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Recruiting NCT05873413

Motivations, Attitudes, and Perceptions Study

No phase Interventional Alcohol Drinking Sexual Violence Social Norms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motivate-the-Bystander, Motivate-the-Bystander+Alcohol, Attention-only Control.
Who it may be relevant to
Registry conditions: Alcohol Drinking, Sexual Violence, Social Norms. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Motivate-the-Bystander
    A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
  • 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.
  • Behavioral Attention-only Control
    A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.

Primary outcome measures

  • Alcohol use [Time frame: months 0-9]
  • Daily self-reports of bystander behavior [Time frame: months 0-9]
  • Observational bystander behavior [Time frame: 1-week follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Nebraska-Lincoln — Lincoln

Identifiers

NCT: NCT05873413 · 21912 · R01AA029450

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