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Clinical Trials/NCT05773027
NCT05773027
Completed
Not Applicable

Integrated Alcohol and Sexual Assault Intervention for College Men

Lifespan1 site in 1 country115 target enrollmentOctober 17, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Drinking
Sponsor
Lifespan
Enrollment
115
Locations
1
Primary Endpoint
Alcohol use, heavy drinking quantity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2013
End Date
December 13, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Lifespan
Responsible Party
Principal Investigator
Principal Investigator

Lindsay Orchowski Ph.D.

Associate Professor (Research)

Lifespan

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

Outcomes

Primary Outcomes

Alcohol use, heavy drinking quantity

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion(Change in perceived peer engagement in comparison to control at 6-months.)
  • Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression(Change in peer comfort with sexual aggression relative to control at 6-months.)
  • Attitudes relating to sexual aggression: Rape myth acceptance(Change in rape myth acceptance relative to control at 6-months.)
  • Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention(Change in perceived peer bystander intervention in comparison to control at 6-months.)
  • Attitudes relating to sexual aggression: Labeling of consent(Change in labeling of consent relative to control at 6-months.)
  • Protective behavioral strategies(Change in protective behavioral strategy use in comparison to control at 6-months.)
  • Bystander intervention intention to help strangers(Change in intention to help strangers relative to control at 6-months.)
  • Bystander intervention intention to help friends(Change in intent to help friends relative to control at 6-months.)
  • Perceived peer drinking norms(Change in perceived peer norms relative to control at 6-months.)
  • Attitudes relating to sexual aggression: Hyper gender ideology(Change in hyper gender ideology and increases relative to control at 6-months.)
  • Bystander intervention attitudes(Change in bystander attitudes relative to control at 6-months.)

Study Sites (1)

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