Clinical trial NCT05873413: Motivations, Attitudes, and Perceptions Study
Official title: RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Sexual Violence
Social Norms
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-05-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Alcohol use
timeFrame: months 0-9
measure: Daily self-reports of bystander behavior
timeFrame: months 0-9
measure: Observational bystander behavior
timeFrame: 1-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Sarah J Gervais, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska Lincoln
name: David DiLillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: