Knowledge Accessibility and Availability in Forming Knowledge-to-Text Inferences Among Middle Grade Readers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Knowledge Accessibility and Availability in Forming Knowledge-to-Text Inferences Among Middle Grade Readers (NCT03782012), a randomized na study. The primary outcome is Change in Knowledge Accessibility and Availability.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel study with 241 enrolled participants. Its status is completed. The listed start date is 2019-01-14, and the primary completion date is 2022-05-27. The phase is listed as NA. The sponsor is Buena Vista University, and the listed condition is Reading Problem. The population comprises English learners and monolingual English-speaking students.

The two condition descriptions are Knowledge Supported and Knowledge Not Supported. In the supported condition, students viewed pictures of knowledge-base items for 30 seconds and discussed relations among them. In the not-supported condition, they viewed pictures of the items for 30 seconds. The registry identifies the intervention as behavioral, but does not describe additional differences between conditions or detail how the activities were administered.

The registry’s brief summary describes a project with two experimental studies. It frames the research around the relation of knowledge-base availability and accessibility to inference accuracy and rate, and around whether retrieval practice increases availability and accessibility and improves inference formation. The registry record does not report enough detail to establish how the registered arms map onto each study or to reconstruct the complete sequence of study activities. Specific information about random sequence generation, concealment of allocation, masking procedures, and the allocation ratio is not reported in the registry record.

The primary outcome is a continuous Know-It score, with a stated range from 0 to 14 and a higher score described as better. Assessments are listed immediately after training, one week after training, and one month after training. The registry also lists 14 outcome measures, including measures concerning reading comprehension, reading strategies, word and world knowledge, fluency, inference making, reasoning, and working memory. It lists 0 statistical analyses. No arm-specific enrollment counts, outcome results, or analysis populations are 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: Recruitment was significantly influenced by COVID 19 school closures and restrictions that prevented the recruitment of students spring 2020 through the end of the project.

Overall Study

Analysis population for the primary outcome, as defined in the registry: English learners and Monolingual English speaking students (n = 241)

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 Change in Knowledge Accessibility and Availability, measured over immediately after training KNOW-IT knowledge base items; one week after training KNOW-IT knowledge base items; and 1 month after training KNOW-IT knowledge base items.

The primary endpoint is change in knowledge accessibility and availability, measured with the Know-It task for knowledge-base items taught during the study. The task is described as an individually administered assessment. The registry characterizes accessibility through response rate and availability through response accuracy, linking the endpoint to both how quickly knowledge is retrieved and whether the response is accurate. The reported score is on a scale from 0 to 14, and the registry states that a score of 14 is better.

The listed assessment times are immediately after training, one week after training, and one month after training. Repeated assessments can describe performance at different points after an activity and may help distinguish immediate performance from performance at later assessments. That is a general reason to measure an outcome over time; it does not establish what pattern occurred in this study.

The record does not report how rate and accuracy are combined into the score, whether each time point has a separate analysis, or what change is considered meaningful. It also does not provide a reported comparison of the conditions at any listed time. The endpoint is relevant to the stated research question because it operationalizes knowledge retrieval and accurate response, but the registry’s endpoint description alone cannot show whether either condition changed performance or how the conditions differed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization is a method for assigning participants to study conditions using chance. In general, it is intended to reduce systematic differences between groups at the start of a study, including differences that may not be measured. The registry labels this study randomized, but does not report the sequence-generation method, allocation concealment, or allocation ratio. Those details cannot be reconstructed from the label alone.

A parallel design assigns participants to conditions that are compared during the study, rather than describing the same participants as crossing through all conditions. That is the general meaning of a parallel design. Here, the registry identifies a parallel design and describes Knowledge Supported and Knowledge Not Supported conditions. It does not report enough procedural detail to specify the full participant flow or establish whether other study procedures differed across conditions.

Double masking generally means that two categories of people involved in a study are kept unaware of condition assignments, but the registry does not identify which people were masked or how masking was maintained. In a behavioral study involving a visible discussion activity, the practical meaning of masking may depend on the roles of participants, assessors, and other study staff. Those procedures are not reported in the registry record, so the label should not be taken as a detailed account of who knew each assignment.

The Know-It score is described as a continuous measure from 0 to 14. For a continuous measure, analysts often describe the distribution using a mean and a measure of spread. The registry identifies the mean as the parameter and standard deviation as the dispersion measure. In general, a mean gives a summary of the average score, while a standard deviation describes variation in scores around that mean. Neither statistic is reported by condition or assessment time in the registry record.

The task description distinguishes accessibility, represented by response rate, from availability, represented by response accuracy. In general, these capture related but nonidentical aspects of performance: prompt retrieval and correct retrieval need not change in the same way. The registry does not specify the scoring formula, the unit of response rate, or how the accuracy and rate information are combined in the stated 0-to-14 score. Consequently, the score’s components cannot be separately interpreted from the registry description.

