Alcohol Drinking, Sexual Assault
Conditions
Brief summary
Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.
Detailed description
Specific aims are as follows: Aim 1 (Stage IA): Modify Alcohol and Sexual Assault Prevention (ASAP) content to an eHealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities). Aim 1a: Assess normative behaviors (n = 500) regarding alcohol use and SA for feedback. Aim 1b: Adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group \[n=5 from each group\]). Aim 2 (Stage IB): Open Pilot Trial. Obtain usability of ASAP among 30 students who engage in HED (10 from each risk group) in an open pilot trial. Aim 3 (Stage IB): A pilot to assess effect size and variability for planning a randomized trial in the future. Randomize students who engage in HED to ASAP or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. Sample size was determined to estimate the variability within a reasonable margin of error. This calculation also accounted the low base rates of SA and 20% attrition. This led to a sample size of 162 students (n=54 from each risk group).
Interventions
BEHAVIORALPositive Change (+Change)
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Sponsors
Arizona State University
Medical University of South Carolina
Rhode Island Hospital
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will receive an online intervention targeting alcohol misuse and sexual assault among college students. This will include a personalized normative feedback approach. In the first part of the study, there will be an open pilot (1 arm) and in the second part of the study there will be a control condition (2 arms - intervention + control)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-25 years old * Current student at university of study * Valid email address at university of study * Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment and Recruitment | within 2 year recruitment period | Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study |
| Feasibility of Retention | within 3 months of baseline participation | Feasibility of retention was assessed by the number of participants retained in the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control This is an assessment only control condition. | 82 |
| Positive Change (+Change) This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Positive Change (+Change): This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation. | 83 |
| Total | 165 |
Baseline characteristics
| Characteristic | Total | Control | Positive Change (+Change) |
|---|---|---|---|
| Age, Continuous | 20.35 years STANDARD_DEVIATION 1.62 | 20.5 years STANDARD_DEVIATION 1.59 | 20.2 years STANDARD_DEVIATION 1.66 |
| Enrolled in the study before the COVID-19 pandemic | 87 Participants | 38 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 24 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 58 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized More than One Race | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Prefer not to Answer | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 121 Participants | 63 Participants | 58 Participants |
| Region of Enrollment United States | 165 Participants | 82 Participants | 83 Participants |
| Sex/Gender, Customized Cisgender heterosexual man | 57 Participants | 29 Participants | 28 Participants |
| Sex/Gender, Customized Cisgender heterosexual woman | 54 Participants | 27 Participants | 27 Participants |
| Sex/Gender, Customized Sexual or gender minority | 54 Participants | 26 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 83 |
| other Total, other adverse events | 0 / 82 | 0 / 83 |
| serious Total, serious adverse events | 0 / 82 | 0 / 83 |
Outcome results
Primary
Feasibility of Enrollment and Recruitment
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Time frame: within 2 year recruitment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Feasibility of Enrollment and Recruitment | 82 Participants |
| Positive Change (+Change) | Feasibility of Enrollment and Recruitment | 83 Participants |
Primary
Feasibility of Retention
Feasibility of retention was assessed by the number of participants retained in the study
Time frame: within 3 months of baseline participation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Feasibility of Retention | 71 Participants |
| Positive Change (+Change) | Feasibility of Retention | 70 Participants |