NCT05873413

Brief Summary

The goal of this clinical trial is to compare the impact of providing participants with

  • Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors?
  • Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors?
  • Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities? Participants will:
  • Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors)
  • Complete either MTB, MTB+ALC, or the attention control condition online
  • Complete the virtual reality simulation in the lab
  • Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention

Trial Health

77
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Mar 2024May 2026

First Submitted

Initial submission to the registry

May 1, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

May 1, 2023

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Alcohol use

    Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.

    months 0-9

  • Daily self-reports of bystander behavior

    Bystander behavior is assessed with electronic daily diaries weekly for 9 months.

    months 0-9

  • Observational bystander behavior

    Bystander behavior is assessed with a virtual environment called Bystander in Sexual Assault Virtual Environments (B-SAVE). Participants experience a virtual "house party" and are exposed to 10 situations in which they can intervene or not. Responses are recorded and coded for the presence and effectiveness of intervention attempts.

    1-week follow-up

Study Arms (3)

Motivate-the-Bystander

ACTIVE COMPARATOR

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.

Behavioral: Motivate-the-Bystander

Motivate-the-Bystander+Alcohol

EXPERIMENTAL

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.

Behavioral: Motivate-the-Bystander+Alcohol

Attention-only control

PLACEBO COMPARATOR

A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.

Behavioral: Attention-only Control

Interventions

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.

Also known as: MTB
Motivate-the-Bystander

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.

Also known as: MTB+ALC
Motivate-the-Bystander+Alcohol

A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.

Also known as: Control
Attention-only control

Eligibility Criteria

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

You may qualify if:

  • Individuals ages 18-25
  • Heavy drinkers (as defined by using the AUDIT)
  • English fluency
  • Community members from Lancaster and surrounding counties in Nebraska
  • Signed and dated consent form
  • Stated willingness to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Sarah J Gervais, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR
  • David DiLillo, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 24, 2023

Study Start

March 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers after the completion of the primary endpoint by contacting PIs DiLillo and Gervais or NIAAADA. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. In addition, this study will comply with NIAAA Data Sharing Plans. All deidentified data will be shared with NIAAA for inclusion into the NIAAA Data Archive following the template provided by NIAAA.

Locations