A Social Media Intervention for High-intensity Drinking in a National Sample of Emerging Adults
Phase: NA
Conditions: Drinking Behavior
Sponsor: University of Michigan

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ClinicalTrials.gov Cover Page: 
 
Official Title: A social media intervention for high-intensity drinking in a national sample of 
emerging adults 
 
NCT #: 04721925 
 
Final Approval Date for Protocol Document: 5/19/22 
 
 
 
 

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Study Protocol 
v.6 – 4/2022 
 
 
 
IRBMED #:          HUM00162416 
 
Study Title:        SnappyHour 
 
Grant Title:  
A social media intervention for high-intensity drinking in a national sample of 
emerging adults 
 
Principal Investigator:  
Erin E. Bonar, PhD 
 
Co-Investigators:  
 
Anne C. Fernandez, PhD 
 
 
     
 
 
 
Jason E. Goldstick, PhD 
 
 
 
 
 
 
Maureen A. Walton, MPH, PHD 
 
 

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Background 
 
Alcohol is the most prevalent substance of abuse consumed by U.S. citizens age 12+, costs the U.S. 
$249 billion per year21, and is responsible for ~88,000 deaths per year.22 Alcohol use often begins in 
adolescence (ages 12-17); emerging adults (EAs, ages 18-25) have the highest prevalence of past-month 
use at 57.1%. 
The 2017-2021 NIAAA Strategic Plan notes increases in extreme binge drinking23 (having 8+ drinks for 
women, 10+ for men, i.e., twice a traditional “binge” episode), also called high intensity drinking (HID), 
which increases risk for adverse consequences. Data from Monitoring the Future (MTF) show that 1 in 9 
(11%) EAs reported a past 2-week HID episode of 10+ drinks, with 1 in 24 (4%) reporting episodes of 15+ 
drinks,24 with higher rates of HID in men versus women. Peak prevalence of HID occurs around ages 21-
22;25 Among past-year drinkers, past 2-week HID ranges from 14% to 17% across ages 18 to 26.26 HID is 
associated with simultaneous alcohol/cannabis use27 and alcohol/non-medical prescription drug use 
(NMPDU),28 increasing risk for overdose.  
Excessive alcohol use is responsible for over 88,000 deaths in the U.S. per year4 and poses a significant 
burden on public health and safety, with alcohol-related Emergency Department visits increasing an 
estimated 57% from 2001-2011. Alcohol consumption, particularly binge drinking (4+/5+ drinks), reaches 
peak prevalence in emerging adulthood (ages 18-25).6 Emerging adults (EAs) comprise a high-risk group 
for short and long-term consequences of alcohol use such as increased risk for sexual assault, injury, risk-
taking (e.g., unprotected sex, fighting), social/interpersonal problems, academic consequences, and risk for 
future alcohol use disorders.7 High intensity drinking may intensify these risks.  
There are no prior interventions for HID specifically, and EAs who engage in HID may not respond to 
traditional interventions, in part because cognitive factors (e.g., motives) associated with HID appear to 
differ from those related to traditional binge drinking. Thus, it is critical to identify optimal strategies for 
interventions that may build upon principles of efficacious BIs (e.g., motivational interviewing [MI] 
approaches, harm reduction), while reaching a broader population of EAs (outside of school/healthcare), 
and targeting the most extreme, acutely risky form of drinking, HID. Such interventions could disrupt high-
risk alcohol use trajectories among the riskiest drinkers, preventing costly public health outcomes of HID for 
EAs. 
With constant use of mobile social media (SM) by EAs, SM is a novel platform for intervening within EAs’ 
daily lives, outside of school or healthcare settings. Mobile messaging apps (e.g., Snapchat) uniquely create 
a direct, private mode of communication to an individual allowing delivery of dynamic intervention content 
(e.g., videos, messages, photos) that is organic to EAs’ daily lives and addresses the factors associated 
with high- risk drinking (e.g., motivations, peer influences). EAs commonly interact with similar-aged peers 
on SM, thus we seek to leverage peers as health coaches for intervention delivery to act as positive 
prosocial influences, facilitating and encouraging rapport and connection in a highly-used, widespread, and 
scalable platform. As of 10/2018, Snapchat had 186 million daily active users, an increase of 8 million over 
the past year.17 For EAs in the U.S., ~80% use Snapchat, with users under age 25 spending M=40 min/day 
on the app.18,19 
        There is an urgent need to create tailored, scalable, wide-
reaching, and cost-efficient interventions for HID that build upon 
principles of efficacious alcohol interventions and empirical data from 
the HID literature.8 HID is not a drinking pattern specific to college 
students, and occurs among non-college EAs as well. 
Interventions that harness technologies such as SM that 
have individual, private delivery features (e.g., auto-delete) 
to intervene within EAs’ daily life contexts could have high 
impact, unconstrained by setting. Thus, we are seeking to 
develop and test a peer coach delivered SM based 
intervention for EAs engaging in High Intensity Drinking. The 
study will be guided by a conceptual framework, as illustrated in 
Figure 1. The “Why, How”20 model of Motivational Interviewing is 
informed by Self-Determination Theory49,50 in concert with motivational 
theories of alcohol use.51,52 We are implicitly guided by the trans-
theoretical model53,54, strengths and resiliency approaches,55,56 principles of 
Figure 1. Guiding conceptual model 

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harm reduction,57 and social ecological approaches,58-60 including SM influence.61 
We propose to iteratively develop and pilot test, in a RCT design, a peer-led SM intervention for HID 
among male and female EAs. We will use national online recruitment and bachelor’s-level peers trained in 
MI and cognitive behavioral strategies to deliver dynamic intervention content via Snapchat over 8 weeks, 
focusing on the “Why, How”20 model of MI to address HID. Given that EAs with HID may have experienced 
consequences, but are likely to be ambivalent about ceasing alcohol use, engaging EAs focused on 
reasons for change (Why, eliciting benefits/consequences) and use of protective strategies (How) using a 
participant-centered MI-based approach to reduce negative consequences and overall consumption is 
needed.  
In summary, we propose developing a theory-driven MI-based SM intervention for HID using Snapchat 
due to: 1) the modest efficacy of prior BIs for EAs’ alcohol consumption, which have not targeted HID; 2) the 
ability to harness peer coaches to promote intervention engagement; 3) the frequency of Snapchat use by 
EAs, a highly used, relatively private medium; 4) the ability to include messages in varied formats (e.g., 
video, images, text) by which intervention content can stay novel over time; and 5) the use of auto-deleted 
private Snapchat messaging, wherein EAs may be more comfortable engaging with coaches about 
intervention content. 
 
Objective 
In this project, there are two specific aims: 
 
Aim #1: Develop a SM mobile-messaging peer coach intervention for EAs with HID. With iterative focus 
testing, we will develop intervention content via crowdsourcing (mTurk), an EA advisory panel, student 
research assistants, and iteratively focus test it with up to 50 EAs (25 male/25 female) recruited online 
nationally. 
In this aim, our goal is to recruit 50 participants, who will meet the eligibility criteria, provide consent, and 
complete a baseline survey, inclusive of the intervention content provided by other EAs through 
crowdsourcing, the advisory panel, and research assistants. The 50 EAs will help further curate the 
intervention content by providing feedback in preparation for Aim 2. 
 
Aim #2: Conduct a randomized clinical trial of the SM intervention (SnappyHour), where we will examine 
its feasibility and acceptability as our primary outcome measures. As exploratory, other outcomes we will 
examine the preliminary efficacy of the SM intervention versus control (referral to NIAAA’s Rethinking 
Drinking guide; N=50-52 per group) on HID episodes and consequences. Assessments will occur after 
intervention-start at a 2-month post-test and a 4-month follow-up to also examine other exploratory 
outcomes, including secondary effects on other substance use, and measurement of potential moderators 
(e.g., sex) and mediators (e.g., drinking motives). We will also quantify engagement with content (e.g., type: 
videos, images; topic: benefits, protective strategies; dose) and costs to guide future implementation.  
 
After iteratively developing intervention content (Aim 1) using national crowdsourcing, feedback 
from an EA advisory group, and focus testing with EAs recruited via SM nationally, we will recruit 
(Aim 2) 102 EAs with HID for a pilot RCT. Our approach is guided by prior work on BIs for 
adolescent/EAs alcohol use, use of SM to recruit EAs, MI training protocols for peers, and 
packaging interventions for translation.  
 
