- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160702
Using VR to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors (VR)
March 17, 2021 updated by: University of Nebraska Lincoln
Using Virtual Reality to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors
With the present project, we will a evaluate a new, motivational interviewing (MI) intervention for increasing bystander behaviors to prevent sexual violence.
In the intervention, motivational interviewing will be used to build each participant's unique motivation for engaging in bystander intervention behaviors.
To assess the efficacy of the intervention, we will utilize the Bystanders in Sexual Assault Virtual Environments (B-SAVE), a virtual reality measure of bystander behaviors, along with self-report measures examining relevant bystander behaviors and attitudes.
We will also examine key moderators of intervention efficacy to provide valuable knowledge (e.g., whom the intervention is most effective for) for further tailoring of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will provide a comprehensive examination of Motivate-The-Bystander and provide information about whom the intervention is most effective for.
Specifically, at T1, participants will be randomly assigned to the MTB condition, a motivational interviewing intervention designed to increase participants' bystander intervention behaviors, or an assessment only control condition.
All participants will complete a battery of self-report measures, including our three proposed moderators (gender, alcohol use, and rape myth acceptance).
Participants assigned to the MTB condition will also engage in a motivational interviewing intervention designed to build each participant's unique motivation for engaging in bystander intervention behaviors.
Approximately two months later, at T2, participants will complete a battery of self-report measures assessing their bystander behaviors and attitudes over the past two months.
Then, all participants will complete the B-SAVE, where they provide open ended verbal responses to a series of sexually risky and non-risky interactive scenes they witness in the virtual environment.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nebraska
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Lincoln, Nebraska, United States, 68588
- University of Nebraska Lincoln
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-25, English speaking
Exclusion Criteria:
- Non English speaking.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Motivate-The-Bystander
Participants assigned to the MTB condition arm.
|
MTB is a motivational interviewing intervention designed to increase bystander intervention behaviors.
During MTB, participants will discuss their knowledge and experiences with bystander intervention.
Participants will then create a plan to increase their bystander intervention behaviors in the future.
The interviewer will utilize a variety of motivational interviewing techniques to help guide the conversation towards change (e.g., asking questions in an open-ended manner, reflecting participants' personal values).
|
NO_INTERVENTION: Assessment only control condition
Participants assigned to the assessment only condition arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bystander in Sexual Assault Virtual Environment (BSAVE)
Time Frame: Two months after the intervention
|
The primary outcome measure consists of participants' open ended verbal responses to a series of sexually risky and non-risky interactive scenes they witness while in the virtual house party.
|
Two months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bystander Attitudes Scale
Time Frame: Two months after the intervention
|
A self-report measure assessing participants' bystander related attitudes.
|
Two months after the intervention
|
Bystander Behavior Scale
Time Frame: Two months after the intervention
|
A self-report measure assessing participants' actual bystander behaviors over the past two months.
|
Two months after the intervention
|
Bystander Efficacy Scale
Time Frame: Two months after the intervention
|
A self-report measure assessing participants' confidence in their ability to engage in future bystander behaviors.
|
Two months after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 27, 2019
Primary Completion (ACTUAL)
February 15, 2021
Study Completion (ACTUAL)
February 15, 2021
Study Registration Dates
First Submitted
November 9, 2019
First Submitted That Met QC Criteria
November 9, 2019
First Posted (ACTUAL)
November 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 19260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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