Auditory-Perceptual Training Via Telepractice: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Auditory-Perceptual Training Via Telepractice (NCT04858035), a na na study. The primary outcome is Averaged Perception Percent Accuracy Score.

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group behavioral study sponsored by Montclair State University. The listed study start date is 2022-01-21, and the primary completion date is 2024-06-30. The condition is speech sound disorder. The phase is listed as NA, and masking is listed as NONE. The registry enrollment is 10.

The planned design is a multiple-baseline study across subjects. Participants begin with baseline sessions that probe perceptual acuity for /r/, then begin perceptual training in a staggered fashion. The arm description says participants would be randomly assigned to one of 7 possible transition points, ranging from 3 to 9 baseline sessions. This describes random assignment of the timing of the transition, not random assignment to separate treatment and control groups. The record does not provide details of how that timing assignment was implemented.

All participants were to receive 12 sessions of perceptual training over 4 weeks. The primary endpoint description places the averaged perception score in maintenance sessions, described as 3 sessions across 1 week. The registry also describes production probes before and after treatment to assess transfer to /r/ production. Production training appears in the intervention list, but its specific role and schedule are not reported in the registry record.

The single-group structure is important for interpretation. Repeated observations across baseline and treatment phases can help describe whether changes align with the timing of intervention for participants. Without a separate concurrent control group, however, the design does not provide the same direct between-group contrast as a randomized controlled trial. The record does not report the statistical analysis plan, implementation details, or numerical results needed to evaluate the strength of evidence for change.

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: No significant events were encountered over the course of this study.

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 Averaged Perception Percent Accuracy Score, measured over Participants' perception progress was tracked across all treatment phases. The averaged percent accuracy score reported here was collected during maintenance sessions (3 sessions across 1 week)..

The primary endpoint is the averaged perception percent accuracy score. It is a continuous measure: scores express accuracy on a perception task as percent accuracy, and the registry identifies the intended summary as a mean with standard deviation. The endpoint is described as an average collected during maintenance sessions, after perceptual training. The timeframe specifies 3 maintenance sessions across 1 week.

A perception accuracy measure is relevant to the stated study objective because the training targets auditory perception of /r/. Measuring performance during maintenance can describe accuracy after the training period rather than only during the initial training sessions. The registry also describes production probes before and after treatment, which address a related but distinct question: whether any changes in perception correspond to changes in /r/ production.

The record does not specify the exact task scoring procedure, how observations across sessions were combined into the reported average, or how the standard deviation was calculated. It also does not provide the primary endpoint’s mean, standard deviation, participant-level data, or a treatment-effect estimate. Consequently, the endpoint’s observed level, variability, and precision are not reported in the registry record. The measure’s description establishes what was intended to be assessed, but it is not enough to determine the result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record describes a continuous primary outcome summarized as a mean and standard deviation. A mean is a measure of the average value in a set of observations. A standard deviation describes how dispersed observations are around that average. These summaries can help convey both the central level of performance and variability among measurements, but neither numerical summary is reported for this endpoint in the registry record.

What does a maintenance average represent?

The endpoint is an averaged percent accuracy score collected during maintenance sessions. A percentage accuracy score represents the proportion of task responses scored as accurate, expressed on a percent scale. The registry says the reported average was collected during maintenance, after perceptual training, and describes maintenance as 3 sessions across 1 week. It does not state whether the average was calculated first within each participant and then across participants, or by another method. That detail matters because different averaging procedures can give different weight to participants or sessions.

The primary endpoint description does not provide a baseline value or a numerical contrast between baseline and maintenance. A maintenance average on its own would describe performance at that phase; a claim about change would require a relevant comparison, such as a baseline-to-maintenance contrast, together with information about variability and the analysis approach. Those results are not reported in the registry record.

How does the multiple-baseline design work?

In general, a multiple-baseline-across-subjects design observes participants during baseline and begins intervention at staggered times. If changes repeatedly occur after intervention begins rather than during baseline, that pattern can contribute evidence that timing of intervention is associated with change. The registry describes baseline probes of perceptual acuity for /r/ and treatment initiation at one of 7 possible points, ranging from 3 to 9 baseline sessions.

That design description is not itself an analysis result. To assess the pattern, readers would need the repeated observations, the actual transition timing for participants, and a clear account of how changes were evaluated. The registry record does not report these data or the statistical model used. It also does not provide enough information to assess whether baseline performance was stable or whether a consistent pattern appeared across participants.

What can randomization mean in this design?

The arm description says participants would be randomly assigned to a point for transitioning from baseline to treatment. This is randomization of intervention timing within a single-group design. It is not evidence of random allocation to a separate untreated control group. The allocation field is listed as NA, and the study model is listed as SINGLE GROUP. As a general principle, randomizing the timing of a transition can help reduce the role of systematic choice in deciding when treatment begins. The registry does not report how the timing assignment was carried out or whether it was followed as planned.

What does a confidence interval add?

In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while the interval’s position relative to a meaningful reference can help with interpretation. The registry does not report a confidence interval or an endpoint estimate, so neither the direction nor precision of an effect can be evaluated from these results.

Standard deviations and confidence intervals answer different questions. A standard deviation describes spread among observations; a confidence interval describes uncertainty in an estimate. Neither can be reconstructed from the registry’s outcome description alone, and no calculations are made from the enrollment figure.

What does the record say about planning calculations?

The record describes planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect, and distinguishes participants per arm for 80% power from other planning quantities. These are planning assumptions, not evidence that the study had observed power. The primary observed effect needed to interpret such illustrations is not reported in the registry record. The study itself is described as single-group, so the two-arm planning assumptions should not be mistaken for the trial’s design or for an observed comparison.

Over-dispersion is a general statistical concern when data vary more than a model’s assumed distribution allows. In that situation, standard errors from a model that assumes less variation may be too small, making uncertainty appear lower than it is. The registry record does not identify a model or state whether over-dispersion was assessed; it would be inappropriate to assume that it applied to this study.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Online Speech Perception Training")
n   <- c(10)
m   <- c(84.74)
sp  <- c(9.53)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Online Speech Perception Training  10  84.740  9.530  77.923  91.557

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures, including the primary perception accuracy endpoint and secondary outcomes named Raw Change in Percent Accuracy Perception Task and Perceptually Rated Accuracy of /r/ Word Production. It lists 0 analyses. The names of outcomes do not reveal how many hypotheses were tested or which comparisons were planned. A multiplicity strategy for handling the possibility of several statistical tests is not reported in the registry record.

In general, when many outcomes or comparisons are assessed, the chance of obtaining at least one apparently notable result by chance can increase. Statistical approaches can address that issue, but the registry does not report whether any such approach was planned or used. Since no inferential analyses are listed, there are no posted test results from which to assess multiplicity in practice.

Missing-data methods are not reported in the registry record. The entry does not state how incomplete session data, missed maintenance measurements, or withdrawals were handled. Nor does it report the number of participants contributing to each endpoint or the number of observations available at each phase. The enrollment figure is not a substitute for endpoint-specific denominators.

Analysis populations are also not reported. The record does not specify whether analyses included all enrolled participants, only participants who began treatment, participants with complete data, or another group. Because these details and numerical outcome results are absent, the posted record does not permit assessment of missing-data bias or how analysis-population choices may affect estimates.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

For the group labeled Online Speech Perception Training, the registry lists 10 participants at risk for serious adverse events and 0 affected. It also lists 10 at risk for other adverse events and 0 affected. Deaths are listed as 0. No top serious adverse-event terms are listed.

These are the safety figures recorded for the study. A zero count means no events of the specified type are listed in this record; it does not by itself establish that no event occurred outside the reporting or observation captured by the registry. The record does not provide details about how adverse events were solicited, defined, assessed, or followed over time. It also does not state whether the figures apply to every intervention phase or how long participants were observed for safety.

These counts should be read separately from the study’s primary perception endpoint. They do not indicate whether perceptual accuracy changed, and they do not establish a causal comparison with an untreated group. The single-group design and absence of a described comparator mean that the adverse-event figures are descriptive registry entries, not comparative estimates of safety.

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

The registry record documents a study designed to examine online perceptual training for children with RSE and atypical perception, with a focus on perception of /r/ and possible transfer to speech production. It identifies a maintenance-phase average of perception percent accuracy as the primary endpoint and describes a staggered multiple-baseline approach. These details clarify the research question and intended measurement.

The record does not report the numerical primary endpoint result, a change estimate, variability, confidence interval, or inferential analysis. As a result, it does not establish whether perception scores increased, remained similar, or decreased. It also does not provide numerical results for the production outcomes, so transfer from perception to production cannot be evaluated from this record.