Aim 1 Methods: Intervention Development 
We will iteratively develop SM content for the 8-week intervention via multiple sources, using a 
participatory action approach and user ratings during focus testing with EAs with HID recruited nationally 
(Fig. 2). We will have workers from a crowdsource platform (mTurk; a workforce where workers are paid 
token amounts for brief tasks) create a library of potential content. A diverse advisory group, consisting of 
approximately 5 Research assistants (RAs) and 5 community members will first provide feedback on 
content acceptability and intervention preference. Thus, content will be selected for user focus testing based 
on fit with our conceptual model, appropriateness (e.g., no images glamorizing use, offensive jokes) and 
ratings of receptivity by EAs. Up to 50 EAs will be recruited from social media ads online to further refine 
and develop intervention content. All Aim 1 participants will receive a resources list and link to Rethinking 

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Drinking at the conclusion of participation.  
 
Enrollment: We aim for a target enrollment of up to 50 EAs (targeting ~50% male/female) nationally, ages 
18-25, who report past-month HID and Snapchat use, in two waves of 
approximately 25 each. 
 
Recruitment and Study Procedures: To ensure representation of both 
sexes we will recruit approximately 50% males and 50% females. Using a 
similar approach to the National Epidemiologic Survey on Alcohol and 
Related Conditions (NESARC), we will attempt to oversample minorities 
who are African American and Hispanic (~20%). Thus, we expect 
approximately 67% Caucasian, 20% African American, 3% Asian, 1% 
Native American/Alaskan Native, 1% Hawaiian/Pacific Islander, and 8% 
more than 1 race and 20% Hispanic. 
Participants will be nationally recruited from advertisements on SM 
platforms (e.g., Snapchat, Facebook, Instagram). The advertisement will 
re-direct users to an online privacy notice page (required by Snapchat) and 
an online informed consent page (waivers of documentation and parental 
consent [for states where 18 is not age of majority] will be obtained from the 
IRB), participants will be invited to print or save a copy of the informed 
consent before moving onto a brief online screening survey on 
Qualtrics to determine eligibility for Aim 1.  
Following determination of eligibility, negative screens will receive a thank you page ending their 
participation in the study. This page will also include the study’s website which will include a resource list 
with contact information for national organizations that can provide assistance in the areas of substance use 
and physical/mental health and well-being. No identifying information will be collected from participants who 
are not eligible for the study, although the IP address of the device used to complete the survey will be 
automatically recorded by Qualtrics.  
Eligible participants will be notified of their eligibility and asked to provide contact information for 
verification purposes and to contact them with the baseline survey. After completing the contact information 
form, participants will see a “Thank You” message.  
From the pool of eligible and verified participants, study staff will select participants to receive an 
invitation to continue to the next part of the study (baseline). Screening items will be used to select 
participants representing a variety of characteristics (e.g., gender, race/ethnicity) to ensure that intervention 
content is widely acceptable among individuals in the study’s target age group.      
Selected participants will receive an email containing a link to the consent and baseline survey in 
Qualtrics. Participants who indicate that email is not their preferred method of communication will receive a 
text/social media notification (depending on their preferred contact method) directing them to the email with 
their consent and survey link. We will send reminders via different contact methods (e.g., email, private 
message on social media, text) to encourage completion of this survey. 
After completing the baseline survey, participants will be redirected to a separate Qualtrics form and 
asked to indicate their payment preferences. Upon completing this form, participants will again see a “Thank 
You” message that includes the study’s website which includes a resource list, including Rethinking 
Drinking. Participants who fully consent and successfully complete the baseline survey to rate user 
acceptability and intervention preference on the proposed intervention content will receive a $35 electronic 
gift card as compensation.  
Based on ratings from the first wave of ~25 people (Wave 1), we will archive, modify content, add new 
content as needed, and recruit Wave 2 in the same manner to rate revised content. In both waves, 
participants will also rate their preferences (e.g., time of day, number of messages per day, days received, 
etc.) for delivery of intervention snaps.  
 
Study Eligibility Criteria. Screening inclusion criteria includes: (1) be age 18-25 (2) reside in the U.S. (3) 
being able to read English. Additional eligibility criteria for baseline includes (1) self-reported past-month 
HID (using an item based on MTF144) and (2) regular Snapchat use (at least 3 days/week), consistent with 
our proposed intervention structure to send snaps on approximately 3 days/week.  Participants will be 
excluded if they fail identity verification based on: 1) IP addresses, 2) survey time completion, 3) repeat 
Figure 2. Developing and refining intervention content 

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attempts or 4) survey responses. We will turn on the “Prevent Ballot Box Stuffing” option in Qualtrics to 
prevent repeated attempts from the same IP address.   
 
Measures. 
Screening Survey. Study eligibility will be assessed through a screening survey using items adapted 
from prior work or created specifically for this study. The screening survey includes questions inquiring 
about participants’ demographics based on national surveys, (e.g., the Youth Risk Behavior Survey146), 
past-month HID (eligibility criteria) based on MTF144, and social media involvement.147  Screening measures 
will also query participants’ other substance use.  
 
Baseline Survey. Participants will respond with individual and descriptive characteristics regarding their 
demographics information and background characteristics using items based on national surveys (e.g., 
Youth Risk Behavior Survey146). Additional questions include gathering feedback on snapchat intervention 
preferences (e.g., when to share content, frequency of snaps to send, additional content that they would like 
to see). Next, participants will review and rate content for potential inclusion in the intervention, based on 
feedback received from the advisory panel and research assistants. Participants will also have the 
opportunity to suggest additional intervention content that may be relevant to this topic.  
 
Data Analysis 
Intervention development will involve identifying content with superior ratings by participants, and does 
not involve formal statistical inference. We will conduct descriptive analyses of participants’ ratings to inform 
refinements of the intervention content. 
 
This protocol initially focused on the methods for Aim 1 of the study. As we prepare to commence 
Aim 2, below we are submitting an amendment to reflect protocol changes to Aim 2 as a result of 
the formative work conducted in Aim 1.  
 
 Aim 2 Methods: Pilot RCT  
Starting in Year 2, in a 2-arm RCT, we will pilot the SnappyHour intervention versus a control group (n=50-
52 per group) among EAs with HID (balanced on sex and age group). Screened, eligible participants will 
complete baseline measures, their assigned condition for 8 weeks, a 2-month (after intervention-start) post-
test after the active intervention period (to measure intervention acceptability, changes in outcomes during 
the intervention period, and mechanisms of change), and a 4-month (after intervention-start) outcomes 
assessment. 
 
Enrollment: Target enrollment is 102 EAs (approximately 50% males and 50% females) between the ages 
of 18-25. We will conduct a 2-arm pilot RCT of the Snapchat intervention versus a control group (n=50-52 
per group) among EAs with HID (balanced on sex and age group). We will enroll participants in 3-4 waves 
to allow breaks between 8-week intervention periods for staff.  
 
Recruitment and Study Procedure. Recruitment and enrollment procedures will follow those used in Aim 
1 above. To ensure representation of both sexes we will recruit approximately 50% males and 50% 
females. Using a similar approach to the National Epidemiologic Survey on Alcohol and Related Conditions 
(NESARC), we will attempt to oversample minorities who are African American and Hispanic (~20%). Thus, 
we expect approximately 67% Caucasian, 20% African American, 3% Asian, 1% Native American/Alaskan 
Native, 1% Hawaiian/Pacific Islander, and 8% more than 1 race and 20% Hispanic. 
 
Study participants will be recruited via SM advertisements that appears on social media applications (e.g., 
primarily Snapchat, but Instagram, Facebook etc., as needed). Ads will be targeted to U.S users ages 18-
25. When users swipe up or click on an advertisement, they will be redirected to a privacy notice (as 
required by Snapchat, our primary recruitment modality), and subsequently, a screening informed consent 
page. After indicating their agreement to the consent online (with a waiver of parental consent for states 
with age of majority >18 and a waiver of documentation of consent given our online procedures) and 
completing a captcha (to protect against bots), participants will complete a ~5-min eligibility survey.  

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Participants will have the option to print or save a copy of the screening informed consent form before 
moving on to the online screening survey. Prior to conclusion of the screening survey, regardless of their 
eligibility, participants will view a page within the survey that includes crisis information and the study’s 
website which will include a resource list with contact information for national organizations that can provide 
assistance in the areas of substance use and physical/mental health and well-being. Participants will click a 
button to acknowledge they have viewed this information.  
 
Individuals who screen negative will receive a thank you page ending their participation in the study. No 
identifying information will be collected from participants who are not eligible for the study, although the IP 
address of the device used to complete the survey will be automatically recorded by Qualtrics. IP address will 
be used to verify participant’s location to confirm that they reside in the U.S. Aim 1 participants are excluded 
from Aim 2. IP address will be referenced to ensure that Aim 2 participants have not completed Aim 1’s 
baseline survey. Eligible participants will be notified of their eligibility and asked to provide contact information 
for verification purposes and to contact them with the baseline survey. After completing the contact information 
form (stored separately from their study data), participants will see a “Thank You” message and link to the 
study resources.  
 
