Integrated Alcohol and Sexual Assault Intervention for College Men

Alcohol Drinking Clinical Trial

Official title:

Integrated Alcohol and Sexual Assault Intervention for College Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773027
• Other study ID #: R34AA020852
• Status: Completed
• Phase: N/A
• Start date: October 17, 2013
• Est. completion date: December 13, 2017

Study information

• Verified date: March 2023
• Source: Lifespan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Sexual Assault

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.