Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder (NCT05986565), a randomized na study. The primary outcome is Change in Mean Knowledge About FASD From Baseline to 6 Weeks.

2. Clinical Question

The registry describes the study purpose as assessing whether the website is acceptable and usable by teachers. Its stated feasibility focus includes enrollment and retention of study participants and acceptability of assessments. The primary outcome is a continuous knowledge score, measured using the Fetal Alcohol Spectrum Disorder Knowledge survey. Higher scores indicate more knowledge about fetal alcohol spectrum disorder.

The record identifies a randomized, parallel-group study with no masking. The delayed-treatment arrangement means the intended early comparison is between teachers offered website access and teachers whose access is delayed. The primary endpoint timeframe is baseline to 6 weeks, and the endpoint population is participants with data at 6 weeks. The registry record does not report a single primary comparison or numerical results for this endpoint, so it does not establish the size or precision of any difference between groups.

3. Trial Design

This is a completed randomized, parallel-group behavioral pilot trial of the FMF Teacher Companion website. The registry lists the phase as not applicable and identifies the University of Rochester as sponsor. Enrollment is recorded as 37. The study started on 2023-08-24, and primary completion is recorded as 2024-01-29. The record describes two arms: Website Treatment and Delayed Treatment Control. The control arm is described as receiving the same intervention as the experimental arm delayed by 6 weeks.

Random allocation is recorded, but the registry record does not report the method used to generate the allocation sequence, whether allocation was concealed, or whether any stratification or balancing factors were used. Masking is listed as none. That means the record does not describe blinding of participants or study staff; it does not, by itself, specify whether any outcome assessment was conducted independently.

The intervention is behavioral training delivered through a website adapted from the Families Moving Forward Program. The registry describes the original program as an evidence-based intervention for caregivers of children with fetal alcohol spectrum disorder. The study population and intervention are therefore focused on teachers and a teacher-adapted website, rather than on direct treatment of students.

The listed study purpose is feasibility and acceptability, not a confirmatory assessment of a clinical treatment effect. Enrollment, retention, and acceptability of assessments are identified as ways to examine feasibility. Although the record lists 13 outcome measures and 9 analyses, it does not report a complete analysis plan, the allocation details, or numerical results for the primary endpoint. Further details about the planned visit schedule, intervention-use requirements, and procedures for monitoring website use are 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: Out of a total of 145 people who completed the consent and screening process, 37 were deemed eligible and 108 were ineligible for the following reasons: 12 did not meet eligibility criteria, 21 were incomplete, and 75 were suspected fraudulent.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants with data at 6 weeks

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 Mean Knowledge About FASD From Baseline to 6 Weeks, measured over baseline to 6 weeks.

The primary endpoint is change in mean knowledge about fetal alcohol spectrum disorder from baseline to 6 weeks. Knowledge is measured with the Fetal Alcohol Spectrum Disorder Knowledge survey. The registry describes the survey score as ranging from 0-33, with higher scores indicating more knowledge. The outcome is continuous, and the listed summary measure is the mean with standard deviation. The stated population for this endpoint is participants with data at 6 weeks.

A knowledge score is relevant to this pilot because the intervention is educational and is intended for teachers. Measuring change can describe whether scores differ over the assessment timeframe. A comparison of change between immediate website access and delayed access could describe the early difference between those study conditions. That interpretation depends on the actual outcome estimates and the analysis used, which are not reported as a single primary comparison in the registry record.

The registry does not report the mean scores at baseline or follow-up, the mean change, a between-arm estimate, or its uncertainty. It also does not report how survey scoring was handled when items were missing. Consequently, the endpoint definition explains what was intended to be measured, but does not support a numerical conclusion about the observed change in teacher knowledge.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a continuous outcome summarized by a mean and standard deviation. General statistical explanation: a mean describes the central value of a set of scores, while a standard deviation describes how spread out individual scores are around that mean. These summaries can help characterize scores within an arm, but a comparison between arms requires a defined contrast and its estimate. The registry record does not report one single primary comparison for this outcome.

What does change from baseline mean?

General statistical explanation: a change score is formed by comparing a participant’s later measurement with that participant’s baseline measurement. A group mean change describes the average within-person change among the participants included in that analysis. A comparison of mean changes between randomized groups addresses whether the average change differs between the study conditions over the stated timeframe. It is not interchangeable with comparing only the follow-up means, and the interpretation depends on the analysis specified and the data included.

For this trial, the named timeframe is baseline to 6 weeks, and the primary endpoint population is participants with data at 6 weeks. The registry does not give the baseline and follow-up means, the mean changes, or a between-group change estimate. It also does not state whether the primary analysis compared change scores directly, adjusted for baseline score, or used another approach. Those details are not reported in the registry record, so a specific analysis method should not be inferred from the endpoint label.

How should uncertainty be understood?