From the pool of eligible and verified participants, study staff will select participants to receive an invitation to 
continue to the next part of the study (baseline). Screening items will be used to select participants 
representing a variety of characteristics (e.g., gender, race/ethnicity) to ensure that the intervention is widely 
acceptable among individuals in the study’s target age group. Selected, verified participants will be invited to 
view and agree to the RCT consent in Qualtrics, followed by an online baseline survey. Selected participants 
will receive an email containing a link to the consent and baseline survey in Qualtrics. Participants who 
indicate that email is not their preferred method of communication will receive a text/social media notification 
(depending on their preferred contact method) directing them to the email with their consent and survey link. 
We will send reminders via different contact methods (e.g., email, private message on social media, text) to 
encourage completion of this survey and completion of study enrollment. 
 
Those who complete baseline measures will be randomized to their assigned condition for 8 weeks, and will 
later be asked to complete a 2-month post-test after the active intervention period, and a 4-month outcomes 
assessment. Compensation at baseline will be a $35 electronic gift card (e.g., Amazon.com, Target, etc.) for 
participants who complete all baseline activities. Compensation will be a $35 electronic gift card for the 2-
month post-test and a $40 electronic gift card for the 4-month follow-up. 
 
Inclusion/Exclusion Criteria. For screening, participants must: be age 18-25, reside in the U.S., be able to 
read English, view, and click on a social media ad. Eligibility criteria for baseline and randomization is self-
reported past-month HID (using an item based on MTF144) and regular Snapchat use (at least 3 days/week). 
Participants will be excluded if they fail identity verification (see prior studies132,133) based on: 1) IP 
addresses, 2) survey time completion, 3) repeat attempts, and 4) survey responses. Aim 1 participants are 
excluded from Aim 2. 
 
Randomization and Consideration of Key Biological Variables. Randomization to conditions will be 
balanced based on sex and age (18-20, 21-25 years) using urn randomization in blocks of 4. After completing 
the baseline survey, participants will be informed which condition (intervention, control) they were randomized 
into via Qualtrics. 
 
Intervention condition. Overview: Participants randomized to the intervention will be initially provided with a 
link to the NIAAA’s guide Rethinking Drinking website, a list of national resources located on our study 
website, and the study’s Snapchat user safety agreement. Participants in the intervention group will be 
instructed on how to add our study’s account as a Snapchat contact. Participants will be invited to accept the 
friend invite from our study account. Participants may be contacted by a study team member via phone, email, 
or their preferred method of communication to aid them in adding peer coaches on Snapchat. Once we 
confirm participants as contacts, peer coaches will send a test/welcome “snap” to confirm the connection. 
They will also be directed to an orientation video (up to 3 mins) that provides an introduction to how 
SnappyHour works (e.g., frequency and types of “snaps”/ stories to expect, duration, coach availability), 

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introduces peer coaches, and notes that coaches are not available 24/7 and in the event of crisis the 
participants should contact 911 or the crisis text line (text “HOME” to 741741). Pre-selected intervention 
content will be sent to participants up to 7 days a week on Snapchat. Snapchat involves 2-way messaging; 
when participants in the intervention condition reply to messages, coaches will discuss content, in a MI-
consistent manner using reflections, open ended questions, and affirmations to participants during their 
scheduled shifts.  
 
Intervention Content. Participants will receive pre-selected snaps (e.g., coach-initiated snaps, snapchat 
stories, engagement cues) up to 3 times per day (with the number and type varying across days to increase 
novelty), from peer coaches over 8 weeks. Based on our Aim 1 pilot work, we have revised our plan and 
content for the intervention. Sample content based on iterative participant feedback is available in the 
uploaded “Aim 2 Snapchat Messaging Description”. A variety of snaps and stories will be used to prompt 
participants to review and discuss intervention themes (see Table 1) and to promote engagement. Snaps 
and stories sent by coaches include a variety of multi-media messages (pictures, text, gifs, videos, links to 
articles or coping exercises with screenshots, etc.). The initial content is stored in a content library 
accessible to staff, but wording will be tailored to the individual participant, consistent with motivational 
interviewing (MI) 
 
Table 1. Intervention Themes 
Dealing with stress 
Explore stress management, address coping motives for alcohol use, 
enhance self-efficacy and behavioral intentions to manage stress 
Free time activities 
Engage in developing free-time activities that promote healthy and 
valued activities and avoid/reduce use 
What young adults do 
Explore online/offline norms for alcohol use, strategies for managing 
use (e.g., refusal skills), social/conformity motives 
Relationships  
Engage in developing strategies for managing situations with peers, 
significant others, and parents; healthy social support 
Staying out of trouble 
Discuss risk perceptions, protective behavioral strategies (e.g., avoid 
drunk driving), planning ahead (e.g., safe rides) 
Staying healthy  
Address physical/health motives (e.g., sleep, pain), long-term health 
impacts, avoiding risky behaviors, mental health 
Handling tricky situations 
Address motives in healthier ways; managing temptations with 
cognitive/behavioral skills 
Getting support 
Explore benefits of change, planning, and cognitive/behavioral 
strategies for making changes if desired 
 
    Our content involves MI consistent coach greetings that are consistent with the 
Why/How model of MI. Peer-coaches will encourage discussion of content by 
eliciting discussion around theoretically-determined intervention topics shown 
above. Snaps will also be used to encourage engagement. Coaches will reply to 
comments with MI strategies (e.g., reflection, affirmation), including managing 
sustain talk (e.g., come alongside, agree with a twist), and eliciting protective 
behavioral strategies for drinking less. Messages address 1) Why (evoking 
reasons for change), and/or How (Tools for change). Based on our ongoing 
cannabis intervention on Snapchat, we have developed a peer coach guidelines 
outlining basic MI principles, protocols for posting, risk assessment, and peer-
coach professionalism. We have also revised the User Safety Agreement from 
our cannabis Snapchat intervention (HUM00139068) for use in this study which 
outlines guidelines for participants (e.g., privacy, no snapping opportunities to buy 
or receive drugs with peer-coaches; no racial or political slurs, respect and 
confidentiality). Once participants in the intervention group are informed of the 
group they are randomized to, they are directed to a Qualtrics page containing 
the User Safety Agreement and they will be sent an additional copy of it via email. 
Snaps will be monitored during the 8-week period by scheduled peer-coaches 
who can contact rotating on-call supervisors (all highly experienced in MI) who 
Figure 3. Snapchat screenshot 
of messages received/opened 

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include the investigators, study coordinator, and our lab network of clinical post-docs, and clinical social 
workers, who work as a team across studies address potential participant risk situations. We will note in the 
orientation video that we cannot monitor snaps 24/7, and include crisis numbers.    
  
Tracking Engagement with 
Intervention Content. Coaches will 
track messages in an electronic log, 
noting whether snaps were known to 
be viewed (Fig. 3 shows messages 
sent/opened) and types of content 
discussed to quantify engagement. 
Coaches monitor Snapchat to 
determine if messages were viewed 
and send periodic reminders (e.g., 
via SMS) to prompt engagement 
when messages go unopened; these 
messages will be recorded on a log. 
 
Coach Responses and Risk 
Management. If participants respond 
to snaps of intervention content, 
coaches will use MI skills68 (e.g., 
reflections, open questions, 
affirmations) to reply during shifts, 
which will primarily be in the 
afternoon and evening, based on 
participant feedback in Aim 1. 
Coaches will be trained in 
collaborative MI strategies to 
manage sustain talk, if any arises. 
Coaches will have access to on-call 
supervisors experienced in MI, 
including Drs. Bonar and Fernandez, 
the study coordinator, and our lab 
network of clinical post-docs and 
social workers. All on-call 
supervisors have experience 
managing risk assessments (e.g., 
suicidal ideation) using procedures 
from our current online intervention 
study, where staff private message 
and talk by phone to participants in 
high risk situations. See DSMP for 
more details.  
 
Control condition: Control participants will be provided with a link to and be asked to review NIAAA’s 
guide Rethinking Drinking.145 Additionally, participants will be provided with a list of national resources 
located on our study website. To balance receipt of this information across groups, we will provide the 
intervention condition participants with a link to review Rethinking Drinking at baseline as part of study 
resources. 
 
