RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use
Phase: NA
Conditions: Alcohol Drinking, Sexual Violence, Social Norms
Sponsor: University of Nebraska Lincoln

 
 
 
 
 
 
MOTIVATIONS, ATTITUDES, AND PERCEPTIONS STUDY 
Protocol Number*: 21912 
National Clinical Trial (NCT) Identified Number:   NCT05873413 
Principal Investigators*: David DiLillo, PhD & Sarah Gervais, PhD 
Sponsor: University of Nebraska-Lincoln 
Grant Title: RCT of a combined MI intervention to address bystander behaviors 
in the context of alcohol use 
Grant Number*: 1R01AA029450-01A1 
Funded by: National Institute for Alcohol Abuse and Alcoholism (NIAAA)Version 
Number:  2.0 
13 January 2026 
 
 

 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 5 
1.3 
Schedule of Activities .......................................................................................................................... 6 
2 
INTRODUCTION ............................................................................................................................................ 9 
2.1 
Study Rationale .................................................................................................................................... 9 
2.2 
Background......................................................................................................................................... 10 
2.3 
Risk/Benefit Assessment .................................................................................................................. 10 
2.3.1 
Known Potential Risks ................................................................................................... 10 
2.3.2 
Known Potential Benefits .............................................................................................. 12 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 12 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 16 
4 
STUDY DESIGN ........................................................................................................................................... 17 
4.1 
Overall Design .................................................................................................................................... 17 
4.2 
Scientific Rationale for Study Design.............................................................................................. 19 
4.3 
Justification for Intervention ............................................................................................................. 20 
4.4 
End-of-Study Definition ..................................................................................................................... 20 
5 
STUDY POPULATION ................................................................................................................................ 20 
5.1 
Inclusion Criteria ................................................................................................................................ 21 
5.2 
Exclusion Criteria ............................................................................................................................... 21 
5.3 
Lifestyle Considerations .................................................................................................................... 21 
5.4 
Screen Failures .................................................................................................................................. 21 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 21 
5.6 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 23 
5.6.1 
Study Intervention or Experimental Manipulation Description ................................. 23 
5.6.2 
Administration and/or Dosing ....................................................................................... 24 
5.7 
Fidelity ................................................................................................................................................. 24 
5.7.1 
Interventionist Training and Tracking .......................................................................... 24 
5.8 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 25 
5.9 
Study Intervention/Experimental Manipulation Adherence.......................................................... 25 
5.10 
Concomitant Therapy ........................................................................................................................ 25 
5.10.1 
Rescue Therapy ............................................................................................................. 25 
6 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 25 
6.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 26 
6.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 26 
6.3 
Lost to Follow-Up ............................................................................................................................... 26 
7 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 27 
7.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 27 
7.2 
Safety Assessments .......................................................................................................................... 27 
7.3 
Adverse Events and Serious Adverse Events ............................................................................... 28 
7.3.1 
Definition of Adverse Events ........................................................................................ 28 
7.3.2 
Definition of Serious Adverse Events .......................................................................... 28 

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7.3.3 
Classification of an Adverse Event .............................................................................. 29 
7.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 29 
7.3.5 
Adverse Event Reporting .............................................................................................. 29 
7.3.6 
Serious Adverse Event Reporting ............................................................................... 30 
7.3.7 
Reporting Events to Participants ................................................................................. 30 
7.3.8 
Events of Special Interest ............................................................................................. 30 
7.3.9 
Reporting of Pregnancy ................................................................................................ 30 
7.4 
Unanticipated Problems .................................................................................................................... 30 
7.4.1 
Definition of Unanticipated Problems .......................................................................... 30 
7.4.2 
Unanticipated Problems Reporting .............................................................................. 31 
7.4.3 
Reporting Unanticipated Problems to Participants ................................................... 31 
8 
STATISTICAL CONSIDERATIONS .......................................................................................................... 31 
8.1 
Statistical Hypotheses ....................................................................................................................... 31 
8.2 
Sample Size Determination .............................................................................................................. 32 
8.3 
Populations for Analyses .................................................................................................................. 33 
8.4 
Statistical Analyses............................................................................................................................ 33 
8.4.1 
General Approach .......................................................................................................... 33 
8.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 33 
8.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 34 
8.4.4 
Safety Analyses .............................................................................................................. 35 
8.4.5 
Baseline Descriptive Statistics ..................................................................................... 35 
8.4.6 
Planned Interim Analyses ............................................................................................. 35 
8.4.7 
Review Board considering conclusion or continuation of the study.Sub-Group Analyses 35 
8.4.8 
Tabulation of Individual Participant Data .................................................................... 36 
8.4.9 
Exploratory Analyses ..................................................................................................... 36 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 36 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 36 
9.1.1 
Informed Consent Process ........................................................................................... 36 
9.1.2 
Study Discontinuation and Closure ............................................................................. 37 
9.1.3 
Confidentiality and Privacy ........................................................................................... 38 
9.1.4 
Future Use of Stored Specimens and Data ............................................................... 39 
9.1.5 
Key Roles and Study Governance .............................................................................. 39 
9.1.6 
Safety Oversight ............................................................................................................. 39 
9.1.7 
Clinical Monitoring .......................................................................................................... 40 
9.1.8 
Quality Assurance and Quality Control ....................................................................... 40 
9.1.9 
Data Handling and Record Keeping ............................................................................ 42 
9.1.10 
Protocol Deviations ........................................................................................................ 42 
9.1.11 
Publication and Data Sharing Policy ........................................................................... 42 
9.1.12 
Conflict of Interest Policy .............................................................................................. 43 
9.2 
Additional Considerations ................................................................................................................. 43 
9.3 
Abbreviations and Special Terms ................................................................................................... 43 
9.4 
Protocol Amendment History ........................................................................................................... 45 
10 
REFERENCES ........................................................................................................................................ 55 
 

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STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
5-27-2022 
 
Name*:  David DiLillo 
 
Title*: Willa Cather Professor 
 
Investigator Contact Information 
Affiliation*:  University of Nebraska-Lincoln 
Address: Department of Psychology, 238 Burnett Hall 
Telephone:402-770-1485 
Email: ddilillo@unl.edu 
 
 
 
 
 
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Motivations, Attitudes, and Perceptions Study 
 
Grant Number: 
1R01 AA029450 
 
Study 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 1-2 weeks 
post intervention. Participants’ bystander behaviors, alcohol use, and 
relevant contextual variables will be assessed weekly using electronic 
daily diaries immediately following the final virtual session until 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. 
 
Objectives*: 
 
The primary objective of the proposed project is to evaluate the efficacy 
of MTB+ALC in comparison to MTB and an attention control condition. 
The secondary objective is to assess self-reported individual differences 
in alcohol use and bystander outcomes and secondary endpoints.  
Endpoints*: 
Primary study endpoints are: 1) reduced drinking, and 2) increased 
bystander behaviors. Secondary study endpoints are 1) SV perpetration, 
2) SV victimization, 3) alcohol expectancies, 4) prosocial and 
personality traits, and 5) other theoretical and empirical factors related 
to primary outcomes. 
  

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Study Population: 
The population for this study will be male and female young adult 
community members recruited from Lincoln, Omaha, NE and 
surrounding areas. Participants who are English speaking and ranging 
from ages 18-25 will be eligible for inclusion in the study. 
 
Phase* or Stage: 
Indicate Phase or Stage, as appropriate. Institutes and Centers may 
differ in their preferences for categorizing research. Consult with your 
Program Official (PO) This is a phase II trial.  
 
Description of 
Sites/Facilities Enrolling 
Participants: 
Once deemed eligible, participants will complete the baseline self-report 
measures via Qualtrics and then will be guided to schedule their 
intervention session via Calendly. The MTB, MTB+ALC and control 
sessions will then be completed via zoom. Participants will be instructed 
to find a private location for completing the session. Post-intervention 
participants will complete EDD follow up surveys (months 0-9) and be 
scheduled to complete self-report measures and the B-SAVE in the 
virtual reality lab (Burnett Room 12. Participants will be run 
individually, thus will not witness or have access to other participants 
identity or responses. During informed consent, participants will be 
notiﬁed that all information will be de identiﬁed and kept conﬁdential. 
 
Description of Study 
Intervention/Experimental 
Manipulation: 
Participation will involve baseline survey, 1 virtual intervention session, 
one in-person lab visit and a series of 40 electronic daily diary (EDD) 
follow-up surveys. First, participants will complete various self-report 
measures via baseline. The baseline survey is expected to take 
approximately 1.5 - 2 hours. Then they will be scheduled and 
randomized to their virtual session to complete MTB, MTB+ALC, or a 
control condition which takes 60-180 minutes per session. Participants 
will then come to the lab 1-2 weeks later to complete self-report 
measures and the B-SAVE, a VR- based tool for assessing bystander 
behaviors in risky sexual situations. The BSAVE is expected to take 
approximately 1.5 hours. Immediately following the final virtual session 
participants will be sent EDD follow-up surveys to complete weekly via 
Qualtrics. The EDD surveys are expected to take 10 minutes weekly for 
months 0 through 9. In sum, participation in the entire study will take 
approximately 10 hours. 
 
Study Duration*: 
Estimated time is 48 months 
 
 
 

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Participant Duration: 
Approximately 9 months 
1.2 
SCHEMA  
 
Pre-Screening 
Day -30 to  
Day 1 
 
 
 
 
 
Time 1 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
Time 2 
Day 7± 7 
 
 
Time 3 
Day 7 ± 7  
 
 
 
 
 
Total N: 450 
Pre-screen potential participants by inclusion and exclusion criteria; if eligible receive baseline. 
Conduct informed consent process. Perform baseline assessments. 
 
For further description, refer to Section 1.3, Schedule of Activities 
Control 
N = ~150   
MTB 
N = ~150  
Weekly EDD Follow-up Surveys (months 0-9) 
 
Randomize 
MTB+ALC 
N = ~150   
BSAVE 
Total N: 450 
Baseline Measures; schedule intervention session. 

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1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
 
Pre-screening 
(Pre-consent) 
 
Baseline 
Day 1 
Virtual 
Intervention 
Session(s) 
Day 1 ±7 
 Weekly EDD 
Follow-up Surveys 
(months 0-9) 
 Day 7 ±7 
BSAVE Session 
Day 7 ±7 
Review Eligibility 
X 
 
 
 
 
Informed Consent 
X 
X 
X 
 
X 
Demographics 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outcome Evaluation 
 
 
 
 
 
Randomization 
 
X 
 
 
 
Control & Experimental 
Interventions – MTB, MTB+ALC, & 
Control 
 
 
X 
 
 
BSAVE Bystander Intervention 
Virtual Reality Simulation Task 
 
 
 
 
X 
Outcome Expectancies for 
Intervening 
 
X 
 
 
X 
Bystander Efficacy Scale  
 
X 
 
 
X 
DERS-SF 
 
X 
 
X 
 
Bystander Intention to Help Scale-
Short Form 
 
 
 
 
X 
Urica 
 
X 
 
 
X 
 
TSFP-short version (sexual assault 
measures) 
 
X 
 
 
 
Social Reactions Questionnaire 
(Negative Reactions to Disclosure) 
 
X 
 
 
 
Barriers to Sexual Assault 
Bystander Intervention 
 
X 
 
 
 
The Revised Conflict Tactics Scale 
(CTS2) 
 
X 
 
 
 
Childhood Trauma Questionnaire 
Short Form CTQ-SF 
 
X 
 
 
 
ILLINOIS RAPE MYTH ACCEPTANCE 
– SUBTLE VERSION  
 
X 
 
 
 
 
Toronto Empathy Questionnaire 
 
 
 
 
X 

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Pre-screening 
(Pre-consent) 
 
Baseline 
Day 1 
Virtual 
Intervention 
Session(s) 
Day 1 ±7 
 Weekly EDD 
Follow-up Surveys 
(months 0-9) 
 Day 7 ±7 
BSAVE Session 
Day 7 ±7 
Big Five Inventory‐10 (BFI‐10) 
 
 
 
 
X 
Dirty Dozen Short Dark Triad (SD3) 
 
 
 
 
X 
Alcohol Use Disorder Identification 
Test 
 
X 
 
 
 
The Alcohol Expectancies 
Regarding Sex, Aggression, and 
Sexual Vulnerability Questionnaire 
(AESAS) 
 
 
 
X 
 
 
 
 
 
X 
Decisional Balance for Immoderate 
Drinking 
 
 
 
 
X 
Drinking Motives Questionnaire 
 
X 
 
 
 
NIDA-Modified Alcohol, Smoking 
and substance Involvement 
Screening Test 
 
X 
 
 
 
The Couples Satisfaction Index (CSI)  
 
 
 
 
X 
Individuality in Couples 
Questionnaire (ICQ) 
 
 
 
 
X 
The Experiences in Close 
Relationships-Short form 
 
 
 
 
X 
Experience of Dehumanization 
Measure (EDHM) 
 
 
 
 
 
X 
Interpersonal Sexual Objectification 
Scale 
 
X 
 
 
 
Interpersonal Sexual Objectification 
Scale – Perpetration (ISOS-P) 
 
X 
 
X 
 
Interpersonal Sexual Objectification 
Scale – Victimization (ISOS-V) 
 
 
 
X 
 
Self-Objectification Beliefs and 
Behavior Scale 
 
X 
 
X 
 
Daily Discrimination Scale 
 
 
 
X 
 
Self-Compassion Scale Short Form  
(SCS-SF)  
 
 
 
 
X 
LEC-5 
 
X 
 
 
 
PCL 
 
X 
 
 
 
Drinking Norms Rating Form  
 
X 
 
 
 
Sexual Assertiveness Questionnaire 
(SAQ) 
 
X 
 
 
 
Sexual Norms Inventory-Perception 
of Bystander Intentions Subscale 
 
X 
 
 
 
Urica-DV 
 
X 
 
 
X 

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Pre-screening 
(Pre-consent) 
 
Baseline 
Day 1 
Virtual 
Intervention 
Session(s) 
Day 1 ±7 
 Weekly EDD 
Follow-up Surveys 
(months 0-9) 
 Day 7 ±7 
BSAVE Session 
Day 7 ±7 
CDSES (Controlled Drinking Self-
Efficacy Scale) 
 
 
 
 
X 
Bystander Decision Balance Scale 
(Baynard et al 2005) 
 
 
 
 
X 
CEMI (Client Experiences of 
Motivational Interviewing) 
 
 
 
 
X 
EDD Outcome Measures- 
Timeline Followback (TLFB) 
 
X 
 
X 
 
Competency Checklist 
 
 
 
 
X 
IGroup Presence Questionnaire 
(IPQ) 
 
 
 
 
 
X 
Adverse Events Reporting 
 
X 
X 
X 
 
Phubbing Scale 
 
X 
 
 
 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Existing bystander interventions to reduce sexual assault, and associated evaluations, are promising but 
suffer from significant limitations. First, psychoeducational approaches, which present identical material 
to all participants, may not be the most effective in prompting bystander behaviors. These interventions 
do not address factors, such as individual motivations and readiness to change, which may be crucial 
drivers of bystander behaviors. Second, current bystander intervention trainings do not address the 
adverse impact that bystander alcohol use may have on intervention attempts, even though bystanders 
often consume alcohol in SV situations. If bystanders are themselves drinking, and intoxication impairs 
bystander intervention attempts, then training efforts that fail to address bystander alcohol use will be of 
limited utility. Heavy drinkers, in particular, may have more opportunities to intervene because they 
frequent alcohol-laden situations where SV risk is common, yet they may have less SV interventions 
because alcohol consumption undermines bystander behavior. At the same time, if heavy drinkers could 
be motivated to drink less and intervene more, then they would be exceptionally well-positioned to 
prevent sexual assaults. Finally, prior evaluations of bystander trainings ask participants to report 
retrospectively about their bystander intervention attempts over periods ranging from 3 to 6 months. This 
is problematic because participants may not accurately recall details about sexual risk situations or their 
responses to them over such extended periods of time. Thus, key information about the impact of 
bystander training may be missed by the sole use of retrospective self-reports.  
 
