Prevention of Alcohol-related Sexual Revictimization in College: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prevention of Alcohol-related Sexual Revictimization in College (NCT05257603), a randomized na study. The primary outcome is Days Per Month Hazardous Drinking.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, parallel-group pilot trial. Participants were assigned to RPCW or HEC. The registry record lists the study as completed and reports enrollment of 72. Its brief summary describes an intended study of 96 college women; the reason the recorded enrollment differs from that figure is not reported in the registry record. The record lists the sponsor as State University of New York at Buffalo, gives a start date of 2022-03-05, and gives a primary completion date of 2023-11-30.

The intervention’s stated aims were to address hazardous drinking, perception of cues that may signal sexual-assault risk, and behavioral skills in situations associated with risk. The brief summary describes two on-line education modules and two in-person group skills sessions, including problem-solving training and behavioral rehearsal. HEC is described as a time-and-attention control. The record identifies masking as single, but who was masked is not reported in the registry record.

The primary outcome was continuous: average number of hazardous drinking days per month. Follow-up intervals were baseline to post-intervention, approximately 1 to 2-weeks; post-intervention to 3-month follow-up; and 3- to 6-month follow-up. The outcome description says the number analyzed can differ across rows because participants completed different follow-up measurements. It also identifies the analysis as intent to treat, although the remaining explanation of the analysis population is incomplete in the registry record.

The record lists additional outcomes concerning emotion regulation, protective behavioral strategies, and dating self-protection against rape. It does not report the detailed allocation procedure, the identity of the masked party, or a full statistical analysis plan.

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: Participants who were screened as eligible, provided informed consent to participate, were assigned to condition and completed the first in-person session of the study protocol were considered to have entered the controlled trial. Therefore, participants could have been eligible, consented and assigned to condition, but if they did not complete the baseline measure or attend the first in-person session, they would not have been considered a participant in the clinical trial.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Change in number of participants analyzed in different rows indicates the number of participants who completed each of the follow-up measurements. In other words, it indicates the attrition from follow-up after completing the intervention. This was an intent to treat analysis, so all participants were included.

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 Days Per Month Hazardous Drinking, measured over Baseline to post-intervention (approximately 1 to 2-weeks); Post-intervention to 3-month follow up; 3- to 6-month follow up.

The primary endpoint, Days Per Month Hazardous Drinking, is a mean of a continuous measure. It counts the average number of days in a month on which a participant consumed 4 or more drinks on a given day or drinking occasion. The record says this measure was assessed at each interval, from baseline to post-intervention, post-intervention to 3-month follow-up, and 3- to 6-month follow-up.

Using a defined drinking-day threshold turns a participant’s reported drinking pattern into a count that can be compared over time and between randomized groups. The mean describes the average count in the analyzed group; the standard deviation describes how much individual values vary around that average. These are complementary summaries: a mean alone does not show whether participants had similar or widely varying drinking-day counts.

The endpoint aligns with one stated intervention aim: reducing hazardous drinking. It is not, by itself, a measure of sexual revictimization, risk-cue perception, or the full range of behavioral skills addressed by RPCW. The registry record does not report the observed means, standard deviations, changes, or between-group estimates for this endpoint. Therefore, the direction, magnitude, and precision of the posted outcome cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial used randomized allocation to compare two parallel groups. In a randomized trial, assignment is intended to make the groups comparable on average at the start of the study, including with respect to measured and unmeasured characteristics. Randomization does not guarantee exact balance in a pilot with a modest enrollment, and it does not remove uncertainty from follow-up loss or measurement. The registry record identifies the allocation as randomized, but the detailed sequence-generation and concealment procedures are not reported in the registry record.

What a continuous endpoint means

The primary measure is a count summarized as a mean: average hazardous drinking days per month. The registry definition sets the threshold at 4 or more drinks on a given day or drinking occasion. A mean is useful for describing the overall level of the measure, while the standard deviation describes participant-to-participant spread. A mean difference can summarize a contrast between groups or time points, but the registry record does not report such an estimate for this outcome.

General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while neither width nor location alone determines whether a result is practically important. A p-value describes how compatible the observed data are with a specified null model, assuming the analysis model is appropriate. The registry record does not report confidence intervals or p-values for the primary outcome.

Repeated assessment and group comparison

The registered timeframe includes multiple intervals: baseline to post-intervention, approximately 1 to 2-weeks; post-intervention to 3-month follow-up; and 3- to 6-month follow-up. Measurements from one participant across time are related rather than independent. General statistical explanation: an analysis of repeated measures should account for that within-person relationship when estimating changes or comparing trajectories. The specific model used for this trial is not reported in the registry record.

