Motivations, Attitudes, and Perceptions Study

NCT ID: NCT05873413

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-05-31

Brief Summary

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

1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone

2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol)

3. A control condition focused on reducing stress

The main questions it aims to answer are:

• 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

Detailed Description

During young adulthood, an estimated one in five women experience sexual assault. The investigators seek to reduce this violence by motivating young adults to intervene with their peers to prevent sexual assault-an approach known as bystander intervention. Current bystander training is conducted in group sessions involving education about how to recognize and intervene in response to sexual risk situations. Although successful in changing knowledge and attitudes about sexual assault prevention, evaluations of these programs have rarely focused on changing actual bystander behaviors. Further, while bystander alcohol use is common in sexual risk situations, and undermines intervention attempts, alcohol consumption by bystanders is not explicitly targeted in existing intervention training programs. To address these gaps, the investigators will conduct a RCT comparing the efficacy of: 1) the recently developed bystander intervention, Motivate-the-Bystander (MTB), 2) MTB with an MI alcohol component (MTB+ALC), and 3) an attention control condition for reducing alcohol use and increasing bystander behaviors in response to sexual risk. Bystander behaviors will be assessed observationally during a virtual reality-based house party at 2 months post intervention. Participants' bystander behaviors, alcohol use, and relevant contextual variables will be assessed with an EMA measurement design using electronic daily diaries at baseline and weekly post intervention until month 9. The investigators expect that, compared to MTB alone and the control condition, MTB+ALC will produce significantly greater reductions in overall drinking and increases in prosocial bystander behaviors in a diverse sample of 450 young adults who are heavy drinkers. If the hypotheses are confirmed, results will support use of the combined MI-based bystander-alcohol intervention as an effective means of reducing drinking and motivating bystander behaviors among those at highest risk for sexual violence.

Conditions

Alcohol Drinking; Sexual Violence; Social Norms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Motivate-the-Bystander

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

Group Type: ACTIVE_COMPARATOR

Motivate-the-Bystander

Intervention Type: BEHAVIORAL

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

Motivate-the-Bystander+Alcohol

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

Group Type: EXPERIMENTAL

Motivate-the-Bystander+Alcohol

Intervention Type: BEHAVIORAL

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

Attention-only control

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

Group Type: PLACEBO_COMPARATOR

Attention-only Control

Intervention Type: BEHAVIORAL

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

Interventions

Motivate-the-Bystander

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

Intervention Type: BEHAVIORAL

Motivate-the-Bystander+Alcohol

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

Intervention Type: BEHAVIORAL

Attention-only Control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MTB; MTB+ALC; Control

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Nebraska Lincoln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah J Gervais, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

David DiLillo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Locations

University of Nebraska-Lincoln

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carrie Murphy

Role: CONTACT

carrie.murphy@unl.edu

4024723772

Facility Contacts

Sarah Gervais, PhD

Role: primary

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AA029450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21912

Identifier Type: -

Identifier Source: org_study_id