- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873413
Motivations, Attitudes, and Perceptions Study (MAP)
June 13, 2024 updated by: University of Nebraska Lincoln
RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
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
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carrie Murphy
- Phone Number: 4024723772
- Email: carrie.murphy@unl.edu
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68588
- Recruiting
- University of Nebraska-Lincoln
-
Contact:
- Sarah Gervais, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
Other Names:
|
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.
|
A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.
Other Names:
|
Placebo Comparator: Attention-only control
A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
|
A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use
Time Frame: months 0-9
|
Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.
|
months 0-9
|
Daily self-reports of bystander behavior
Time Frame: months 0-9
|
Bystander behavior is assessed with electronic daily diaries weekly for 9 months.
|
months 0-9
|
Observational bystander behavior
Time Frame: 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.
|
1-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah J Gervais, PhD, University of Nebraska Lincoln
- Principal Investigator: David DiLillo, PhD, University of Nebraska Lincoln
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
May 1, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 24, 2023
Study Record Updates
Last Update Posted (Actual)
June 17, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21912
- R01AA029450 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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