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Integrated Alcohol and Sexual Assault Intervention for College Men

Primary Purpose

Alcohol Drinking, Sexual Assault

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAFE
Mindfulness-Based Control Condition
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 22 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sexual Assault and Alcohol Feedback and Education (SAFE)

Mindfulness-Based Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Sexual aggression perpetration
Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.

Secondary Outcome Measures

Protective behavioral strategies
Assessed via the Self Control Questionnaire (Minimum = 37, Maximum = 185). Higher scores mean more positive outcomes.
Perceived peer drinking norms
Assessed via the drinking norms rating form (Minimum = 0, Maximum = unspecified). Higher scores mean worse outcomes.
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).
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).
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).
Attitudes relating to sexual aggression: Rape myth acceptance
Assessed via the rape myth acceptance scale (Minimum = 7, Maximum = 140, higher are worse outcomes).
Attitudes relating to sexual aggression: Hyper gender ideology
Assessed via the hyper gender ideology scale (Minimum = 19, Maximum = 114, higher scores are worse outcomes).
Attitudes relating to sexual aggression: Labeling of consent
Assessed via the labeling of consent scenarios (Minimum = 1, Maximum= 10, higher scores are better outcomes).
Bystander intervention intention to help strangers
Assessed via the intentions to help strangers scale (Minimum = 0, Maximum = 800, higher scores are better outcomes).
Bystander intervention intention to help friends
Assessed via the bystander intentions to help friends scale (Minimum = 0, Maximum = 1000, higher scores are better outcomes).
Bystander intervention attitudes
Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).

Full Information

First Posted
February 22, 2023
Last Updated
March 15, 2023
Sponsor
Lifespan
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1. Study Identification

Unique Protocol Identification Number
NCT05773027
Brief Title
Integrated Alcohol and Sexual Assault Intervention for College Men
Official Title
Integrated Alcohol and Sexual Assault Intervention for College Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 17, 2013 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Sexual Assault

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sexual Assault and Alcohol Feedback and Education (SAFE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness-Based Control Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SAFE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Control Condition
Intervention Description
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 Outcome Measure Information:
Title
Alcohol use, heavy drinking quantity
Description
Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Time Frame
Change from baseline alcohol use at 6 months.
Title
Alcohol use, drinks per week
Description
The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Time Frame
Change from baseline alcohol use at 6 months.
Title
Sexual aggression perpetration
Description
Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
Time Frame
Change in severity and frequency in comparison to control at 6-months.
Secondary Outcome Measure Information:
Title
Protective behavioral strategies
Description
Assessed via the Self Control Questionnaire (Minimum = 37, Maximum = 185). Higher scores mean more positive outcomes.
Time Frame
Change in protective behavioral strategy use in comparison to control at 6-months.
Title
Perceived peer drinking norms
Description
Assessed via the drinking norms rating form (Minimum = 0, Maximum = unspecified). Higher scores mean worse outcomes.
Time Frame
Change in perceived peer norms relative to control at 6-months.
Title
Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention
Description
Assessed via the sexual social norms inventory, perceived peer bystander intervention (Minimum = 8, Maximum = 40, higher scores better outcomes).
Time Frame
Change in perceived peer bystander intervention in comparison to control at 6-months.
Title
Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion
Description
Assessed via the sexual social norms inventory, regarding perceived peer engagement in sexual coercion (Minimum = 7, Maximum = 35, lower are better outcomes).
Time Frame
Change in perceived peer engagement in comparison to control at 6-months.
Title
Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression
Description
Assessed via the sexual social norms inventory, perception of peer comfort with sexual aggression (Minimum = 7 , Maximum = 35, lower are better outcomes).
Time Frame
Change in peer comfort with sexual aggression relative to control at 6-months.
Title
Attitudes relating to sexual aggression: Rape myth acceptance
Description
Assessed via the rape myth acceptance scale (Minimum = 7, Maximum = 140, higher are worse outcomes).
Time Frame
Change in rape myth acceptance relative to control at 6-months.
Title
Attitudes relating to sexual aggression: Hyper gender ideology
Description
Assessed via the hyper gender ideology scale (Minimum = 19, Maximum = 114, higher scores are worse outcomes).
Time Frame
Change in hyper gender ideology and increases relative to control at 6-months.
Title
Attitudes relating to sexual aggression: Labeling of consent
Description
Assessed via the labeling of consent scenarios (Minimum = 1, Maximum= 10, higher scores are better outcomes).
Time Frame
Change in labeling of consent relative to control at 6-months.
Title
Bystander intervention intention to help strangers
Description
Assessed via the intentions to help strangers scale (Minimum = 0, Maximum = 800, higher scores are better outcomes).
Time Frame
Change in intention to help strangers relative to control at 6-months.
Title
Bystander intervention intention to help friends
Description
Assessed via the bystander intentions to help friends scale (Minimum = 0, Maximum = 1000, higher scores are better outcomes).
Time Frame
Change in intent to help friends relative to control at 6-months.
Title
Bystander intervention attitudes
Description
Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).
Time Frame
Change in bystander attitudes relative to control at 6-months.
Other Pre-specified Outcome Measures:
Title
Motivation to change
Description
Assessed via the Contemplation latter (Minimum = 0, Maximum = 10, higher scores are better outcomes).
Time Frame
Change in motivation relative to control from baseline to immediately after the session.
Title
Self-Efficacy
Description
Assessed via the brief situational confidence questionnaire (Minimum = 0, Maximum = 100, higher scores are better outcomes).
Time Frame
Change in self-efficacy relative to control at from baseline to immediately after the session.
Title
Drinking intentions
Description
Assessed via the drinking intention weekly report (Minimum = 0, Maximum = Unspecified, higher scores are worse outcomes).
Time Frame
Change in drinking intentions relative to control from baseline to immediately after the session.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identify as male.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing requests can be made by contacting the study PI.
IPD Sharing Time Frame
Data can be requested from the PI .
IPD Sharing Access Criteria
A data sharing agreement can be requested by contacting the PI.

Learn more about this trial

Integrated Alcohol and Sexual Assault Intervention for College Men

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