Sexual AssaultVRNCT04160702
Using VR to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors
A study testing Motivate-The-Bystander (MTB) in people with Sexual Assault, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault
- What is being tested?
- Motivate-The-Bystander (MTB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-25, English speaking
Who cannot join
- Non English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Lincoln
Lincoln, Nebraska, 68588
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexual Assault
- Being tested
- Motivate-The-Bystander (MTB)
- Keywords
- sexual assault prevention, motivational interviewing, bystander intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivate-The-Bystander (MTB)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Motivate-The-Bystander | Experimental | Participants assigned to the MTB condition arm. Receives: Behavioral: Motivate-The-Bystander (MTB) |
| Assessment only control condition | No intervention | Participants assigned to the assessment only condition arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bystander in Sexual Assault Virtual Environment (BSAVE)
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.
Measured: Two months after the intervention
Secondary outcomes (3)
Bystander Attitudes Scale
A self-report measure assessing participants' bystander related attitudes.
Measured: Two months after the intervention
Bystander Behavior Scale
A self-report measure assessing participants' actual bystander behaviors over the past two months.
Measured: Two months after the intervention
Bystander Efficacy Scale
A self-report measure assessing participants' confidence in their ability to engage in future bystander behaviors.
Measured: Two months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start27 Sep 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Individuals will be randomly assigned to complete either a motivational interviewing intervention to increase bystander behaviors or an assessment only control condition. The outcome variables are post-treatment bystander behaviors, measured through both self-report measures and a virtual realty assessment of bystander behaviors. The primary analyses will consist of a series of multiple regressions with intervention group (0 = control, 1 = MI training) interacting with each of the moderators to predict post-treatment bystander behaviors (self-reported and B-SAVE).
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160702
- Sponsor's protocol ID
- 19260
- Acronym
- VR
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors
- ClinicalTrials.gov ID
- NCT04160702
- Acronym / sponsor ID
- VR / 19260
- Conditions
- Sexual Assault
- Keywords
- sexual assault prevention, motivational interviewing, bystander intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to complete either a motivational interviewing intervention to increase bystander behaviors or an assessment only control condition. The outcome variables are post-treatment bystander behaviors, measured through both self-report measures and a virtual realty assessment of bystander behaviors. The primary analyses will consist of a series of multiple regressions with intervention group (0 = control, 1 = MI training) interacting with each of the moderators to predict post-treatment bystander behaviors (self-reported and B-SAVE).
| Arm | Type | Receives |
|---|---|---|
| Motivate-The-Bystander | Experimental | Behavioral: Motivate-The-Bystander (MTB)Participants assigned to the MTB condition arm. |
| Assessment only control condition | No intervention | –Participants assigned to the assessment only condition arm. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ages 18-25, English speaking
Key exclusion criteria (1 listed)
- Non English speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivate-The-Bystander (MTB)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). | Behavioural | Motivate-The-Bystander |
Primary outcome
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.
3 secondary outcomes
Bystander Attitudes Scale
Time frame: Two months after the intervention
Bystander Behavior Scale
Time frame: Two months after the intervention
Bystander Efficacy Scale
Time frame: Two months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Sexual Assault
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
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Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
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Study of Cross-Cutting E-Health Prevention Approaches
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Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
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uSafeUS+ App Pilot Testing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivate-The-Bystander (MTB) in people with Sexual Assault, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bystander in Sexual Assault Virtual Environment (BSAVE) (time frame: Two months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.