Our long-term goal is to reduce the prevalence of SV through evidence-based preventive interventions 
that can be easily adopted, implemented, and sustained across multiple settings. The present project 
represents a significant step toward that goal. Specifically, we propose to evaluate a promising new 
intervention to increase bystander behaviors, Motivate-the-Bystander (MTB), in combination with a 
proven motivational interviewing intervention to reduce alcohol use (ALC) with a sample of heavy 
drinkers. To our knowledge, this will be the first in-person intervention to explicitly target bystander 
motivations to intervene and bystander alcohol use as barriers to bystander intervention. This combined 
bystander-alcohol use intervention will be evaluated in a randomized controlled trial (RCT) that 
incorporates scientifically rigorous methods not found in prior bystander evaluation studies. In particular, 
rather than relying on long-term retrospective self-reports, we will assess key SV risk and alcohol-related 
outcomes multimodally with electronic daily diaries completed within a week of SV events and a validated 
virtual reality-based measure of observed bystander behaviors. We will test this combined MTB+ALC 
intervention with a community sample of young adults who are heavy drinkers. Our central hypothesis is 
that this novel MTB+ALC intervention will be superior to attention control and MTB alone in promoting 
bystander interventions in response to sexual risk. 
 
Aim 1: Compare the impact of MTB to an attention control condition on bystander intervention behaviors. 
Hypothesis 1: MTB (vs. attention control) will increase prosocial bystander behaviors at measured via B-
SAVE and weekly EDD follow-ups (months 0-9).  
 
Aim 2: Compare the impact of MTB+ALC to MTB on bystander intervention behaviors. Hypothesis 2: 
MTB+ALC (vs. MTB or attention control) will (a) increase prosocial bystander behaviors, and (b) decrease 
overall alcohol use measured via weekly EDD follow-ups (months 0-9).  
 

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Aim 3: Compare the impact of MTB+ALC to MTB on alcohol use proximal to opportunities for bystander 
intervention. Hypothesis 3: MTB+ALC (vs. MTB or attention control) will reduce alcohol use in risky sexual 
situations; lower proximal alcohol use will be a mechanism explaining why MTB+ALC increases prosocial 
bystander behavior.  
 
2.2 
BACKGROUND  
 
Sexual violence (SV) is a major public health problem among young adults in the U.S (Breiding et al., 2014; 
Cantor et al., 2017).  Bystander intervention programs, which train witnesses to intervene to diffuse risky 
sexual situations (Banyard, 2008), are a common approach to sexual assault prevention. Typical bystander 
intervention trainings consist of group psychoeducational presentations about risk factors for sexual 
assault, taking responsibility for intervening, and how to intervene (Banyard et al., 2007). Evaluations of 
these interventions have focused primarily on attitudinal and intent-to-intervene outcomes, which are 
positively impacted by bystander training. The few studies to examine actual bystander behaviors in 
response to sexual risk show increases in self-reported intervention attempts following training.  
 
We will test the efficacy of a new bystander intervention (MTB) in conjunction with a well-established 
motivational enhancement intervention (ALC) to reduce alcohol use. Strengths of this RCT include 
recruitment of a diverse community (rather than college) sample of heavy drinkers, multimodal 
assessment of bystander behaviors using a virtual reality paradigm, which allows for direct observation 
of intervention attempts, and weekly electronic daily diaries, to provide unprecedented detail about 
proximal associations between bystander alcohol use, opportunities for bystander intervention, 
intervention behaviors, and key contextual variables surrounding those behaviors. With evidence of its 
efficacy following this RCT, MTB+ALC could be quickly disseminated to enhance alcohol reduction and SV 
prevention efforts among young adults. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 
 
Potential risks to participants are most likely to arise in relation to the following aspects of our study: (1) 
participation is not anonymous; (2) participants will be asked potentially sensitive questions about alcohol 
use, recent sexual victimization experiences, and sexual violence intervention opportunities and behaviors 
with the battery of questionnaires at baseline as well as with the EDDs; (3) participants complete MI 
interventions in which they discuss sexual risk situations (MTB; MTB+ALC) and alcohol use (MTB+ALC); (4) 
participants will engage in the B-SAVE, which involve fictional, but realistic and immersive sexual risk 
scenarios; (5) participants will complete the B-SAVE in which they wear an oculus rift and navigate a virtual 
environment while occupying physical space in the real environment (i.e., walking around). Safeguards to 
manage the risks associated with breaches of confidentiality, emotional distress, and virtual reality are 
detailed in the Protection Against Risks section below.  
 

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The first concern, which is associated with all research that is not anonymous, is breach of confidentiality. 
Realization of this risk could cause negative social consequences. Given that data will be linked to 
participants’ identities in between the baseline assessment to 9-month follow-up, this is an important risk 
to consider. We believe that the risk is very low, given that most data are collected electronically and all 
data will be stored securely and separately from identifying data. Further, all self-report data will be 
collected through Qualtrics, a secure online survey service. Several safeguards and procedures for 
protecting data will be in place.  
 
The second concern is that participants may feel uncomfortable answering potentially sensitive questions. 
For example, some people may experience distress when providing self-reports of sexual victimization. 
Likewise, participants may experience discomfort when providing self-reports of sexual violence 
intervention opportunities and behaviors, particularly if they failed to intervene or help. Finally, 
participants may experience embarrassment when reporting alcohol use, especially heavy drinking. 
Participants will be reminded that they have the right to refuse to answer any question during the study 
(baseline, daily diary follow-ups) or to discontinue participation at any time. All self-report measures are 
programmed to allow participants to skip any question, but still complete the survey. 
 
The third concern relates to participation in the MTB and MTB+ALC interventions. Participants may 
experience some adverse psychological reactions such as feeling upset or discomfort as they undergo the 
intervention. For example, a potential risk is that a participant may gain a new awareness of a situation in 
which a woman was at-risk for sexual violence and the participant did not previously intervene. Likewise, 
participants may learn that their drinking behaviors are not normative, which may make them feel 
uncomfortable. Although these instances represent some degree of risk, we have designed the 
procedures to minimize adverse reactions. For example, MI interventions are delivered in a non-
judgmental, supportive manner. 
 
Regarding the fourth concern, it is possible that completing the B-SAVE with fictional, but highly realistic 
and immersive sexual risk scenarios (depicting objectifying commentary, unwanted touching, and 
coercive tactics for sex), may induce emotional distress. Furthermore, people with victimization 
experiences may be particularly likely to experience distress when engaging in the B-SAVE. Relevant to 
these concerns are a number of recent articles specifically examining whether participation in trauma-
related research causes distress or “re-traumatizes” participants. This work does not support the 
conclusion that participating in trauma-related research, including studies that involve disclosing 
traumatic or abusive experiences, results in lasting psychological distress or harm to participants (Black & 
Black, 2007; Ullman, 2007; Becker-Blease & Freyd, 2007; Cromer et al., 2006). Additionally, although the 
visual displays and dialogue used in the B-SAVE may be upsetting to some due to their sexual content, 
none of the scenes involve sexual threat directed toward participants. Moreover, the party environment 
and interactions depicted in the virtual environment are situations that young adults are exposed to in 
their daily life (Banyard et al., 2007). Researchers who have exposed participants to sexual content in the 
form of self-reported descriptions, vignettes, audio or video recordings, or through virtual reality have not 
found long-term adverse reactions (Jouriles et al., 2009; Jouriles et al., 2016; Messman-Moore & Brown, 
2006; Parks et al., 2016). 
 
The fifth concern specific to the proposed study is exposing participants to virtual reality, which raises the 
possibility of cybersickness, physical injury, and aftereffects. Virtual reality can create conflict in some 
participants because sensory cues from a variety of modalities (e.g., auditory, visual, vestibular, 
proprioceptive) are incongruent between the virtual environment and the real-life physical environment. 
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body based on prior real-life experiences (e.g., the visual displays provide information to the brain that 
one is walking more quickly through the virtual environment than the actual physical environment). This 
conflict is unlikely with the virtual reality technology we are using because the virtual reality parameters 
closely approximate the physical reality (e.g., a 20’ X 20’ house is depicted in a 20’ X 20’ lab room; sensors 
track the participants’ movements in real time, so that the physical displays correspond to bodily 
expectations). Nonetheless, the B-SAVE could still cause cybersickness (Stanney et al., 1997) in some 
individuals. Cybersickness is thought to resemble motion sickness and result in similar symptoms such as 
nausea, vomiting, eyestrain, disorientation, ataxia, and vertigo (Kennedy et al., 1994; Rizzo et al., 2002). 
Additionally, because people are walking in a real life physical environment when they are navigating the 
virtual environment, there can be increased risk for injury (e.g., falling, bumping into walls on the 
perimeter). A final issue is aftereffects or difficulties with reorienting to the real world following 
immersion in virtual reality. There can be a lag between leaving the virtual environment and adjusting to 
the sensorimotor requirements of the real world. Thus, participants can have disturbed locomotion, 
changes in postural control, or perceptualmotor disturbances because they have adapted to the 
sensorimotor requirements of the virtual reality. A number of procedures are in place to allow participants 
to safely complete the virtual reality B-SAVE measure. 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
 
Participants who complete the MTB intervention may benefit from increased knowledge and skills related 
to bystander interventions, and those who complete the MTB+ALC intervention may additionally benefit 
from increased knowledge about problematic drinking. All participants will receive monetary 
compensation for involvement in the study. Participants who complete the MTB+ALC intervention may 
reduce their drinking, which could have several positive health benefits. Additionally, although not a direct 
benefit to participants, those who complete the MTB or MTB+ALC interventions may demonstrate 
increased behaviors to prevent others sexual assault, therefore helping potential sexual assault victims. 
Further, the proposed investigation will provide data that is critical to developing an evidence base for 
interventions (MTB and MTB+ALC) on decreasing drinking and increasing bystander behaviors, leading to 
dissemination and valuable information for future heavy drinking as well as sexual violence prevention 
efforts. The risks associated with this study are expected to be outweighed by the potential benefits of 
these findings. 
 
2.3.3 ASSESSMENT 
OF 
POTENTIAL 
RISKS 
AND 
BENEFITS  
 
Rationale for Exposing Participants to Risk 
Given our aim to reduce sexual assault, it would not be possible to conduct the MTB intervention without 
exposing participants to potentially upsetting content. Similarly, for a rigorous assessment of bystander 
outcomes, it is necessary to supplement traditional self-report measures with VR, which is not subject to 
social desirability bias.  
 
Minimization of Risks 
Upon arriving at each scheduled appointment (baseline, intervention and B-SAVE), and before beginning 
any part of the study, the informed consent process will take place. All participants will read a written 
copy of the Informed Consent Form (ICF) and be able to ask questions before signing. The ICF will clearly 

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state that participation is voluntary and that participants can withdraw from the study at any time without 
penalty. Participants will have the opportunity to ask questions prior to consenting, and may withdraw 
from the study at this or any other point. The informed consent form will explicitly state that the B-SAVE 
may contain sexually aggressive cues, and that some study procedures and questionnaires may induce 
negative feelings (e.g., reporting on alcohol use; reporting on sexual victimization). The ICF will also 
explicitly state that some participants may experience cybersickness and/or aftereffects when 
participating in virtual reality research. In the event that a potential participant seems ill at ease or shows 
any behavioral signs of ambivalence in the lab (e.g., taking an inordinately long time to read the consent 
form, hesitating before signing the form, asking questions revealing concern about the study tasks), that 
individual will be reminded that participation is not required and that he or she may choose not to consent 
without penalty. In short, the informed consent protocol is structured to ensure that individuals 
understand the full nature of the study and feel comfortable agreeing to participate before providing 
consent. 
 
In addition to informing participants of the nature and associated risks of the study, a number of 
precautions will be implemented. Protection against risks associated with confidentiality breaches. 
Several procedures that have been used previously by the MPIs will be followed to ensure confidentiality 
of all research participants. Following our established procedures, all research staff will be trained in the 
importance of maintaining confidentiality and will complete the required NIH training in protection of 
human research participants. They will be informed that breach of confidentiality may result in 
termination of employment and will sign a pledge attesting to their commitment to maintaining subject 
confidentiality. All presentations of the project data will report findings in terms of groups; no individual 
identifying information will be presented. All computers that will store data for this project are in locked 
rooms when users are not present.  
 
All computers, servers, and Cloud storage files (i.e., restricted SharePoint folders) are password-protected. 
Only individuals with a correct password can gain access to individual computers, servers, or restricted 
SharePoint folders. To protect individual computers from unauthorized intrusion, computer users do not 
have administrative privileges on workstations and servers, and therefore are unable to install 
unauthorized applications and services or modify critical system files that could create vulnerabilities. In 
addition, firewalls protect each individual computer, server, and SharePoint folders from intrusion. 
Further, the University of Nebraska-Lincoln has additional firewalls and other security devices to protect 
the network infrastructure from outside their campus. Auditing and password security policies are 
enabled on computers, servers, and SharePoint folders to track login attempts and restrict unauthorized 
access.  
 
Consent forms will not be stored with any data and will be secured in another location from the primary 
study data. The central list of subject IDs and names will also be stored in a locked cabinet at a separate 
location and/or in a separate SharePoint folder.  
 
MTB and MTB+ALC interventions will be video recorded and the digital file downloaded for transcription. 
The video file will be transcribed verbatim and coded for fidelity; participants will be identified numerically 
only. The digital files will then be destroyed to protect confidentiality following transcription and coding. 
Transcribed files will be stored on a restricted SharePoint folder on password protected computer in a 
locked room. All data will be stored securely and separately from identifying data. Paper consent forms 
for all the in-person data collection sessions will be stored in locked file cabinets in the laboratory, 
separate from the data. A code key which links participant names to the unique ID number and any hard 

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copies of participants’ data will be kept in separate locked filing cabinets. Upon completion of the follow-
up B-SAVE session and EDDs, the code key that links participants’ identity to their data will be destroyed. 
 
Protection against risks associated with experience of emotional distress as a result of answering sensitive 
questions about heavy drinking, sexual victimization, or sexual violence intervention behavior. This project 
includes the potential risk that participants may fear repercussions for (1) reporting underage or heavy 
drinking to the research team, (2) reporting an incident of sexual violence to the research team, (3) 
reporting the type of sexual violence intervention behavior in which they engaged, or (4) reporting that 
they did not engage in any sexual violence intervention behavior after witnessing a sexual violence event 
or a situation at-risk for sexual violence. For instance, participants may fear that researchers will review 
their responses and render some negative judgment (e.g., if the participant is under 21 and reports 
drinking alcohol; if the participant did not intervene in a sexually risky situation). To protect against this 
potential risk, participants will be clearly told in the consent process that some of the questions asked 
may be distressing. They will also be reminded that they have the right to refuse to answer any question 
during any study phase (i.e., baseline, follow-up B-SAVE, follow-up electronic daily diaries) or to 
discontinue participation at any time. All instruments are programmed to allow participants to skip any 
question but still complete the survey. In addition, participants will be informed that all responses are 
confidential and are submitted directly to a secure database housed on a non-university, secure web-
based server. They will be further reminded during the informed consent process that members of the 
research team do not monitor their responses. Thus, during the period in which participants’ responses 
are identifiable, the research team will not access the data. These procedures will not only minimize 
participants’ fear of potential repercussions, but they also maximize the reliability and validity of data 
obtained during the project. 
 
