Integrated Alcohol and Sexual Assault Intervention for College Men

Not Applicable

Completed

• Conditions: Alcohol Drinking; Sexual Assault
• Interventions: Behavioral: SAFE; Behavioral: Mindfulness-Based Control Condition

• Registration Number: NCT05773027
• Lead Sponsor: Lifespan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-17
• Primary Completion: 2017-12-13
• Study Completion: 2017-12-13
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sexual Assault and Alcohol Feedback and Education (SAFE)	SAFE	SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review.
Mindfulness-Based Control Condition	Mindfulness-Based Control Condition	The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review.

Primary Outcome Measures

Name	Time	Method
Alcohol use, heavy drinking quantity	Change from baseline alcohol use at 6 months.	Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Sexual aggression perpetration	Change in severity and frequency in comparison to control at 6-months.	Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
Alcohol use, drinks per week	Change from baseline alcohol use at 6 months.	The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion	Change in perceived peer engagement in comparison to control at 6-months.	Assessed via the sexual social norms inventory, regarding perceived peer engagement in sexual coercion (Minimum = 7, Maximum = 35, lower are better outcomes).
Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression	Change in peer comfort with sexual aggression relative to control at 6-months.	Assessed via the sexual social norms inventory, perception of peer comfort with sexual aggression (Minimum = 7 , Maximum = 35, lower are better outcomes).
Attitudes relating to sexual aggression: Rape myth acceptance	Change in rape myth acceptance relative to control at 6-months.	Assessed via the rape myth acceptance scale (Minimum = 7, Maximum = 140, higher are worse outcomes).
Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention	Change in perceived peer bystander intervention in comparison to control at 6-months.	Assessed via the sexual social norms inventory, perceived peer bystander intervention (Minimum = 8, Maximum = 40, higher scores better outcomes).
Attitudes relating to sexual aggression: Labeling of consent	Change in labeling of consent relative to control at 6-months.	Assessed via the labeling of consent scenarios (Minimum = 1, Maximum= 10, higher scores are better outcomes).
Protective behavioral strategies	Change in protective behavioral strategy use in comparison to control at 6-months.	Assessed via the Self Control Questionnaire (Minimum = 37, Maximum = 185). Higher scores mean more positive outcomes.
Bystander intervention intention to help strangers	Change in intention to help strangers relative to control at 6-months.	Assessed via the intentions to help strangers scale (Minimum = 0, Maximum = 800, higher scores are better outcomes).
Bystander intervention intention to help friends	Change in intent to help friends relative to control at 6-months.	Assessed via the bystander intentions to help friends scale (Minimum = 0, Maximum = 1000, higher scores are better outcomes).
Perceived peer drinking norms	Change in perceived peer norms relative to control at 6-months.	Assessed via the drinking norms rating form (Minimum = 0, Maximum = unspecified). Higher scores mean worse outcomes.
Attitudes relating to sexual aggression: Hyper gender ideology	Change in hyper gender ideology and increases relative to control at 6-months.	Assessed via the hyper gender ideology scale (Minimum = 19, Maximum = 114, higher scores are worse outcomes).
Bystander intervention attitudes	Change in bystander attitudes relative to control at 6-months.	Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States