Follow-Up Procedures. Self-report surveys will be self-administered online via Qualtrics at 2-month post-
test ($35 compensation) and at the 4-month follow-up ($40 compensation). Assessment reminders will be 
sent in a variety of ways, which may include via e-mail, private Snapchat messaging, SMS text message, 
mail and/or phone call and other social media, based on contact information participants provided in their 
Table 1. Measures 
Descriptive Information, Individual and Social Influences 
Demographics (from Youth Risk Behavior Survey146) 
S, B, 
P, F 
Social media involvement147 
S, P,F 
Drinking Motives Questionnaire Revised Short Form148 
B,P,F 
Alcohol Expectancy Questionnaire Adolescent Brief 149 
B,P,F 
Perceived risk of HID modified from MTF144 
B,P,F 
Readiness to change alcohol use150,151 
B,P 
Mental health: Patient Health Questionnaire-8 
Generalized Anxiety Disorder-7 
B,P,F 
Protective Behavioral Strategies Scale-20158 
B,P,F 
Peer use of alcohol/HID based on MTF144 
B,P,F 
Alcohol online norms and exposure74,159 
B,P,F 
AUDIT-C 
S,P, F 
Short-Form PCL-5 
B,P,F 
UCLA Loneliness Scale 
B,P,F 
Berkman-Syme Social Network Index (SNI) 
B,P,F 
COVID-19 
B,P,F 
Choices for Intervention Topics 
B 
Strengths and Goals 
B 
Minute Discounting Task 
S,P,F 
Brief Assessment of Alcohol Demand 
S,P,F 
Activity Level Questionnaire 
B,P,F 
Other Outcomes 
Past-Month HID (eligibility criteria) based on MTF144 
S, P, F 
Brief Young Adult Alcohol Consequences165 
B,P, F 
Alcohol-impaired driving166 
B,P,F 
Daily Drinking Questionnaire 
B,P,F 
Tobacco and Nicotine use  
S,P,F  
Cannabis frequency (by modality) 
S,P,F 
Frequency of Illicit Drugs 
B,P,F 
Frequency of Rx Drug Misuse 
B,P,F 
Feasibility/Acceptability of Intervention 
Intervention acceptability ratings 
P 
Control acceptability ratings 
P 
S=Screening, B=Baseline, P=2 month post-test, F=4-month 
follow-up 

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screening survey.  
 
Study Measures. Whenever possible we will use reliable and valid measures from prior studies with 
emerging adults (Table 1). 
 
Screening survey. To assess study eligibility and characterize the study sample, participants will be asked 
about their demographics, social media involvement, and health behaviors, including alcohol use. The 
screening survey should last 5 minutes. 
 
Baseline and Follow-up Assessments. Participants will be asked to self-report measures including 
demographics; SM use; alcohol expectancies, consequences, and motives; protective strategies, etc. 
Although trial outcomes focus on feasibility and acceptability, the main behavioral dependent measures of 
interest for related to the intervention are alcohol consumption (e.g., HID episodes, daily drinking 
questionnaire, AUDITC) and alcohol-related negative consequences. Other measures include: age and sex 
as potential moderators; and peer influences, risk perceptions, discounting rate mental health symptoms as 
potential mediators; and feasibility/acceptability (adapted from prior work). The baseline and follow-ups are 
expected to last 30-40 minutes. The 2- and 4-month surveys will mirror the baseline survey measures with 
the inclusion of acceptability measures at 2-months and removal of baseline measures of intervention topic 
preferences and strengths and goals which can be used by peer coaches to tailor intervention content.  
 
Data Management and Analysis 
Please see Aim 2 Data Analysis Plan in the DSMP below. 
 
Human Use Considerations and Protections (Aims 1 and 2) 
 
Eligibility and study informed consent will be administered online (a waiver of documentation of 
consent is requested) as the first pages of the screening and baseline surveys, respectively. The consent 
document will include information on the general nature of the study, privacy rights, expectations for 
participation, the voluntary nature of participation, and that participation can be withdrawn at any time. 
Because of the sensitive nature of the information collected, as an added protection for subjects, this 
research is covered by a Certificate of Confidentiality from NIH. Study documents will make explicit the 
voluntary nature of the subjects’ participation as well as potential situations for breaking confidentiality (see 
below for more information about limitations to confidentiality). Participants will be informed that their 
answers to the screening questions will be used to determine their eligibility for a research study. No 
identifying information will be collected from those who complete the screen and are ineligible or choose not 
to participate in the study, although the IP address of the device used to complete the screening survey will 
be automatically recorded in Qualtrics.  
 
Since the age of majority varies across states (i.e., age 18 in most states, age 19 in Alabama and 
Nebraska, and age 21 in Mississippi), a waiver of parental consent is also requested for those 
participants who are in the study’s target age group but are under the legal age of consent in their state of 
residence (i.e., AL, NE, MS). The same consent document described previously will be used for minors and 
adults. According to the Federal regulations governing research (45 CFR 46),163 Section 116(d) allows a 
waiver of the parental permission requirement for informed consent when (a) the research involves no more 
than minimal risk, (b) the waiver would not adversely affect the rights and welfare of the participants, (c) the 
research could not practicably be carried out without a waiver, and (d) whenever appropriate, the 
participants will be provided with additional pertinent information after participation.  
 
a) This study involves no more than minimal risk. Every effort will be made to ensure that study 
participants are protected from risk. For screening eligibility, we will not collect any identifiers from 
participants unless they screen eligible for and are interested in enrolling in the main study. Screening data 
will be anonymous for those participants who are not eligible or interested in the main study. Participants 
will be informed in the consent document about the procedures taken to maintain and protect their 
confidentiality, including assigning unique ID, securing data on secure UM servers, and that this study is 
covered by a Certificate of Confidentiality.  

11 
 
 
b) The waiver of parental consent does not adversely affect the rights and welfare of the subjects (age 
18-20 in certain states). Screening data will be anonymous for those participants who are not eligible, as 
well as those who are eligible but choose not to enroll in the baseline studies. To the extent possible given 
legal requirements on information required in the informed consent, the consent form is written in simple 
terms that should be understandable to individuals of varying ages and education levels. Participants will be 
able to download a copy of the consent form which contains contact information for research study staff 
should questions arise following enrollment. Participants who are eligible for the study and are interested in 
continuing will provide contact information and can indicate the method they prefer for being contacted.  
 
c) The research could not practicably be carried out without a waiver. This research could not be 
practicably conducted without a waiver of parental consent because we would not be able to ensure 
confidentiality around the participant’s substance use if parental consent were required for participants 
under the age of majority in their state (age 18-20 in certain states). Lack of a waiver of parental consent 
would hinder recruitment, particularly of young adults engaging in high-risk behaviors, and more importantly, 
have the potential to severely limit the generalizability of the findings. Research shows lower rates of young 
adult enrollment when parental consent is required, and that participants with lower risk (less substance 
use) are disproportionally enrolled (higher risk/greater use less likely to participate).  
 
d) Whenever appropriate, the participants will be provided with additional pertinent information. After 
completing the screening and baseline surveys, participants will receive an electronic link which contains 
resources with contact information for national and community resources, including suicide hotlines, mental 
health and substance use treatment, etc.  
 
We also request a waiver of consent for re-consent of minors (in states where the age of majority is 
greater than 18) who reach the age of majority in their state while participating in the study (between 
screening completion and baseline invitation). As described above, this study involves no more than 
minimal risk to subjects. Given the brief length of time in which a participant is part of this study, it will not be 
feasible to obtain immediate consent for any minors (age 18-20 in certain states) who reach the age of 
majority during the study. Furthermore, we anticipate that all study assessments will be completed online.    
 
Every effort will be made to ensure that study participants are protected from risks.  Although it is not 
expected that there will be any risks to participants because of online screening and baseline assessment 
procedures, the risk of violation of confidentiality exists because human participants are giving personal 
information. Consent documents will contain a statement explaining mandatory reporting requirements for 
information regarding child abuse and intention to harm self or others. We do not expect that participants 
will disclose such information in the context of this study, since our assessments do not inquire about these 
behaviors. However, we will notify participants when/if we must make any mandatory reports based on 
information they disclose and we will only disclose the minimum information necessary. Participants will be 
informed in the consent about the procedures taken to maintain and protect their confidentiality.  
To minimize the risk of violating confidentiality, RAs will make every effort to ensure that study data are 
always kept confidential. Staff training procedures will include information about the importance of 
confidentiality and techniques to maintain confidentiality of all information reported by research participants. 
Staff will maintain human subjects and confidentiality certifications through the U-M Program for Education 
and Evaluation in Responsible Research and Scholarship system.  
 
Unique identification numbers will be assigned to participants. All computerized databases with survey data 
will identify participants by this number and will be saved on a secure, encrypted, password-protected 
server. For participant tracking, one electronic document will be maintained linking participants’ ID numbers 
to their names. This password-protected document will be kept in a restricted-access folder on a secure 
research server. This document will be deleted as soon as the study is completed. All data will be collected 
specifically for use on this project.  
 
Participants’ Snapchat IDs can be viewed on study cell phones/ipads; however, we will change the front 
page of coaches’ Snapchat apps to display generic participant IDs (see Figure 3). Study cell phones and 

12 
 
tablets will be password-protected and only accessed by study staff who have completed and maintain 
mandatory training in the protection of human subjects and good clinical practices. 
 
