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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02983864
Other study ID # 16-F-33
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date November 2019

Study information

Verified date March 2020
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.


Description:

Although research suggests that sexual assault interventions based on Bystander and Social Norms theory help to reduce sexual assault among college men, these programs do not completely eliminate sexual assault and their effects tend to fade over time. Unfortunately, there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual assault perpetration among college men and (2) whether alcohol interventions can be incorporated into existing sexual assault programs for college men (i.e., Bystander/Social Norms programs). Therefore, the objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention. Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and Intervention for College Students (BASICS), an empirically-supported intervention for college student drinking. The integrated alcohol and sexual assault intervention, which we have termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will be modeled after BASICS and empirically-supported Bystander and Social Norms interventions for sexual assault. The current study will recruit 100 college men who are sanctioned by their university to receive an alcohol intervention for violating a campus alcohol policy: by definition an indicated and at-risk population for sexual assault perpetration. Men will be followed for 6 months to determine the effects of the intervention on sexual assault perpetration and other primary outcomes (e.g., bystander behavior).


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date November 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be 18 or older; must be an Ohio University student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University

Exclusion Criteria:

- Under the age of 18

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BASICS
A one session intervention focused on reducing drinking with motivational interviewing
Integrated BASICS
A one session intervention focused on reducing drinking and sexual behavior while drinking
Relaxation
A one session intervention focused on increasing relaxation skills
Integrated Bystander
A one session intervention focused on reducing sexual assault with a focus on the role of alcohol

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ohio University U.S. Department of Justice

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual Experiences Survey A self-report measure that examines potential sexual assault behaviors 6 months post-intervention
Secondary Bystander Behavior Scale A self-report measure that examines opportunities and engagement in prosocial bystander behavior. 6 months post-intervention
Secondary Illinois Rape Myth Acceptance Scale A self-report measure that examines rape supportive beliefs 6 months post-intervention
Secondary Sexual Social Norms Inventory A self-report measure that examines sexual normative beliefs 6 months post-intervention
Secondary Alcohol use Disorders Identification Test A self-report measure that examines alcohol use 6 months post-intervention
Secondary Comprehensive Effects of Alcohol A self-report measure that examines expectancies of alcohol use 6 months post-intervention
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