Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Completed NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1