NCT04160702

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

November 9, 2019

Last Update Submit

March 17, 2021

Conditions

Keywords

sexual assault preventionmotivational interviewingbystander intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two months after the intervention

Secondary Outcomes (3)

  • Bystander Attitudes Scale

    Two months after the intervention

  • Bystander Behavior Scale

    Two months after the intervention

  • Bystander Efficacy Scale

    Two months after the intervention

Study Arms (2)

Motivate-The-Bystander

EXPERIMENTAL

Participants assigned to the MTB condition arm.

Behavioral: Motivate-The-Bystander (MTB)

Assessment only control condition

NO INTERVENTION

Participants assigned to the assessment only condition arm.

Interventions

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).

Motivate-The-Bystander

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-25, English speaking

You may not qualify if:

  • Non English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Lincoln

Lincoln, Nebraska, 68588, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2019

First Posted

November 13, 2019

Study Start

September 27, 2019

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations