Alcohol DrinkingMAPNCT05873413
Motivations, Attitudes, and Perceptions Study
A study testing Motivate-the-Bystander and Motivate-the-Bystander+Alcohol in people with Alcohol Drinking and Sexual Violence, run by University of Nebraska Lincoln at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Sexual Violence, Social Norms
- What is being tested?
- Motivate-the-Bystander and Motivate-the-Bystander+Alcohol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588
Sarah Gervais, PhD
About this study
Official title: 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
Read more
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
Read the 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.
- Conditions
- Alcohol Drinking, Sexual Violence, Social Norms
- Being tested
- Motivate-the-Bystander, Motivate-the-Bystander+Alcohol, Attention-only Control
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivate-the-BystanderBehavioural
Also called MTB
A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.
Motivate-the-Bystander+AlcoholBehavioural
Also called MTB+ALC
A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.
Attention-only ControlBehavioural
Also called Control
A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.
| Study group | Role | What they receive |
|---|---|---|
| Motivate-the-Bystander | Active comparator | A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors. Receives: Behavioral: Motivate-the-Bystander |
| Motivate-the-Bystander+Alcohol | Experimental | A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors. Receives: Behavioral: Motivate-the-Bystander+Alcohol |
| Attention-only control | Placebo comparator | A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced. Receives: Behavioral: Attention-only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.
Measured: months 0-9
Daily self-reports of bystander behavior
Bystander behavior is assessed with electronic daily diaries weekly for 9 months.
Measured: months 0-9
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.
Measured: 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Mar 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sarah J Gervais, PhD, Principal investigator, University of Nebraska LincolnDavid DiLillo, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873413
- Sponsor's protocol ID
- 21912
- Other IDs
- R01AA029450
- Acronym
- MAP
- Status last verified
- Apr 2026
- First submitted
- 1 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
- ClinicalTrials.gov ID
- NCT05873413
- Acronym / sponsor ID
- MAP / 21912
- Conditions
- Alcohol Drinking, Sexual Violence, Social Norms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivate-the-Bystander | Active comparator | Behavioral: Motivate-the-BystanderA Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors. |
| Motivate-the-Bystander+Alcohol | Experimental | Behavioral: Motivate-the-Bystander+AlcoholA Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors. |
| Attention-only control | Placebo comparator | Behavioral: Attention-only ControlA Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivate-the-BystanderAlso: MTBA Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors. | Behavioural | Motivate-the-Bystander |
| Motivate-the-Bystander+AlcoholAlso: MTB+ALCA Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors. | Behavioural | Motivate-the-Bystander+Alcohol |
| Attention-only ControlAlso: ControlA Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced. | Behavioural | Attention-only control |
Primary outcome
Alcohol use
Time frame: months 0-9
Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.
Daily self-reports of bystander behavior
Time frame: months 0-9
Bystander behavior is assessed with electronic daily diaries weekly for 9 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah J Gervais, PhD principal investigator
University of Nebraska Lincoln
David DiLillo, PhD principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivate-the-Bystander and Motivate-the-Bystander+Alcohol in people with Alcohol Drinking and Sexual Violence, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Murphy (4024723772, carrie.murphy@unl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: months 0-9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.