Protection against risks associated with distress during the MTB and MTB+ALC interventions. Our MTB 
and MTB+ALC interventions are constructed in a manner such that participants themselves detail their 
values and recall their previous experiences with bystander interventions and drinking. As such, it is 
unlikely that participants will report situations they themselves are unwilling to discuss and may have 
adverse reactions too. However, participants in the MTB+ALC intervention condition will receive 
normative feedback on drinking and they may feel distress or embarrassment for heavy drinking. 
Furthermore, discussing sexual risk situations and previous bystander opportunities during MTB and 
MTB+ALC could still cause participants emotional discomfort. If a participant experiences an adverse 
psychological reaction, MI interventionists will be available for counsel and will use active listening 
techniques (e.g., reflection, empathic understanding) and administer a distress protocol to help alleviate 
participant distress. To further safeguard this risk, Dr. David DiLillo (MPI), a licensed clinical psychologist 
in the state of Nebraska, will train, supervise, and consult with MI interventionists to implement 
procedures to minimize risks and protect participants in the event an adverse reaction occurs. Dr. DiLillo 
will also be “on call” to consult about unforeseen issues that may arise, as well as speak to participants 
who might experience intense distress. In addition, the Psychological Consultation Center, which provides 
services to the community of Lincoln and is staffed by numerous doctoral student therapists and doctoral-
level psychologists, is housed in Burnett Hall at the University of Nebraska-Lincoln where study sessions 
will take place. This permits quick access to a counselor, if needed.  
 
The informed consent form will clearly spell out that the MTB and MTB+ALC interventions and some of 
the questions are of a personal nature and may cause some degree of distress. We will also provide mental 
health referral information to each participant and participants will complete the Alcohol Use Disorders 
Identification Test (AUDIT) and given appropriate referrals if requested. Specifically, we will provide the 
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Helpline (1-800-662-4357) which provides 24/7 mental and/or substance use disorder counseling. We will 
also refer to a local mental health facility, the UNL Psychological Consultation Center, 325 Burnett Hall, 
402-472-2351, which serves community members on a sliding fee basis and treats substance use, anxiety, 
depression, PTSD, and trauma. Although unlikely, if a participant expresses intent to harm himself or 
herself, or another individual, project staff will take immediate steps to ensure the safety of participants 
or other individuals (e.g., by calling 911). 
 
Protection against risks associated with experience of emotional distress as a result of the BSAVE. To 
address the risk of emotional distress related to completing the B-SAVE, participants will be reminded that 
they can withdraw from the study or skip any measures or tasks at any time. Additionally, during the 
debriefing process, participant’s responses will be discussed in a nonjudgmental way (e.g., participants 
will be reminded that people have a variety of responses on the B-SAVE including intervening and not 
intervening). Furthermore, during informed consent and debriefing, participants will receive contact 
information for local mental health agencies that provide affordable (sliding fee) services (i.e., the UNL 
Psychological Consultation Center, 325 Burnett Hall, 402-472-2351) as well as a local and national 24-hour 
crisis hotlines (i.e., Voices of Hope, 402-475-7273; RAINN National Sexual Assault Hotline, 1-800-656-
4673), should they experience any emotional difficulties resulting from participating in the study. To 
manage potential risks arising during the lab-based portions of the study, trained graduate research 
assistants will staff the in-lab data collection sessions. The research assistants will closely monitor research 
participants for behavioral signs of distress (e.g., taking an exceptionally long time to complete portions 
of the study, asking questions revealing concern about the B-SAVE), in which case participants will be 
offered a break and reminded of the option to withdraw from the study at any point. Furthermore, to 
determine if distress increases over the course of the B-SAVE, we will assess distress at the beginning of 
the study and at the end. In the event of continued distress, Dr. David DiLillo (MPI), a licensed clinical 
psychologist in the state of Nebraska, will be available in person or via telephone to consult with the 
research assistant and/or speak with the participant until distress levels abate. In the event that distress 
persists (but there is no threat of imminent harm) participants will be referred to local agencies providing 
counseling services on a sliding scale basis (see above). Although unlikely, if participants express intent to 
harm themselves, or another individual, project staff will take immediate steps to ensure the safety of 
participants or other individuals (e.g., by calling 911). 
 
Protection against concerns related to cybersickness, potential injury, and aftereffects. Several 
protections will be in place to address these concerns. First, our motion tracking system reduces the 
chances for cybersickness because it is calibrated to synchronize real-life, three dimensional movements 
with virtual reality movement, so that the visual displays that participants see as they navigate the virtual 
environment closely resemble the physical sensations they feel as they navigate the real world physical 
environment. Furthermore, participants will be in the virtual environment for a relatively short period of 
time (approximately 15 minutes), further reducing the chances of cybersickness (Kennedy et al., 1995) 
Anyone who reports experiencing such symptoms such as cybersickness will be immediately removed 
from the virtual environment and offered to sit in a quiet space until symptoms subside (they tend to 
subside very quickly once someone is removed from the virtual environment). They will be reminded that 
they can withdraw from the study at any time without penalty. They will also be told that should any of 
the symptoms arise, they should tell the research assistant immediately. If symptoms persistent, we will 
end the study and participants will be monitored until the symptoms completely subside. A sickness bin 
will be kept in the VR lab in case a participant vomits. To ensure participants do not bump into walls while 
wearing the VR headset, research assistants will be trained to shadow participants as they walk around 
the room during the B-SAVE. They will redirect the participant if the person comes within three feet of a 
wall or other object. Once the study has ended, participants will be led to a quiet space where they can 

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sit and walk around.  Participants will be reminded that if they experience any symptoms they should seek 
medical attention right away. Although very unlikely, if a participant experiences medical symptoms, 
project staff will take immediate steps to ensure the safety of participants or other individuals (e.g., by 
calling 911). 
 
Why the value of the information to be gained outweighs the risks  
The results of the proposed research are expected to provide initial evidence for the MTB+ALC 
intervention and additional evidence for the MTB intervention on increasing individuals’ behaviors to 
prevent sexual assault. Previous bystander interventions provided to large groups of individuals have 
shown limited success in engaging bystanders to actually act to prevent assault, and the results of this 
proposed study may provide evidence for the efficacy of an individualized, value-driven approach to 
motivate potential bystanders. Further, this work addresses a significant gap in the literature, as previous 
bystander interventions have typically relied on retrospective self-reported behavioral and attitudinal 
measures for assessment. By using virtual reality, our results maximize both internal and ecological 
validity, and we will be able to assess actual bystander behaviors as they unfold in simulated sexual risk 
scenarios. Furthermore, by using EDDs, we will assess self-reported bystander behaviors that are strong 
in external validity shortly (within 1 week) after they occur. This should allow us to examine bystander 
behaviors in potentially unprecedented detail. These novel measurement approaches may provide 
valuable evidence for the potential efficacy of the intervention and can guide future prevention efforts. 
The risks of this study are expected to be minimal, and, as heavy drinking and sexual assault pose 
significant psychological and physical risk to individuals, potential benefits outweigh the potential risks to 
participants. 
3 
OBJECTIVES AND ENDPOINTS  
 
Primary study endpoints are: 1) reduced drinking, and 2) increased bystander behaviors. Drinking will be 
assessed with self-reports in electronic daily diaries (EDD). Bystander behaviors will also be assessed with 
EDD and observed directly with a VR-based measure of bystander behaviors called the Bystanders in 
Sexual Assault Virtual Environments (B-SAVE). In this study, 450 men and women aged 18-25 will be 
recruited from Lincoln, NE using passive methods. Potential participants will be screened, consented, and 
enrolled. After obtaining consent, the baseline survey will be administered and will assess self-reported 
individual differences in alcohol use and bystander outcomes and secondary endpoints (SV perpetration, 
victimization, alcohol expectancies, prosocial and personality traits, and other theoretical and empirical 
factors related to primary outcomes). 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
 
 
 
The overarching goal is to 
evaluate the efficacy of 
MTB+ALC in comparison to 
MTB and an attention control 
condition. 
 
1) reduced drinking  
2) increased 
bystander 
behaviors  
Briefly identify the 
hypothesized role that each 
measure plays in the study 
objectives, e.g., moderator, 
mediator, causal mechanisms, 
covariate.   
These endpoints serve as the 
outcome variables necessary 
This column is 
optional and can 
be included when 
appropriate. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
for evaluating the goals of the 
intervention. 
Secondary 
 
 
 
The secondary objective is to 
assess self-reported 
individual differences in 
alcohol use and bystander 
outcomes and secondary 
endpoints. 
 
1) SV perpetration, 
2) SV victimization, 
3) alcohol 
expectancies 
4) prosocial and 
personality traits  
5) other theoretical 
and empirical 
factors related to 
primary outcomes  
Briefly identify the 
hypothesized role that each 
measure plays in the study 
objectives, e.g., moderator, 
mediator, causal mechanisms, 
covariate.   
These endpoints are 
understood to serve as 
potential moderators. 
 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 
 
Our first hypothesis is that MTB (vs. attention control) will increase prosocial bystander behaviors at each 
follow-up. Our second hypothesis is that MTB+ALC (vs. MTB) will increase prosocial bystander behaviors 
and decrease overall alcohol use measured via B-SAVE and weekly EDD follow-ups. Our third hypothesis 
is that MTB+ALC (vs. MTB or attention control) (a) will reduce alcohol use in risky sexual situations and (b) 
lower proximal alcohol use will be a mechanism explaining why MTB+ALC increases prosocial bystander 
behavior. 
 
This is a Phase II trial. It will be a single site trial. A futility analysis is planned when 75% of the sample has 
been recruited (refer to details in Section 9.4.6, Planned Interim Analysis). Stratifications are planned 
based on racial and ethnic identity (refer to details in Section 9.4.7, Sub-Group Analyses). No sub-studies 
are planned.  
 
Our study will use a randomized design. Once individuals complete the baseline survey, they will be 
randomized to an automated stratified block randomization program. This procedure ensures equal 
numbers of participants across 3 intervention groups (MTB, MTB+ALC, control). As our recruitment 
approach will ensure that 36% of our sample are from racial or ethnic minority groups, we will first stratify 
by race/ethnicity, resulting in two strata: non-minority and minority. We will also use this approach for 
gender and sexual orientation. For each stratum, a separate block randomization sequence will be used 
to assign people to one of 3 intervention groups: 1) MTB, 2) MTB+ALC, 3) Attention control. 
 
The first study intervention, MTB, is an individual, face-to-face, MI session designed to enhance bystander 
intervention behavior in sexual risk situations. MTB is grounded in principles of motivational interviewing 
and is informed by brief interventions for other behaviors such as alcohol use (Miller et al., 1988). MTB 

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begins with brief psychoeducational information, presented in an MI-consistent manner according to the 
elicit-provide-elicit framework (Miller & Rollnick, 2002). MTB sessions are individually-tailored and 
incorporate personalized feedback from online measures of participant attitudes and current bystander 
behaviors. Consistent with MI-principles, MTB incorporates an exploration of a participant's values and 
goals (e.g., being a good friend, being an advocate for women) in relation to bystander behavior, and 
emphasizes individual autonomy with respect to potential behavior change. One key feature of MTB is an 
exploration of possible bystander behaviors a participant may be willing to initiate over the course of the 
study. The participant selects one or more of these behaviors to focus on over the next 9 months, and the 
interventionist reinforces the choice through the MI-consistent use of confidence and importance rulers. 
Throughout the MTB session the interventionist uses tailored open-ended questions, reflections, and 
strategic summaries to elicit and enhance change talk related to bystander behaviors.  
 
Participants in MTB+ALC will receive MTB and an additional MI session with personalized feedback to 
address alcohol use and alcohol-related consequences. The ALC portion of MTB+ALC follows a traditional 
manualized format following MTB. The session begins with rapport building and exploration of personal 
values and goals related to alcohol use. The interventionist explores both the positive and negative 
aspects of drinking and provides a personalized feedback report tailored to the participant's alcohol use 
and alcohol related consequences. This computer-generated feedback report summarizes: 1) past-month 
frequency and quantity of drinking and heavy drinking; 2) normative comparisons for past- month 
frequency and quantity of drinking and heavy drinking; 3) past-month typical and peak BAC; 4) BAC 
interpretation guides; 5) alcohol-related consequences and risk factors for alcohol problems (past year); 
and 6) other alcohol-related outcomes (i.e., calorie intake, cost of alcohol use, and time allocated to 
alcohol consumption in comparison to other activities). The interventionist presents each topic in a non-
judgmental style and invites discussion and reflection. The interventionist uses MI techniques throughout 
the discussion (i.e., respecting autonomy, open-ended questions, reflective listening, eliciting change talk, 
providing feedback that supports self-efficacy). Following the presentation of the personalized feedback 
report, the interventionist explores the participant's interest in changing drinking behavior. All 
participants are also provided with a menu of options of potential changes in alcohol use. Participants 
who identify an interest in change collaboratively set goals with the facilitator and identify a change plan.  
 
The attention control condition begins with an introduction and general rapport building. The 
interventionist reviews the rationale for treatment, stating that life transitions during young adulthood 
may be stressful. Next, an exploration phase addresses the participant's typical level of daily stress and 
reviews current participant-employed coping behaviors. To promote treatment expectancies, a rationale 
and instructional exercise for progressive muscle relaxation is provided. The session concludes with a 
recommendation that the participant practice these techniques regularly.  
 
At T2, participants will complete self-report measures (see measures) and the BSAVE. The B-SAVE virtual 
house party was developed by PIs DiLillo and Gervais using virtual reality software and hardware. This 
setting was selected because parties: (1) often involve heavy drinking; (2) are a high risk setting for SV, 
and; (3) are bystander intervention-appropriate (i.e., unwanted sexual advances are visible to onlookers, 
see Figure 3). The virtual environment for the party consists of a house including a front porch, a living 
room, a kitchen, and a bedroom. The overall dimensions are approximately the same (20 x 20 feet) as the 
room that houses the VR lab, thus enabling users to walk and move freely in the VR environment. MPIs 
DiLillo and Gervais programmed the B-SAVE using state-of-the-art virtual reality software and hardware 
(Worldviz LLC), creating a fully immersive experience. The virtual house is populated with individuals and 
small groups of same- and mixed-gender avatars who are racially diverse (33% representing racial/ethnic 
minority groups) from different sexual orientations (heterosexual, lesbian/gay), casually dressed, and 

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appear to be young adult aged. Non-verbal cues from the avatars (e.g., smiling, leaning toward or away 
from someone) as well as environmental cues to bolster immersion in the overall party setting (e.g., party 
music, a cooler with beer, a keg, red Solo cups) are present in the environment. Following a practice period 
to acclimate to VR, participants proceed through the 10 scenes of the BSAVE (5 risk, 5 neutral). In each 
scene, participants are prompted at two points in the conversation (with a flashing microphone) to 
verbalize their response in that situation, providing 10 opportunities to intervene in sexual risk situations. 
The VR system simultaneously records non-verbal behaviors (e.g., location: moving toward or away from 
avatars; gaze: head movements). If no verbal response is provided for 3 seconds, the scene automatically 
continues. Each neutral scene contains two response opportunities (not analyzed) to reduce demand 
characteristics. Following each scene, participants are directed to the next scene with an arrow. Risk 
scenes encountered in the B-SAVE contain both subtle and blatant sexual risk cues and show: a man 
sharing a nude photograph of an ex-girlfriend without her consent to another man; a woman experiencing 
unwanted sexual touching while dancing with a male acquaintance; two men making rape supportive 
jokes and talking about a drinking woman in sexually derogatory ways; the female victim of the revenge 
porn (from the earlier scenario); and a man pressuring an obviously intoxicated woman to remove her 
clothes against her will in a bedroom. These risk scenes are interspersed among the following neutral (i.e., 
non-risk) scenes: a man greeting the participant at the front door; two women and one man recounting a 
recent night of heavy drinking; two women engaging in small talk by a keg; an intoxicated man talking 
with his girlfriend; and two women planning to leave the party for a consensual hook-up.  
 
