly.
Intervention
The behavioral intervention is functional communication training, abbreviated FCT. Its stated aim is to address inflexible communication responding and the reemergence of severe destructive behavior when challenges to treatment integrity occur. The record describes alternating signaled intervals of reinforcement and extinction, but the intervention description is incomplete, so additional procedural details are not reported in the registry record.
Comparator
No separate comparison group is listed. The study is recorded as single-group, with allocation marked NA and masking listed as none. The registry record therefore does not describe a randomized, like-for-like comparison of FCT with another intervention or control condition.
Primary question
The primary outcome concerns the average of appropriate communication responses during successive five-minute sessions. Responses were selected for each participant based on language level, using the Peabody Picture Vocabulary Test, fourth edition, and/or the Expressive Vocabulary Test, third edition. The registry record does not report numerical outcome results or an inferential estimate of change.
3. Trial Design
The registry lists Behavioral Economics and Communication as a completed study of functional communication training. It records a single-group model, enrollment of 9, allocation as NA, and no masking. The study is not described as a randomized comparison, and no separate control arm is listed. Its design therefore does not support a direct between-group estimate of the intervention’s effect.
The registry dates the study start to 2019-04-22 and primary completion to 2021-08-20. The listed phase is NA, and the study kind is other. These registry labels describe the record but do not supply further design detail. A protocol, detailed schedule of study procedures, or sample-size justification is not reported in the registry record.
Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected during successive 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis for the primary outcome was mean responding during a 5-min session. The record says data summaries, including rate and percent of session, were used to develop a graphical presentation, but the description of how the data were evaluated is incomplete.
The registry lists two outcome measures, but the primary measure is the one described in detail in the available record. It reports no analyses and does not give a detailed statistical analysis plan. Further information about sequencing of intervention conditions, criteria for changing conditions, or how repeated observations were handled is not reported in the registry record.
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: There were no significant events that occurred during the study.
Overall Study
| Stage | Functional Communication Training (FCT) |
|---|---|
| STARTED | 9 |
| Acquisition of Variant Responding | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Throughout the study, data were recorded via a computer-based data collection program. Data summaries (i.e., rate, percent of session) were uploaded to an Excel spreadsheet allowing for development of a graphical presentation (i.e., scatterplot line graph) of the data. The data were evaluated using structured visual inspection criteria. A total of 510 FCT sessions were analyzed across 9 participants (range, 9 - 146).
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: Participants of the current study were 9 individuals, between the ages of 5-13 years diagnosed with autism spectrum and co-morbid severe destructive behavior.
| Characteristic | Unit | Functional Communication Training (FCT) |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 9 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 9 |
| Rate of problem behavior | responses per minute | 2.03 (0 to 47.8) |
6. Primary Endpoint
The registry lists the primary outcome as Averge of Aappropriate Communication Responses, measured over Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | direct observation of 5-min sessions |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Average of Appropriate Communication Responses, with a spelling error in the registry title. It measures appropriate communication responses selected for each participant according to language level, identified with the Peabody Picture Vocabulary Test, fourth edition, and/or the Expressive Vocabulary Test, third edition. The stated unit is direct observation of 5-min sessions, and the outcome parameter is a mean. The registry describes second-by-second data collection during successive 5-min (300 s) sessions and identifies mean responding within each 5-min session as the unit of analysis.
This type of measure is intended to capture communication behavior during observed treatment sessions. In general, a mean can summarize a participant’s responding within a defined observation period, while repeated session-level measurements can describe how behavior varies over time. The registry also identifies full range as the dispersion measure, but no numerical mean or range is reported in the registry record.
The record describes data summaries such as rate and percent of session, and a graphical presentation using a scatterplot line graph. These details indicate that repeated observations were collected, but the exact operational definition of a response, the final reported metric, and the method used to evaluate the data are not fully described. Outcome results and uncertainty estimates are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies appropriate communication responses as the primary outcome and records 9 participants in a single-group study. It does not report numerical values for that endpoint, participant-level trajectories, a group summary, or an inferential analysis. The posted record therefore does not allow a reader to quantify the observed communication response or its variability, nor to assess how precisely an estimated change was measured.