For the online surveys, participants will be reminded that they may refuse to answer any questions that 
make them uncomfortable and that they may terminate the assessment at any time. However, some 
questions that relate to eligibility and specific outcomes will require response in order to continue in the 
study and receive payment for the survey. As described above, all participants will also receive substance 
use and mental health resources via a website link after completing the screening and baseline surveys. 
Participants’ confidentiality will be breached by the research study only to protect the safety and welfare of 
research participants and only in accordance with state and federal law. 
 
 
Potential Risks 
Every effort will be made to ensure that study participants are protected from risks. Although it is not 
expected that there will be any risks to participants because of online screening and baseline assessment 
procedures, the risk of violation of confidentiality exists because human participants are giving personal 
information. Consent forms will contain a statement explaining mandatory reporting requirements for 
information regarding child abuse and intention to harm self or others, should this be disclosed in the 
context of the research, although we will not be collecting any assessment data on these topics. 
 
We expect that participants will not disclose such information regarding suicidality, homicidality, or child 
abuse as in the context of an online study, but should information to this effect be shared in any interactions 
with or messages to study staff, we will provide appropriate referrals to national hotlines and follow 
appropriate reporting procedures. We will notify participants when/if we must make any mandatory reports 
based on information they disclose and we will only disclose the minimum information necessary. 
Participants will be informed in the consent documentation about the procedures taken to maintain and 
protect their confidentiality. Consent forms will explain that although intervention Snapchat messages will be 
sent/received only by study staff, that their activity on Snapchat is still accessible to Snapchat and subject to 
the app’s terms of use. We will inform participants that during their participation that the Snapchat 
messages received from them are saved for tracking purposes within the study’s Snapchat account. We will 
inform participants that messages are also stored in password-protected computer logs by ID number, not 
names stored on our internal servers in password protected databases and they will be deleted from study 
accounts after participation. Text of messages to/from participants may be temporarily copied to a file on the 
password-protected local device (only accessible by study staff) prior to transfer to the secure drive. For 
example, this is necessary given frequent VPN network outages, times when we are temporarily kicked off 
the VPN, or times of shift overlap when multiple staff are logging study interactions. Note that identifiers are 
not included in temporary logging of these messages. The consent will also state that we cannot guarantee 
protection of Snapchat data from third-party access. At baseline, participants in the intervention group will 
be asked acknowledge a User Safety Agreement that includes guidelines for interactions with peer coaches 
(e.g., agreeing not to send graphic images) based on a procedure used in our prior and ongoing social 
media-based studies. Although young people post publicly about illegal behaviors such as underage 
drinking and drug use and on social media74-79,185-188 and may not be concerned about joining a study 
discussing alcohol and other drug use, we will remind participants of potential risks.  
 
Participants could potentially experience emotional discomfort as a result of being asked very personal 
questions or because of intervention content. Because the study takes place solely online via mobile 
devices and computers, all eligible and verified participants will receive crisis/referral information as part of 
the emailed informed consent and via a national resource listing from the study’s website that will be linked 
for all participants at baseline and at 2- and 4-month assessments. Intervention participants will be made 
aware during consent, in the User Safety Agreement, and in the study introduction video that coaches will 
be “snapping” in shifts and thus may not be available in the event of a crisis. On the closing page of each 
survey they will be reminded of crisis hotlines/text-lines and national substance abuse and mental health 
resources should they experience discomfort that they wish to address with a professional. The electronic 
resource page on the website (sent to all participants at baseline and assessments) will include national 
resources including suicide hotlines/text-lines, mental health and substance use treatment, etc. Our prior 

13 
 
studies have involved phone and web-based follow-ups; thus, we will use established protocols for 
addressing any crisis or harm situations that may arise, including having national hotline phone and text 
numbers. If a participant shares specific information about their own dangerous behaviors (e.g., driving 
impaired, self-harm), we will privately message them to express concern, provide safety plans, and discuss 
referral information, using protocols established in our prior and ongoing work. 
 
Participants will be informed that we will take steps necessary to secure their data. Online data collected 
as part of screening and baseline assessments and analysis of intervention interactions will also be stored 
in secure, password-protected databases on the secure U-M network. Participants will be instructed at the 
close of each web-based survey (e.g., screening, baseline, post-test, follow-up) of steps they can take to 
further protect their privacy (e.g., clear browser history). In Aim 2, peer coaches sharing content via 
Snapchat will do so in private spaces using privacy screens where others who are not part of the research 
team could not see the data. Study cell phones and iPads (which have apple encryption) used to send and 
store Snapchats will have strong password protection and will only be accessed by study staff in private 
locations.  
 
These risks will be noted as a possibility in the informed consent document with a statement 
encouraging participants to not leave their mobile devices or computers open/unlocked (i.e., they will be 
encouraged to use a passcode), and not to leave study webpages open and viewable when not using them. 
In addition, to limit inadvertent disclosure of participation in the study to family or others, we will suggest that 
participants use strong passwords (mix of upper/lower case letters, numbers, symbols) on their mobile 
devices and email accounts that they give the study for contact. Further, participants will choose how they 
wish to be contacted by the study for surveys and reminders (e.g., email, text message, social media 
messages) and in any of these contacts we will not include sensitive information about substance use. 
 
Protections Against Risks 
To minimize the risk of violating confidentiality, RAs will make every effort to ensure that study data are 
always kept confidential. Research staff will sign a pledge of confidentiality. Staff training procedures will 
include information about the importance of confidentiality and techniques to maintain confidentiality of all 
information reported by research participants. Staff will maintain human subjects and confidentiality 
certifications through the U-M Program for Education and Evaluation in Responsible Research and 
Scholarship system and will complete CITI Good Clinical Practice Training. Consent documents will fully 
explain the study procedures, potential risks, and potential benefits. 
Unique identification numbers will be assigned to participants. Any data forms (e.g., Snapchat message 
logs) will be coded with this number, rather than with a name. Computer data files (e.g., screening/baseline/ 
follow-up data, message logs, contact information database) will be saved with passwords on a secured 
network, and will not contain names, birthdates, etc. For participant tracking, one list will be maintained 
linking participants’ ID numbers to their names. This list will be kept in a password-protected restricted 
folder on a secure research server. This list will be deleted as soon as the study is completed. In 
accordance with NIH rules, we will also receive a Certificate of Confidentiality from the NIH to protect the 
confidentiality of our data from legal requests. Finally, specific information collected during this research 
study will not be available to family or friends or others outside of the study team. All data will be collected 
specifically for use on this project  
When sending Snapchat messages, coaches will do so in private spaces using privacy screens where 
others who are not part of the research team could not see the data. Study cell phones and ipads (which 
use apple encryption) used to send Snapchats will be password protected and only accessible to study 
staff, as commonly done in our research studies.  
Research staff will be trained to handle (i.e., discuss and refer as needed) unexpected issues that may 
arise. Because this is an online study, participant contact with research staff is limited, but participants could 
disclose this information via Snapchat messages or to staff who contact them for follow-up reminders. In all 
instances, staff will follow a written protocol regarding reporting these incidents to the PI and taking 
appropriate referral or legal action as indicated. In addition, the IRB board at UM will be informed of any 
incidents as appropriate (see Data and Safety Monitoring Plan). Of note, the investigators have substantial 
prior clinical and research experience with at-risk populations, including online research with at-risk 
drinkers. 