Repeated assessments can be analyzed in several general ways. Analysts might compare condition means at each assessment, model change over time, or estimate a condition-by-time pattern. These approaches answer related but distinct questions and rely on choices about the outcome and covariance structure. The registry lists assessments immediately after training, one week after training, and one month after training, but does not report which model or comparison was used. No analysis method, adjustment strategy, or estimate is listed.

In general, an effect estimate expresses the size and direction of a comparison, while a confidence interval conveys uncertainty around that estimate. A p-value addresses compatibility of the observed data with a specified null model under the chosen analysis; it does not by itself measure importance or precision. None of these results is reported for the primary outcome. The absence of reported estimates means neither the magnitude nor the uncertainty of any difference can be evaluated.

When outcome variability is greater than a model assumes, standard errors and inferential conclusions can be affected; this general issue is often called over-dispersion in settings where a model assumes less variability than the data exhibit. The registry does not identify an analysis model or report variability estimates, so there is no basis to diagnose over-dispersion for this study. More generally, model checking requires the data and methods, neither of which are described in detail in the record.

The record lists 14 outcome measures and 0 analyses. When a study examines multiple outcomes or time points, multiplicity is a general statistical consideration: the more comparisons made, the greater the opportunity for apparently notable results by chance if each is interpreted independently. Researchers may prespecify a primary comparison, use adjustment procedures, or describe a hierarchy of tests. The registry record does not report whether such a strategy was used, nor does it identify which of the multiple outcome measures were analyzed.

The record also contains a sample-size assumption statement describing planning illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. Such calculations are general planning tools: they illustrate the number of participants per arm associated with a stated target power for an assumed effect. They are not observed power, do not establish the effect actually found, and are not a substitute for outcome estimates and uncertainty intervals. The observed effect and the numerical planning results are not reported in the registry record. A trial’s own sample-size justification is not reported in the registry record.

Missing-data handling, analysis populations, and sensitivity analyses are also not described. In general, missingness can affect both the number of observations contributing to a comparison and the interpretation of results, particularly when the reasons for missing measurements relate to outcome values or study condition. Without participant flow by condition, counts assessed at each time, and the analysis approach, the extent and treatment of missing data cannot be evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and identifies a primary outcome assessed immediately after training, one week after training, and one month after training. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. These features create multiple possible ways to summarize or compare results. In general, testing many outcomes or time points can increase the chance of finding an apparently unusual result, even when there is no underlying difference, unless the analysis plan accounts for the number and structure of comparisons.

The record does not report a multiplicity strategy, such as a prespecified hierarchy, a defined primary contrast across time, or an adjustment method. It also lists 0 statistical analyses, so there are no reported estimates or inferential results to interpret across the outcomes. This does not establish whether analyses were conducted outside the registry record; that information is not reported in the registry record.

Information about missing outcome measurements is not reported. The registry gives total enrollment but does not provide the number assessed at each time point or by condition, reasons for missingness, or a method for handling missing data. It does not identify an intention-to-treat, per-protocol, or other analysis population. These omissions prevent assessment of whether the analyzed participants, if analyses were conducted, represented all enrolled participants or a selected subset.

The registry also does not report sensitivity analyses or details about adjustment for baseline variables. These are general elements that can help readers understand how robust an estimate is to analysis choices. Without a stated analysis plan and participant-level flow information, the impact of missingness, multiplicity, and analytic decisions cannot be judged from the registry record.

11. 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.

The registry lists safety information separately for English Learners and Monolingual English Speaking Students. For English Learners, 145 participants are listed as at risk for serious adverse events and 0 as affected; 145 are listed as at risk for other adverse events and 0 as affected. For Monolingual English Speaking Students, the corresponding figures are 96 at risk and 0 affected for serious adverse events, and 96 at risk and 0 affected for other adverse events. Deaths are listed as 0 in both groups. No top serious adverse event terms are listed.

These figures describe what the registry record reports; they do not establish that no event occurred outside the registry’s reporting scope or observation period. The record does not specify the safety surveillance period, how events were collected, or whether the at-risk counts correspond to all participants in each group for the full study. It also does not provide additional event details or definitions. The counts should therefore be read as registry-reported safety entries, not as a complete account of all possible experiences during participation.

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

The registry record establishes that a randomized, double-masked, parallel study enrolled 241 participants and was marked completed. It describes a comparison between viewing knowledge-base pictures with discussion of relations among items and viewing the pictures without that discussion. The primary outcome concerns performance on the Know-It task at three assessment times. These details define the research question and the measurement approach.

