Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R34AA026032 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPLASH Intervention Condition | Experimental | Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts |
|
| Diet and Physical Activity Condition | Other | Two in-person group sessions addressing increasing healthy eating and physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPLASH Intervention Condition | Behavioral | Two-session in person group discussions focusing on behaviors in drinking contexts |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate post intervention (same day as intervention), after first session on day 1 |
| 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) | Immediate post intervention (same day as intervention), after second session on ~Day 14 |
| Heavy Alcohol Use | Number of standard drinks consumed in a typical week over the past 30 days | Change from baseline to 6 month follow-up |
| 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). | Change from baseline to 6 month follow-up |
| 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. | Change from baseline to 6 month follow-up |
| Bystander Behaviors Self-efficacy Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 6 month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lucy Napper, PhD | Lehigh University | Principal Investigator |
| Shannon Kenney, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh University | Bethlehem | Pennsylvania | 18015 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Initial recruitment occurred between 9/23/21 and 10/12/21 at two U.S. colleges
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SPLASH Intervention Condition | SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts |
| FG001 | Diet and Physical Activity Condition | Control Condition: Two-session in person group discussions focusing on college health behaviors |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SPLASH Intervention Condition | SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts |
| BG001 | Diet and Physical Activity Condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Immediate post intervention (same day as intervention), after first session on day 1 |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPLASH Intervention Condition | SPLASH Intervention Condition: Two-session in person group discussions focusing on behaviors in drinking contexts |
Not provided
Not provided
Trial was primarily designed to test feasibility and acceptability and not powered sufficiently to detect group differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucy Napper | Lehigh University | 610 758 4689 | lun214@lehigh.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Sep 30, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000067292 | Alcohol Drinking in College |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Condition | Behavioral | Two-session in person group discussions focusing on college health behaviors |
|
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.
| Change from baseline to 6 month follow-up |
| 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 | Change from baseline to 6 month follow-up |
| 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 | Change from baseline to 6 month follow-up |
Control Condition: Two-session in person group discussions focusing on college health behaviors
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Drank alcohol past 30 days | Count of Participants | Participants |
|
| Had unprotected sex past 30 days | Count of Participants | 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) | 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). | Posted | Count of Participants | Participants | Immediate post intervention (same day as intervention), after second session on ~Day 14 |
|
|
|
| Primary | Heavy Alcohol Use | Number of standard drinks consumed in a typical week over the past 30 days | 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. | Posted | Mean | Standard Error | Drinks per week | Change from baseline to 6 month follow-up |
|
|
|
| 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). | 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. | Posted | Number | adjusted percentage of participants | Change from baseline to 6 month follow-up |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | Units on a scale | Change from baseline to 6 month follow-up |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Change from baseline to 6 month follow-up |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | Change from baseline to 6 month follow-up |
|
|
|
| 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 | Adjusted means are reported from a Generalized Estimating Equations (GEE) model addressing missing data. | Posted | Mean | Standard Error | score on a scale | Change from baseline to 6 month follow-up |
|
|
|
| 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 | Adjusted means are reported from a mixed model addressing missing data. | Posted | Mean | Standard Error | perceived percentage of other students | Change from baseline to 6 month follow-up |
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Diet and Physical Activity Condition | Control Condition: Two-session in person group discussions focusing on college health behaviors | 0 | 110 | 0 | 110 | 0 | 110 |
Not provided
Not provided
|
| 6 months |
|
| 6 months |
|
| 6months |
|
| 6 months |
|
| Drinking PBS 1 month |
|
|
| Drinking PBS 6 months |
|
|
| Sex PBS Baseline |
|
|
| Sex PBS 1 month |
|
|
| Sex PBS 6 months |
|
|
| 6 months |
|
| 6 month norms |
|