Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use (NCT06410287), a randomized na study. The primary outcome is Nurse Stigma Toward Perinatal Substance Use.

2. Clinical Question

3. Trial Design

This was a completed pilot clinical trial with randomized allocation, a parallel-group model, and no masking. The registry lists 99 enrolled participants and identifies the sponsor as the University of Michigan. The recorded start date is 2024-07-01, and the primary completion date is 2024-11-30. The phase is listed as NA.

The two groups are described by hospital setting. Participants from the hospital randomized to the experimental group were invited to use the web-based ArtSpective program. Participants from the hospital randomized to the control setting were invited to complete a baseline survey. This description indicates that the hospitals were assigned to the experimental and control settings; details of the randomization procedure, including how the assignment sequence was generated or concealed, are not reported in the registry record.

The intervention was intended to be asynchronous, with the program open for one month. The registry describes follow-up invitations at intervals tied to program completion or baseline assessment. The control-arm description ends before the full follow-up process is specified, so its complete sequence cannot be established from the record.

The trial was designed to examine feasibility and limited effectiveness, rather than to establish a definitive clinical effect. Its primary outcome was nurse stigma toward perinatal substance use, and acceptability was listed as a secondary outcome. The registry does not report a sample-size justification, the intended enrollment target, or the detailed statistical analysis plan. Although the trial status is completed, the outcome results 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.

Phase 1

Phase 2

Reasons for not completing this period:

Phase 3

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Phase 3: Interview Site 2 group did not participate in interviews.

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 Nurse Stigma Toward Perinatal Substance Use, measured over Baseline (Phase 1a); immediately post intervention (Site 1) or 7-30 days post baseline (Site 2) (Phase 1b); immediately post (Site 2) or 30 days post intervention (Site 1) (Phase 2); 30 days post (Site 2) or 60 days post intervention (Site 1) (Phase 3).

The primary endpoint is a score on the Modified Attitudes About Drug Use in Pregnancy Scale. It is intended to measure negative or stigmatizing attitudes and beliefs among registered nurses toward perinatal substance use. The total score ranges between 1 and 5, with scores closer to 1 associated with a more positive outcome. The registry describes the endpoint as a mean with standard deviation.

This measure is relevant to the trial’s stated question because the intervention aims to address stigma, and the scale operationalizes attitudes and beliefs as a continuous score. A continuous measure can describe both the average score in a group and how scores vary among participants. It does not, on its own, establish how an individual nurse behaves in practice or whether care changes.

Measurement was planned at baseline and at several post-baseline points. The schedule differs by hospital group: the registry names immediate post-intervention and later follow-up points for Site 1, and post-baseline and later points for Site 2. Those time points are not collapsed in the registry record into one reported comparison. Actual means, standard deviations, and changes in scores are not reported in the registry record, so the direction and precision of any observed outcome cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Design and allocation. The registry identifies the study as randomized, parallel, and unmasked. In a parallel design, participants in each group are followed in the group to which they are assigned rather than crossing over between conditions. Random allocation is generally used to reduce systematic differences between groups at the start of a study. The registry describes hospital settings assigned to experimental and control conditions, but the method used to generate and implement that assignment is not reported in the registry record. Because no masking was used, participants and relevant study personnel were not described as masked to group assignment.

Continuous outcome summaries. The primary outcome is a continuous scale score, and the registry specifies a mean and standard deviation. In general, a mean describes the average score in a group, while a standard deviation describes the spread of scores around that average. A mean difference between groups can summarize the contrast, but it needs to be interpreted in relation to the scale’s direction: scores closer to 1 are associated with a more positive outcome. The registry does not report the group summaries or an estimated difference, so no such contrast can be interpreted for this trial.

Repeated measurements. The scale was planned at baseline and multiple follow-up points. Repeated measurements can describe how scores change over time and how the pattern differs between groups. A valid analysis must make clear which time point or pattern is being estimated and how within-participant measurements are handled, because observations from the same participant are related. The statistical model, covariance structure, and prespecified primary contrast are not reported in the registry record. The record notes several outcome time points and does not reduce them to one comparison.

Estimation and uncertainty. In general, an estimate describes the size and direction of a result, and a confidence interval describes a range of values compatible with the data under the analysis assumptions. A p-value addresses how compatible the observed data are with a specified null hypothesis under those assumptions; it is not a measure of the size or practical importance of an effect. No confidence interval, p-value, or effect estimate for the primary outcome is reported in the registry record. The registry does not specify whether the planned analysis was based on a particular model or adjusted for baseline scores.

