Trial Outcomes & Findings for A Multi-Component Alcohol and Sex Risk Intervention for College Students (NCT NCT05180539)
NCT ID: NCT05180539
Last Updated: 2025-04-30
Results Overview
Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.
COMPLETED
NA
274 participants
Immediate post intervention (same day as intervention), after first session on day 1
2025-04-30
Participant Flow
Initial recruitment occurred between 9/23/21 and 10/12/21 at two U.S. colleges
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).
Participant milestones
| Measure |
SPLASH Intervention Condition
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
140
|
|
Overall Study
COMPLETED
|
107
|
110
|
|
Overall Study
NOT COMPLETED
|
27
|
30
|
Reasons for withdrawal
| Measure |
SPLASH Intervention Condition
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
27
|
30
|
Baseline Characteristics
A Multi-Component Alcohol and Sex Risk Intervention for College Students
Baseline characteristics by cohort
| Measure |
SPLASH Intervention Condition
n=134 Participants
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=140 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
134 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
68 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender/non-binary
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Drank alcohol past 30 days
|
87 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Had unprotected sex past 30 days
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate post intervention (same day as intervention), after first session on day 1Population: 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).
Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.
Outcome measures
| Measure |
SPLASH Intervention Condition
n=99 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Would recommend program to friend (after Session 1)
|
91 Participants
|
—
|
|
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Overall Satisfaction (after Session 1)
|
86 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediate post intervention (same day as intervention), after second session on ~Day 14Population: 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 second in-person session (follow-up data was still collected for these participants).
Satisfaction with the program content after session 2. Percent of participants reporting that they were moderately-to-very satisfied with the program. For participants who did not attend the first session this occurred on Day 1. For Participants who did attend the first session this occurred around Day 14 (range between day 12 and 17)
Outcome measures
| Measure |
SPLASH Intervention Condition
n=87 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
Overall Satisfaction (After Session 2 [~ Day 14)
|
83 Participants
|
—
|
|
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
Would recommend program to friend (After Session 2) [~ Day 14)
|
83 Participants
|
—
|
PRIMARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted means are reported from a Generalized Estimating Equations (GEE) model that accounts for missing data if participants missed a follow-up survey.
Number of standard drinks consumed in a typical week over the past 30 days
Outcome measures
| Measure |
SPLASH Intervention Condition
n=106 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=109 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Heavy Alcohol Use
Baseline
|
7.1 Drinks per week
Standard Error 0.8
|
5.6 Drinks per week
Standard Error 0.7
|
|
Heavy Alcohol Use
1 month
|
6.7 Drinks per week
Standard Error 0.7
|
5.3 Drinks per week
Standard Error 0.6
|
|
Heavy Alcohol Use
6 months
|
6.0 Drinks per week
Standard Error 0.7
|
4.7 Drinks per week
Standard Error 0.6
|
PRIMARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted proportions are reported from a GEE model that accounts for missing data if participants missed a follow-up survey.
Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).
Outcome measures
| Measure |
SPLASH Intervention Condition
n=107 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=110 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Alcohol Use Before or During Sex
Baseline
|
0.3 adjusted percentage of participants
|
0.3 adjusted percentage of participants
|
|
Alcohol Use Before or During Sex
1 month
|
0.4 adjusted percentage of participants
|
0.4 adjusted percentage of participants
|
|
Alcohol Use Before or During Sex
6 months
|
0.3 adjusted percentage of participants
|
0.3 adjusted percentage of participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted means are reported from a mixed model that accounts for missing data if participants missed a follow-up survey.
Willingness to engage in bystander behaviors. Mean scale scores range from 1 to 7. Higher scores indicate more greater willingness to engage in bystander behaviors.
Outcome measures
| Measure |
SPLASH Intervention Condition
n=106 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=109 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Bystander Behaviors Willingness Questionnaire
Baseline
|
6.0 Units on a scale
Standard Error 0.1
|
5.8 Units on a scale
Standard Error 0.1
|
|
Bystander Behaviors Willingness Questionnaire
1month
|
5.1 Units on a scale
Standard Error 0.1
|
5.1 Units on a scale
Standard Error 0.1
|
|
Bystander Behaviors Willingness Questionnaire
6months
|
6.0 Units on a scale
Standard Error 0.1
|
5.9 Units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted means are reported from a GEE model that accounts for missing data if participants missed a follow-up survey.