Different approaches can target different quantities. A comparison at a particular follow-up asks how the groups differ at that time. A change-score comparison asks whether average change differs between groups. A model using repeated observations can estimate a pattern across several intervals. These approaches have different assumptions and interpretations. The registry record does not provide enough detail to identify which approach produced the primary analysis, beyond describing the measure, intervals, and an intent-to-treat analysis.

Variation and model assumptions

General statistical explanation: a standard deviation describes variability among individual observations; it is not the same as the uncertainty in a group mean. A model for a continuous outcome often relies on assumptions about the distribution of observations or model residuals. Counts can be skewed or show greater variability than a simple model expects. Over-dispersion means that variability exceeds what a chosen count model anticipates; if present and ignored, standard errors and confidence intervals may be misleading. This is a general consideration, not a reported finding about these trial data. The registry record does not identify a distributional model, diagnostics, or any correction for over-dispersion.

Because the endpoint is defined as a mean, the posted analysis would need to be interpreted in light of how it handled repeated measurements, variable follow-up, and the observed distribution. No such results or model details are reported in the registry record. The standard deviation is named as the dispersion measure, but numerical values are not reported.

Planning calculations and observed results

General statistical explanation: a sample-size calculation describes the amount of information a future study might need under specified assumptions, such as a target effect, significance level, allocation, and power. A planning illustration based on an observed effect is not an observed-power estimate and does not establish that the trial was adequately powered. The registry record describes planning assumptions for illustrations, including a two-sided significance level of 0.05, equal allocation, and a normal approximation. It does not report a completed primary-outcome estimate on which to base a numerical interpretation of those illustrations, and it does not report the trial’s own sample-size justification.

The record includes no numerical primary-outcome results to recalculate. No independent estimate should be inferred from the enrollment or intervention descriptions. Details about interim analyses, model specification, covariate adjustment, and statistical software are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 8 outcome measures and 8 analyses. The primary outcome is hazardous drinking days per month. Secondary outcomes include the Difficulties in Emotion Regulation Scale, the State Difficulties in Emotion Regulation Scale, the Protective Behavioral Strategies Scale, and the Dating Self-Protection Against Rape Scale. The record does not report results for these measures in the material.

When a study examines multiple outcomes, time points, or comparisons, the chance of at least one apparently unusual result can increase if every test is interpreted separately without accounting for the family of tests. General statistical explanation: multiplicity procedures can adjust significance thresholds or confidence intervals, while a prespecified hierarchy can distinguish a primary question from exploratory ones. The analysis plan for multiplicity, including whether any adjustment was used, is not reported in the registry record. The presence of several analyses alone does not show that a particular correction was required or applied.

The primary outcome description states that the analysis was intent to treat. It also explains that changes in the number analyzed across rows reflect completion of follow-up measurements, indicating attrition after intervention. The detailed missing-data method, the number with missing observations at each assessment, and any sensitivity analyses are not reported in the registry record. Intent-to-treat labeling does not, on its own, specify how missing measurements were handled or guarantee that every randomized participant contributed an observed value at every time point.

The record does not describe the exact analysis population, protocol deviations, or how participants with incomplete follow-up were included in each estimate. These omissions limit assessment of the effects of missingness and of the multiplicity strategy.

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 record lists 37 participants at risk in the RPCW arm and 35 in the HEC arm. It reports 0 serious events affecting participants in either arm, 0 other events affecting participants in either arm, and 0 deaths in either arm. No serious event terms are listed.

These figures should be read as the adverse-event information recorded for the trial, not as proof that no adverse experiences occurred. A recorded count of zero means that the registry record reports zero affected participants for that category; it does not establish that every possible harm was assessed or that an event could not have occurred outside the reporting definitions or collection period. The record does not provide further detail on event definitions, monitoring procedures, or the timing and completeness of adverse-event collection.

The different numbers at risk reflect the arm-specific counts reported in the safety record. They are not outcome-effect estimates and do not establish comparative safety. With no reported event terms and no additional safety detail, the figures support only a narrow description of what was entered in the registry record.

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

The registry record establishes that a completed randomized pilot trial compared RPCW with HEC and selected hazardous drinking days per month as its primary outcome. It describes an intended population of college women with a history of sexual assault and recent hazardous drinking, and explains that the intervention addressed drinking, risk-cue perception, and behavioral skills. The record also gives the follow-up intervals and describes HEC as a time-and-attention control.