14 
 
For the online surveys, participants will be reminded that they may refuse to answer any questions that 
make them uncomfortable and that they may terminate assessments at any time. All participants are free to 
terminate the assessment or intervention at any time or refuse to respond to questionnaire items. However, 
some questions that relate to eligibility and specific outcomes will require response in order to continue in 
the study and receive payment for the survey. As described above, all participants will also receive 
substance use and mental health resources via links to the study’s website. Furthermore, Aim 2 participants 
will be explicitly instructed during the consent process that, although there will be study staff (peer coaches) 
interacting with them via Snapchat in designated shifts (if assigned to this condition), no one will be 
monitoring messages continuously (24/7). The integration of motivational interviewing techniques into 
intervention interactions is non-confrontational and helps to eschew any form of coercion or threat. The 
investigators of this project will use established protocols from prior and current work to guide staff in 
responding to crisis or harm situations via Snapchat or during follow-up contacts. In current and prior social 
media-based online interventions, we have developed procedures for managing these situations when 
communicating with participants via social media. As described above, all participants will also receive a link 
to substance use and mental health resources in a community resource listing on the study’s website. 
Regarding Snapchat messages, content of new messages do not appear on a participant’s phone 
notification screen and are only viewable when opened by the participant, taking at least 2-3 clicks before 
content is viewable. Because Snapchat use is common among emerging adults, it is unlikely that others will 
know that the participant is in a research study just by seeing Snapchat or a new notification on their phone. 
We will instruct participants to view messages from the coaches where they cannot be seen or heard and 
also to consider using a password/passcode on their cell phone. Snapchat messages are typically 
automatically deleted after both parties have viewed the snaps. However, features within the settings 
portion of the Snapchat app allow participants to manually change the chat settings to “delete after 24 hours 
after viewing”, instead of the usual chat deletion “after viewing” option. Further, users may choose to save a 
message at the moment of viewing. We will save messages in our study app during study participation to 
facilitate responding to participants in the app and our study documentation. Participants will be informed 
that they still risk having messages viewed by others if anyone else accesses their cell phone or has access 
to their Snapchat account. Messages during the intervention Snapchats sent by the study team will not 
directly mention details obtained from assessments about participants’ own reports of illegal behaviors, 
instead they will be theoretically grounded statements based on MI behavior change (e.g., weighing 
pros/cons of alcohol use in relation to goals and motives). During informed consent, participants will be 
informed that the researchers do not control Snapchat’s access to their messages and that they are still 
subject to Snapchat terms of use. Furthermore, participants will be explicitly instructed during the consent 
process that, although there will be study staff interacting with them via Snapchat (if assigned to this 
condition), no one will be monitoring messages continuously (24/7) and that in the event of a crisis they 
should call 911 or utilize the crisis resources in the community resource listing, from the study’s website. 
Supervisors (Drs. Bonar, Fernandez, and Walton) and members of our lab network of clinical research post-
docs and social workers will be on call to assist study staff in the event a participant discloses risk for self-
harm or other crisis situation. 
Participants’ confidentiality will be breached by the research team only to protect the safety and welfare 
of research participants and only in accordance with state and federal law. The exceptions to confidentiality 
include if the participant reports acute suicidality, homicidality, or the physical or sexual abuse of a child, this 
could happen via a Snapchat message or other study-related interaction. Regarding disclosure via social 
media, we have protocols in place, and we had only 1 participant describe suicidality out of 955 risky 
drinkers ages 16-24 in a recently completed study. Protocols were followed and the participant was deemed 
moderate risk and given appropriate resources. In our clinical trials with patient populations in the 
emergency department and substance use treatment settings, we also have experience dealing with these 
issues. Thus, staff will receive training in crisis assessment and management procedures in the unlikely 
event that participants reveal suicidal and/or homicidal ideation, or child physical/sexual abuse. If the 
participant discloses suicidality or homicidality, staff will attempt to contact the participant to assess risk 
level and provide appropriate follow-up (e.g., suicide hotline numbers, safety check, etc.). Although study 
assessments will not ask about child abuse, in the unlikely event that a participant self-discloses the abuse 
of a child, staff will be trained to report this information to local child protective services/family independence 
agencies via anonymous report. This exception to breaking confidentiality – the case where a participant 
reveals child abuse, suicidality, or homicidality – will be explained in detail to participants in the consent 

15 
 
forms and prior to completing the reporting process. We will always inform participants when we must make 
a mandatory report. Staff will also be trained to manage responses to potentially inappropriate messages 
from participants (e.g., asking on dates, sending explicit images) and participants will also acknowledge our 
User Safety Agreement to avoid misuse of Snapchat with study staff. 
In addition, the IRB board at UM will be informed of any incidents as appropriate (see Data and Safety 
Monitoring Plan). Of note, the investigators have substantial prior clinical and research experience with at-
risk populations, including online research with at-risk drinkers. 
 
Potential Benefits 
Participation in the proposed study could potentially benefit participants in a few important ways. First, it 
is possible that the assessments may be beneficial to all participants by asking them to review their 
substance use. Therefore, these assessments may actually serve as a very minimal intervention (as could 
any study with questions that prompt participants to consider their risky behaviors). Indeed, participants in 
our previous investigations have commented that they have found the questions to be helpful; participants 
in human subjects research focused on substance use for EAs have previously reported benefits of 
participation such as helping their communities and peers.191,192 Second, all baseline participants in both 
Aims will receive a link to the NIAAA interactive and evidence-based resource Rethinking Drinking, with 
information resources and referral information for substance use and mental health treatment. In addition, 
participants in the intervention group may be helped by participating in the intervention. In sum, potential 
benefits for the research outweigh the risks for the participants.  
 
Importance of Knowledge to be Gained 
Given that risky alcohol use often reaches a peak during emerging adulthood, as well as the correlation 
with other substance use, the individual and societal cost of these behaviors, and the fact that many 
emerging adults with risky drinking patterns do not seek help for their drinking, the development of effective 
targeted prevention interventions is clearly needed. Given the current penetration of social media into the 
lives of young people, the potential reach for interventions using this medium, and the ability to harness 
peers to engage emerging adults in interventions that may facilitate behavior change, the knowledge to be 
gained from this research is significant. The risks to participants are reasonable in relation to the importance 
of this knowledge to be gained and potential public health impact of developing an effective program to 
reduce the use of and consequences associated with high intensity drinking among emerging adults. 
 
Data Safety Monitoring Plan (Aims 1 and 2) 
 
Below, please find the information contained in the DSMP solicited and approved by NIAAA during the 
funding process, which is being updated for Aim 2. 
 
1. A description of the entity(ies) responsible for monitoring the trial (e.g., an independent 
monitoring group or person, DSMB, etc.) and procedures for monitoring subject safety. 
 
The investigators will be responsible for monitoring the trial and data quality and safety. All research 
projects involving human participants require approval from the University of Michigan Medical School’s 
Institutional Review Board (IRBMED). A Certificate of Confidentiality will be issued for this study per NIH 
procedures. 
 
Dr. Bonar (PI) will ensure that all relevant IRBMED policies, procedures and stipulations are being 
followed and she will be responsible for ensuring that project staff adhere to the UM IRBMED policies 
including the following: (1) All participants will understand, agree to, and provide consent before 
participating;  (2) Strict adherence to a participant’s right to withdraw or refuse to answer questions will 
be maintained; (3) Assessments and interventions will be confidential and no names will be associated 
with the obtained research data; (4) Identifying information will be kept separate from the coded 
participant data; (5) All identifying information will be kept locked at all times and computer files will be 
saved with passwords on secure servers; and (6) Participants will be informed in writing in the consent 
form on how to contact the PI and IRBMED office with any questions and/or concerns. In directly 
supervising research staff, the investigators will be responsible for monitoring these confidentiality 

16 
 
procedures. Quality control and reliability of screening, baseline and follow-up data will be monitored via 
regular meetings where data frequencies are examined. Drs. Bonar and Goldstick will also monitor the 
quality of the data files via supervision of the data manager. 
 
2. Name of the responsible party (e.g., Principal Investigator, Study Physician if different than PI) 
who will distinguish a serious adverse event (SAE) from a non-serious adverse event (AE) and 
provide attributions (causality and severity). Provide a detailed accounting of how SAEs, AEs, 
and unanticipated problems will be managed consistent with local IRB guidelines (e.g. reporting 
requirements).  
 
Dr. Bonar (PI) will be responsible for distinguishing severity of and reporting adverse events.  We will 
adhere to UM IRBMED policies regarding the timing of reporting adverse events to the IRB. The timing 
of the reporting of any at least possibly study-related adverse event to the UM IRBMED will be 
dependent on the severity of the event, and whether such adverse events were expected (included in 
the informed consent) and/or related or unrelated to the research. According to UM IRBMED, all 
adverse events must be reported for those defined as: “An adverse event is any experience or abnormal 
finding that has taken place during the course of a research project and was harmful to the subject 
participating in the research, or increased the risks of harm in the research, or had an unfavorable 
impact on the risk/benefit ratio.”  Per the “NIAAA Data and Safety Monitoring Plan Requirements for 
NIAAA-Funded Clinical Trials,” serious adverse events (e.g., hospitalization for suicidal ideation 
uncovered during study interaction) and unanticipated events related to the study will be reported to 
IRBMED and NIAAA within 48 hours of learning of the event. Non-threatening potentially serious 
adverse events that are causally related to the research will be reported to the IRBMED within 7 days of 
learning of the event.  A summary of adverse events that occurred during the previous year will be 
included in the annual progress report to NIAAA. 
 
3. A description of the follow-up plans for SAE and unresolved unanticipated problems. 
The PI will be responsible for follow-up on all SAEs and unresolved unanticipated problems until 
resolution or stabilization. 
 
4. Risks associated with study participation. 
a) Although it is not expected that there will be any risks to participants because of online screening 
and baseline assessment procedures, the risk of violation of confidentiality exists because human 
participants are giving personal information. 
b) Although intervention Snapchat messages will be sent/received only by study staff, participants’ 
Snapchat accounts are still accessible to Snapchat and subject to the app’s terms of use. Further, 
we cannot guarantee protection of Snapchat data from third-party hackers.   
Participants could potentially experience emotional discomfort as a result of being asked personal 
questions or because of intervention content.  
 