T3 will consist of a series of weekly follow-up surveys immediately post final virtual intervention session 
until 9-months after T1. We will employ a prospective electronic daily diaries (EDD) approach in which 
participants report their prosocial bystander behaviors and alcohol use each day. Study participants will 
receive a prompt to provide past-week reports of bystander and drinking-related outcomes. Morning was 
chosen as the ideal time because SV situations and drinking can occur well into night; querying participants 
in the morning is therefore the best time to capture the prior day’s activities in their entirety. Drinking 
and bystander-related outcomes will be assessed, each with a yes-no screening question, followed by 
drop down and open-ended responses options (see Weekly Electronic Diary). Alcohol consumption will 
be assessed as the number of standard drinks consumed over the past 24 hours on a 1-25 scale (with 
definitions of standard drinks provided). The time of the first and last drink will be collected as well, to 
examine drinking in relation to sexual risk and bystander opportunities. Responses to these items will 
provide unique and rich data addressing the occurrence of bystander behaviors in alcohol vs. nonalcohol 
contexts (i.e., when others are consuming alcohol) and bystander alcohol use in relation to interventions 
targeting the perpetrator, victim, or other bystanders. Finally, because of the high co-occurrence between 
alcohol and other substance use (e.g., cannabis, opioids, sedatives, stimulants, psychedelics) we will also 
assess the timing and levels of any other substances participants may have used on each occasion (refer 
to Section 1.3, Schedule of Activities). 
 
 
 
 
 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 

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 We selected the relaxation attention control condition because it is similar to prior control conditions 
used in prior evaluations of the MI-based ALC intervention and is designed to control for nonspecific 
factors by providing equivalent levels of attention. There are no known potential problems associated 
with the control group. 
 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
MTB is an individual, face-to-face, 60-minute MI intervention designed to enhance bystander intervention 
behavior in sexual risk situations. MTB is grounded in principles of MI and is informed by brief 
interventions for other behaviors such as alcohol use and weight loss. MTB sessions are individually-
tailored and incorporate personalized feedback to address bystander attitudes and previous bystander 
behaviors. Following MTB, participants in the MTB+ALC condition will receive a 60-minute MI intervention 
with personalized feedback to address alcohol use and alcohol-related consequences. Several factors led 
us to select MI as the unifying framework for our combined bystander-alcohol intervention. First, MI has 
proven to be efficacious in helping individuals change a variety of behaviors related to other forms of 
interpersonal violence (e.g., intimate partner violence) and for reducing substance use, including drinking. 
Second, MI is flexible; rather than comprising a single set of techniques, it represents a style of interaction 
with a client and is rooted in the several interrelated principles, including: expressing empathy through 
reflective listening; identifying discrepancies between clients' goals or values and their current behavior; 
avoiding direct confrontation; adjusting to resistance; and supporting client self- efficacy and optimism. 
Thus, although MTB and ALC target different behaviors for change, they share hallmark features of MI; 
therefore, each intervention serves to reinforce principles promoted in the other. Further, providing 
content tailored to the individual’s values, goals, and abilities may boost intervention efficacy by 
enhancing message impact and perceived relevance to participants, rather than presuming a “one size fits 
all” group format. Finally, our selection of a brief evidence-based preventive intervention is intended to 
ensure that our intervention can be easily adopted, implemented, and sustained across multiple settings. 
 
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if they have completed the baseline assessment, 
the randomly assigned intervention or control condition (i.e., MTB, MTB+ALC, control), 1-week B-SAVE 
follow-up, and weekly EDD follow-up assessments.  
 
The end of the study is defined as completion of the 9-month follow-up assessment shown in the Schedule 
of Activities (SoA), Section 1.3. 
 
 
 
 
5 
STUDY POPULATION 
 

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5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Individuals ages 18-25 
2. Heavy drinkers (as defined by using the AUDIT, see measures) 
3. English fluency 
4. Community members from Lincoln, Omaha, NE and surrounding areas  
5. Signed and dated consent form 
6. Stated willingness to comply with study procedures 
5.2 
EXCLUSION CRITERIA 
 
This project does not have any pre-determined exclusion criteria beyond the need to meet inclusion 
criteria for the study. 
 
5.3 
LIFESTYLE CONSIDERATIONS 
N/A 
 
5.4 
SCREEN FAILURES 
Individuals who do not meet the criteria for participation in this trial (screen failure) because of not 
meeting one or more inclusion criteria that are likely to change over time may be rescreened.  
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Recruitment: Our targeted sample size is N = 450 women and men between 18 and 25 
years of age (n ≈150 per condition). Initial recruitment will take place on a rolling basis 
over a 36-month period. Recruitment for this clinical trial will utilize methods used 
previously by the research team with advertisements via multiple media outlets to 
ensure we have adequate reach of our targeted population. We will use a broad 
recruitment strategy that includes advertising online, in local newspapers, and via 
community flyers (in buses, bars, liquor stores, etc.) and that will target young adults 
who are heavy drinkers in Lincoln, Omaha, NE and surrounding areas. Ads will ask 
respondents to contact the laboratory via a QR code, e-mail, or phone to complete an 
initial eligibility screening. To enhance the generalizability of our results, we will use a 
broad recruitment strategy that includes advertising online (e.g., Craigslist, social 
media), in newspapers, and in places in the community via flyers that target young 
adults who are heavy drinkers in Lincoln, Omaha, NE and surrounding areas. In doing 
so, we will use strategies from Co-Is Orchowski and Parrott and our own research to 
recruit heavy drinkers (e.g., posting fliers in bars; outside liquor stores). We will also 
utilize a list of students from the UNL Bursar’s office as needed. Ads will ask 
respondents to contact the laboratory via an online survey, email, or phone, to 
complete the initial eligibility screening. Eligibility screening will take place using a 
Qualtrics form (see Eligibility Screening). The link to this form will be provided to 

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participants either through email (for those who email the lab) or via a QR code on 
advertisements. Individuals who call the lab may be screened on the phone.  
 
To increase sample size, participants will also be recruited through BuildClinical—a 
recruitment service used for NIH-funded research—to advertise the study. 
BuildClinical is a data-driven platform that helps academic researchers recruit 
participants for research studies more efficiently using social media, software, and 
machine learning. They work with IRBs in the United States to adhere to all the 
appropriate guidelines and procedures. They utilize study-specific advertisements to 
engage participants on digital platforms such as Facebook, Google, WebMD, etc. and 
redirect them to a study-specific landing page should they click it. On the landing 
page, the person can complete a brief online questionnaire (called the “Screening 
Form” in the above link) that gets routed into BuildClinical's platform to enhance 
recruitment (e.g., to ensure the correct populations are being reached and to inform 
adjustments to the algorithm) before being directed to the study team’s Qualtrics 
screening survey to determine eligibility. (Importantly, the brief 
questionnaire/screening form used by BuildClinical is for recruitment purposes only 
and those data will not be accessed by the investigative team.)  BuildClinical's Secure 
Socket Layer (SSL) software encrypts all inputted information and keeps the 
information private and HIPAA compliant. The backend servers are stored in the 
United States at some of the most secure data centers in the world. 
 
To be eligible, participants must be between 18 and 25 years old and meet NIAAA 
criteria for heavy drinking via alcohol screening items. Those who meet inclusion 
criteria and provide informed consent will be provided a link to the baseline 
assessment and later scheduled for a virtual lab visit to undergo one of the three 
treatment conditions. Using conservative estimates from past studies conducted by 
MPIs DiLillo and Gervais as well as Co-Is Orchowski and Parrott, including substantial 
samples of heavy drinkers, the above recruitment efforts will generate approximately 
26 calls per month. We estimate that 13 (50%) will be deemed eligible, provide 
consent, and be randomly assigned to intervention condition (N = 450). (See table 
below for a month-by-month schedule of baseline and follow-up sessions.)  
 
Retention: Our team has had significant success in retaining large, community-based cohorts including 
heavy drinkers. We conservatively estimate a 25% attrition rate from baseline to the last 9-month EDD, 
which is greater than other longitudinal research including MI-interventions with heavy drinkers (attrition 
at 9- to 12-month follow-ups = 15-20%). To maximize retention, we will employ several proven strategies 
successfully used in previous studies involving community-based samples of heavy drinkers. We will 
collect and verify extensive contact information after informed consent using a data collection form 
adapted from MPI DiLillo and colleagues. We will attain contact information for people from participants’ 
differing social networks (e.g., non-drinking and drinking family and friends), to ensure retention across 
the 9-month period (e.g., a subset of our sample might enter alcohol use disorder rehabilitation programs 
and thereby have more contact with non-drinkers than drinkers compared to when they were initially 
recruited). Qualtrics will be used to automatically send text messages and email reminders about pending 
follow-up assessments (i.e., VR B-SAVE lab session; EDD surveys). For EDD surveys specifically, participants 
will receive daily email and/or text message reminders until each survey is completed; once a survey is 
completed, reminders for that survey will stop. We will use multiple additional strategies to boost 

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retention, including: 1) maintaining cell phone, address, email and other records (e.g., social media 
handles); 2) sending email “meeting” invites; 3) emailing and texting reminders prior to each EDD period; 
and 4) holding incentives until several tasks have been completed. Finally, participants will be paid $30-
$40 for completion of online baseline measures (1.5– 2 hours).They will also receive $20 per hour for 1 
virtual intervention session (1-3 hours). They will be paid $40 for the lab visit when they complete the B-
SAVE (1.5 hours). In addition to this standard compensation, participants will be eligible for two bonuses: 
a $15 bonus if they complete the baseline online measures within 2 days of providing consent, and 
another $15 bonus if they complete your Zoom session within 3 weeks of finishing the online measures. 
Participants will be paid $5 for each follow-up survey. Participants will also receive a $2 bonus for each 
follow-up survey they complete on Sundays.  
 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
5.6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
5.6.1 STUDY 
INTERVENTION 
OR 
EXPERIMENTAL 
MANIPULATION DESCRIPTION 
 
Participants in this study will be randomly assigned to receive one of three interventions: MTB, MTB+ALC, 
and attention control. Intervention conditions will last approximately 60-120 minutes and will be 
administered by a trained interventionist.  
 
MTB: MTB is an individual, face-to-face, MI session designed to enhance bystander intervention behavior 
in sexual risk situations. MTB is grounded in principles of motivational interviewing and is informed by 
brief interventions for other behaviors such as alcohol use (Miller, Sovereign, & Krege, 1988) and weight 
loss (Smith West, DiLillo, Bursac, Greene & Gore, 2007). Because the concept of bystander intervention 
may not be familiar to some participants, MTB begins with brief psychoeducational information, 
presented in an MI-consistent manner according to the elicit-provide-elicit framework (Miller & Rollnick, 
2002). MTB sessions are individually-tailored and incorporate personalized feedback from online 
measures of participant attitudes and current bystander behaviors. Consistent with MI-principles, MTB 
incorporates an exploration of a participant's values and goals (e.g., being a good friend, being an 
advocate for women) in relation to bystander behavior, and emphasizes individual autonomy with respect 
to potential behavior change. One key feature of MTB is an exploration of possible bystander behaviors a 
participant may be willing to initiate over the course of the study. The participant selects one or more of 
these behaviors to focus on over the next 9 months, and the interventionist reinforces the choice through 
the MI-consistent use of confidence and importance rulers. Throughout the MTB session the 
interventionist uses tailored open-ended questions, reflections, and strategic summaries to elicit and 
enhance change talk related to bystander behaviors.  
 
MTB+ALC: Participants in MTB+ALC will receive an additional MI session with personalized feedback to 
address alcohol use and alcohol-related consequences. The ALC portion of MTB+ALC follows a traditional 
manualized format following MTB. The session begins with rapport building and exploration of drinking-
related personal values and goals. The interventionist explores both the positive and negative aspects of 
drinking and provides a personalized feedback report tailored to the participant's alcohol use and alcohol 
related consequences. This computer-generated feedback report summarizes: 1) past-month frequency 

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and quantity of drinking and heavy drinking; 2) normative comparisons for past-month frequency and 
quantity of drinking and heavy drinking; 3) past-month typical and peak BAC; 4) BAC interpretation guides; 
5) alcohol-related consequences and risk factors for alcohol problems (past year); and 6) other alcohol-
related consequences and risk factors for alcohol problems (past year; and 6) other alcohol-related 
outcomes (i.e., calorie intake, cost of alcohol use, and time allocated to alcohol consumption in 
comparison to other activities). The interventionist presents each topic in a non-judgmental style and 
invites discussion and reflection. The interventionist uses MI techniques throughout the discussion (i.e., 
respecting autonomy, open-ended questions, reflective listening, eliciting change talk, providing feedback 
that supports self-efficacy). Following the presentation of the personalized feedback report, the 
interventionist explores the participant's interest in changing drinking behavior. All participants are also 
provided with a menu of options of potential changes in alcohol use. Participants who identify an interest 
in change collaboratively set goals with the facilitator and identify a change plan. ALC lasts 90-150 
minutes. 
 
Attention control: The attention control condition is designed to control for nonspecific factors by 
providing equivalent levels of contact time and attention. Like the active treatment conditions, the 
attention control condition begins with an introduction and general rapport building. The interventionist 
reviews the rationale for treatment, stating that life transitions during young adulthood may be stressful. 
Next, an exploration phase addresses the participant's typical level of daily stress and reviews current 
participant-employed coping behaviors. To promote treatment expectancies, a rationale and instructional 
exercise is provided. Specifically, progressive muscle relaxation is introduced and practiced. The session 
concludes with a recommendation that the participant practice these techniques regularly. The entire 
Attention control session lasts approximately 90 minutes. 
 
5.6.2 ADMINISTRATION AND/OR DOSING 
 
The study intervention will be administered individually, in two face-to face sessions (60-120 minutes).   
 
5.7 
FIDELITY 
 
5.7.1 INTERVENTIONIST TRAINING AND TRACKING 
 
Interventionists will then complete a two-day intensive training program with Consultant Nadine 
Mastroleo, Ph.D., in which prescribed and proscribed behaviors are enumerated and practiced through 
group and didactic instruction as well as role- playing techniques. Following training, interventionists will 
complete practice sessions and provide self-ratings of competence and adherence. Once interventionists 
feel ready, they will record two sessions with pilot participants (who meet study inclusion criteria). 
Interventionists will be certified when they are deemed proficient in accordance with the Motivational 
Interviewing Treatment Integrity scale (MITI; Moyers et al., 2005) MPIs DiLillo and Gervais and Co-Is V. 
DiLillo and Orchowski are or will be certified on the latest version of the MITI. 

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Co-I V. DiLillo, a licensed psychologist who oversaw the implementation of MTB during the pilot RCT, will 
employ treatment integrity/fidelity checks for MTB. Co-I Orchowski, also a licensed clinical psychologist, 
will implement these procedures for ALC. Twenty percent of sessions will be randomly reviewed and rated 
for adherence to protocols using the MITI Coding Manual 4.2.1 on an ongoing basis. The MITI is a 
behavioral coding system that is the most commonly used treatment integrity measure in clinical trials of 
MI. If someone does not meet the requirements of the MITI, they will receive remedial training and 
complete practice sessions until adequate levels of adherence and competence are achieved. 
 
5.8 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
 
Once individuals complete the baseline survey, they will be randomized to an automated stratified block 
randomization program. This procedure ensures equal numbers of participants across 3 intervention 
groups (MTB, MTB+ALC, control). As our recruitment approach will ensure that 36% of our sample are 
from racial or ethnic minority groups, we will first stratify by race/ethnicity, resulting in two strata: non-
minority and minority. We will also use this approach for gender and sexual orientation. For each stratum, 
a separate block randomization sequence will be used to assign people to one of 3 intervention groups: 
1) MTB, 2) MTB+ALC, 3) Attention control. 
 
Interventionists must know which participants are receiving which intervention, precluding them from 
being blinded to conditions. However, coders will be blind to condition when coding the electronic daily 
diaries and responses to the VR B-SAVE for the primary endpoints (e.g., bystander outcomes, alcohol use). 
This should reduce any bias related to coding endpoints.  
 
