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Motivations, Attitudes, and Perceptions Study (MAP)

Primary Purpose

Alcohol Drinking, Sexual Violence, Social Norms

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Motivate-the-Bystander
Motivate-the-Bystander+Alcohol
Attention-only Control
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Motivate-the-Bystander

    Motivate-the-Bystander+Alcohol

    Attention-only control

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Alcohol use
    Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.
    Daily self-reports of bystander behavior
    Bystander behavior is assessed with electronic daily diaries weekly for 9 months.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    June 15, 2023
    Sponsor
    University of Nebraska Lincoln
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05873413
    Brief Title
    Motivations, Attitudes, and Perceptions Study
    Acronym
    MAP
    Official Title
    RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2026 (Anticipated)
    Study Completion Date
    May 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska Lincoln
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare the impact of providing participants with A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Sexual Violence, Social Norms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivate-the-Bystander
    Arm Type
    Active Comparator
    Arm Description
    A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
    Arm Title
    Motivate-the-Bystander+Alcohol
    Arm Type
    Experimental
    Arm Description
    A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.
    Arm Title
    Attention-only control
    Arm Type
    Placebo Comparator
    Arm Description
    A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivate-the-Bystander
    Other Intervention Name(s)
    MTB
    Intervention Description
    A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivate-the-Bystander+Alcohol
    Other Intervention Name(s)
    MTB+ALC
    Intervention Description
    A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Attention-only Control
    Other Intervention Name(s)
    Control
    Intervention Description
    A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
    Primary Outcome Measure Information:
    Title
    Alcohol use
    Description
    Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.
    Time Frame
    months 0-9
    Title
    Daily self-reports of bystander behavior
    Description
    Bystander behavior is assessed with electronic daily diaries weekly for 9 months.
    Time Frame
    months 0-9
    Title
    Observational bystander behavior
    Description
    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.
    Time Frame
    1-week follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carrie Murphy
    Phone
    4024723772
    Email
    carrie.murphy@unl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah J Gervais, PhD
    Organizational Affiliation
    University of Nebraska Lincoln
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David DiLillo, PhD
    Organizational Affiliation
    University of Nebraska Lincoln
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers after the completion of the primary endpoint by contacting PIs DiLillo and Gervais or NIAAADA. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. In addition, this study will comply with NIAAA Data Sharing Plans. All deidentified data will be shared with NIAAA for inclusion into the NIAAA Data Archive following the template provided by NIAAA.

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    Motivations, Attitudes, and Perceptions Study

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