Those design details do not establish an intervention effect. The registry record does not report the primary-outcome means, changes, between-group estimates, confidence intervals, or significance tests. It is therefore not possible to say from the record whether the groups differed on hazardous drinking days, in which direction a difference may have gone, or how precise any estimate was. Nor can the stated aims be treated as demonstrated results.

The outcome is one part of a wider set of concerns addressed by the study. A change in hazardous drinking days would not alone establish a change in sexual revictimization, perception of risk cues, or behavioral skills. Conversely, the record’s lack of posted outcome estimates does not establish that there was no difference. It leaves the comparative result unreported.

The registry reports 72 enrolled participants, while its brief summary describes an intended sample of 96. That difference is relevant context for interpreting the study’s scale, but the reason is not reported in the registry record. Changing numbers analyzed across follow-up measurements also indicate that follow-up completion varied. Without detailed estimates and missing-data methods, the degree to which incomplete follow-up affected the results cannot be assessed.

Accordingly, the record supports a description of the research question, design, outcome definition, and recorded safety counts. It does not support a quantitative conclusion about the effectiveness or safety of either condition.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a pilot randomized study can address both feasibility-related questions and initial outcome measurement. The brief summary identifies feasibility of recruitment, acceptability, safety, and initial efficacy data as goals. The registered primary endpoint is a defined continuous measure, hazardous drinking days per month, assessed over several intervals. Clear endpoint definitions and timing are important because they determine what a group comparison would mean.

At the same time, the registry record reports enrollment of 72 and describes an intended enrollment of 96 in its brief summary. The reason for the difference is not reported in the registry record. A pilot’s observed data can inform planning for a later study, but estimates from a small study may be imprecise. Planning illustrations are not observed power and should not be confused with evidence that a result has or has not been established.

The study also highlights the importance of follow-up completeness. The record says the number analyzed varies because participants completed different follow-up measurements. Such variation affects how much information is available at each interval and makes transparent reporting of missing-data methods important. The record identifies an intent-to-treat analysis but does not describe the missing-data procedures.

Finally, the intervention has multiple stated aims and the record lists multiple outcome measures and analyses. This makes it important to distinguish the primary question from secondary or exploratory questions and to report how multiplicity was handled. The analysis plan and outcome estimates are not reported in the registry record, so the statistical contribution that can be assessed is chiefly the trial’s design and measurement framework rather than its comparative 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 direct limitation of interpretation is that the registry record does not report numerical results for the primary outcome. There are no means, standard deviations, changes, between-group estimates, confidence intervals, or p-values for hazardous drinking days per month. The direction, magnitude, and precision of any observed contrast therefore remain unknown from this record.

The record reports enrollment of 72, while the brief summary describes a planned study of 96. The reason for the difference is not reported in the registry record. The primary outcome description also notes that the number analyzed varies across follow-up rows because participants completed different measurements. Although the analysis is labeled intent to treat, the specific missing-data method and follow-up completion counts by assessment are not reported.

Other details needed for a fuller assessment are absent. The registry record does not identify who was masked, describe the randomization procedures, specify the statistical model, or report an analysis plan for multiplicity. It does not report whether interim analyses occurred, how outcome distributions were assessed, or whether sensitivity analyses were performed. These details should not be inferred from the trial’s design label or outcome descriptions.

The listed primary endpoint measures hazardous drinking days, not sexual revictimization itself. The trial’s broader stated aims therefore extend beyond what can be inferred from this single endpoint. The record lists secondary measures, but does not report their numerical findings in the information. Safety reporting is also limited to the recorded counts and does not include additional event-collection detail.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Prevention of Alcohol-related Sexual Revictimization in College — NCT05257603.
• Registry record last updated 2024-12-31; status last verified 2024-12.
• Results first posted 2024-12-31.
• 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

NCT05257603 is a completed randomized, single-masked, parallel-group pilot trial sponsored by State University of New York at Buffalo. The record lists enrollment of 72, with a start date of 2022-03-05 and primary completion date of 2023-11-30. Its brief summary describes an intended enrollment of 96; the reason for the difference is not reported in the registry record.

The trial compared Revictimization Prevention for College Women with a Health Education Control among college women. The primary outcome was mean hazardous drinking days per month, assessed across intervals from baseline through 6-month follow-up. The registry record describes the analysis as intent to treat and notes varying follow-up completion. It lists 8 outcome measures and 8 analyses, but does not report numerical primary-outcome estimates or the detailed statistical and missing-data methods.

The safety record lists 0 serious events, 0 other events, and 0 deaths in both arms. These counts describe registry reporting and do not provide a complete assessment of safety.