Skip to main content
OpenTrials
Completed

NCT Number: NCT05773027

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Sexual Assault

Age range

18 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAFE

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Protective behavioral strategies

    Time frame: Change 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.

  2. Perceived peer drinking norms

    Time frame: Change 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.

  3. Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention

    Time frame: Change 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).

  4. Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion

    Time frame: Change 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).

  5. Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression

    Time frame: Change 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).

  6. Attitudes relating to sexual aggression: Rape myth acceptance

    Time frame: Change 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).

  7. Attitudes relating to sexual aggression: Hyper gender ideology

    Time frame: Change 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).

  8. Attitudes relating to sexual aggression: Labeling of consent

    Time frame: Change 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).

  9. Bystander intervention intention to help strangers

    Time frame: Change 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).

  10. Bystander intervention intention to help friends

    Time frame: Change 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).

  11. Bystander intervention attitudes

    Time frame: Change in bystander attitudes relative to control at 6-months.

    Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).

Other outcomes

  1. Motivation to change

    Time frame: Change 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).

  2. Self-Efficacy

    Time frame: Change 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).

  3. Drinking intentions

    Time frame: Change 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).

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.