MAP: Motivations, Attitudes, and Perceptions Study

Sponsor
University of Nebraska Lincoln (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05873413
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
450
3
36.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivate-the-Bystander
  • Behavioral: Motivate-the-Bystander+Alcohol
  • Behavioral: Attention-only Control
Phase 3

Detailed Description

During young adulthood, an estimated one in five women experience sexual assault. We 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, we will conduct a RCT comparing the efficacy of: 1) our 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 a measurement burst design using electronic daily diaries at baseline and 3, 6, and 9 months post intervention. We 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 our hypotheses are confirmed, results will support the use of our 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Motivate-the-Bystander

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

Behavioral: Motivate-the-Bystander
A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
Other Names:
  • MTB
  • Experimental: 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: 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.
    Other Names:
  • MTB+ALC
  • Placebo Comparator: Attention-only control

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

    Behavioral: Attention-only Control
    A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
    Other Names:
  • Control
  • Outcome Measures

    Primary Outcome Measures

    1. Alcohol use [months 0-9]

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

    2. Daily self-reports of bystander behavior [months 0-9]

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

    3. Observational bystander behavior [1-week follow-up]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Nebraska Lincoln
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Sarah J Gervais, PhD, University of Nebraska Lincoln
    • Principal Investigator: David DiLillo, PhD, University of Nebraska Lincoln

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Nebraska Lincoln
    ClinicalTrials.gov Identifier:
    NCT05873413
    Other Study ID Numbers:
    • 21912
    • R01AA029450
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2023