Clinical trial NCT05773027: Integrated Alcohol and Sexual Assault Intervention for College Men
Official title: Integrated Alcohol and Sexual Assault Intervention for College Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Sexual Assault
Lead sponsor: Lifespan
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 115
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.


Eligibility criteria: Inclusion Criteria:

* Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
* Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months

Exclusion Criteria:

* Displaying symptoms consistent with alcohol use withdrawal
* Reporting current suicidal or homicidal ideation
* Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder

Primary outcomes:
measure: Alcohol use, heavy drinking quantity
timeFrame: Change from baseline alcohol use at 6 months.
measure: Alcohol use, drinks per week
timeFrame: Change from baseline alcohol use at 6 months.
measure: Sexual aggression perpetration
timeFrame: Change in severity and frequency in comparison to control at 6-months.
Secondary outcomes:
measure: Protective behavioral strategies
timeFrame: Change in protective behavioral strategy use in comparison to control at 6-months.
measure: Perceived peer drinking norms
timeFrame: Change in perceived peer norms relative to control at 6-months.
measure: Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention
timeFrame: Change in perceived peer bystander intervention in comparison to control at 6-months.
measure: Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion
timeFrame: Change in perceived peer engagement in comparison to control at 6-months.
measure: Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression
timeFrame: Change in peer comfort with sexual aggression relative to control at 6-months.
measure: Attitudes relating to sexual aggression: Rape myth acceptance
timeFrame: Change in rape myth acceptance relative to control at 6-months.
measure: Attitudes relating to sexual aggression: Hyper gender ideology
timeFrame: Change in hyper gender ideology and increases relative to control at 6-months.
measure: Attitudes relating to sexual aggression: Labeling of consent
timeFrame: Change in labeling of consent relative to control at 6-months.
measure: Bystander intervention intention to help strangers
timeFrame: Change in intention to help strangers relative to control at 6-months.
measure: Bystander intervention intention to help friends
timeFrame: Change in intent to help friends relative to control at 6-months.
measure: Bystander intervention attitudes
timeFrame: Change in bystander attitudes relative to control at 6-months.
Other outcomes:
measure: Motivation to change
timeFrame: Change in motivation relative to control from baseline to immediately after the session.
measure: Self-Efficacy
timeFrame: Change in self-efficacy relative to control at from baseline to immediately after the session.
measure: Drinking intentions
timeFrame: Change in drinking intentions relative to control from baseline to immediately after the session.
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: