A Multi-Component Alcohol and Sex Risk Intervention for College Students: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Multi-Component Alcohol and Sex Risk Intervention for College Students (NCT05180539), a randomized na study. The primary outcome is Heavy Alcohol Use.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, parallel-group behavioral trial with a planned enrollment of 274 participants. The registry lists the study as completed, with Lehigh University as sponsor. The study started on 2021-09-23, and primary completion was recorded as 2022-05-08. The phase is listed as NA.

The registry describes the project as a small randomized pilot trial. Its stated aims included demonstrating the feasibility and acceptability of recruitment methods and the research design, as well as evaluating preliminary evidence of intervention efficacy. These aims are important context: a pilot can examine whether study procedures are workable while also collecting outcome data, but those aims do not by themselves establish that the outcome data were analyzed or that an intervention effect was demonstrated.

Participants were assigned to the SPLASH Intervention Condition or a comparator described as the Diet and Physical Activity Condition. Both were behavioral conditions involving in-person group sessions. The intervention addressed alcohol harm reduction and intervening to reduce sexual violence in drinking contexts; the comparator addressed healthy eating and physical activity. The registry does not report the randomization procedure, how allocation was concealed, the masking procedures, or who was masked.

The primary outcome was heavy alcohol use, assessed as change from baseline to 6 month follow-up. The listed secondary outcomes concern protective behaviors related to alcohol and sex, perceived student drinking norms, and perceived student sex norms. The record lists 9 outcome measures, but it does not give a complete account of their results or analyses. The number of analyses is listed as 0. Further details of the planned statistical analysis 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: Participants who consented to participate were not assigned to condition if: (1) they were unavailable to attend intervention meetings, (2) they expressed they were no longer interested in participating after completing baseline assessment, or (3) they withdrew for unknown reasons prior to randomization (e.g., they did not complete information necessary to sign up to attend the intervention sessions).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Program satisfaction not examined in control condition (diet and physical activity group). Missing data reflects the study design. Participants could attend 1 or 2 study sessions. Data is missing for participants who did not attend the first in-person session (follow-up data was still collected for these participants).

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 Heavy Alcohol Use, measured over Change from baseline to 6 month follow-up.

Heavy alcohol use was the primary outcome. It was measured as the number of standard drinks consumed in a typical week over the past 30 days, expressed as drinks per week. The outcome timeframe was change from baseline to 6 month follow-up. This is a continuous measure, and the registry identifies its parameter as a mean, with standard error as the dispersion measure.

As a general statistical concept, a continuous measure can retain information about different levels of reported consumption rather than reducing the outcome to a category such as present or absent. Comparing change over follow-up can describe how the measured outcome shifted from baseline in each randomized group. A comparison between groups is needed to assess whether the observed changes differed between the assigned conditions. The registry record does not report group means, changes, a between-group estimate, or its uncertainty, so the size and precision of any difference cannot be described.

The outcome is relevant to the study’s stated focus on hazardous alcohol use. Its interpretation depends on the definition and time window: the measure concerns a typical week over the past 30 days, rather than a count of all drinks consumed across the entire follow-up period. The posted record does not report additional measurement details, such as how the questionnaire was administered or how incomplete responses were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization, masking, and parallel assignment describe aspects of how a trial is organized, but they do not substitute for outcome results. The registry identifies this study as randomized, single-masked, and parallel. It does not explain the sequence-generation method, allocation concealment, the identity of the masked people, or whether masking remained intact. Those details are not reported in the registry record.

What does randomization contribute?

General statistical explanation: Random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics at the start of a trial. It supports a causal comparison when participants are analyzed according to their randomized groups and when follow-up and outcome measurement are adequately handled. Randomization does not guarantee that groups will be identical, especially in a pilot, and it does not remove the need to report baseline data, participant flow, outcome estimates, and uncertainty. The registry record does not provide those details for this comparison.

What does a parallel design mean?

General statistical explanation: In a parallel-group design, participants are assigned to a condition and assessed over follow-up while remaining in that assigned group. The trial identifies SPLASH and a Diet and Physical Activity comparator. The registry does not report whether the main analysis followed the assigned groups regardless of participation, or whether another analysis population was used. The distinction matters because excluding participants after randomization can affect how well a comparison preserves the balance created by assignment.

How should change in a continuous outcome be understood?