General statistical explanation: a confidence interval expresses the range of values reasonably compatible with an estimate under the assumptions of the analysis. Its width conveys precision: narrower intervals indicate more precise estimates, while wider intervals indicate greater uncertainty. A p-value addresses compatibility of the data with a specified null hypothesis under an analysis model; it does not measure the size or importance of an effect. The registry record does not report a confidence interval or p-value for a single primary comparison, so neither statistical precision nor a test result can be assessed from the listed primary-outcome information.

Randomization is intended to make study groups comparable on average with respect to factors that could influence outcomes. General statistical explanation: random allocation can reduce systematic differences at assignment, but it does not guarantee that groups will be identical in a particular study. The registry records random allocation, while the sequence-generation and concealment procedures are not reported in the registry record. Masking is listed as none. For an educational website intervention, participants and staff may know the assigned access timing; the registry does not report any additional blinded outcome assessment.

Why does the delayed-treatment comparison need context?

The delayed-treatment control is described as receiving the same intervention delayed by 6 weeks. For the primary timeframe, the intended contrast is therefore between immediate website access and delayed access. General statistical explanation: a delayed-treatment design can provide a comparison during a period when access differs between groups. Its interpretation depends on the timing of outcome assessments and on the exact analysis population. The registry does not report a single primary comparison, so the actual contrast used for the posted primary result cannot be identified from the record.

What can the scale tell readers?

The survey range is 0-33, and higher scores indicate more knowledge. General statistical explanation: a bounded score has a limited possible range, so its distribution may be affected by floor or ceiling patterns when many scores lie near an endpoint. The record does not report the observed score distribution, and no claim about floor or ceiling effects can be made. A mean and standard deviation are the registered summary measures, but without their values they do not describe the observed score pattern.

The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is described as a fraction of the observed effect. Such a planning exercise is not observed power, and it is not the trial’s own design justification. The record does not report the protocol’s sample-size justification or the numerical planning illustrations. The observed effect estimate needed to understand the illustration is also not reported as a single primary comparison in the registry record.

General statistical explanation: when outcome variability exceeds what a simple model assumes, standard errors and confidence intervals from that model may be too small, leading to overly confident conclusions. Such extra variability is often called over-dispersion in settings where a model expects less variation than is observed. The primary endpoint is continuous and described using a mean and standard deviation; the registry does not identify a model involving over-dispersion or report diagnostics for it. Therefore, over-dispersion is a general statistical consideration, not a reported feature of this analysis.

The registry lists 13 outcome measures and 9 analyses. General statistical explanation: multiple outcomes or analyses can increase the chance of apparently notable results if each is tested separately. Methods such as prespecifying a primary contrast or adjusting for multiple comparisons can address that concern, but the appropriate approach depends on the study’s analysis plan. The registry record does not report whether multiplicity adjustment was used, how outcome measures map to analyses, or whether interim analyses were planned. Those procedures should not be assumed.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 13 outcome measures and 9 analyses. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. The registry record does not report a single primary comparison or numerical primary-outcome results. It does not describe how the listed outcomes and analyses were prioritized, whether any multiplicity adjustment was planned or used, or whether interim analyses were conducted. The statistical plan is not reported in the registry record.

General statistical explanation: when many outcomes, time points, or contrasts are examined, the chance of a nominally unusual finding can increase if all are treated as separate confirmatory tests. Prespecifying a primary comparison or adjusting for multiplicity can help control that issue. Without a reported analysis plan, readers cannot tell whether the listed analyses were exploratory, confirmatory, or handled under a stated multiplicity strategy.

The endpoint population is participants with data at 6 weeks. This is a complete-data description of the population contributing to the endpoint, but the registry does not report the number analyzed in each arm, the amount or pattern of missing data, reasons for missingness, or methods for handling missing scores. It does not state whether imputation, a likelihood-based approach, or another method was used. Those details are not reported in the registry record.

Retention is named as part of the feasibility assessment, but numerical retention findings are not reported in the registry record. Consequently, the amount and potential impact of missing follow-up data cannot be evaluated. The record also does not state whether the analysis followed intention-to-treat principles, used a per-protocol population, or applied another analysis-population definition beyond the stated 6-week-data population.

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 no serious adverse events, no other adverse events, and no deaths in the Website Treatment arm, with 21 participants at risk. It lists no serious adverse events, no other adverse events, and no deaths in the Delayed Treatment Control arm, with 16 participants at risk. These are the posted counts for the arm-specific groups identified as at risk.

Zero recorded events means that the registry entries contain no events in these categories for the stated groups. It does not establish that every possible adverse experience was absent, nor does it show how events were collected or classified. The registry record does not report detailed event definitions, surveillance procedures, or a narrative of individual events. No serious-event terms are listed.

These figures are descriptive safety information, not a comparative safety analysis. The record does not provide an estimated between-arm difference or uncertainty interval for adverse events. The counts should therefore be read as the registry’s reported event totals alongside the stated at-risk groups, rather than as proof of the absence of all safety concerns.

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

The study addresses a practical question: whether a website adapted for teachers can be used and accepted, and whether the study procedures support a feasibility assessment. The registry identifies enrollment, retention, and acceptability of assessments as relevant feasibility considerations. It also defines a knowledge survey endpoint over baseline to 6 weeks. Together, these details describe the study’s aims and intended measurements.