Distribution and model choices. A mean-based analysis summarizes the score numerically, but its adequacy depends on the observed distribution and the analysis assumptions. In general, investigators assess whether a model’s assumptions are reasonable and whether the outcome has features that require a different approach. The score is bounded between 1 and 5, but the registry does not report its observed distribution or the model used. No analysis details are reported that would establish whether assumptions were checked or how any departures were addressed.

Planning illustrations. The registry includes assumptions for a planning illustration based on the observed effect: a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. Numerical sample-size results for such illustrations are not reported in the registry record, and the calculation is explicitly a planning illustration rather than the trial’s design justification. Any sample-size illustration should be interpreted as a planning quantity, not as observed power or evidence that the trial did or did not detect an effect. The trial’s own sample-size justification is not reported in the registry record.

Analysis specification. The registry lists one analysis, but the detailed statistical procedure, the contrast tested, and the handling of baseline and follow-up values are not reported in the registry record. A count of analyses does not itself reveal whether a model was adjusted, which participants contributed data, or how repeated measurements were combined. These details are necessary to reproduce or fully evaluate an analysis. Without the reported results and methods, statistical interpretation must remain limited to the stated outcome definition and measurement schedule.

10. Multiplicity, Missing Data and Analysis Populations

The primary stigma outcome was planned for baseline and multiple post-baseline assessments. Multiple time points create more than one possible way to compare groups or describe change. In general, when several statistical comparisons are considered, the chance of obtaining at least one apparently notable result can increase unless the comparisons are planned and interpreted appropriately. The registry does not report a multiplicity strategy, such as a hierarchy of comparisons or an adjustment for multiple testing. It also does not identify a single time-point contrast as the primary statistical comparison.

Acceptability is listed as a secondary outcome, and the registry reports two outcome measures in total. Details of the acceptability measure and its analysis are not reported in the registry record. The number and nature of all planned comparisons, including any subgroup or sensitivity analyses, are also not reported. The record states one analysis, but it does not give enough detail to determine how that analysis relates to the several scheduled outcome time points.

Missing-data handling is not reported in the registry record. The record describes planned surveys and follow-up invitations, but it does not state how incomplete scales, missed visits, or participants without follow-up data were to be handled. It does not report the number of participants contributing data at each assessment or the reasons for missing measurements.

The analysis population is likewise not specified in sufficient detail. The record does not say whether participants were analyzed according to assigned group, whether analysis required completion of the intervention, or how participants with partial data were treated. The Phase 3 note says the Site 2 group did not participate in interviews; that statement concerns interviews and should not be assumed to describe completion of the stigma scale. Without a stated analysis population and missing-data approach, the extent to which the planned comparisons preserve the randomized assignment cannot be assessed.

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 reports zero serious adverse events, zero other adverse events, and zero deaths in each group. For Site 1, 47 participants are listed as at risk for serious adverse events and 47 as at risk for other adverse events. For Site 2, the corresponding at-risk counts are 52 and 52. The listed number of participants affected is zero for each category in both groups.

These figures describe what the registry record reports; they do not establish that no adverse events occurred outside the recorded categories or observation process. The definitions of adverse events, collection procedures, monitoring period, and completeness of reporting are not reported in the registry record. The record also lists no top serious-event terms.

Zero recorded events should therefore be read as a safety-reporting result within the registry’s stated counts, not as proof that the intervention has no risks. The at-risk counts are not the same as evidence that all participants were assessed continuously or that all possible events were captured. The record does not give additional detail needed to evaluate ascertainment or compare the groups’ safety experience beyond these counts.

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

The trial addresses a meaningful research question: whether an asynchronous arts-based educational program can be delivered to nurses and whether it may change measured stigma toward perinatal substance use. Its randomized, parallel design and defined scale provide a framework for comparing the two settings. The registry also identifies acceptability as a secondary outcome, reflecting interest in more than scale scores alone.

What the record does not establish is an observed change in stigma. There are no reported group scores, effect estimates, confidence intervals, or statistical test results. Accordingly, it is not possible to say from the registry record whether the intervention group’s scores were more positive, less positive, or similar to the control group’s scores. The record likewise does not report whether participants found the program acceptable or whether delivery was feasible.