Confidence to engage in bystander behaviors. Higher scores indicate more greater confidence in ability to engage in bystander behaviors. Mean scale scores range from 1 to 5.
Outcome measures
| Measure |
SPLASH Intervention Condition
n=106 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=109 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Bystander Behaviors Self-efficacy Questionnaire
Baseline
|
4.1 units on a scale
Standard Error .07
|
4.0 units on a scale
Standard Error .07
|
|
Bystander Behaviors Self-efficacy Questionnaire
1 month
|
4.0 units on a scale
Standard Error .09
|
4.1 units on a scale
Standard Error .09
|
|
Bystander Behaviors Self-efficacy Questionnaire
6 months
|
4.1 units on a scale
Standard Error .09
|
3.9 units on a scale
Standard Error .08
|
SECONDARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Strategies related to drinking were analyzed separately to those related to sex. Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted means are reported from a mixed model addressing missing data.
Self-reported frequency of using strategies to reduce alcohol risks and promote positive sexual experiences \[unpublished measure\]. Higher scores indicate more frequent use of protective strategies. Scores range from 0 to 5 for both subscales.
Outcome measures
| Measure |
SPLASH Intervention Condition
n=103 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=102 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Sex PBS 6 months
|
3.7 score on a scale
Standard Error .15
|
3.4 score on a scale
Standard Error .14
|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Drinking PBS 6 months
|
3.5 score on a scale
Standard Error 0.12
|
3.5 score on a scale
Standard Error .12
|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Sex PBS Baseline
|
3.4 score on a scale
Standard Error .13
|
3.2 score on a scale
Standard Error .12
|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Drinking PBS
|
3.4 score on a scale
Standard Error .10
|
3.4 score on a scale
Standard Error .09
|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Drinking PBS 1 month
|
3.6 score on a scale
Standard Error 0.12
|
3.3 score on a scale
Standard Error .11
|
|
Alcohol and Sex Related Protective Behavioral Strategies Use
Sex PBS 1 month
|
3.3 score on a scale
Standard Error 0.15
|
3.3 score on a scale
Standard Error .15
|
SECONDARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Adjusted means are reported from a Generalized Estimating Equations (GEE) model addressing missing data.
Perceived descriptive norms are assessed using a variation on the Drinking Norms Rating Form. Respondents estimate the number of standard drinks consumed by other students on their campus for each day in a typical week in the past 30 days; daily estimates are summed to yield perceived number of drinks per week for student peers; range of scores can go from zero to no upper limit
Outcome measures
| Measure |
SPLASH Intervention Condition
n=106 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=108 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form
Baseline
|
13.1 score on a scale
Standard Error .9
|
13.5 score on a scale
Standard Error .9
|
|
Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form
1 month
|
10.1 score on a scale
Standard Error .7
|
10.8 score on a scale
Standard Error .7
|
|
Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form
6 months
|
10.4 score on a scale
Standard Error .7
|
13.0 score on a scale
Standard Error .7
|
SECONDARY outcome
Timeframe: Change from baseline to 6 month follow-upPopulation: Adjusted means are reported from a mixed model addressing missing data.
Respondents estimate the percent of same-campus peers who use alcohol before or during sex
Outcome measures
| Measure |
SPLASH Intervention Condition
n=99 Participants
Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts
|
Diet and Physical Activity Condition
n=94 Participants
Control Condition: Two-session in person group discussions focusing on college health behaviors
|
|---|---|---|
|
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
Baseline Norms
|
54.6 perceived percentage of other students
Standard Error 2.4
|
56.0 perceived percentage of other students
Standard Error 2.3
|
|
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
1 month norms
|
36.7 perceived percentage of other students
Standard Error 2.5
|
52.9 perceived percentage of other students
Standard Error 2.5
|
|
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
6 month norms
|
44.1 perceived percentage of other students
Standard Error 2.6
|
54.0 perceived percentage of other students
Standard Error 2.4
|
Adverse Events
SPLASH Intervention Condition
Diet and Physical Activity Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place