The registry record does not report a single primary comparison or numerical results for the knowledge endpoint. It therefore does not show the observed amount of change in scores, the difference in change between immediate and delayed access, or the precision of any such estimate. The record also does not provide numerical findings for enrollment, retention, or assessment acceptability. Completion status should not be substituted for those results.

The record cannot establish whether the intervention changed teachers’ knowledge, whether any change was attributable to website access, or whether the intervention was acceptable to teachers. Those conclusions require reported outcome estimates and appropriate analysis details. A registered score scale and a stated timeframe describe how an outcome was intended to be measured; they do not reveal the study’s observed result.

The listed safety counts are zero for serious adverse events, other adverse events, and deaths in each arm. These are reassuringly limited entries in the registry’s event summary, but they do not amount to a full safety assessment or prove that no adverse experiences occurred. The event-collection methods and detailed safety results are not reported in the registry record.

As a pilot, the study’s purpose is framed around feasibility and acceptability. Even if numerical results were available, a pilot’s findings would need to be interpreted in light of its design, endpoint population, missing-data handling, and precision. The record does not report enough primary-outcome information to estimate that precision. It also does not provide a basis for extending findings beyond the teachers and study procedures described in the record.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it connects an educational intervention with a measurable teacher knowledge outcome while also emphasizing feasibility. The registry separates the practical study aims—enrollment, retention, and acceptability of assessments—from the continuous primary endpoint. That distinction matters: a study can be designed to learn whether procedures are workable without being a definitive test of an outcome effect.

The randomized, parallel-group design and delayed-treatment control define a potentially interpretable early comparison. The primary outcome uses a score with a stated direction, so a reported contrast could be interpreted in relation to whether higher scores indicate greater knowledge. Yet the registry record does not report a single primary comparison or its numerical result. This makes the absence of an estimate, not merely the absence of a significance test, central to interpretation: readers cannot assess magnitude or precision.

The endpoint population is limited to participants with data at 6 weeks. That definition makes missing-data reporting especially relevant. Without arm-specific analysis counts and information about follow-up completeness, the contribution of missing outcomes to the result cannot be assessed. Similarly, the presence of multiple outcome measures and analyses makes it important to know how the primary question was distinguished from other analyses. Those details are not reported in the registry record.

The trial’s pilot and feasibility focus also places emphasis on transparent reporting of procedures and uncertainty. A clearly reported estimate, confidence interval, and analysis population would help readers distinguish an imprecise early signal from evidence that a particular effect is unlikely. In the absence of those results, the registry supports an account of the design and outcome definitions, but not a quantitative assessment of intervention effects or feasibility performance.

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.

A central limitation of the registry information is that the primary outcome is not reduced to one comparison, and numerical results for that endpoint are not reported. The record does not give arm-level baseline or follow-up scores, mean changes, a between-group estimate, confidence intervals, or p-values. The size and precision of any change in knowledge therefore cannot be assessed from the registry record.

The endpoint population is participants with data at 6 weeks, but the record does not report arm-specific numbers analyzed, the extent or reasons for missing follow-up data, or the method used to handle missing values. This limits evaluation of how well the endpoint analysis represents the randomized groups. Retention is part of the stated feasibility purpose, but numerical retention results are not reported in the registry record.

The study is listed as unmasked. The record does not describe blinded outcome assessment or explain whether assessors were kept unaware of assignment. Because the intervention is a website for teachers, awareness of access timing may be part of the study context, but the registry does not report procedures intended to address potential expectation or reporting effects.

The record lists multiple outcome measures and analyses without describing a multiplicity strategy or a complete statistical analysis plan. It also does not report the randomization sequence method or allocation concealment. Finally, the study is described as a pilot focused on feasibility and acceptability; the registry information does not provide a basis for treating it as a definitive effectiveness evaluation. These limitations concern what is reported in the record and do not establish that additional procedures were not conducted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder — NCT05986565.
• Registry record last updated 2025-01-29; status last verified 2025-01.
• Results first posted 2025-01-29.
• 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

The registry describes NCT05986565 as a completed, randomized, unmasked, parallel-group behavioral pilot trial sponsored by the University of Rochester. Enrollment is recorded as 37. The study started on 2023-08-24, with primary completion on 2024-01-29. It evaluates a teacher-adapted Families Moving Forward website, comparing immediate access with access delayed by 6 weeks.

The stated purpose is to assess acceptability and usability, with feasibility considered through enrollment, retention, and assessment acceptability. The primary endpoint is change in mean FASD knowledge from baseline to 6 weeks, measured with a survey scored from 0-33, with higher scores indicating more knowledge. The endpoint population is participants with 6-week data.

The registry record does not report a single primary comparison or numerical primary-outcome results. It lists zero serious adverse events, zero other adverse events, and zero deaths in each arm. Details of the statistical plan, missing-data handling, and multiplicity procedures are not reported in the registry record.