Alcohol Drinking Clinical Trial
Official title:
Integrated Alcohol and Sexual Assault Intervention for College Men
Verified date | March 2023 |
Source | Lifespan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Lifespan |
United States,
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. |
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