Alcohol and Violence Prevention for College Students

• Sponsor: Georgia State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04089137
• Collaborator: Arizona State University (Other), Medical University of South Carolina (Other), Rhode Island Hospital (Other)
• Enrollment: 165
• Locations: 2
• Arms: 2
• Actual Duration (Months): 41.8
• Patients Per Site: 82.5
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking; Sexual Assault	Behavioral: Positive Change (+Change)	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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)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)
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Alcohol and Violence Prevention for College Students
• Actual Study Start Date: Mar 15, 2018
• Actual Primary Completion Date: Sep 8, 2021
• Actual Study Completion Date: Sep 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control This is an assessment only control condition.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. Feasibility of retention [within 3 months of baseline participation]

   Feasibility of retention was assessed by the number of participants retained in the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria other than not meeting inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State University	Tempe	Arizona	United States	85281
2	Georgia State University	Atlanta	Georgia	United States	30303

Sponsors and Collaborators

• Georgia State University
• Arizona State University
• Medical University of South Carolina
• Rhode Island Hospital

Investigators

• Principal Investigator: Amanda K Gilmore, PhD, Georgia State University

Study Documents (Full-Text)

• Informed Consent Form - Mar 4, 2021

More Information

Publications

None provided.

• Responsible Party: Amanda Gilmore, Assistant Professor, Mark Chaffin Center for Healthy Development and Department of Health Policy and Behavioral Sciences, School of Public Health, Georgia State University
• ClinicalTrials.gov Identifier: NCT04089137
• Other Study ID Numbers: H20066
• First Posted: Sep 13, 2019
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

No Results Posted as of Nov 26, 2021