Integrated Alcohol and Sexual Assault Intervention for College Men

Study Overview
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Brief Summary
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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.

Official Title
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Integrated Alcohol and Sexual Assault Intervention for College Men

Conditions
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Alcohol Drinking, Sexual Assault

Intervention / Treatment
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* Behavioral: SAFE
* Behavioral: Mindfulness-Based Control Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sexual Assault and Alcohol Feedback and Education (SAFE)<br>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. | Behavioral: SAFE<br>* 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.<br>|
| Active Comparator: Mindfulness-Based Control Condition<br>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. | Behavioral: Mindfulness-Based Control Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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