The design matters for interpretation. A single-group study without a separate comparator can describe observations made during the study, but it cannot by itself separate an intervention-associated pattern from other explanations for change over time. For example, general statistical reasoning recognizes that time, repeated exposure, changes in observation conditions, and other concurrent influences can affect measurements. Whether any such influences occurred in this study is not reported in the registry record.
The registry describes successive short sessions and repeated data collection, which means measurements from the same participant may be related. In general, repeated observations on one person should not automatically be treated as independent observations. The analytic approach should account for the design and dependence structure, or use an appropriate method for the type of data. The record does not identify the method used to evaluate these observations; the analysis description ends before the method is named.
No confidence interval, p-value, effect estimate, or model-based result is reported in the registry record. A confidence interval, in general, conveys the precision of an estimated quantity under the assumptions of the analysis. Without an estimate and its uncertainty, the magnitude and precision of an outcome pattern cannot be assessed from this record. The registry also lists zero analyses, so there is no reported statistical test to interpret.
The study is marked completed, but completion status is not itself evidence of a particular outcome. The registry’s stated goals concern communication variability and the reemergence of severe destructive behavior when treatment integrity is challenged. The primary endpoint addresses communication responses, but numerical findings for it are absent. The record therefore does not establish whether the planned aims were achieved or how the outcome behaved across participants.
The most defensible reading is descriptive: the record documents a small, single-group behavioral study with repeated observation of communication, but does not provide enough outcome or analysis information to estimate the direction, size, or precision of any change. It also does not support a causal comparison with another treatment or condition.
9. Statistical Methods Explained
The study is recorded as single-group, with no masking and no randomized allocation. In general, random allocation helps balance known and unknown participant characteristics across comparison groups, while masking can reduce the influence of expectations on some study procedures or assessments. Neither feature is listed for this study, and there is no separate comparator in the registry. These design features limit what can be inferred from any observed change, even if outcome values were available.
What does a mean represent?
The primary outcome is a mean of appropriate communication responses within a 5-min session. In general, a mean condenses a set of measurements into a central summary. Its meaning depends on what counts as a response, how observations are recorded, and the time interval over which they are summarized. The registry says data were collected second by second and that the unit of analysis was mean responding during a 5-min session. It does not give numerical session means or a complete operational definition of the response.
Participants’ appropriate responses were selected according to language level, using the Peabody Picture Vocabulary Test, fourth edition, and/or the Expressive Vocabulary Test, third edition. Tailoring the response definition in this way may make the measure participant-specific. In general, participant-specific definitions require clear reporting so readers can understand what was counted for each person and whether the measure was applied consistently. Further details of that process are not reported in the registry record.
Why does repeated measurement matter?
Observation took place over successive 5-min sessions during 60-min visits, with visits 3-5 days/week. Repeated measurement can show within-participant patterns that a single endpoint measurement would miss. However, measurements from the same participant are often statistically related. General analysis principles caution against treating every observed interval as if it came from a different independent participant. Appropriate methods may describe trajectories, account for clustering within individuals, or use a design-specific approach. The registry does not say which method was used to evaluate the data.
The record says summaries included rate and percent of session and that a scatterplot line graph was developed. In general, graphs can help display variation and temporal patterns, while numerical summaries can make aspects of those patterns easier to compare. Neither presentation alone specifies a statistical model or establishes that a pattern was caused by the intervention. The exact evaluation method is not reported in the registry record; the registry’s description is incomplete at that point.
What would uncertainty estimates add?
A point estimate describes an observed quantity, while a confidence interval gives a range of values compatible with the data under the model and assumptions used. General interpretation of an interval depends on how the data were sampled and analyzed. No point estimate or confidence interval for the primary outcome is reported in the registry record. Likewise, no p-value or test result is listed. There is therefore no inferential result from which to assess statistical compatibility with a null hypothesis, and no precision estimate with which to judge uncertainty in an effect estimate.
The registry reports full range as the dispersion measure. In general, a range describes the span from the smallest to the largest observed value and can be sensitive to extreme observations. The record does not give the range values. It also does not report a standard deviation or another numerical measure of spread for the primary endpoint.
What analysis details are absent?
The registry lists two outcome measures and zero analyses. It does not identify a prespecified statistical model, an analysis population, a method for handling missing observations, or a multiplicity procedure. These are distinct issues: the analysis model governs how measurements are represented; the analysis population defines which participants or observations are included; missing-data methods address unobserved measurements; and multiplicity procedures address interpretation when multiple outcomes or tests are considered.
In general, over-dispersion occurs when observed variability is greater than a model’s assumptions allow. A model that fails to account for it can give misleadingly narrow uncertainty estimates. Whether over-dispersion is relevant to these data cannot be determined from the registry record, because the distribution of responses and the analysis method are not reported.
The record includes no numerical sample-size planning outputs. Any sample-size illustration based on an observed effect would be a planning exercise under stated assumptions, not observed power and not a substitute for a reported analysis. The registry’s own sample-size justification is not reported in the registry record. Consequently, the statistical evidence cannot be reconstructed from the design description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures but reports zero analyses. It does not describe which outcomes were tested, whether any outcome was designated for a particular inferential comparison beyond the primary designation, or whether multiple tests were planned. A procedure for controlling or otherwise addressing multiplicity is not reported in the registry record.
In general, multiplicity arises when several outcomes, time points, contrasts, or statistical tests are considered. Examining more than one result can make isolated findings harder to interpret unless the analysis plan explains how those comparisons are handled. The existence of two listed outcomes does not, by itself, establish that two statistical tests were conducted; no analyses are reported.
Missing-data information is also not reported in the registry record. The record does not state whether any session observations or participant outcomes were missing, why values might be missing, or how missing observations were handled. It does not identify an analysis population or specify whether all enrolled participants were included in the outcome evaluation. Enrollment is 9, but the number contributing primary outcome data is not reported in the registry record.
These omissions matter because a complete interpretation depends not only on the outcome definition, but also on which observations contributed to an estimate and how incomplete observations were treated. No missing-data method, sensitivity analysis, or multiplicity adjustment can be attributed to the study from the registry information available.
11. 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 |
|---|---|---|---|
| Functional Communication Training (FCT) | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Functional Communication Training (FCT) | 0 of 9 |
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 |
|---|---|
| Functional Communication Training (FCT) | 0 of 9 |
The registry lists one FCT group with 9 participants at risk for serious adverse events and 0 serious adverse events reported. It also lists 9 participants at risk for other adverse events and 0 other adverse events reported. Deaths are listed as 0. No serious adverse event terms are listed.
These are registry event counts for the recorded group. They should be read as the events reported in the registry, not as proof that the intervention carries no risk. A zero count in a study with 9 participants does not establish that an event could never occur, and it cannot provide a precise estimate of event frequency. No comparative safety estimate is available because the study has no separate comparison group.
The record does not describe adverse-event definitions, monitoring procedures, duration of safety follow-up, or whether events were independently assessed. Those details are not reported in the registry record. The figures therefore convey the recorded counts, while the safety assessment methods and the extent to which the counts capture all relevant events remain unclear.
12. What the Result Does, and Does Not, Mean
The record describes a completed, single-group study of functional communication training, with enrollment of 9 and repeated measurement of appropriate communication responses. It identifies a primary session-level mean outcome and explains that responses were selected in relation to participants’ language levels. These details establish the broad measurement focus, but the registry does not report numerical primary outcome results or analyses.
Accordingly, the record does not show the observed size or direction of any change in communication responding, the degree of variation among participants, or the precision of an estimate. It does not support a conclusion that communication improved, worsened, or remained unchanged. Nor does it report enough information to evaluate a statistical association between intervention exposure and the primary outcome.