General statistical explanation: A change outcome describes the difference between a participant’s measurement at follow-up and their baseline measurement. A group-level summary can report the mean change, while a between-group estimate compares the groups’ changes. The registry describes the primary outcome as change from baseline to 6 month follow-up and identifies the mean as the parameter. It does not report the direction or magnitude of change in either group, nor the method used to compare changes.

The standard error describes the precision of an estimated mean under a statistical model; it is not a measure of how much individual participants vary. A confidence interval, when reported, uses an estimate and its standard error to convey a range of values compatible with the data and model. A narrow interval indicates greater precision than a wide interval, while neither interval alone establishes that a result is clinically important. No outcome standard errors or confidence intervals are reported in the registry record.

What does over-dispersion mean in general?

General statistical explanation: Over-dispersion occurs when observed variability is greater than a statistical model assumes. It can make standard errors too small if the model does not account for that extra variability, which in turn can make intervals too narrow and statistical tests too optimistic. This concept is especially relevant to some count outcomes. The primary outcome is identified as a continuous mean measure, and the registry does not report a model or an over-dispersion assessment. It would not be appropriate to claim that over-dispersion was present or that a correction was used.

What can be inferred from the planning assumptions?

The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. However, no planning participant counts or effect-size values are included in the record. The registry does not report the trial’s own sample-size justification, and the planning assumptions should not be treated as that justification.

General statistical explanation: A sample-size calculation is a planning tool for estimating how many participants may be needed under specified assumptions. An illustration based on an observed effect is conditional on that effect and the stated assumptions; it does not show that the trial had a particular probability of detecting an effect after the fact. Such a calculation is not observed power, and it cannot replace reporting the estimate, uncertainty, and analysis results. No completed-trial power conclusion can be drawn from the planning description.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures and names secondary outcomes concerning alcohol and sex related protective behavioral strategies, perceived student drinking norms, and perceived student sex norms. Multiple outcomes and comparisons can create a multiplicity issue: when many statistical tests are considered, the chance of at least one apparently unusual result can increase. General statistical explanation: Researchers may address this by defining a primary outcome in advance, specifying a testing sequence, or adjusting inference across tests. The registry does not report whether any such approach was planned or used.

The number of analyses is listed as 0, and outcome-specific statistical results are not reported. The primary endpoint is identified, but the record does not state whether the secondary outcomes were confirmatory or exploratory, how many comparisons were planned, or whether subgroup analyses were considered. A multiplicity adjustment, if any, is not reported in the registry record.

The registry describes an analysis sample requiring completion of the baseline survey, attendance at at least one in-person group meeting, and completion of at least one follow-up survey. It also says that participants who did not complete the 1 month follow-up could still complete the 6 month follow-up. The description ends after referring to the 1 month or 6 month follow-up, so no additional eligibility detail can be inferred from that wording. The numbers meeting the stated criteria are not reported.

The record does not explain how missing outcome data were handled. Imputation, complete-case analysis, sensitivity analyses, and reasons for missingness are not reported in the registry record. General statistical explanation: Missing data can affect estimates when participants with observed outcomes differ systematically from those without them. The implications depend on why data are missing and on the methods used to address them. Without follow-up counts and a stated analysis approach, the effect of missing data on the comparison 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 lists serious adverse event counts for the SPLASH Intervention Condition and the Diet and Physical Activity Condition. For the SPLASH group, 107 participants are listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For the Diet and Physical Activity group, 110 participants are listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths.

These are the posted counts, not a comparison adjusted for follow-up time or participant characteristics. The registry record does not provide event descriptions, follow-up duration for safety, or an explanation of how the at-risk denominators were determined. No serious adverse event terms are listed.

General statistical explanation: A count of zero reported events does not establish that an event is impossible or that the true event frequency is zero. The interpretation depends on the amount and duration of observation, how events were defined and collected, and the completeness of reporting. The posted counts should therefore be read as the registry’s reported safety figures, rather than as proof of an absence of all possible harms.

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

The record establishes that a randomized behavioral pilot trial was conducted to evaluate a multi-component intervention for college students. It identifies the primary outcome as change in heavy alcohol use from baseline to 6 month follow-up and describes the intervention and comparator sessions. It also reports serious adverse event counts for the two listed conditions.

The record does not establish whether the intervention changed alcohol use relative to the comparator. No primary outcome group summaries, between-group estimate, confidence interval, or p-value are reported. The listed safety counts do not supply evidence about alcohol-use effects, and they cannot resolve the missing efficacy results.

