Motivations, Attitudes, and Perceptions Study

Alcohol Drinking Clinical Trial

— MAP  

Official title:

RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873413
• Other study ID #: 21912
• Secondary ID: R01AA029450
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: University of Nebraska Lincoln
• Contact: Carrie Murphy
• Phone: 4024723772
• Email: carrie.murphy[@]unl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Exclusion Criteria: This project does not have any pre-determined exclusion criteria beyond the need to meet inclusion criteria for the study.

Related Conditions & MeSH terms

• Alcohol Drinking
• Sexual Violence
• Social Norms

Intervention

Behavioral:
• Motivate-the-Bystander
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.
• Attention-only Control
A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.

Locations

Country	Name	City	State
United States	University of Nebraska-Lincoln	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use	Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.	months 0-9
Primary	Daily self-reports of bystander behavior	Bystander behavior is assessed with electronic daily diaries weekly for 9 months.	months 0-9
Primary	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