Alcohol and Violence Prevention for College Students
Primary Purpose
Alcohol Drinking, Sexual Assault
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Change (+Change)
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Drinking
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
Sites / Locations
- Arizona State University
- Georgia State University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Positive Change (+Change)
Arm Description
This is an assessment only control condition.
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.
Outcomes
Primary Outcome Measures
Feasibility of enrollment and recruitment
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Feasibility of retention
Feasibility of retention was assessed by the number of participants retained in the study
Secondary Outcome Measures
Full Information
NCT ID
NCT04089137
First Posted
August 27, 2019
Last Updated
November 22, 2021
Sponsor
Georgia State University
Collaborators
Arizona State University, Medical University of South Carolina, Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04089137
Brief Title
Alcohol and Violence Prevention for College Students
Official Title
Alcohol and Violence Prevention for College Students
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Arizona State University, Medical University of South Carolina, Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Sexual Assault
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This is an assessment only control condition.
Arm Title
Positive Change (+Change)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Change (+Change)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of enrollment and recruitment
Description
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Time Frame
within 2 year recruitment period
Title
Feasibility of retention
Description
Feasibility of retention was assessed by the number of participants retained in the study
Time Frame
within 3 months of baseline participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda K Gilmore, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing of individual participant data, only de-identified data.
Citations:
PubMed Identifier
35867393
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.
Results Reference
derived
Learn more about this trial
Alcohol and Violence Prevention for College Students
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