5.9 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
N/A 
 
5.10 CONCOMITANT THERAPY 
N/A 
 
5.10.1 RESCUE THERAPY 
N/A 
 
 
 
 
 
 

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6 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
6.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
 
 
If a clinically significant finding is identified (including, but not limited to changes from baseline) after 
enrollment, the investigator or qualified designee will determine if any change in participant 
management is needed. Any new clinically relevant finding will be reported as an adverse event (AE). 
 
The data to be collected at the time of study intervention discontinuation will include the following: 
The reason(s) for discontinuing the participant from the intervention, and methods for determining the 
need to discontinue. 
 
 
6.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives  
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
Subjects who sign the informed consent form and are randomized but do not receive the study 
intervention may be replaced.  Subjects who sign the informed consent form, and are randomized and 
receive the study intervention, and subsequently withdraw, or are discontinued from the study, will not 
be replaced. 
 
6.3 
LOST TO FOLLOW-UP 
 

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A participant will be considered lost to follow-up if he or she or they does not complete any of the follow-
ups. The following actions must be taken if a participant fails to complete study protocols at each of the 
time-points: 
 
• 
For participants who fail to complete any of the follow ups, the study personnel will contact them 
(e.g., phone call, text message) 6 times for each follow up. 
• 
Should the participant continue to be unreachable for all of the follow ups, he, she, or they will 
be considered to have withdrawn from the study with a primary reason of lost to follow-up. 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
 
Primary study endpoints are: 1) reduced drinking, and 2) increased bystander behaviors. Drinking will be 
assessed with self-reports in electronic daily diaries (EDD). Bystander behaviors will also be assessed 
with EDD and observed directly with a VR-based measure of bystander behaviors called the Bystanders 
in Sexual Assault Virtual Environments (B-SAVE). In this study, 450 men and women aged 18-25 will be 
recruited from Lincoln, Omaha, NE and surrounding areas using passive methods. Potential participants 
will be screened, consented, 
and enrolled. Determinations of eligibility will be based on an initial eligibility screening via an online 
survey, e-mail, or phone. Individuals will be eligible to participate if they meet the following criteria: 
1. Individuals ages 18-25 
2. Heavy drinker (For men, 5+ drinks on a single occasion or more than 15 drinks per week during 
the last month. For women, 4+ drinks on a single occasion or more than 8 drinks per week) 
3. Lincoln, Omaha, NE and surrounding areas community members 
4. Signed and dated consent form 
5. Stated willingness to comply with study procedures 
 
After obtaining consent, the baseline survey will be administered and will assess self-reported individual 
differences in alcohol use and bystander behavior, as well as other theoretical and empirical factors 
related to primary outcomes. Participants will then be given instructions for completing the weekly EDD 
surveys post final intervention through month 9. Participants will self-report the number of standard 
drinks consumed in the past week (our primary alcohol use endpoint), as well as whether they 
intervened as a bystander if there was an opportunity to do so (our primary bystander behavior 
endpoint). One-week post-intervention, investigators will schedule a lab appointment for participants to 
complete the B-SAVE. The follow-up B-SAVE includes 5 risk scenes within a house party in which 
participants are prompted at two points in the conversation (with a flashing microphone icon) to 
verbalize their response in that situation, providing 10 opportunities to intervene in sexual risk 
situations. Responses are recorded and coded and reflect the presence or absence of intervention 
attempts (0=no, 1= yes). Along with the intervention attempts from the EDD, sum intervention attempts 
during the B-SAVE is the primary outcome of interest for assessing bystander behaviors.  
 
7.2 
SAFETY ASSESSMENTS 

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The MI interventionists or trained graduate research assistants will be present during all study sessions 
and will be responsible for ensuring participants' safety on a daily basis. The MPIs, Dr. DiLillo and Dr. 
Gervais, will be available in the building or by phone during all study sessions. Throughout data 
collection, the MPIs will meet with the MI interventionists and graduate research assistants weekly and 
the rest of the study team (i.e., Co-Is) monthly to monitor participant safety, among other aspects of the 
study (e.g., evaluating progress, reviewing procedures). 
7.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
7.3.1 DEFINITION OF ADVERSE EVENTS 
 
7.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
This protocol uses the definition of serious adverse event from HRPP Policy 13.001: an event resulting in 
any of the following outcomes: 
A. Death 
B. A serious threat to life, health, safety or welfare of the subjects 
C. Inpatient hospitalization (for a person not already hospitalized) or prolongation or hospitalization 
(for a patient already hospitalized) 
D. Persistent or significant disability or incapacity 
E. Required intervention to prevent permanent impairment or damage 
F. Congenital anomaly and/or birth defects 
G. An event that jeopardizes the subject and may require medical or surgical treatment to prevent 
one of the preceding outcomes 
H. The rights, safety, or welfare of subjects is seriously jeopardized. 
 
7.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 

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7.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by the study team based on temporal relationship and his/her judgment. The degree of certainty 
about causality will be graded using the categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
 
7.3.3.3 EXPECTEDNESS  
 
The study team will be responsible for determining whether an adverse event (AE) is expected or 
unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the study procedures. 
 
7.3.4 TIME PERIOD AND FREQUENCY FOR EVENT 
ASSESSMENT AND FOLLOW-UP 
 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during the intervention, VR B-SAVE lab session, or any of the electronic daily diary follow-
up surveys.  
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to make 
a determination), and time of resolution/stabilization of the event. All AEs occurring while on study will 
be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
The study team will record events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Events will be 
followed for outcome information until resolution or stabilization. 
 

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7.3.5 ADVERSE EVENT REPORTING  
 
Per our Data and Safety Monitoring Plan, the DSMB will receive quarterly reports of any adverse events, 
and an annual report summarizing all AEs will be provided to the NIAAA Project Officer. The report will 
include confirmation of adherence to the data and safety monitoring plan, b) a summary of any data and 
safety monitoring issues that occurred since the previous reporting period, c) a description of any changes 
in the research protocol or in the data and safety monitoring plan that either does or potentially affect 
risk, and d) all new and continuing IRB approvals. Finally, the PI will report any adverse events to the UNL 
IRB within 48 hours of when any of the research team members become aware of the incident. 
 
7.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event (SAE). Per our Data and Safety Monitoring Plan, SAEs will be reported 
within 48 hours (via telephone and/or e-mail) to the University of Nebraska IRB, the DSMB, and the NIAAA 
Project Officer.  
 
7.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
 
7.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
 
7.3.9 REPORTING OF PREGNANCY  
 
 
N/A 
 
7.4 
UNANTICIPATED PROBLEMS 
 
7.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 

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• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
7.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will include 
the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study 
sponsor/funding agency within 48 hours of the investigator becoming aware of the event  
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 48 
hours of the investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within 48 hours of the IRB’s receipt of the report of the 
problem from the investigator 
 
7.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
8 
STATISTICAL CONSIDERATIONS  
 

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8.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Endpoint(s):  
 
 The main hypotheses are: MTB (vs. attention control) will increase prosocial bystander behaviors  
measured via B-SAVE and weekly EDD follow-ups (months 0-9; Hypothesis 1); MTB+ALC (vs. MTB) will 
increase prosocial bystander behaviors and decrease overall alcohol use  
measured via weekly EDD follow-ups (months 0-9; Hypothesis 2); MTB+ALC (vs. MTB and attention 
control) (a) will reduce alcohol use in risky sexual situations and (b) lower proximal alcohol use will be a 
mechanism explaining why MTB+ALC increases prosocial bystander behavior (Hypothesis 3). 
 
A formal statistical analysis plan will not be completed. Thus, relevant information is provided below in 
each subsection.  
• 
Secondary Endpoint(s): 
 
n/a 
 
8.2 
SAMPLE SIZE DETERMINATION 
Primary study endpoints are: 1) reduced drinking, and 2) increased bystander behaviors. Drinking will be 
assessed with self-reports in electronic daily diaries (EDD). Bystander behaviors will also be assessed with 
EDD and observed directly with a VR-based measure of bystander behaviors called the Bystanders in 
Sexual Assault Virtual Environments (B-SAVE). Specifically, our main outcome variable for testing 
Hypothesis 1 will be bystander intervention attempts during the B-SAVE and from electronic daily diary 
reports (EDD; 0 = no, 1 = yes). Our main outcome variables for testing Hypothesis 2 will be bystander 
intervention attempts, as well as alcohol use from the EDD (number of standard drinks consumed over 
the past week. Our main outcomes for Hypothesis 3 will be bystander intervention attempts from the 
EDD. 
 
The null hypotheses are: (1) there will be no difference between MTB and the control condition on 
bystander intervention attempts across the B-SAVE and EDD, (2) there will be no difference between MTB, 
MTB+alc, and the control condition on bystander intervention attempts across the B-SAVE and EDD or on 
the number of standard drinks reported on the EDD, and (3) changes in alcohol use proximal to risky sexual 
situations will not account for differences in bystander intervention attempts.  
 
Cohen’s f effect sizes and Sobel test statistics (R2ab) were used to determine power sufficient for the 
current study. Power estimates were conducted in G*Power (Faul et al., 2007). The alpha’s examined 
were .05 for at least 80% power. Analyses of data using pilot data suggest that MTB is associated with 
improved bystander attitudes and likelihood to intervene with large effect sizes (Grandgenett, 2021), with 
a Cohen’s f of approximately 0.58 compared to attention-control group, which falls above the threshold 
large effect size under conventional rules of thumb (large effect = 0.40). Considering a more conservative 
expected medium effect size of f = 0.25 and 75% attrition by the 9-month follow-up, the statistical power 
is over 0.80 to detect a mean difference between two groups (i.e., MTB vs. control, Aim 1) and over 0.90 
to detect a mean difference among three groups (MTB vs. MTB+ALC vs. control, Aim 2). Power calculations 
of the Sobel test for a sample of N = 336 were conducted for the indirect effect of MTB+ALC on bystander 
behaviors via reduction of alcohol use (vs. MTB and control; Aim 3). Assuming a small effect size, the 
indirect effect would account for 5.5% of the variance in bystander outcomes (R2ab = 0.055). With a sample 

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of 336 individuals, there is over 0.80 power to detect such an indirect effect. These calculations indicate 
that our sample size is sufficient for addressing all endpoints and accounts for attrition.  
 
We will have one dichotomous outcome: bystander intervention attempts (measured across B-SAVE and 
EDD). In the B-SAVE, participants have 5 opportunities to intervene. In daily life, participants have varied 
opportunities to intervene. Specifically, our pilot data from the MTB RCT showed that young adults from 
the community reported approximately two SV intervention opportunities in a 1-month period (M = 2.26, 
SD = 1.55). Thus, we expect that participants will report 9-18 SV bystander intervention opportunities over 
the 9-month period. The rate of intervention attempts during these opportunities is exploratory, given 
lack of prior EDD data. Further, based on our eligibility criteria, we expect that men will report 2-4 drinks 
per day and women will report 1-3 standard drinks per day. 
 
Given our use of rigorous retention strategies, we expect 95% retention at the 1-2-week follow-up and 
75% original sample retention for the 9-month EDD. This would result in 405 participants with B-SAVE 
outcome scores (135 per treatment group) and approximately 336 participants with B-SAVE outcome 
scores and complete EDD weekly measures (112 per treatment group). Multivariate imputation via 
chained equations (MICE) will be used to impute missing data on both predictors and outcome variables. 
MICE is a flexible and widely used method that builds prediction models for variables with missing data 
using all other variables in the dataset and draws randomly from the predictive distribution. 
 
We will not be conducting qualitative analyses, a cluster-randomized or individually randomized group-
treatment trial, or using a Bayesian approach.  
 
8.3 
POPULATIONS FOR ANALYSES 
 
 We are using a modified intention-to-treat analysis population (i.e., all randomized participants who 
complete the intervention).  
8.4 
STATISTICAL ANALYSES 
 
8.4.1 GENERAL APPROACH 
 
 We will not be using qualitative data. For quantitative data, categorical data will be presented as 
percentages and n’s. Continuous data will be presented as means with standard deviations. For inferential 
tests, we will consider statistical significance based on p-values < .05 and confidence intervals that do not 
cross zero. These will be two-tailed inferential tests. We will check our data for normality and corrective 
procedures (e.g., transformation, predictive mean matching) will be applied.  
 
8.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
 
Primary study endpoints are: 1) bystander intervention attempts, 2) bystander effectiveness, and 3) drinking. 
Bystander behaviors will be assessed with weekly EDD (electronic daily diaries) and observed directly with 
a VR-based measure of bystander behaviors called the Bystanders in Sexual Assault Virtual Environments 

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(B-SAVE). Drinking will be assessed with self-reports in weekly electronic daily diaries (EDD). Scores on 
the B-SAVE will be taken at 1-week post-intervention. Scores on the EDD measures will be taken weekly 
for 9 months post-intervention. 
The outcomes will be intervention effectiveness scores coded from B-SAVE, aggregate scores of 
intervention effectiveness derived from coding the weekly EDD bystander behaviors, and aggregate scores 
of alcohol use from the weekly EDD bystander behaviors. Bystander intervention attempts is a binary 
variable where 1 = intervention attempt occurred and 0 = no attempt. Bystander effectiveness is an interval 
variable ranging from -5 (very ineffective; the action would likely facilitate sexual aggression) to +5 (very 
effective; the action would likely disrupt an instance of sexual assault). Drinking is an interval variable that 
represents the number of standard drinks consumed each day for the past week.  
 
A unified statistical modeling framework will be employed to compare intervention groups on both B- 
SAVE bystander scores and weekly EDD scores. All models will be estimated using the latent variable 
modeling software Mplus. Multigroup structural equation modeling (MG-SEM) will be used to explicitly 
test for differences in bystander intervention effectiveness between the MTB and attention control 
condition, and between MTB and MTB+ALC treatment groups, on all primary endpoints while controlling 
for pre-intervention bystander behaviors, alcohol use, and other relevant variables (e.g., SV victimization, 
polysubstance use). We will also utilize the multigroup modeling approach with dynamic SEM (DSEM), a 
method for modeling intensive repeated measures (e.g., daily measures within each weekly EDD) in an 
SEM framework via Mplus. We will embed the weekly EDD DSEM into an MG-SEM to disaggregate 
within- and between-person effects of alcohol use proximal to bystander behaviors. This combined model 
will enable the use of random effects in the DSEM portion of the model as potential outcomes as well as 
sequential mediators. This full model will allow us to explicitly test if changes in alcohol use proximal to 
risky sexual situations account for differences in bystander behaviors. The model can be extended to 
compare the trajectory of bystander intervention effectiveness and the effects of alcohol use on bystander 
behaviors across the three treatment groups. 
 
This is not a cluster-randomized or individually randomized group-treatment trial.  
 
Variances and covariances across repeated measures will be estimated using MG-SEM and DSEM. 
Specifically, DSEM is a dynamic multilevel modeling approach that involves specifying the form of 
intraindividual longitudinal trajectories or time series models while allowing for quantitative differences in 
the parameters of the trajectories between subjects. 
 
Results of statistical procedures will be presented as estimates with standard errors and/or confidence 
intervals from our MG-SEM and DSEM models.  
 
Participants will be 450 women and men aged 18-25 who speak English and are heavy drinkers. Our sample 
will contain heavy drinkers based on NIAAA criteria (men who consume 5 drinks on any day or more than 
15 drinks per week in the past month; women who consume 4 drinks on any day or more than 8drinks per 
week in the past month). 
 
Multivariate imputation via chained equations (MICE) will be used to impute missing data on both 
predictors and outcome variables. MICE is a flexible and widely used method that builds prediction models 
for variables with missing data using all other variables in the dataset and draws randomly from the 
predictive distribution. 
 
Although we have two endpoints for Hypothesis 2, we did not adjust statistically for Type I error criteria 
because we are interested in whether MTB+ALC improves bystander behavior and reduces alcohol use – 
two separate outcomes.  

