College Drinking
Conditions
Brief summary
Hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. The current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). The study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. Preliminary evidence of intervention efficacy will also be evaluated.
Interventions
BEHAVIORALSPLASH Intervention Condition
Two-session in person group discussions focusing on behaviors in drinking contexts
BEHAVIORALControl Condition
Two-session in person group discussions focusing on college health behaviors
Sponsors
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lehigh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be student at the site university
Exclusion criteria
* Students who have participated in relevant site specific studies will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bystander Behaviors Self-efficacy Questionnaire | Change from baseline to 6 month follow-up | 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. |
| Heavy Alcohol Use | Change from baseline to 6 month follow-up | Number of standard drinks consumed in a typical week over the past 30 days |
| Alcohol Use Before or During Sex | Change from baseline to 6 month follow-up | Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0). |
| Bystander Behaviors Willingness Questionnaire | Change from baseline to 6 month follow-up | 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. |
| Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session | Immediate post intervention (same day as intervention), after first session on day 1 | Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program. |
| Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session | Immediate post intervention (same day as intervention), after second session on ~Day 14 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | Change from baseline to 6 month follow-up | 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 |
| Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire | Change from baseline to 6 month follow-up | Respondents estimate the percent of same-campus peers who use alcohol before or during sex |
| Alcohol and Sex Related Protective Behavioral Strategies Use | Change from baseline to 6 month follow-up | 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. |
Countries
United States
Participant flow
Recruitment details
Initial recruitment occurred between 9/23/21 and 10/12/21 at two U.S. colleges
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| SPLASH Intervention Condition SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts | 134 |
| Diet and Physical Activity Condition Control Condition: Two-session in person group discussions focusing on college health behaviors | 140 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 30 |
Baseline characteristics
| Characteristic | SPLASH Intervention Condition | Diet and Physical Activity Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 134 Participants | 140 Participants | 274 Participants |
| Drank alcohol past 30 days | 87 Participants | 94 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 20 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 120 Participants | 228 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Had unprotected sex past 30 days | 36 Participants | 41 Participants | 77 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 34 Participants | 28 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 12 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 78 Participants | 85 Participants | 163 Participants |
| Region of Enrollment United States | 134 Participants | 140 Participants | 274 Participants |
| Sex/Gender, Customized Female | 64 Participants | 58 Participants | 122 Participants |
| Sex/Gender, Customized Male | 68 Participants | 76 Participants | 144 Participants |
| Sex/Gender, Customized Transgender/non-binary | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 110 |
| other Total, other adverse events | 0 / 107 | 0 / 110 |
| serious Total, serious adverse events | 0 / 107 | 0 / 110 |
Outcome results
Primary
Alcohol Use Before or During Sex
Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).
Time frame: Change from baseline to 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPLASH Intervention Condition | Alcohol Use Before or During Sex | Baseline | 0.3 adjusted percentage of participants |
| SPLASH Intervention Condition | Alcohol Use Before or During Sex | 1 month | 0.4 adjusted percentage of participants |
| SPLASH Intervention Condition | Alcohol Use Before or During Sex | 6 months | 0.3 adjusted percentage of participants |
| Diet and Physical Activity Condition | Alcohol Use Before or During Sex | 6 months | 0.3 adjusted percentage of participants |
| Diet and Physical Activity Condition | Alcohol Use Before or During Sex | Baseline | 0.3 adjusted percentage of participants |
| Diet and Physical Activity Condition | Alcohol Use Before or During Sex | 1 month | 0.4 adjusted percentage of participants |
Primary
Bystander Behaviors Self-efficacy Questionnaire
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.
Time frame: Change from baseline to 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Bystander Behaviors Self-efficacy Questionnaire | Baseline | 4.1 units on a scale | Standard Error 0.07 |
| SPLASH Intervention Condition | Bystander Behaviors Self-efficacy Questionnaire | 1 month | 4.0 units on a scale | Standard Error 0.09 |
| SPLASH Intervention Condition | Bystander Behaviors Self-efficacy Questionnaire | 6 months | 4.1 units on a scale | Standard Error 0.09 |
| Diet and Physical Activity Condition | Bystander Behaviors Self-efficacy Questionnaire | Baseline | 4.0 units on a scale | Standard Error 0.07 |
| Diet and Physical Activity Condition | Bystander Behaviors Self-efficacy Questionnaire | 1 month | 4.1 units on a scale | Standard Error 0.09 |
| Diet and Physical Activity Condition | Bystander Behaviors Self-efficacy Questionnaire | 6 months | 3.9 units on a scale | Standard Error 0.08 |
Primary
Bystander Behaviors Willingness Questionnaire
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.
