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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA029450 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this clinical trial is to compare the impact of providing participants with
The main questions it aims to answer are:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivate-the-Bystander | Active Comparator | A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors. |
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| 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. |
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| Attention-only control | Placebo Comparator | A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivate-the-Bystander | Behavioral | A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Alcohol use | Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months. | months 0-9 |
| Daily self-reports of bystander behavior | Bystander behavior is assessed with electronic daily diaries weekly for 9 months. | 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. | 1-week follow-up |
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Inclusion Criteria:
Exclusion Criteria: This project does not have any pre-determined exclusion criteria beyond the need to meet inclusion criteria for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Murphy | Contact | 4024723772 | carrie.murphy@unl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah J Gervais, PhD | University of Nebraska Lincoln | Principal Investigator |
| David DiLillo, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska-Lincoln | Recruiting | Lincoln | Nebraska | 68588 | United States |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2026 | Apr 17, 2026 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Apr 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Motivate-the-Bystander+Alcohol | Behavioral | A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors. |
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| Attention-only Control | Behavioral | A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced. |
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