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8.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
n/a 
 
8.4.4 SAFETY ANALYSES 
 
n/a 
 
8.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
 We will monitor demographic variables throughout recruitment (i.e., race/ethnicity, sexual/gender 
identity, education, SES) using descriptive statistics (e.g., percentages). Further, we will test for efficacy 
across racial/ethnic groups by testing for a subgroup by treatment group interaction effect at the α=.05 
level. If the interaction is not statistically significant, following the guidelines in Rothwell (2005), Schulz 
and Grimes (2005), and Friedman et al. (2010), no further testing will be conducted for individual 
subgroups. In the event of a significant interaction test, we will conduct statistical testing of efficacy for 
each individual subgroup. 
8.4.6 PLANNED INTERIM ANALYSES  
 
 Power analyses have been conducted to assure that we have a sufficient number of participants (n = 450) 
to detect differences between MTB, MTB+ALC, and control intervention conditions. We will conduct a 
futility analysis in accordance with the recommendations of Sully et al. (2014). Based on their recent 
analysis of publicly funded RCTs, Sully and colleagues (2014) recommended that a futility analysis be 
conducted when 75% of the target sample had been recruited using a boundary of γ = 0.3. Based on this 
approach, if we have less than 0.3 observed power to detect the hypothesized effects, the trial will be 
stopped. Notably, this approach does not require any alpha adjustment. Co-Investigator Dr. Katherine 
Masyn will be responsible for overseeing the interim analyses.  
 
The overall project will be stopped if there is evidence of harm, if there is no likelihood of benefit, or if 
there is overwhelming evidence of treatment benefit. Given the nature of the intervention, it is unlikely 
that participants will experience adverse events. However, DSMB meetings will be held every 12 
monthsbeginning in Year 1 of the study to evaluate these possibilities. SAEs will be reported to the DSMB 
Chair 
as soon as they occur. The DSMB Chair will determine whether an in-person meeting or teleconference 
is needed. Prior to the meetings, a written report containing descriptions of any AEs or SAEs as well as 
any preliminary findings will be sent to DSMB members. Preliminary findings will not be made 
available to individuals outside of the DSMB. Each meeting will include time to review the progress of 
the study and to answer questions from members of the DSMB. During the meeting, the DSMB will 
review reports of AEs and SAEs. If we have reached 75% of our targeted sample for the futility analysis, 
then we will review these analyses of outcome data to determine whether the current study needs to be 
changed or terminated depending on whether there is clear evidence of harm, futility, or benefit. A 
determination will be made as to whether the trial should continue as designed, should be changed, or 
should be terminated based on the data and make recommendations to the NIH and the Institutional 
8.4.7 REVIEW BOARD CONSIDERING CONCLUSION OR CONTINUATION OF THE STUDY.SUB-
GROUP ANALYSES 

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 We have proactively decided to adopt a conservative power analytic approach to subgroup analyses for 
racial and ethnic groups aimed at safeguarding against multiplicity concerns. The first step in the subgroup 
analysis will be to test for a subgroup by treatment group interaction effect. There are two general schools 
of thought regarding whether an adjustment to the power calculation be made for such a test of 
interaction. One possible approach is to make a change to the power analysis to increase the sample size 
needed for the interaction test. Another is to power the study on efficacy of its primary outcome and 
avoid further adjustment for an interaction test. We have chosen this second approach to conservatively 
protect against a false positive finding. 
 
Subgroup analyses will proceed with first testing for efficacy across the racial/ethnic groups by testing for 
a subgroup by treatment group interaction effect at the α=.05 level. If the interaction is not statistically 
significant, following the guidelines in Rothwell (2005), Schulz and Grimes (2005), and Friedman et al. 
(2010), no further testing will be conducted for individual subgroups. This approach is analogous to 
requiring a significant overall F-test in an ANOVA analysis before proceeding to conduct multiple 
comparison tests. Interaction tests provide proper caution and consider the limited information available 
in subgroups. Ceasing to continue on to test for individual effects in the absence of a significant interaction 
test is the most effective statistical approach for avoiding inappropriate subgroup findings.  
 
In the event of a significant interaction test, we will conduct statistical testing of efficacy for each 
individual subgroup. Rothwell (2005) suggests the use of an alpha spending function with testing efficacy 
of individual subgroups to adjust for the multiplicity problems that ensue as a result of multiple statistical 
tests on the same outcome. Alpha spending functions were developed to address multiplicity concerns 
that occur with multiple statistical tests performed on the same primary outcome in a randomized 
controlled trial. Alpha spending functions are used to avoid an inflated number of false positives that 
results with multiple statistical tests (Todd et al 2001). Many types of alpha functions have been 
developed to support different analysis strategies. We will use the Pocock alpha spending function to 
implement an equal alpha level across subgroups, which suggests an alpha level for each subgroup 
analysis of α=0.01 (Pocock et al., 2002). We have adjusted these levels to account for the sample size 
differentials between subgroups. 
8.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
 Individual participant data will be listed by measure and time point. 
8.4.9 EXPLORATORY ANALYSES 
 
 We do not have planned exploratory analyses at this time.  
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 

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9.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. The following consent materials are submitted with this protocol: Informed Consent 
04.21.22, ICH-GCP consent form.  
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
 
 Upon arriving at each scheduled appointment (baseline, intervention and B-SAVE), and before beginning 
any part of the study, the informed consent process will take place. All participants will read an online 
copy of the informed consent form (see Informed Consent Form 4.21.22, ICH-GCP consent form), and a 
member of the lab (e.g., research assistant) will be available to answer questions via email or phone. 
During virtual and lab-based sessions lab members will verbally review the information provided in the 
form. The participant will have ample opportunity to ask questions and decline participation if they so 
choose. If participants agree to participate, they will click on an I agree button on the informed consent 
form. There will also be a text box on the Informed Consent Form where participants will type their name 
so that the researchers are able to keep track of each participants informed consent document between 
each timepoint (T1-T3). The participant will also be provided a copy of the informed consent form for their 
records. At T2, a member of the lab (e.g., research assistant) will verbally review the informed consent 
form. Participants will again have the opportunity to ask questions and decline participation if they so 
choose.  
 
In addition to providing consent to participate in the study as a whole, the consent form will provide 
participants with information about sharing their study data with the National Institute of Mental Health 
Data Archive (NDA) and ask if they consent to data sharing. Individuals can participate in the study 
regardless of whether or not they provide consent for NDA data sharing. Individuals are informed they 
can revoke consent for data sharing at any time. No new data will be shared with NDA, but already shared 
data cannot be removed.   
 
We request to waive parental consent for those who are 18 years old. All participants--including those 
under the age of 19--will review a copy of the informed consent form and sign the form if they agree to 
participate. 
 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigators, NIAAA, and regulatory 
authorities (e.g., DSMB). If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding 
agency and will provide the reason(s) for the termination or suspension. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
 

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Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance of study staff to the protocol   (ie, significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies (OHRP, 
DSMB).] 
9.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the National Institute of Alcoholism and Alcohol Abuse. This 
confidentiality is extended to the data being collected as part of this study. Data that could be used to 
identify a specific study participant will be held in strict confidence within the research team. No 
personally-identifiable information from the study will be released to any unauthorized third party 
without prior written approval of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participants’ contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored on a secure, restricted Microsoft SharePoint site. This will not include the 
participant’s contact or identifying information. Rather, individual participants and their research data will 
be identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and on the secure, restricted Microsoft SharePoint site will be secured and 
password protected. At the end of the study, all study databases will be de-identified and archived at the 
NIAAA Data Archive (NIAAADA). 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  

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It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate and consistent with the NIAAA Data Archive Sharing Plan. 
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy.] 
 
9.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
 
Data collected for this study will be analyzed and stored on a secure, restricted Microsoft SharePoint site. 
After the study is completed, the de-identified, archived data will be transmitted to and stored at the 
NIAAADA, for use by other researchers including those outside of the study. Permission to transmit data to 
the NIAAADA will be included in the informed consent.  
 
When the study is completed, access to study data and/or samples will be provided through NIAAADA. 
 
9.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Principal Investigator 
David DiLillo, PhD, Willa Cather Professor and 
Department Chair 
Sarah Gervais, PhD, Susan Rosowski Professor 
University of Nebraska - Lincoln  
University of Nebraska - Lincoln  
238 Burnett Hall 
238 Burnett Hall 
 402-472-3297 
 402-416-6287 
ddilillo@unl.edu 
sgervais2@unl.edu 

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There are no study leadership committees. PIs DiLillo and Gervais will be responsible for the conduct, 
management, and oversight of the trial. Other study team members include the co-investigators Dominic 
Parrott, PhD, Lindsay Orchowski, PhD, Vicki DiLillo, PhD, and Katherine Masyn, PhD, as well as consultant 
Nadine Mastroleo, PhD.  
 
Study staff and participants can report study misconduct directly to the UNL IRB. Participants are provided 
the UNL IRB contact information in the informed consent form. 
9.1.6 SAFETY OVERSIGHT 
 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertise. A Chair with no conflicts of interest who has been the Principal 
Investigator of NIAAA funded projects on alcohol use and violence will be identified. The Chair will recruit 
at least two other members with complementary expertise in the areas relevant to the proposed project 
(e.g., alcohol use, including by people who are heavy drinkers, bystander intervention, sexual 
aggression/victimization). The NIH Project Officer will serve as an ex-officio member of the DSMB. All 
members of the DSMB will be voting members and be appointed for the life of the project. Members of 
the DSMB will be independent from the study conduct and free of conflict of interest. The DSMB will meet 
at least annually to assess safety and efficacy data from each year of the study. Prior to the meetings, a 
written report containing study information (see below) will be sent to DSMB members. Each meeting will 
include time to review the progress of the study and to answer questions from members of the DSMB. 
Any serious adverse events (SAE) or unanticipated problems will be reported to the DSMB within 48 hours 
and the DSMB will receive quarterly reports of any adverse events (AE).  
 
Members of the DSMB will perform the following activities: 
a. Review the research protocols, the DSMP, and informed consent documents. 
b. Review progress of the trial, including analysis of data quality and timeliness, participant 
recruitment, accrual, and retention, participant risk versus benefit ratio, and other factors that 
may affect outcomes. 
c. Review unanticipated problems, serious adverse event reports, and adverse events, provide 
feedback, and provide oversight to ensure that reports are relayed to the IRB and to NIAAA 
whether there is an effect on participant safety. 
d. Review analyses of outcome data and review reports of related studies to determine whether 
the 
current study needs to be changed or terminated. Preliminary findings will not be made 
available to individuals outside the DSMB. All data in the report will be confidential. 
e. Determine whether the trial should continue as designed, should be changed, or should be 
terminated based on the data and make recommendation to the NIH and the IRB considering 
conclusion or continuation of the study. 
f. Review proposed modifications to the study prior to their implementation. 
g. Protect the confidentiality of the trial data and the results of the monitoring as appropriate. 
h. Determine whether and to whom outcomes results should be released prior to reporting of 
study 
results. 
i. Following DSMB meetings, provide appropriate NIH staff with written information concerning 
their findings. 

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9.1.7 CLINICAL MONITORING 
N/A 
 
9.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
 
All data collection will occur on UNL’s campus. PIs DiLillo and Gervais will perform internal quality 
management of study conduct, data collection, documentation and completion.  
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database.  To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. 
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities.] 
 
9.1.9 DATA HANDLING AND RECORD KEEPING  
 
 
9.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 

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Data collection will be the responsibility of the clinical trial staff at UNL under the supervision of PIs DiLillo 
and Gervais. The investigators will be responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
We will have paper (e.g., consent forms, compensation records) and electronic source documents (e.g., 
measures completed by participants in Qualtrics, audio recorded responses to the B-SAVE). All source 
documents will be completed in a neat, legible manner to ensure accurate interpretation of data. Paper 
source documents will be stored in a locked file cabinet, while electronic data will be stored securely on 
the restricted SharePoint site and a password-protected computer. 
 
Hard copies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study.   
 
9.1.9.2 STUDY RECORDS RETENTION  
 
Upon completion of the study, the list linking participant names to their numerical identifier will be 
deleted. Video ﬁles and all data will be kept for seven years in accordance with recommendations by the 
American Psychological Association (APA).  
9.1.10 PROTOCOL DEVIATIONS   
 
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within two working days of identification of the protocol deviation, or within two working days 
of the scheduled protocol-required activity. All deviations will be addressed in study source documents 
and reported to our NIAAA Program Official. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements. Further details about the handling of protocol deviations will be 
included in the MOP. 
9.1.11 PUBLICATION AND DATA SHARING POLICY  
 
 

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This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
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. 
 
9.1.12 CONFLICT OF INTEREST POLICY 
 
Any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or 
any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict 
of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial. The University of Nebraska Lincoln has an established 
Conflict of Interest in Research Policy that will be followed and complies with Public Health Service 
requirements.  
 
9.2 
ADDITIONAL CONSIDERATIONS 
 
N/A 
 
9.3 
ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 

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EDD 
Electronic Daily Diaries 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
MOP 
Manual of Procedures 
MTB 
Motivate-the-Bystander 
MTB+ALC 
Motivate-the-Bystander with Alcohol Component 
NCT 
National Clinical Trial 
NIAAA 
National Institute of Alcoholism and Alcohol Abuse 
NIAAADA   National Institute of Alcoholism and Alcohol Abuse Data Archive 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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9.4 
PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
1.1 
04/13/2023 
1) We request to update the 
study title to Motivations, 
Attitudes, and Perceptions 
Study. 
2) We request to revise the 
study timeline to have 
participants complete the 
BSAVE Virtual reality 
assessment (T2) approximately 
1-2 weeks post-intervention 
instead of 2 months post-
intervention. 
3) We request to complete the 
follow-up retrospective surveys 
that assess alcohol use and 
bystander behavior from the 
previous week for a period of 9 
months, rather in three 21-day 
bursts (see Weekly Electronic 
Diary for new measure to 
accommodate weekly follow-up 
assessment). 
4) We request to revise payment 
for the follow-up surveys to be 
$5 per weekly survey. 
5) We request to shift T1 
intervention sessions to be held 
virtually over Zoom. 
6) We request to update the 
Informed Consent Form to 
reflect the above changes (see 
Informed Consent Form 
03.30.23 with tracked changes 
& Informed Consent Form 
03.30.23 clean). 
1) We would like to provide 
a more generic title that 
does not reveal the purpose 
of the study. 
2) Having participants 
complete the BSAVE 1-2 
weeks after intervention 
should allow us to better 
examine the short-term 
impact of our interventions 
on bystander behavior. 
3) This will allow us to 
examine alcohol use and 
bystander behavior during 
the entire duration of the 
study, rather than only 63 
days. 
4) This update will allow us 
to allocate payment to 
participants in a way that 
matches the proposed 
follow-up survey timeline 
changes. 
5) By holding T1 sessions 
virtually, this will allow 
participants greater 
flexibility to schedule these 
sessions. 
6) The revised Informed 
Consent Form describes the 
above changes. 
1.2 
08/04/2023 
Baseline Assessment: 
1. Baseline Assessment: We request to 
have participants consent and complete 
the baseline questionnaires via Qualtrics 
prior to their first session. 
1.This change will allow us to 
have time to review baseline 
measures prior to administering 
the first intervention content. 

