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Integrated Alcohol and Sexual Assault Intervention for College Men

Integrated Alcohol and Sexual Assault Intervention for College Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05773027
Enrollment
115
Registered
2023-03-17
Start date
2013-10-17
Completion date
2017-12-13
Last updated
2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Sexual Assault

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.

Interventions

BEHAVIORALSAFE

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.

BEHAVIORALMindfulness-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.

Sponsors

Lifespan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol use, heavy drinking quantityChange 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.
Alcohol use, drinks per weekChange 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.
Sexual aggression perpetrationChange 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.

Secondary

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

Other

MeasureTime frameDescription
Motivation to changeChange in motivation relative to control from baseline to immediately after the session.Assessed via the Contemplation latter (Minimum = 0, Maximum = 10, higher scores are better outcomes).
Drinking intentionsChange in drinking intentions relative to control from baseline to immediately after the session.Assessed via the drinking intention weekly report (Minimum = 0, Maximum = Unspecified, higher scores are worse outcomes).
Self-EfficacyChange in self-efficacy relative to control at from baseline to immediately after the session.Assessed via the brief situational confidence questionnaire (Minimum = 0, Maximum = 100, higher scores are better outcomes).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026