The absence of a separate control group is relevant to causal interpretation. Even if numerical changes were available, a single-group design would require careful attention to the repeated baseline observations and timing of intervention. The registry record does not provide the participant-level trajectories or analysis details needed to evaluate those patterns. A result from a staggered design can be informative, but the design label alone is not evidence that a treatment effect occurred.

The safety entries list no serious adverse events, other adverse events, or deaths in the stated group. These figures are descriptive and do not substitute for full information about event monitoring or comparison with another group.

Thus, the registry supports conclusions about the study’s stated purpose, design, endpoint, and recorded safety counts. It does not support a conclusion about efficacy, the size or precision of any effect, durability beyond the stated maintenance measurement period, or the broader applicability of results. Those judgments require numerical outcome findings and enough analysis detail to understand how they were obtained.

14. Why This Trial Matters Statistically

This study raises a statistical question that is not captured by a simple treatment-versus-control contrast: whether changes in perception align with the staggered start of training across participants. A multiple-baseline design can use the timing of intervention and repeated observations to examine that pattern. It therefore makes the sequence and stability of measurements central to interpretation, not merely the average score after treatment.

The endpoint also connects two different kinds of performance: perception accuracy and production of /r/. The registry lists a perception endpoint and a production-related secondary outcome, while its study objective asks whether perceptual gains transfer to production. These outcomes address related but distinct questions. Numerical results for both would be needed to evaluate whether change in one domain corresponds to change in the other; those results are not reported in the registry record.

Statistically, the record illustrates why design information and result information must be considered together. Knowing that an endpoint is a mean with standard deviation does not reveal the observed level or uncertainty when the values themselves are missing. Knowing that transition timing was to be randomized does not establish that a control group was used. Likewise, a completed status does not supply the outcome estimates needed to judge the evidence.

The listed planning assumptions also underscore a useful distinction: planning calculations based on an observed effect are not the same as an analysis of the trial’s actual data, and planning power is not observed power. In this case, the observed effect is not reported in the registry record, so those planning assumptions cannot be interpreted as a result. The central statistical importance of this record is therefore its design question and the limits of what can be inferred without posted endpoint data.

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 most direct limitation for interpretation is that the registry record does not report numerical results for the primary endpoint. The average perception accuracy, its standard deviation, any baseline comparison, and any interval estimate are absent. Without those quantities, neither the direction nor magnitude of change can be assessed.

The record does not include participant-level observations or trajectories across baseline, treatment, and maintenance. This is particularly consequential for a multiple-baseline design, because evidence depends on how measurements behave over time and in relation to the timing of intervention. The listed transition options do not show which transition points were actually used or what happened after each transition.

The registry describes a single-group study and does not identify a concurrent control group. The timing of treatment was to be staggered, but the record does not provide enough information to judge how this design addressed other changes over time. Masking is listed as NONE. Details of outcome-assessor procedures are not reported in the registry record.

Outcome definitions and analysis details are limited. The record does not describe the scoring rules for perception accuracy, the exact method used to average maintenance measurements, or the analysis model. It lists 3 outcome measures and 0 analyses, while multiplicity procedures, missing-data handling, and analysis populations are not reported. The intervention list includes production training, but its content and timing are not described. The brief arm description ends before giving full maintenance details; the primary endpoint timeframe does state that maintenance involved 3 sessions across 1 week.

Participant characteristics beyond the condition and stated atypical perception are not reported in the registry record. These limitations constrain assessment of precision, risk of bias, reproducibility, and applicability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Auditory-Perceptual Training Via Telepractice — NCT04858035.
• Registry record last updated 2025-09-05; status last verified 2025-09.
• Results first posted 2025-09-05.
• 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.

19. Record Summary

NCT04858035 is a completed, single-group behavioral study sponsored by Montclair State University. It concerns online perceptual training for children with speech sound disorder and atypical perception of /r/. The registry lists enrollment of 10 and describes a multiple-baseline-across-subjects design with staggered treatment initiation. Participants were to receive 12 perceptual-training sessions over 4 weeks, with perception accuracy assessed during maintenance sessions described as 3 sessions across 1 week.

The primary outcome is averaged perception percent accuracy, summarized in the registry as a mean with standard deviation. The record lists 3 outcome measures and 0 analyses, but does not report numerical primary or secondary outcome results, estimates of change, or measures of uncertainty. Serious adverse events, other adverse events, and deaths are each listed as 0 for the stated group. Missing-data methods, analysis populations, and a multiplicity strategy are not reported in the registry record. The available entry therefore describes the intended study and recorded safety counts but does not establish the size or precision of an outcome effect.