Procedures to address these risks are detailed in the Protection of Human Subjects portion of the 
grant application [note for IRBMED: and these are detailed in the above human use section and 
throughout the IRBMED electronic application] 
 
Confirmation that SAEs and unanticipated events which are considered “at least possibly 
related” during the treatment and follow-up phases will be reported to the local IRB and to 
NIAAA within 48 hours of knowledge of the SAE and all other SAEs and unanticipated events 
must be reported within the time period mandated by the local IRB.  
 
SAEs and unanticipated events which are considered “at least possibly related” during the 
intervention and follow-up phases will be reported to NIAAA within 48 hours of knowledge of the SAE 
and reported to UM IRBMED per UM guidelines depending on severity. 
 
5. A statement confirming that the Annual Report will include the following: a summary of all AEs, 
confirmation of adherence to the DSMP, a summary of any data and safety monitoring issues 

17 
 
since prior reporting period, a description of the changes in the research protocol or DSMP and 
all new and continuing IRB approvals.  
 
The annual RPPR will contain the following: 
-a summary of all AEs 
-confirmation of adherence to the DSMP 
-a summary of any data and safety monitoring issues since the last RPPR 
-a description of changes in the research protocol or DSMP 
-new/continuing IRB approvals 
 
6. Study inclusion and exclusion criteria 
 
These inclusion/exclusion criteria apply to both Aim 1 and Aim 2 studies. 
 
For screening, participants must: be age 18-25, reside in the U.S., and be able to read English (as they 
are recruited via advertisements written in English). Eligibility criteria for baseline and randomization is 
self-reported past-month HID and regular Snapchat use (at least 3 days/week). Participants will be 
excluded if they fail identity verification based on: 1) IP addresses, 2) survey time completion, 3) repeat 
attempts, and 4) survey responses. Aim 1 participants are excluded from Aim 2. 
 
A statement confirming that trained clinical staff will be present or on call when study 
procedures take place, based on level of risk and consistent with approved protocol, policies 
and guidance from the local IRB and/or other regulatory and monitoring entities. Examples 
include (but are not limited to) the administration of alcohol, other drugs and/or medications; 
invasive or other study procedures or testing; etc. The types of trained personnel (e.g.: nurse, 
nurse practitioner, physician assistant, physician, etc.) should be stated. 
 
Drs. Bonar and Fernandez will be responsible for providing regular supervision to research staff who 
have contact with participants. The investigators will provide training to all research staff (e.g., 
bachelor’s level health coaches and research assistants, master’s level study coordinator) who are 
interacting with participants via the intervention regarding procedures for identifying, managing, and 
responding appropriately to acute warning signs of distress (e.g., messages to peer coaches that reflect 
distress). Staff will receive training in risk assessment and management procedures in the event that 
participants reveal via study-related interaction any suicidal and/or homicidal ideation or child abuse.     
If staff becomes aware of any of these issues, they will follow written guidelines to assess level of risk 
and will immediately page Dr. Bonar, Dr. Fernandez, or Dr. Walton for consultation in moderate or 
high/acute risk cases. If necessary, authorities will be notified and participants will be notified of 
reporting requirements.  
 
7. For studies in which alcohol is administered, provide assurance that NIAAA guidelines for the 
administration of alcohol will be followed. These guidelines can be found here: Alcohol 
Administration Human Laboratory Studies. 
 
Not applicable 
 
8. Describe the plan for referral to treatment during follow-up phases for any research participant 
who requires additional intervention due to significantly increased alcohol consumption or 
serious psychiatric/medical symptoms. 
 
All participants will receive link to a webpage containing a resource list (e.g., substance use disorder 
treatment, mental health, crisis lines) at baseline and follow-ups and all will receive a link to NIAAA’s 
Rethinking Drinking as part of participation. Crisis resource information is also provided prior to the 
close of study surveys. During study interaction, if we believe a participant could benefit from additional 
treatment services we will email/private message them a link to locate treatment in their area (SAMHSA 

18 
 
treatment locator) as well as contact information for 24/7 crisis lines. We have done this in prior work 
with online interventions via social media.  
 
9. Describe procedures for data quality assurance and protecting confidentiality of participant data 
(e.g., Certificate of Confidentiality).  
Quality Assurance Plan 
Quality assurance will be accomplished in several ways listed below under supervision of the Study 
Coordinator and Data Manager, overseen by Drs. Bonar/Goldstick.  
Recruitment. We have experience identifying fraudulent cases by examining data for integrity, 
falsification, multiple attempts, IP addresses, etc. We will use procedures currently employed in ongoing 
research.  
Screening Survey. During each screening wave, the Data Manager will print frequency data from 
screening surveys and examine for out-of-range values; the Study Coordinator will look at eligibility 
criteria and randomization tables to determine they are correct; the Study Coordinator and Data 
Manager will ensure all screening data are backed-up; the Study Coordinator will ensure that all 
screening participants are accounted for in tracking database and update the study flow chart to ensure 
accurate numbers recorded as screened, baseline, refused, or withdrawn.  
Baseline Assessments. During each recruitment wave, the Data Manager and Study Coordinator will 
review baseline data for accuracy and out of range values; ensure that all baseline data are backed-up; 
ensure that all baseline participants are accounted for in tracking database; update flow chart to ensure 
accurate numbers of baselines recorded as completed or refused. Assessments (baseline and follow-
up) will contain an item unique to participants that will assist in ensuring that the participant and not 
someone else is completing their surveys (e.g., name of street they grew up on, name of high school 
mascot).  
Intervention period. The Study Coordinator will review Snapchat message logs for accuracy and 
consistency after close of each intervention wave; note weekly supervision with Dr. Bonar/Dr. 
Fernandez will also include review of message logs.  
Follow-up Assessments. Monthly, the Data Manager and Study Coordinator will review follow-up 
data for accuracy and out of range values; ensure that all follow-up data are backed-up; insure that all 
follow-up interviews are accounted for in the tracking database; update flow chart to ensure accurate 
numbers of follow-up assessments recorded as completed, missed, refused, or withdrawn.   
Protecting Confidentiality 
To minimize the risk of violating confidentiality, RAs will make every effort to ensure that study data 
are always kept confidential. Research staff will sign a pledge of confidentiality and will understand that 
violation of confidentiality is reason for dismissal. Staff training procedures will include information about 
the importance of confidentiality and techniques to maintain confidentiality of all information reported by 
research participants. Staff will maintain human subjects and confidentiality certifications through the U-
M Program for Education and Evaluation in Responsible Research and Scholarship system and will 
complete CITI Good Clinical Practice Training. Consent documents will fully explain the study 
procedures, potential risks, and potential benefits. 
Unique identification numbers will be assigned to participants. Any data forms (e.g., Snapchat 
message logs) will be coded with this number, rather than with a name. Computer data files (e.g., 
screening/baseline/ follow-up data) will be saved with passwords on a secured network, and will not 
contain names, birthdates, etc. Message logs may be temporarily recorded on the local study device, 
without identifiers, prior to saving in the secure log on the secure drive. The contact information 
database will be password protected and securely stored and will not be attached to participants’ survey 
or message data and only accessible to study staff.  For participant tracking, one list will be maintained 
linking participants’ ID numbers to their names. This list will be kept in a password-protected document 
on a secure research drive folder only accessible to study staff. This list will be deleted as soon as the 
study is completed. In accordance with NIH rules, we will also receive a Certificate of Confidentiality 
from the NIH to protect the confidentiality of our data from legal requests. Finally, specific information 
collected during this research study will not be available to family or friends or others outside of the 
study team. All data will be collected specifically for use on this project. All data will be collected 
specifically for use on this project. 

