Integrated Alcohol and Sexual Assault Intervention for College Men

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Sexual Assault
• Intervention / Treatment: Behavioral: SAFE; Behavioral: Mindfulness-Based Control Condition

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sexual Assault and Alcohol Feedback and Education (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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to change	Assessed via the Contemplation latter (Minimum = 0, Maximum = 10, higher scores are better outcomes).	Change in motivation relative to control from baseline to immediately after the session.
Self-Efficacy	Assessed via the brief situational confidence questionnaire (Minimum = 0, Maximum = 100, higher scores are better outcomes).	Change in self-efficacy relative to control at from baseline to immediately after the session.
Drinking intentions	Assessed via the drinking intention weekly report (Minimum = 0, Maximum = Unspecified, higher scores are worse outcomes).	Change in drinking intentions relative to control from baseline to immediately after the session.

Collaborators and Investigators

• Sponsor: Lifespan

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2013
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: R34AA020852 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing requests can be made by contacting the study PI.
• IPD Sharing Time Frame: Data can be requested from the PI .
• IPD Sharing Access Criteria: A data sharing agreement can be requested by contacting the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No