Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
1 other identifier
interventional
192
1 country
1
Brief Summary
The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are:
- Does alcohol intoxication and gender influence bystander barriers and sexual violence intervention?
- Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among men, compared to women?
- Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among those with higher, compared to lower, prosocial bystander attitudes? Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 12, 2024
June 1, 2024
1.8 years
January 10, 2023
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Articulated Thoughts of Barriers to Bystander Intervention
Participants will verbally respond to a heat-of-the-moment scenario where they are a bystander of a risky alcohol-related sexual violence situation using the articulate thoughts in simulated situations paradigm \[Davidson et al., 1983\].
35 minutes to 2.5 hours post-drinking
Articulated Thoughts of Intentions to Intervene as a Bystander
Participants will verbally respond to a heat-of-the-moment scenario where they are a bystander of a risky alcohol-related sexual violence situation using the articulate thoughts in simulated situations paradigm \[Davidson et al., 1983\]
35 minutes to 2.5 hours post-drinking
Study Arms (2)
Alcohol Intoxication
EXPERIMENTALParticipant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.
No-Alcohol Control
ACTIVE COMPARATORParticipant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.
Interventions
Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the ascending limb
Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the descending limb
Participants will be assigned to a no alcohol control condition
Eligibility Criteria
You may qualify if:
- Between the ages of 21 and 30
- Report that on at least 3 days in the past year they have consumed an alcohol quantity on a single occasion that was equal or greater to the dose administered in the lab
You may not qualify if:
- Currently seeking treatment or in recovery for an alcohol or substance use disorder
- A medical condition or medication use in which alcohol consumption is medically contraindicated
- Pregnant, nursing, or has engaged in sexual intercourse without effective contraception in the past two weeks
- If the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia State University
Atlanta, Georgia, 30302, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruschelle M Leone, PhD
Georgia State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 10, 2023
First Posted
January 27, 2023
Study Start
March 9, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 12, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
IPD will be available in the NIAAA Data Archive.