Alcohol and Violence Prevention for College Students

Alcohol Drinking Clinical Trial

Official title:

Alcohol and Violence Prevention for College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089137
• Other study ID #: H20066
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: September 8, 2021

Study information

• Verified date: November 2021
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Sexual Assault

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia
United States	Arizona State University	Tempe	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Georgia State University	Arizona State University, Medical University of South Carolina, Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrollment and recruitment	Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study	within 2 year recruitment period
Primary	Feasibility of retention	Feasibility of retention was assessed by the number of participants retained in the study	within 3 months of baseline participation