NCT05773027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

February 22, 2023

Last Update Submit

March 15, 2023

Conditions

Alcohol DrinkingSexual Assault

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (11)

  • Protective behavioral strategies

    Change in protective behavioral strategy use in comparison to control at 6-months.

  • Perceived peer drinking norms

    Change in perceived peer norms relative to control at 6-months.

  • Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention

    Change in perceived peer bystander intervention in comparison to control at 6-months.

  • Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion

    Change in perceived peer engagement in comparison to control at 6-months.

  • Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression

    Change in peer comfort with sexual aggression relative to control at 6-months.

  • +6 more secondary outcomes

Other Outcomes (3)

  • Motivation to change

    Change in motivation relative to control from baseline to immediately after the session.

  • Self-Efficacy

    Change in self-efficacy relative to control at from baseline to immediately after the session.

  • Drinking intentions

    Change in drinking intentions relative to control from baseline to immediately after the session.

Study Arms (2)

Sexual Assault and Alcohol Feedback and Education (SAFE)

EXPERIMENTAL

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

Mindfulness-Based Control Condition

ACTIVE COMPARATOR

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

Interventions

SAFEBEHAVIORAL

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.

Sexual Assault and Alcohol Feedback and Education (SAFE)
Mindfulness-Based Control ConditionBEHAVIORAL

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.

Mindfulness-Based Control Condition

Eligibility Criteria

Age18 Years - 22 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as male.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Displaying symptoms consistent with alcohol use withdrawal
  • Reporting current suicidal or homicidal ideation
  • Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Location

Related Publications (1)

  • Orchowski LM, Merrill JE, Oesterle DW, Barnett NP, Borsari B, Zlotnick C, Haikalis MP, Bekowitz AD. Integrated Alcohol Use and Sexual Assault Prevention Program for College Men Who Engage in Heavy Drinking: Randomized Pilot Study. JMIR Form Res. 2023 Nov 23;7:e47354. doi: 10.2196/47354.

    PMID: 37995129DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research)

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 17, 2023

Study Start

October 17, 2013

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Data sharing requests can be made by contacting the study PI.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data can be requested from the PI .
Access Criteria
A data sharing agreement can be requested by contacting the PI.

Locations

US(1)