They do not reveal what happened to participants’ scores. No condition-specific scores, changes, comparison estimates, confidence intervals, or p-values are reported. The record therefore cannot show whether performance changed, whether the conditions differed, whether any difference persisted across assessments, or how precisely a difference was estimated. The lack of statistical analyses listed in the registry should not be converted into a claim that the study found no difference.

The endpoint combines concepts of response accuracy and response rate, but the registry does not explain the scoring algorithm or report separate results for those concepts. Even if an overall score were reported, interpreting its meaning would require knowing how its components contribute and how observed values vary. The score’s stated range and direction describe the scale, not a result.

The record’s description of a broader project includes questions about inference formation and retrieval practice, and it lists secondary measures related to reading and cognition. Those aims do not establish that each question was tested in the registered comparison or that results were obtained for each measure. The information needed to connect specific aims, study procedures, analyses, and findings is not reported in the registry record.

Accordingly, the registry record supports a description of the study design, population, intervention contrast, endpoint, and reported safety counts. It does not support a conclusion about the effectiveness or lack of effectiveness of either condition, the size of any educational effect, or the value of the activity for readers. Such conclusions would require outcome results and adequate information about their analysis and uncertainty.

13. Why This Trial Matters Statistically

Statistically, this study is notable for defining knowledge accessibility and availability as related but distinct aspects of performance. The registry describes accessibility through response rate and availability through accuracy. That distinction matters because an assessment can capture both whether a response is correct and how readily knowledge is retrieved; a single score may not communicate both components unless its construction and results are reported.

The outcome is assessed at multiple times after training: immediately, one week later, and one month later. Repeated measurement can help distinguish performance soon after an activity from performance at later assessments. It also requires a clear analysis strategy, because a comparison at one assessment time is not the same question as a comparison of change across time. The registry record does not identify the analysis used or report results for these time points.

The condition contrast is focused on whether students discuss relationships among pictured knowledge-base items during a brief viewing activity. This offers a defined behavioral distinction for an investigation of knowledge accessibility and availability. Yet the record does not give outcome estimates, so readers cannot determine whether the design yielded a measurable difference or how uncertain any estimate might be.

The study also lists a broad set of secondary measures, spanning comprehension, strategy use, fluency, inference making, reasoning, and working memory. This breadth makes transparent reporting of outcome selection and multiplicity particularly relevant. The registry’s 0 listed analyses and lack of reported results leave those statistical questions unresolved. The value of the record, therefore, lies in clarifying the study’s stated question and measurement framework while showing what remains necessary for statistical interpretation: the analyses, effect estimates, uncertainty, and participant accounting.

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 interpreting this trial from the registry record is the absence of reported outcome results. No group-level scores, changes, effect estimates, uncertainty intervals, or p-values are listed, and the record lists 0 statistical analyses. Consequently, statistical evidence about the primary endpoint cannot be assessed.

Several design and analysis details are not reported in the registry record. These include the randomization procedure, allocation concealment, allocation ratio, the people covered by double masking, and the analysis model. The record does not specify how the Know-It score combines response rate and accuracy, whether each time point is analyzed separately, or what constitutes a change in the outcome.

Although total enrollment is reported, arm-specific enrollment counts and participant flow at each assessment are not. Information about missing measurements, withdrawals, analysis populations, baseline characteristics, and sensitivity analyses is not reported in the registry record. Without these details, it is not possible to evaluate whether the outcome data are complete or how the analyzed groups may have differed.

The listed 14 outcome measures and multiple primary assessment times make a prespecified approach to multiplicity important for interpreting any analyses. Such an approach is not reported. The registry’s brief summary describes a project with two experimental studies, but the record does not give enough detail to connect the broader aims to the registered condition comparison. Finally, safety reporting provides counts but does not specify the observation period or event-collection procedures. These limitations constrain interpretation of the record; they do not by themselves establish flaws in the conduct of the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Knowledge Accessibility and Availability in Forming Knowledge-to-Text Inferences Among Middle Grade Readers — NCT03782012.
• Registry record last updated 2024-05-16; status last verified 2024-04.
• Results first posted 2024-05-16.
• 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.

18. Record Summary

NCT03782012 is a completed randomized, double-masked, parallel study sponsored by Buena Vista University. The registry reports enrollment of 241 English learners and monolingual English-speaking students. The study compares a Knowledge Supported condition, in which students viewed pictures of knowledge-base items and discussed relations among them for 30 seconds, with a Knowledge Not Supported condition, in which students viewed the pictures for 30 seconds.

The primary outcome is change in knowledge accessibility and availability on the Know-It task, with assessments immediately after training, one week after training, and one month after training. The listed score ranges from 0 to 14, with a higher score described as better. The registry lists 14 outcome measures and 0 statistical analyses. It reports zero serious adverse events, zero other adverse events, and zero deaths in each of the two participant groups. No outcome estimates or statistical comparisons are reported in the registry record.