Time frame: Change from baseline to 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Bystander Behaviors Willingness Questionnaire | 6months | 6.0 Units on a scale | Standard Error 0.1 |
| SPLASH Intervention Condition | Bystander Behaviors Willingness Questionnaire | Baseline | 6.0 Units on a scale | Standard Error 0.1 |
| SPLASH Intervention Condition | Bystander Behaviors Willingness Questionnaire | 1month | 5.1 Units on a scale | Standard Error 0.1 |
| Diet and Physical Activity Condition | Bystander Behaviors Willingness Questionnaire | 6months | 5.9 Units on a scale | Standard Error 0.1 |
| Diet and Physical Activity Condition | Bystander Behaviors Willingness Questionnaire | Baseline | 5.8 Units on a scale | Standard Error 0.1 |
| Diet and Physical Activity Condition | Bystander Behaviors Willingness Questionnaire | 1month | 5.1 Units on a scale | Standard Error 0.1 |
Primary
Heavy Alcohol Use
Number of standard drinks consumed in a typical week over the past 30 days
Time frame: Change from baseline to 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Heavy Alcohol Use | Baseline | 7.1 Drinks per week | Standard Error 0.8 |
| SPLASH Intervention Condition | Heavy Alcohol Use | 1 month | 6.7 Drinks per week | Standard Error 0.7 |
| SPLASH Intervention Condition | Heavy Alcohol Use | 6 months | 6.0 Drinks per week | Standard Error 0.7 |
| Diet and Physical Activity Condition | Heavy Alcohol Use | Baseline | 5.6 Drinks per week | Standard Error 0.7 |
| Diet and Physical Activity Condition | Heavy Alcohol Use | 1 month | 5.3 Drinks per week | Standard Error 0.6 |
| Diet and Physical Activity Condition | Heavy Alcohol Use | 6 months | 4.7 Drinks per week | Standard Error 0.6 |
Primary
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.
Time frame: Immediate post intervention (same day as intervention), after first session on day 1
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPLASH Intervention Condition | Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session | Overall Satisfaction (after Session 1) | 86 Participants |
| SPLASH Intervention Condition | 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
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
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)
Time frame: Immediate post intervention (same day as intervention), after second session on ~Day 14
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPLASH Intervention Condition | Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session | Overall Satisfaction (After Session 2 [~ Day 14) | 83 Participants |
| SPLASH Intervention Condition | Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session | Would recommend program to friend (After Session 2) [~ Day 14) | 83 Participants |
Secondary
Alcohol and Sex Related Protective Behavioral Strategies Use
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.
Time frame: Change from baseline to 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS | 3.4 score on a scale | Standard Error 0.1 |
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS 1 month | 3.6 score on a scale | Standard Error 0.12 |
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS 6 months | 3.5 score on a scale | Standard Error 0.12 |
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS Baseline | 3.4 score on a scale | Standard Error 0.13 |
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS 1 month | 3.3 score on a scale | Standard Error 0.15 |
| SPLASH Intervention Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS 6 months | 3.7 score on a scale | Standard Error 0.15 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS 1 month | 3.3 score on a scale | Standard Error 0.15 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS | 3.4 score on a scale | Standard Error 0.09 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS Baseline | 3.2 score on a scale | Standard Error 0.12 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS 1 month | 3.3 score on a scale | Standard Error 0.11 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Sex PBS 6 months | 3.4 score on a scale | Standard Error 0.14 |
| Diet and Physical Activity Condition | Alcohol and Sex Related Protective Behavioral Strategies Use | Drinking PBS 6 months | 3.5 score on a scale | Standard Error 0.12 |
Secondary
Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form
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
Time frame: Change from baseline to 6 month follow-up
Population: Adjusted means are reported from a Generalized Estimating Equations (GEE) model addressing missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | Baseline | 13.1 score on a scale | Standard Error 0.9 |
| SPLASH Intervention Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | 1 month | 10.1 score on a scale | Standard Error 0.7 |
| SPLASH Intervention Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | 6 months | 10.4 score on a scale | Standard Error 0.7 |
| Diet and Physical Activity Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | Baseline | 13.5 score on a scale | Standard Error 0.9 |
| Diet and Physical Activity Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | 1 month | 10.8 score on a scale | Standard Error 0.7 |
| Diet and Physical Activity Condition | Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form | 6 months | 13.0 score on a scale | Standard Error 0.7 |
Secondary
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
Respondents estimate the percent of same-campus peers who use alcohol before or during sex
Time frame: Change from baseline to 6 month follow-up
Population: Adjusted means are reported from a mixed model addressing missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPLASH Intervention Condition | Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire | Baseline Norms | 54.6 perceived percentage of other students | Standard Error 2.4 |
| SPLASH Intervention Condition | 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 |
| SPLASH Intervention Condition | 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 |
| Diet and Physical Activity Condition | Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire | Baseline Norms | 56.0 perceived percentage of other students | Standard Error 2.3 |
| Diet and Physical Activity Condition | Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire | 1 month norms | 52.9 perceived percentage of other students | Standard Error 2.5 |
| Diet and Physical Activity Condition | Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire | 6 month norms | 54.0 perceived percentage of other students | Standard Error 2.4 |