Clinical trial NCT04089137: Alcohol and Violence Prevention for College Students
Official title: Alcohol and Violence Prevention for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Sexual Assault
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Medical University of South Carolina
name: Rhode Island Hospital
First posted: 2019-09-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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).

Eligibility criteria: 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 exclusion criteria other than not meeting inclusion criteria

Primary outcomes:
measure: Feasibility of Enrollment and Recruitment
timeFrame: within 2 year recruitment period
measure: Feasibility of Retention
timeFrame: within 3 months of baseline participation
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Amanda K Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilmore AK, Leone RM, Oesterle DW, Davis KC, Orchowski LM, Ramakrishnan V, Kaysen D. Web-Based Alcohol and Sexual Assault Prevention Program With Tailored Content Based on Gender and Sexual Orientation: Preliminary Outcomes and Usability Study of Positive Change (+Change). JMIR Form Res. 2022 Jul 22;6(7):e23823. doi: 10.2196/23823.