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Intervention Timelines: 
2a. We request to administer MTB and 
ALC interventions on separate days 
rather than on the same day. 
2b. We request to administer MTB and 
Control interventions on separate days 
rather than on the same day. 
2c. We request to update the timing for 
completing the MTB and Control 
interventions to 1-1.5 hours 
2d. We request to update the timing for 
completing the ALC intervention to 1.5-2 
hours. 
2e. We request to administer the weekly 
follow up surveys will be starting the 
weekend after final intervention. 
Control Condition: 
3. We request to use progressive muscle 
relaxation as the activity that control 
participants will complete. Research 
assistants will guide participants through 
a recording of progressive muscle 
relaxation, where theyll be instructed to 
tense and relax certain muscle groups 
(see "Protocol-Control Condition and 
Recording.docx"). 
Updated Intervention Protocols: 
4. We request to add a questionnaire 
assessing participants current alcohol 
use and consequences (see Measure-
ALC Full Survey.pdf) to our previously 
approved ALC intervention protocol. 
Interventionists will guide the participant 
through completing this questionnaire 
and information the participant provides 
during this measure will be reviewed and 
discussed with participants during the 
ALC intervention. 
Measures: 
5a. We request to replace the existing 
baseline measures(see "Measures-
Baseline(Final).dox", ), in person lab 
session measures (see "Measures-
BSAVE(Final).dox"), and weekly timeline 
follow-back EDDs measures (see 
"Measures-EDD(weekly follow-up 
survey).docx"). 
5b. We request to replace the existing VR 
Party Script with minor script changes 
and updated avatars (see "Measure-VR 
Party Script and Avatar Changes.docx") 
Distress Protocol: 
6. We request to add a standardized 
distress and support protocol (see 
Protocol-Distress&Support 
Resources.docx) in the event that a 
participant becomes distressed during 
participation. This protocol includes 
chronological steps to take to reduce 
2a. Separate intervention 
sessions will reduce significant 
participant burden associated 
with completing both 
interventions on the same day.  
2b. Separate intervention 
sessions reduce significant 
participant burden associated 
with completing both 
interventions on the same day. 
2c. As we finalize the 
interventions it has become 
clear this is how long it will 
take. 
2d. As we finalize the 
interventions it has become 
clear this is how long it will 
take. 
2e. This will allow us to assess 
reductions in alcohol use and 
increases in bystander behavior 
immediately after the final 
intervention 
3. We previously indicated we 
were including the control 
condition but did not provide 
details about that condition.  
4. In order to administer the 
ALC intervention, participants 
need to provide information on 
their current drinking behaviors, 
consequences, and strategies for 
reducing drinking. 
5a. These measures will ensure 
we assess all relevant variables 
at each timepoint with the most 
appropriate measures 
5b. To provide an updated 
version that represents minor 
language changes as well as 
updated avatars. 
6. Although we foresee serious 
participant distress as being 
unlikely, we want to have this 
protocol in place just in case. 
This protocol will provide a set 
of pre-determined steps to 
minimize participant distress 
during the course of the study. 
7a. This change will adequately 
represent changes to session 

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participant distress, including ending the 
study early if necessary and provided 
local and nation support resources. 
Informed Consent: 
7a. We request to update the consent 
form to match new session procedures 
and protocols. Specifically representing 
the updated intervention and session 
timelines (see #2 of change request). 
7b. We request to increase participant 
payment to $20/hour for completing the 
baseline measures, $20/hour for 
completing each zoom session (1-2), $40 
for completing the in-person lab session, 
and $5 for completing each weekly follow 
up survey. with a $20 bonus for 
completing 80% of the total weekly 
surveys. 
7c. We request to update the overall time 
commitment for completing the study to 
approximately 10 hours 
Scheduling: 
8a. We request to utilize Calendly, a 
scheduling website, to schedule all 
participant sessions. Participants will be 
provided with a scheduling link directing 
them to schedule their sessions. 
Available blocks of time will be added to 
the calendar and managed by study staff. 
Participants will not have access to or be 
able to view other calendar events and/or 
anyone elses session information. 
8b. We request to obtain participants 
email address and study ID in Qualtrics 
(see 3 - Pre-Baseline Contact List 
Survey_07.15.22). These two questions 
will be is a separate survey administered 
during the baseline session in order to 
keep identifying information separate 
from participant data. 
Participant Eligibility Screening: 
9a. We request to add brief introductory 
language to the eligibility screening. 
Participants will be directed to this page 
when clicking on the screening link (see 
Eligibility-Description Page 
(screening).docx) 
9b. We request to add a question 
assessing participants previous 
participation in virtual reality studies. 
Question: Have you participated in a 
virtual reality study in the last 12 months? 
If a participant selects yes then an open 
text box will be provided for them to 
describe that study. If their description of 
the prior study matches our virtual reality 
BSAVE then they will no longer be eligible 
to participate. 
Participant Reminders: 
procedures and will properly 
inform participant of study 
tasks. 
7b. This change is in line with 
hourly rates for many types of 
employment and is intended to 
increase interest in the study.  
7c. This change will adequately 
represent the overall time it 
takes to complete the entire 
study 
8a. By allowing participants to 
schedule their sessions, we hope 
to increase the likelihood that 
participants will attend all study 
sessions, as well as reduce any 
inconveniences of scheduling 
via phone. 
8b. This secure contact list will 
be used to send automated 
emails to participants with the 
weekly 9 months follow up 
surveys. Automating this 
process will facilitate adherence 
to the study timeline.   
9a. This change will provide 
potential participants with easier 
access to study information and 
streamline the recruitment and 
eligibility screening process for 
both participants and study 
personnel 
9b.Assessing participants prior 
participation in virtual reality 
studies will allow researchers to 
determine if participants prior 
experiences could bias data 
collection.  
10. This change will increase 
the likelihood of participants 
completing sessions and study 
tasks.  This change also reflects 
previously approved changes to 
study design and protocols. 
11a. This method will allow us 
to recruit more participants into 
the study.  
11b. This change will facilitate 
increased recruitment of 
participants by focusing our 
efforts on popular social media 

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10. We request to add additional session 
reminders (see Reminders (participant)-
Baseline, Virtual, In-person, & follow-
up.docx ) 
Recruitment: 
11a. We request to obtain an email list 
from the UNL Registrar of UNL students 
who are between the ages of 18-25, 
which includes students (1) first and last 
name, (2) gender identity, (3) birthdate, 
and (4) race/ethnicity. Only approved 
personnel at UNL will have access to the 
email list. The research team will 
randomly select students from this list to 
contact via email and invite to participate 
in the study (see Recruitment Email to 
UNL Student Body_06.01.23.). The body 
of the email will include a link and QR 
code to see if they are eligible. Both the 
link and QR code will take them to the IRB 
approved Online Eligibility Survey. The 
research team will send a follow up email 
two weeks after initial contact, for people 
who do not complete the Online Eligibility 
Survey. The content of the follow up 
email will not change (re: Recruitment-
Email to UNL Student Body_06.01.23). 
11b. We request to advertise for our 
study using social media accounts 
associated with our lab (e.g., Map Study 
Facebook page). All advertisements will 
briefly describe the study and send 
interested participants to the eligibility 
screening. In addition, if potential 
participants message us through our 
social media accounts, we will respond 
with a link to the eligibility screening and 
communicate with them as necessary 
(e.g., scheduling). Social media ads will 
be posted to the lab page and will be 
shared using the social media platforms 
advertising features. The researchers will 
not share the advertisements on their 
personal pages. These ads will be set to 
only be shown to participants in the 
Lincoln area. In order to address 
confidentiality concerns that might arise 
if previous or potential participants 
interact with these posts (by liking or 
commenting), we will use a page 
moderation feature that will allow us to 
limit any comments to our posts. 
11c. We request to use new images and 
associated captions (see Recruitment-
Social Media Captions and Ads.docx) to 
be used for our social media advertising. 
11d. We request to revise our craigslist 
recruitment ad and advertising posters 
with minor language changes regarding 
platforms for the age-group of 
interest.  
11c. This change will facilitate 
increased recruitment of 
participants by focusing our 
efforts on popular social media 
platforms for the age-group of 
interest. The new images are 
best suited (e.g., eye-catching, 
properly formatted) to be used 
on these platforms. 
11d. This change will provide 
participants with updated and 
accurate study information. 
11e. This change will provide 
participants with updated and 
accurate study information. 

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our updated study name, screening link, 
and contact information. Some language 
has been removed in order to make the 
advertisements brief (removed 
information is now on the screening 
description page). Please see 
(Recruitment-Craigslist Advertisement 
.docx, Recruitment-Flyer Advertisement 
06.01.23.docx). 
11e. We request to add minor language 
changes to participant recruitment and 
eligibility phone/email templates/scripts 
that reflect changes in study procedures 
and sessions. (see Recruitment-Email & 
Phone Script (tracked 
changes7clean).docx, ,Eligibility-Email 
Template (tracked changes&clean).docx) 
1.3 
12/1/2023 
1. We request to add six additional 
measures, DERS-SF, ISOS-V, ISOS-P, Self-
Objectification Beliefs and Behaviors 
Scale, and the Daily Discrimination Scale 
to our weekly electronic diary. See 
Measures-EDD(11.16.23 Tracked 
Changes) and Measures-EDD(11.16.23 
Clean). These measures are only to be 
completed by participants who do not 
report any weekly instances of risk. 
2. We request to implement minor 
language changes to the weekly 
electronic diary. See Measures-
EDD(11.16.23 Tracked Changes) and 
Measures-EDD(11.16.23 Clean). 
3. We request to add additional questions 
to our weekly electronic diary to further 
assess unwanted sexual behaviors and 
substance use, in addition to alcohol use. 
See Measures-EDD(11.16.23 Tracked 
Changes) and Measures-EDD(11.16.23 
Clean). 
4.We request to provide participants with 
a weekly follow up tips document that 
will be presented to participants at the 
completion of their final intervention (see 
Weekly Follow Up Survey Tips.docx). 
Interventionists will review this document 
with participants to guide/teach them 
how to accurately complete the weekly 
electronic diary. This document will also 
be emailed to participants so they can 
reference it at any time. 
5. We request to add five additional 
measures, Urica-DV, TSFP-short version 
(sexual assault measures), Negative 
Reactions to Disclosure, Sexual Norms 
Inventory-Perception of Bystander 
Intentions Subscale, and SAQ to our 
Baseline measures. See Measures-
Baseline (11.16.23 Tracked Changes) 
and Measures-Baseline (11.16.23 
1. These measures have been 
added to ensure that participants 
who do not report any risk incidents 
that week will take approximately 
the same length of time to 
complete the weekly diary as 
participants who report risk 
incidents. This is intended to de-
incentivize underreporting of sexual 
risk incidents. 
2. These changes will provide 
participants with a clearer 
understanding of how to complete 
the measure and will decrease the 
likelihood of participants 
misinterpretation of specific 
measure items 
3. These updates will better capture 
key variables of interest in the 
study. 
4. This will increase the likelihood 
that participants report accurate 
data and will decrease any 
confusion participants may 
experience while completing the 
measures. 
5. These measures will ensure we 
assess all relevant variables at each 
timepoint with the most appropriate 
measures. 
6. These measures will be replaced 
with additional measures (see 
change request item 5) to better 
assess all relevant variables. 
7. By allowing participants to 
schedule their own sessions, we 
hope to increase the likelihood that 
participants will attend all study 
sessions, as well as reduce any 
inconveniences of scheduling via 
phone. 
8. These measures will ensure we 

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Tracked Changes)". 
6.We request to remove five measures 
(Bystander Intervention Scale, SES-F, 
SES-M, TSFP and the Sexual 
Assertiveness Scale) from our Baseline 
measures. See Measures-Baseline 
(11.16.23 Tracked Changes) and 
Measures-Baseline (11.16.23 Tracked 
Changes). 
7. We request to add additional 
scheduling language to the end of the 
baseline measures. See Measures-
Baseline (11.16.23 Tracked Changes) 
and Measures-Baseline (11.16.23 
Tracked Changes) Once participants 
complete their baseline measures, they 
will be provided with language and a 
Calendly link to schedule their first 
intervention. 
8. We request to add 12 additional 
measures (Urica-DV, Controlled Drinking 
Self-Efficacy Scale, Bystander Decisional 
Balance Scale, CEMI, Decisional Balance 
Scale for Immoderate Drinking, 
Interpersonal Reactivity Index, Big Five 
Inventory10, Short Dark Triad, The 
Couples Satisfaction Index, Individuality 
in Couples Questionnaire (ICQ), The 
Experiences in Close Relationships-
Revised (ECR-Short Form) Questionnaire, 
Sexual Norms Inventory-Perception of 
Bystander Intentions Subscale, and the 
SAQ) to our BSAVE measures. See 
Measures-BSAVE (11.16.23 Tracked 
changes) and "Measures-BSAVE 
(11.16.23 Clean) 
9. We request to add additional eligibility 
language to the end of the eligibility 
screening in Qualtrics (see Measures-
Eligibility Screening 10.18.23 (tracked 
changes) and Measures-Eligibility 
Screening 10.18.23 (tracked changes). 
After completion of screening, 
participants will automatically be notified 
of eligibility. If participants are eligible, 
theyll be presented with language and 
link to complete the consent form. 
Participant screenings that require 
further review to determine eligibility, will 
be presented with language notifying 
them that a study staff will be in touch. 
10a.We request to replace the current 
bonus amount for completing weekly 
electronic surveys from $20 for 
completing 80% of surveys to an 
additional $2 for every survey they 
complete on Sundays. This will increase 
the amount they earn for surveys 
completed on Sundays from $5 to $7 
assess all relevant variables at each 
timepoint with the most appropriate 
measures. 
9. This will aid in the inflow of 
consenting participants and 
minimize the amount of contact 
attempts 
10a. This change will encourage 
participants to complete the weekly 
electronic diary when due on 
Sundays. This will also allow for 
less time/effort and contact 
attempts from staff. 
10b. After finalizing the measure, 
this is how long the measure will 
take to complete. 
11. These changes will accurately 
represent the amount a participant 
can earn for completing the weekly 
electronic diary, as well as the 
amount of time it will take them to 
complete it. 

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(see Informed Consent Form 10.18.23 
(tracked changes)" and Informed 
Consent Form 10.18.23 (clean)"). 
10b. We request to update the amount of 
time it takes to complete the weekly 
electronic diary from 5 minutes to 10 
minutes. (see Informed Consent Form 
10.18.23 (tracked changes) and Informed 
Consent Form 10.18.23 (clean)"). 
11. We request to update recruitment 
forms and participant reminders to 
reflect the changes made to the weekly 
electronic diary bonus as well as the 
amount of time it takes to complete the 
weekly electronic diary (see Recruitment-
Craigslist Advertisement 10.18.23 
(tracked changes & clean), Recruitment-
Email & Phone Script 10.18.23 (tracked 
changes & clean), Recruitment-Flyer 
Advertisement 10.18.23(clean), 
Recruitment-Flyer Advertisement 
10.18.23(tracked changes), Reminders 
(participant)-Baseline & Follow-up 
Reminders 10.18.23(clean), and 
Reminders (participant)-Baseline & 
Follow-up Reminders 10.18.23(tracked 
changes)). 
1.4 
1.11.2024 
1. Consent Form: 
a. We request to revise various aspects 
of the consent form to better describe 
the study's purpose and procedures. See 
Informed Consent Form 12.11.23 
(tracked changes) 
b. We request to add in additional 
language informing participants of 
providing valid data and how they may no 
longer be eligible if they do not. To define 
valid data, participants must complete 
80% of the surveys, respond correctly to 
6 out of 8 attention checks, and take at 
minimum 30 minutes to complete the 
surveys. See "Informed Consent Form 
12.15.23 (tracked changes)" and 
"Informed Consent Form 12.15.23 
(clean)". 
c. We request to add additional language 
to the consent form describing the 
weekly follow-up surveys. 
2. Revised Measures: 
a. We request to make minor language 
changes and add additional questions to 
our study measures. See "Measures-
Baseline (FINAL-tracked changes 
12.15.23)", "Measures-Baseline (FINAL-
Clean 12.15.23)", "Measures-BSAVE 
(Final-Tracked Changes 12.15.23)", 
"Measures-BSAVE (Final Clean-
12.15.23)", "Measures-EDD (FINAL-
Tracked Changes 12.15.23)", "Measures-
1a. These changes describe study 
requirements more clearly and 
describe the purpose of the study in 
a manner that will not compromise 
participants responses during data 
collection (i.e., so responses will 
not be impacted by overly specific 
knowledge related to study aims). 
1b. This will increase the likelihood 
that participants report accurate 
data and will decrease the 
likelihood that participants, will rush 
through the measures 
1c. These changes will provide 
participants with a clearer 
understanding of study tasks and 
will decrease the likelihood of 
participants misinterpretation of 
what the study entails. 
2a. These changes will ensure we 
assess all relevant variables with 
the most appropriate questions. 
These changes will also provide 
participants with a clearer 
understanding of how to complete 
the measures and will decrease the 
likelihood of participants 
misinterpretation of specific 
measure items. 
2b. These items increase the 
likelihood that participants report 
accurate data and will decrease the 