The outcome is a measure of attitudes and beliefs, not a direct measure of clinical practice, patient experience, or care quality. Even a reported difference on the scale would need to be interpreted as a change in that measured construct, rather than automatically as evidence of changed behavior or improved care. The scale’s direction is defined: scores closer to 1 are associated with a more positive outcome. No trial results are available in the registry record to apply that interpretation to observed scores.

The study’s pilot framing also matters. A pilot can help assess delivery and inform later research, but the registry does not report the sample-size justification or numerical findings needed to judge precision. The planning assumptions listed in the record do not substitute for observed outcome estimates or a reported trial analysis. The completed status identifies the study’s administrative status, not the availability of results or evidence of an effect.

Overall, the registry supports understanding what the researchers intended to test and how they planned to measure stigma. It does not support a conclusion about the program’s effectiveness, feasibility, acceptability, or implications for clinical care.

13. Why This Trial Matters Statistically

Statistically, this trial raises questions that are central to evaluating educational interventions: how to define the outcome, how to compare randomized groups, and how to interpret measurements collected repeatedly over time. The Modified Attitudes About Drug Use in Pregnancy Scale gives the study a stated quantitative measure of stigma, while the planned assessments allow the possibility of examining both immediate and later scores.

The design description also makes the unit of assignment important. The groups are described through hospitals randomized to experimental and control settings, while outcomes are collected from participating nurses. In general, when assignment and measurement occur at different levels, the analysis needs to account for the assignment structure. The registry does not report the statistical model or enough detail about the assignment procedure to assess whether or how that structure was handled.

Another statistical issue is the multiplicity created by repeated outcome time points. Decisions about which comparison is primary, how other time points are interpreted, and whether any adjustment is used affect the meaning of reported tests. The registry does not describe those decisions. This is especially relevant in a pilot framed around feasibility and limited effectiveness, where descriptive information and estimation may be as important as a single significance test.

Finally, a clear result requires more than a completed-trial status and an outcome definition. Group summaries, a specified contrast, uncertainty estimates, analysis populations, and missing-data methods are needed to evaluate the evidence. Their absence from the registry record means that readers can identify the study’s statistical questions but cannot judge the magnitude, precision, or robustness of its findings.

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 most immediate limitation for interpretation is that outcome results are not reported in the registry record. The primary endpoint is defined, but the record gives no means, standard deviations, between-group estimates, confidence intervals, or p-values. It also does not report results for the secondary outcome of acceptability or provide findings from the invited interviews.

The planned measurement schedule spans several points and differs by site. The registry does not identify one primary time-point comparison or explain how measurements across time were analyzed. Actual completion counts at each time point and the timing of completed assessments are not reported. This makes it impossible to determine how much outcome information was available or how complete follow-up was.

The group descriptions indicate hospital-based assignment, but the randomization procedure and statistical treatment of that assignment are not reported in the registry record. The record does not specify whether analysis accounted for the way groups were assigned. It also does not report baseline characteristics by group, so the balance of measured participant characteristics cannot be assessed.

Further limitations include the absence of a reported sample-size justification, detailed analysis plan, missing-data methods, and analysis population. The control-arm description is incomplete, and the record does not fully describe survey procedures for that group. The Phase 3 note excludes the Site 2 group from interviews, but interview findings and the relationship between interview participation and the scale analyses are not reported. These omissions restrict assessment of feasibility, potential bias, and the precision of any treatment comparison.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use — NCT06410287.
• Registry record last updated 2026-03-11; status last verified 2026-03.
• Results first posted 2026-03-11.
• 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

NCT06410287 is a completed randomized, unmasked, parallel pilot trial sponsored by the University of Michigan. It enrolled 99 participants and evaluated ArtSpective, a digital arts-based educational intervention intended to address nurse stigma toward perinatal substance use. The experimental and control groups are described by hospital setting.

The primary outcome was a score on the Modified Attitudes About Drug Use in Pregnancy Scale, with scores closer to 1 associated with a more positive outcome. Measurements were planned at baseline and multiple post-baseline time points. Acceptability was listed as a secondary outcome, and participants were also invited to interviews.

The registry record does not report outcome scores, statistical estimates, or findings on feasibility or acceptability. It also does not report the detailed analysis plan, missing-data approach, or analysis populations. The adverse-event figures list zero serious events, zero other events, and zero deaths in both groups.