Integrated Alcohol and Sexual Assault Intervention for College Men

Sponsor
Lifespan (Other)
Overall Status
Completed
CT.gov ID
NCT05773027
Collaborator
(none)
115
1
2
49.9
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SAFE
  • Behavioral: Mindfulness-Based Control Condition
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Integrated Alcohol and Sexual Assault Intervention for College Men
Actual Study Start Date :
Oct 17, 2013
Actual Primary Completion Date :
Dec 13, 2017
Actual Study Completion Date :
Dec 13, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sexual Assault and Alcohol Feedback and Education (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.

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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Alcohol use, heavy drinking quantity [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 [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 [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 Outcome Measures

  1. Protective behavioral strategies [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Motivation to change [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 22 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rhode Island Hospital Providence Rhode Island United States 02904

Sponsors and Collaborators

  • Lifespan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lindsay Orchowski Ph.D., Associate Professor (Research), Lifespan
ClinicalTrials.gov Identifier:
NCT05773027
Other Study ID Numbers:
  • R34AA020852
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 17, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2023