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EDD (FINAL-Clean 12.15.23)", "Measures-
Eligibility Screening (FINAL-Tracked 
Changes 12.15.23)" and "Measures-
Eligibility Screening (FINAL-Clean 
12.15.23)" 
b. We request to add 8 attention check 
items throughout the baseline measures. 
See "Measures-Baseline (FINAL-tracked 
changes 12.15.23)", "Measures-Baseline 
(FINAL-Clean 12.15.23)" 
likelihood that participants, will rush 
through the measures. These items 
will allow for study staff to remove 
those individuals that do not 
provide valid data from the study. 
1.5 
2.5.24 
Participant Reimbursement: 
1a. We request to update participant 
reimbursement for the baseline (online) 
measures from $20/hr to $40 total. 
Consent Form: 
2a. We request to revise the participant 
reimbursement language for the baseline 
(online) measures from $20/hr to $40 in 
our consent form. See Informed Consent 
Form 1.23.24 (Clean) and Informed 
Consent Form 1.23.24 (tracked changes). 
2b. We request to revise the timing 
language for completing the baseline 
(online) measures from 1.5 hours to 1.5-2 
hours in our consent form. See Informed 
Consent Form 1.23.24 (Clean) and 
Informed Consent Form 1.23.24 (tracked 
changes). 
2c. We request to revise the timing 
language for completing the zoom 
session from 1.5-3 hours to 1.5-4 hours. 
See Informed Consent Form 1.23.24 
(Clean) and Informed Consent Form 
1.23.24 (tracked changes). 
Participant Reminders: 
3a. We request to revise the participant 
reimbursement language for the baseline 
(online) measures from $20/hr to $40 in 
our study reminders and advertisements. 
See Eligibility-Email Template 1.23.24 
(tracked changes), Eligibility-Email 
Template 1.23.24 (clean), Recruitment-
Email & Phone Script 1.23.24 (tracked 
changes & clean), Recruitment-Flyer 
Advertisement 1.23.24 (tracked 
changes), Recruitment-Flyer 
Advertisement 1.23.24 (clean), 
Reminders (participant)-Baseline 
1.23.24(tracked changes), Reminders 
(participant)-Baseline 1.23.24(clean). 
3b. We request to revise the timing 
language for completing the baseline 
(online) measures from 1.5 hours to 1.5-2 
hours in study reminders and 
advertisements. See Eligibility-Email 
Template 1.23.24 (tracked changes), 
Eligibility-Email Template 1.23.24 (clean), 
Recruitment-Email & Phone Script 
1.23.24 (tracked changes & clean), 
1a. Due to the online structure of 
the baseline measures, it would 
make it hard for examiners to 
determine the exact time it took for 
participants to complete the 
baseline (online) measures. We 
have estimated that it will take 
approximately 1.5-2 hours to 
complete the baseline measures, so 
$40 will allow participants to be 
paid approximately $20/hour. 
Having a set reimbursement 
amount will cause less confusion 
and avoid possible conflicts with 
participants. 
2a. This accurately describes what 
participants will now be reimbursed 
for completing the baseline (online) 
measures. 
2b.This will accurately describe the 
time it will take participants to 
complete the baseline (online) 
measures. 
2c. This will accurately describe the 
time it will take participants to 
complete the zoom sessions. 
3a.This accurately describes what 
participants will now be reimbursed 
for completing the baseline (online) 
measures. 
3b.This will accurately describe the 
time it will take participants to 
complete the baseline (online) 
measures. 
4a. We may use the video-recorded 
interventions or intervention 
transcripts to develop future 
interventions (e.g., interventions 
involving artificial intelligence or 
machine learning). 

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Recruitment-Flyer Advertisement 1.23.24 
(tracked changes), Recruitment-Flyer 
Advertisement 1.23.24 (clean), 
Reminders (participant)-Baseline 
1.23.24(tracked changes), Reminders 
(participant)-Baseline 1.23.24(clean). 
Data Usage for Future Studies: 
4a. We request to add language to the 
consent form informing participants that 
videos/transcripts from the intervention 
may be used by research staff to create 
materials for future studies (e.g., AI-
based interventions). Only researchersno 
other participantswill see the 
videos/transcripts. 
1.6 
3.19.24 
 
1. We request to add a question to 
assess whether potential participants are 
currently enrolled as a graduate student 
in the UNL Department of Psychologyand 
to exclude those who are current 
students in the department. See 
Measures-Eligibility Screening (Tracked 
changes 3.4.24) and Measures-Eligibility 
Screening (Clean 3.4.24)). 
2. We request to add two questions to 
the screener so that we can exclude 
participants who are unable or unwilling 
to complete an in-person lab session 
within the next four months (see: 
Measures-Eligibility Screening (Tracked 
changes 3.4.24) and Measures-Eligibility 
Screening (Clean 3.4.24)). 
3. We request to add a question 
assessing participants preferred 
pronouns. (see: Measures-Eligibility 
Screening (Tracked changes 3.4.24) and 
Measures-Eligibility Screening (Clean 
3.4.24)). 
4. We request to make minor changes to 
eligibility screening end of survey 
response. (see: Measures-Eligibility 
Screening (Tracked changes 3.4.24) and 
Measures-Eligibility Screening (Clean 
3.4.24)). 
5. We request to change the number of 
weekly drinks required for eligibility (as a 
"heavy drinker") from 7 to 8 for women 
and from 14 to 15 for men. 
 
1. 
This will ensure that 
participant privacy is 
protected by removing the 
risk of a participant 
previously knowing an 
interventionist or study 
staff. 
2. As stated in the consent 
form, participation 
requires attending one in-
person lab session. 
Informing potential 
participants during the 
eligibility screening of the 
in-person lab session and 
assessing their ability to 
attend within four months 
will reduce the likelihood 
of participants missing 
that session or dropping 
out of the study altogether. 
3. This will allow study 
staff to properly address 
participants by using their 
preferred pronouns. 
4. This will provide 
participants with accurate 
instructions on how to 
complete the next steps of 
the study. 
5. These figures represent 
the latest NIAAA 
guidelines. 
 
1.7 
8.29.24 
1. Implemented minor revisions to our 
weekly follow-up surveys. Drafted an 
email to send participants reminding 
them about the importance of completing 
the weekly surveys. We plan to send this 
email periodically (e.g., monthly) as a 
reminder to participants. 
Implementedbroad recruitment methods 
(recruitment email to unl faculty, listserv 
Minor revisions will streamline the 
weekly follow-up surveys for 
participants, by minimizing the 
amount of text they must read. 
Sending a reminder email will boost 
compliance with the weekly survey. 
Adding additional recruitment 
methods will allow us to recruit 
more participants. 

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outreach through daily Nebraskan, 
student organization recruitment, 
snowball sampling, direct recruitment at 
public venues (eg., festivals, tailgate 
events, concerts, sports games, etc. 
 
To increase sample size, new 
participants will be recruited through 
BuildClinicala recruitment service used 
for NIH-funded researchto advertise the 
study  
 
 
Build Clinical will allow us to 
expand our ability to recruit and 
increase recruitment. 
1.8 
10.22.24 
1. Due to requirement by NIAAA, we’ll 
provide information about NDA data 
sharing and ask if participants consent to 
it. If they agree, we will collect the 
following additional demographic 
information (legal first, middle, and last 
name, date of birth, city/municipality of 
birth).  This includes adding email, text, 
and phone call templates to notify 
currently enrolled participants about the 
new survey to collect this additional 
information, including reminders. We will 
also update the informed consent form 
to provide information about NDA data 
sharing and ask if future participants 
consent to it. If they agree, the same 
demographic information as above will 
be collected, by adding these questions 
to the end of the Consent Form Qualtrics 
survey.  
2. Implemented minor revisions to the 
Baseline survey, which involved changes 
to instructions and phrasing of some 
questions and the addition of a new 
measure to assess phone usage. 
1. NIH requires this demographic 
information to be collected from all 
participants as part of its data 
archiving requirements.  These 
variables will be used to create a 
GUID for each participant, which is 
a random alphanumeric code used 
by NIH to identify research 
participants without exposing their 
personal information. Variables not 
needed for other purposes after the 
GUID is created (middle name and 
city/municipality of birth) will be 
deleted after GUID creation.  
2. These changes will improve 
clarity for participants and allow us 
to measure phone usage as a 
potential barrier to bystander 
intervention. 
1.9 
7.14.25 
1.1 Request to Provide a $15 Incentive 
for Timely Completion of Baseline 
Measures 
We propose to offer a $15 virtual 
incentive to participants who complete 
the baseline measures within 48 hours of 
receiving the initial survey link (following 
consent). This incentive will be in 
addition to the previously approved $40 
compensation. 
1.2 Request to Add an Alternative $40 
Virtual Compensation Option for Online 
Measures 
Currently, participants receive the $40 
baseline compensation during their in-
person lab session. We propose giving 
participants the option to receive this $40 
virtually immediately after completing the 
Zoom session, instead of waiting for the 
in-person visit. 
1.Participant Compensation: 
Providing compensation earlier, 
providing additional bonuses, and 
providing compensation for partial 
completion of baseline measures 
will help promote timely completion 
of study tasks, increase participant 
engagement and improve retention. 
2. Participant Schedule: will 
streamline data collection, reduce 
participant burden and improve 
scheduling efficiency  
3. Consent: to accurately represent 
participant payment schedules, 
time commitment, and ensure 
consistency with updated study 
procedures 
4. Recruitment Materials: to 
accurately reflect current 
recruitment efforts, participant 

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1.3 Request to Add a $15 Incentive for 
Timely Completion of the Zoom 
Intervention Session 
 We propose offering a $15 virtual 
incentive for completing the intervention 
session within 3 weeks of completing the 
online measures. This is in addition to 
the previously approved $20/hour 
compensation. 
1.4 Request to Add Partial Compensation 
for Baseline Measure Completion  
We request approval to offer $30 
compensation to participants who 
complete at least 80% of the baseline 
measures. Currently, participants receive 
$40 for completing 100% of baseline 
measures. 
2.1 Request to Update Zoom Session 
Schedule (from 1–2 sessions to 1 
session) 
 We request to update the participation 
schedule from the current protocol 
(participants may be randomly selected 
to attend 1–2 Zoom sessions) to a 
revised format where each participant 
will attend only one Zoom session 
(combining the MTB and ALC sessions). 
In the current design, participants 
assigned to the MTB+ALC condition 
complete two separate intervention 
sessions; under the revised format, these 
sessions will be combined into a single 
session. 
2.2 Request to Allow Participants to 
Proceed to Intervention After Completing 
80% of Baseline Measures 
We request IRB approval to allow 
participants who have completed at least 
80% of baseline measures to move 
forward to the intervention phase of the 
study. Currently, participants are required 
to complete 100% of baseline measures 
before progressing. 
3.1 Request to Update Compensation 
Language 
 We request to update the consent form 
to reflect changes to participant 
compensation (items 1.1–1.3; see 
“Informed Consent Form 7.15.25 [tracked 
changes]”). 
3.2 Request to Update Zoom Session 
Duration 
 We request to revise the stated Zoom 
session time to reflect actual completion 
times (1–3 hours), based on participant 
payment schedules and amounts, 
and study information 
5. Participant Reminders: To 
maintain consistency across study 
material, clearly state 
compensation amounts and inform 
participants of next steps. 

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experience (see “Informed Consent Form 
7.15.25 [tracked changes]”). 
3.3 Request to Update Consent Language 
Regarding Participation Schedule 
 We request to update consent language 
to reflect the change from 1–2 Zoom 
sessions to a single session (see item 
2.1 and “Informed Consent Form 7.15.25 
[tracked changes]”). 
3.4 Request to Add a Post-Consent 
Summary Page in Qualtrics 
 After completing the consent form, 
participants will be directed to a brief 
summary page outlining the study’s time 
commitment and schedule. This includes 
a table of study activities and three 
participation options (see 
“MAP_Consent_Confirmation”). 
 
 
 
2.0 
1.13.26 
1. Request to Add Additional Daily 
Reminders for EDD Weekly Surveys  
We request to implement daily 
participant reminder messages, delivered 
via email or text, to 
encourage timely completion of the EDD 
weekly surveys (see “Daily EDD 
Reminders (Weekly 
Surveys)”). Participants are informed 
prior to beginning the weekly surveys that 
they will receive daily reminders until the 
survey is completed. Each Sunday, for up 
to 40 weeks, participants are sent a link 
to complete that week’s survey; if it is not 
completed on Sunday, daily reminders 
continue through the following Saturday. 
Once the weekly survey is completed, 
reminders stop immediately and do not 
resume until the next scheduled survey, 
ensuring messages are expected, time-
limited, and tied directly to study 
participation.  
1.2 Request to Send Participant Progress 
Updates for Weekly Surveys  
We request to send periodic progress 
update messages to participants who are 
completing the EDD weekly surveys. 
These messages would notify 
participants of their current completion 
status and notify them how 
much compensation they 
can potentially earn by continuing to 
1. Participant Reminders: to 
encourage participant engagement 
and promote continued 
participation. 
2.Recruitment Procedures: broaden 
our reach and support ongoing 
recruitment efforts 
3.Consent Form: to 
provide accurate and concise 
information consistent with 
previously approved changes to 
participant procedures and 
compensation.  
4&5: Removed assessments that 
are not being collected. 

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complete surveys (see “Weekly Survey 
Progress Texts”).  
1.3 Request to Add Statement to Session 
Reminders Regarding Substance Use  
We request to add a brief statement to 
participant session reminders asking 
participants to refrain from 
alcohol use and other substances before 
and during their study sessions. Please 
see “MAP Study Session Reminders 
(Virtual & In-Person)_12.2.25 (tracked 
changes)” for the proposed language.  
2. Request to Expand Snowball 
Recruitment to Include Email 
Communication  
With participants’ permission, we request 
to distribute the approved recruitment 
flyer to participants via email and 
encourage them to share the materials 
with friends or family members who may 
be interested and eligible to 
participate (see 
“Recruitment_UNL_Snowball Sampling 
Script (11.5.25)”).  
2.1 2.1 Request to Revise the Approved 
Snowball Sampling Script to Include 
Maximum Compensation  
We request to update the currently 
approved snowball sampling script to 
include information about the maximum 
compensation available for study 
participation (see 
“Recruitment_UNL_Snowball Sampling 
Script (11.5.25)”).  
2.2 Request to Revise the Approved 
Faculty Email Outreach Template to 
include maximum participation 
compensation   
We request to update the currently 
approved faculty email outreach 
template to include the maximum 
compensation participants can earn (see 
“Recruitment_UNL Faculty Email 
Outreach Template (tracked changes 
11.5.25)”).  
2.3 Request to Revise our previously 
approved Craigslist Advertisement   
We request to update the currently 
approved craigslist ad to include recent 
updates to study procedures and 
compensation (see Craigslist 
Advertisement 11.5.25 (tracked 
changes).  
3.1 Request to Make Minor Revisions 
Using Already Approved Language  
We request minor revisions to the 
consent form to edit a 
statement regarding study sessions from 
“1–2 Zoom sessions” to “1 Zoom 

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session” and to 
include additional language regarding the 
previously approved bonus 
compensation.  
4.Removed Simulation Sickness 
Questionnaire from protocol 
5. Remove Clinical History and Height & 
Weight assessments from protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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