19 
 
Regarding Snapchat messages, content of new messages do not appear on a participant’s phone 
notification screen and are only viewable when opened by the participant, taking at least 2-3 clicks 
before content is viewable. Because Snapchat use is common among emerging adults, it is unlikely that 
others will know that the participant is in a research study just by seeing Snapchat or a new notification 
on their phone.  We will instruct participants to view messages from the coaches where they cannot be 
seen or heard and also to consider using a strong password/passcode on their cell phone. Snapchat 
messages are automatically deleted after viewing, unless a user manually changes their settings to 
“delete after 24 hours after viewing” or manually chooses to save a message. Participants will be 
informed that they still risk having messages viewed by others if anyone else accesses their cell phone 
or has access to their Snapchat account. Messages during the intervention Snapchats sent by the study 
team will not directly mention details obtained from assessments about participants’ own reports of 
illegal behaviors, instead they will be theoretically grounded statements based on MI behavior change 
(e.g., weighing pros/cons of alcohol use in relation to goals and motives). During informed consent, 
participants will be informed that the researchers do not control Snapchat’s access to their messages 
and that they are still subject to Snapchat terms of use. 
Participants’ confidentiality will be breached by the research team only to protect the safety and 
welfare of research participants and only in accordance with state and federal law. The exceptions to 
confidentiality include if the participant reports acute suicidality, homicidality, or the physical or sexual 
abuse of a child, this could happen via a Snapchat message. Regarding disclosure via social media, we 
have protocols in place, and to date we have had only 1 participant describe suicidality out of 955 risky 
drinkers ages 16-24. Protocols were followed and the participant was deemed moderate risk and given 
appropriate resources. In our clinical trials with patient populations in the emergency department and 
substance use treatment settings, we also have experience dealing with these issues. Thus, staff will 
receive training in crisis assessment and management procedures in the unlikely event that participants 
reveal suicidal and/or homicidal ideation, or child physical/sexual abuse. If the participant discloses 
suicidality or homicidality, the facilitator will attempt to contact the participant to assess risk level and 
provide appropriate follow-up (e.g., suicide hotline numbers, safety check, etc.). Although study 
assessments will not ask about child abuse, in the unlikely event that a participant self-discloses the 
abuse of a child, staff will be trained to report this information to local child protective services/family 
independence agencies via anonymous report. This exception to breaking confidentiality – the case 
where a participant reveals child abuse, suicidality, or homicidality – will be explained in detail to 
participants in the consent forms and prior to completing the reporting process. We will always inform 
participants when we must make a mandatory report.  
 
10. Provide a statement indicating certification of IRB approval(s) of the study protocol will be 
provided to NIAAA prior to screening study participants.  IRB approvals should be submitted 
(preferably electronically) to the NIAAA Grants Management Officer (GMO) before initiating a 
proposed clinical trial.  For multi-site studies, the Data Coordinating Center (DCC) and 
associated study sites must submit certification of IRB approval as well as assurance that IRB 
approvals have been obtained for all study sites, are on file at the clinical site and DCC, and are 
available to the NIAAA upon request.  
 
We will provide documentation of IRB approval for all study procedures prior to beginning screening 
participants.  
 
11. Provide the analysis plan including the power calculation(s). There should be discussion of any 
planned interim and/or futility analyses, including adjustments for allocating “alpha” on 
“multiple looks” at the data.  
 
Specific Aim 1. Intervention development will consist primarily of identifying preferences for content 
delivery and content with superior ratings, and thus will not involve formal statistical inference. We will 
conduct descriptive analyses of participants’ data regarding preferences, leading to refinements in 
intervention content. 
 

20 
 
Specific Aim 2. Analyses pertaining to primary outcomes of feasibility and acceptability of the 
intervention are primarily descriptive in nature (e.g., % completing the assigned intervention condition, 
% engaging in Snapchat messaging, ratings of intervention satisfaction). To examine other outcomes 
related to estimating intervention efficacy, in Aim 2, randomized participants will be included in intent-to-
treat analyses, regardless of engagement. By design, groups will be balanced on sex and age; we will 
validate randomization by evaluating covariate balance between groups. If significant differences that 
could confound treatment effect estimates emerge, we will adjust for those variables or stratify analyses. 
Testing for Intervention Effects. We will first compare groups outcomes of HID frequency and alcohol-
related consequences using basic two-sample comparisons, operating on the pre-post differences (e.g., 
4M-Baseline) to test for treatment effects. Our first choice will be a two-sample t-test to compare the 
pre-post differences between groups; considering non-parametric alternatives as needed. We will use 
generalized linear mixed models (GLMMs) to jointly study the 2M and 4M outcomes while adjusting for 
correlations between data points (e.g. repeated measurements on individuals). While baseline 
adjustment is important for guarding against regression to the mean in RCTs, such adjustment at every 
time point may overestimate the treatment effect when there are multiple follow-ups. Baseline 
adjustment at only the first follow-up (2M in this case) corrects this overestimation while also guarding 
against regression to the mean, which will be our approach. Within this framework, the treatment effect 
is estimated by the treatment group indicator in the regression model. We will conduct exploratory sub-
analyses of whether the intervention effect is accumulating or weakening over time, by including time-
by-group interactions. If we ascertain the need, we will control for confounders through their inclusion in 
the model as covariates. Overall, this approach is effectively the same as the ANCOVA method of RCT 
analysis, but modified to account for multiple follow-ups and possibly inhomogeneous treatment effects 
(e.g. time-varying or modified by other factors, see secondary aims, below). Our initial specification will 
be a linear mixed effects model (with Gaussian error distribution) with only a random intercept to capture 
within-individual dependence, but we will scrutinize this choice by examining model diagnostics. If we 
ascertain the need, we will examine other distributional choices (e.g., Poisson, Negative Binomial) and 
more complex random effects structures (e.g., autoregressive). Effect Size Estimation: This pilot will 
provide critical data necessary to inform power analyses for a later efficacy trial. While effect sizes from 
pilot studies can have large standard errors and be unstable, we can use pilot data to estimate point 
estimates and confidence intervals for treatment effect sizes using the R package MBESS. The effect 
size of choice will be the standardized regression coefficient corresponding to the treatment group 
indicator in a model adjusted for the baseline measurement, which will have the same interpretation as 
the standardized mean difference (commonly referred to as Cohen’s D). This analysis will provide a 
basis for calculating the minimal sample size required for a fully powered study while accounting for 
uncertainly in the effect size estimate.  
 
Other exploratory analyses. Other Outcomes: We will use the framework described above for alcohol 
outcomes to analyze other behavioral outcomes (cannabis, NMPDU). Moderation: To assess potential 
moderators (e.g., sex, age) we will include interactions with treatment group in the GLMM models 
above. Mediation: To test if alcohol motives and other variables (e.g., mental health) mediate treatment 
effects, we will use Imai’s causal mediation analysis framework, implemented in the R package 
mediation. Traditional mediation analysis is limited by the class of statistical models (e.g. the linear 
structural model of Baron and Kenny) that can be accommodated. Under technical assumptions of 
sequential ignorability, mediation effects are identifiable using Imai’s framework when models for the 
mediator and outcome are non-linear, have discrete or continuous outcomes, include random effects, or 
are non-parametric. Engagement: Counts from Snapchat message logs (e.g., content viewed, replies), 
will be assessed descriptively to see types of content with high response and to measure dose. We will 
test for sex and age differences in engagement. Cost: We will calculate summary statistics for the total 
intervention-specific costs and mean costs per participant, with confidence intervals. Costs will be 
reported with/without start-up and development, for example, including costs for recruiting and training 
coaches and clinical supervision. As with Dr. Walton’s prior work, net costs (savings) will be calculated 
by subtracting mean costs per participant in the control group from costs per participant for the assigned 
condition, also calculating the incremental cost effectiveness ratio (difference in mean intervention cost 
vs. control divided by difference in mean effectiveness between intervention and control). Change in 
health benefits will be quantified as the difference in alcohol consequences per month for the 

21 
 
intervention vs. control, expressed in dollars per consequence averted. Sensitivity analyses to evaluate 
alternate assumptions for estimated costs will be conducted. Given likely skewness, we will identify 
appropriate ways to generate confidence intervals that do not rely on a normal distribution (e.g., non-
parametric boot-strapping). 
 
Power Analysis. 
For exploratory analyses regarding intervention efficacy, our inferential target (the regression 
coefficient corresponding to treatment group) is effectively equivalent to the comparison of two means, 
for which Cohen’s D is the typical effect size (0.2: small; 0.5: medium; 0.8: large). Under the expected 
sample size (n = 50-52 per group), we will have sufficient power (>80%) to detect effects on outcomes 
at a single time point if D > 0.56, a medium effect size. In analyses involving multiple follow-ups, the 
effective sample size cannot be smaller than the nominal sample size (n = 50-52 per group), and so the 
effect size of D = 0.56 is conservative in that case.  
 
12. Provide the study stopping rules part of the study protocol. Generally, stopping rules reflect one 
of the following conditions: 1) there is clear evidence of harm; 2) there is no likelihood of 
demonstrating treatment benefit (futility); 3) there is overwhelming evidence of the benefit of 
treatment. 
 
The PI will work directly with NIAAA, in the case that project discontinuation is necessary. Should there 
be clear evidence of harm to the participants due to this trial we will cease the trial. Given this is a no 
more than minimal risk study as deemed by our IRB, we do not anticipate evidence of harm. As this is a 
pilot/feasibility trial, we may not be able to detect a treatment effect and thus do not anticipate stopping 
the trial due to evidence of futility or benefit.