Integrated Alcohol and Sexual Assault Intervention for College Men

NCT ID: NCT05773027

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-17

Study Completion Date

2017-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Drinking Sexual Assault

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SAFE

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Control Condition

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lifespan

OTHER

Sponsor Role lead

Responsible Party

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Lindsay Orchowski Ph.D.

Associate Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37995129 (View on PubMed)

Other Identifiers

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R34AA020852

Identifier Type: NIH

Identifier Source: org_study_id

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