Even with outcome values, the design would require cautious interpretation. A single-group design without random allocation or a comparator does not isolate an intervention effect from other influences over time. General methodological reasoning distinguishes an observed pattern from a causal effect: a pattern can be described, while causal attribution generally requires a design and analysis that address competing explanations.
The study’s stated aims include addressing inflexible communication responding and reemergence of severe destructive behavior when treatment integrity is challenged. The primary outcome described is appropriate communication responses. The registry record does not report numerical results for that endpoint, or results for the second listed outcome measure, so it does not establish how either aim was reflected in observed data.
The adverse-event record lists zero serious events, zero other events, and zero deaths among the recorded group. These counts are useful as registry entries, but they are not a comparative safety analysis and do not establish absence of risk. Overall, the record supports a description of the study’s scope and measurement approach, not a conclusion about treatment efficacy or a quantified treatment effect.
13. Why This Trial Matters Statistically
Statistically, this study is notable for its repeated measurement of behavior in short, successive observation sessions rather than a single measurement at the end of treatment. Repeated observations can be valuable for describing individual patterns and variation over time. They also create analytic considerations: observations within a participant may be related, and the chosen method should respect that structure. The registry describes the measurement schedule but does not name the analysis method.
The outcome is linked to an observable behavior and uses response definitions selected according to language level. That makes clarity about operational definitions and consistency of measurement especially important. The record identifies the assessment tools used to inform selection, but does not provide the detailed response definitions or numerical data needed to evaluate reliability, variability, or the shape of individual trajectories.
The single-group design also illustrates the distinction between documenting behavior and estimating a comparative effect. Without a listed comparator or random allocation, the study cannot provide a randomized between-group contrast. This does not erase the descriptive value of repeated observation, but it places limits on causal interpretation.
Finally, the registry lists two outcomes but no analyses, and it does not report numerical outcome summaries or uncertainty estimates. Such omissions prevent readers from assessing effect magnitude, precision, or the role of variation. The study’s statistical importance lies in the questions raised by its measurement structure and design, while the registry record leaves the quantitative findings and analytic approach unresolved.
14. 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 principal limitation for statistical interpretation is that numerical results for the primary outcome are not reported in the registry record. No participant-level observations, session-level means, group summary, or uncertainty estimate is available. As a result, the observed pattern cannot be characterized in magnitude or precision.
The study is listed as single-group, with allocation marked NA, no masking, and no separate comparator. This limits the ability to distinguish intervention-associated changes from other influences. The registry also does not report a detailed statistical analysis plan or name the method used to evaluate the repeated observations.
The primary measure is defined at the session level, with second-by-second data collected during successive five-minute sessions. The data structure may involve related observations within participants, but the registry does not describe how this dependence was addressed. It also does not provide the full operational definitions of appropriate communication responses or report numerical dispersion despite identifying full range as the dispersion measure.
The registry lists two outcome measures and zero analyses. A multiplicity approach, analysis population, and missing-data method are not reported. It is therefore unclear which observations contributed to any outcome assessment and how incomplete observations, if any, were handled. The safety figures are counts without a listed comparator, and details of safety monitoring are not reported in the registry record.
These limitations concern what can be learned from the registry record; they do not establish that unreported procedures or data were absent from the study itself. They do mean that the statistical findings cannot be independently assessed from the recorded information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Behavioral Economics and Communication — NCT05918393.
- Registry record last updated 2026-03-05; status last verified 2023-08.
- Results first posted 2026-03-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
Behavioral Economics and Communication is listed as a completed, single-group study of functional communication training, with enrollment of 9 and no masking. The registry lists problem behavior as the condition and describes a primary endpoint based on mean appropriate communication responses during 5-min sessions.
Participants were seen 3-5 days/week for 60-min visits, with second-by-second data collected across successive sessions. The registry lists two outcome measures and zero analyses. Numerical results for the primary outcome, an inferential analysis, and details of missing-data handling are not reported in the registry record.
For the FCT group, the registry records 0 serious adverse events, 0 other adverse events, and 0 deaths. Because the design has no separate comparator and the outcome findings are not reported, the record does not provide a quantified comparative treatment effect.