The study’s stated goals included assessing feasibility and acceptability and evaluating preliminary evidence of efficacy. Those goals describe what the study sought to examine; the registry does not report whether recruitment or study procedures were feasible or acceptable. Nor does it report results for the secondary outcomes. The number of outcome measures listed should not be treated as the number of outcomes with analyzable results.

General statistical explanation: An estimate is most informative when accompanied by an uncertainty interval and details about who was included in the analysis. Statistical significance, if reported, would address compatibility with a specified statistical model and null hypothesis; it would not by itself determine practical importance. Conversely, a non-significant result would not prove that groups are equivalent. Since no inferential result is posted, neither interpretation applies to this trial record.

The appropriate conclusion is limited: the registry describes a completed randomized pilot and its intended outcome, but the posted information is insufficient to quantify or judge the comparative outcome. Further conclusions would require results and methods that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registry description combines a pilot purpose with a planned comparison of a continuous behavioral outcome. A pilot may be useful for examining recruitment, retention, acceptability, and the practicality of delivering group sessions. Those questions can inform the design of later research, but they require their own measures and results. The registry record does not report those findings.

The primary endpoint is described in a way that makes the intended measurement interpretable: heavy alcohol use is represented by drinks per week, defined through consumption in a typical week over the past 30 days, and assessed as change from baseline to 6 month follow-up. Yet a clear definition alone is not enough to evaluate an intervention effect. The estimate, uncertainty, analysis population, and handling of incomplete follow-up are also important, and those details are not posted.

The record also names secondary outcomes spanning protective strategies and perceived norms. These may reflect different aspects of the study’s stated alcohol and sex risk focus, but the results and the approach to multiple outcomes are not reported. Without that information, readers cannot distinguish planned secondary analyses from results selected after looking at the data.

Finally, the registry’s planning description should be kept separate from evidence about the completed trial. Planning calculations rely on assumptions; they do not show what the trial observed or how precise its estimates were. The central statistical lesson is the distinction between a defined question and a reported answer: the question and design are described, while the numerical outcome findings needed to answer it are absent from the registry record.

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 main limitation for interpreting this trial is that the registry record does not report primary or secondary outcome results. There are no posted group summaries, between-group estimates, or measures of uncertainty for heavy alcohol use. As a result, the comparative effect and its precision cannot be assessed.

The registry’s description of the primary analysis population is incomplete: it specifies baseline survey completion, attendance at at least one in-person group meeting, and completion of at least one follow-up survey, but the final parenthetical is truncated after referring to the 1 month or 6 month follow-up. Actual participant flow and the number included in each outcome analysis are not reported.

Statistical methods are sparsely described. The randomization procedure, allocation concealment, masking details, analysis model, treatment of missing data, multiplicity approach, and sensitivity analyses are not reported in the registry record. The number of analyses is listed as 0, so no analysis-specific estimate can be reviewed.

The intervention list uses Control Condition, while the arm descriptions identify Diet and Physical Activity Condition as the comparator. The record does not explain this naming difference. It also does not report adherence, session attendance by group, or implementation fidelity. These omissions limit interpretation of how the assigned conditions were delivered and how participants contributed data.

Finally, the listed serious adverse event counts do not include event narratives or details about safety follow-up. These limitations concern what can be learned from the posted registry information; they do not establish that the unreported methods or results were absent from the conduct of the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Multi-Component Alcohol and Sex Risk Intervention for College Students — NCT05180539.
• Registry record last updated 2025-04-30; status last verified 2025-04.
• Results first posted 2025-04-30.
• 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

NCT05180539 is a completed randomized, single-masked, parallel behavioral pilot sponsored by Lehigh University. The registry lists planned enrollment of 274 and identifies college drinking as the condition. The study description concerns a multi-component alcohol and sex risk intervention for college men and women ages 18-24. The SPLASH condition involved in-person sessions on alcohol harm reduction and intervening to reduce sexual violence in drinking contexts; the comparator is described as a Diet and Physical Activity Condition.

The primary outcome was change in heavy alcohol use from baseline to 6 month follow-up, measured in drinks per week. The registry also lists secondary outcomes concerning protective strategies and perceived student norms. It reports 9 outcome measures and 0 analyses. Outcome results and detailed statistical methods are not reported in the registry record.

Serious adverse events, other adverse events, and deaths are each listed as 0 in both groups, with 107 and 110 participants listed as at risk, respectively. These figures are registry counts and do not provide a comparative efficacy result.