Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
Phase: NA
Conditions: Cannabis Use
Sponsor: University of Michigan

1 
 
 
 
 
Full Study Title: An App to Reduce Cannabis Use Among Emerging Adults 
 
Date: 3/26/2024 
 
IRBMED #: HUM00222194 
 
ClinicalTrials.gov ID: NCT05824754 
 
Principal Investigator: Inbal Nahum-Shani. Ph.D. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
 
 
MiWaves 
Feasibility of a 2nd generation JITAI to reduce cannabis use among emerging adults 
 
PI: Inbal Nahum-Shani, Ph.D. & Lara Coughlin, Ph.D. 
 
Co-investigators: Erin Bonar, Ph.D., Susan Murphy, Ph.D. & Maureen Walton, Ph.D. 
 
1. Introduction  
 
Advances in mobile health (mHealth) not only allow for accessible and cost-effective 
intervention, but also offer novel opportunities for delivering personalized and adaptive 
interventions in real-time, in the real world. Analogous to personalized medicine, just-in-time 
adaptive interventions (JITAIs) are an emerging approach that operationalizes the 
personalization of the real time selection, and delivery of intervention strategies, based on real 
time data collection.1, 2 This approach has had large clinical impact in managing cardiovascular 
disease and diabetes3, 4 and JITAIs have been developed and evaluated for a wide range of 
behavioral health issues (e.g., mental illness,5 smoking cessation6, 7).  
 
mHealth interventions offer novel opportunities for delivering JITAIs based on real-time data 
collection to reduce substance use. Such approaches are lacking for substance use (SU; 
alcohol, cannabis, opioids) among emerging adults (EAs), which is critical because they are 
avid digital adopters. Also, SU is initiated in adolescence, reaches peak prevalence during 
emerging adulthood, and is associated with morbidity and mortality (i.e., injury, violence, 
suicide, overdose). 
 
Critical challenges exist to developing evidenced-based, personalized, real-time mHealth 
interventions that can address youth SU. 1) Existing mobile interventions for SU primarily focus 
on adults, and/or individuals with substance use disorders (SUDs;<10% of EAs), missing youth 
and young adults with risky use. 2) Adequate engagement with mHealth tools is necessary for 
success;1, 2 yet attrition in mHealth interventions is common,8-10 including those targeting SU.11 
3) There is high heterogeneity in response to mobile interventions targeting EA SU; many EAs 
do not benefit sufficiently from mHealth alone and require some level of human (e.g., coach) 
support to facilitate change.12, 13 Addressing these challenges requires multidisciplinary effort, 
involving clinicians, engineers, methodologists, decision scientists, health economists, computer 
scientists and human-computer interaction (HCI) specialists.1  
 
Current mHealth substance use interventions, including JITAIs, focus primarily on treatment 
seeking samples with substance use disorders (SUDs) and/or adults,11, 14-18 which is a missed 
opportunity to intervene earlier in substance use trajectories by focusing on broader samples of 
non-treatment seeking EAs with risky use. Despite promising emerging data,19 evidence-based 
JITAIs for cannabis use among EAs are lacking. Reducing cannabis and other drug use among 
EAs could have a major public health impact by preventing health consequences (e.g., injury), 
development of SUDs, and associated risk behaviors (e.g., drugged driving). 20-27 To address 

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this gap,28 consistent with the Multi-Phase Optimization Strategy (MOST) approach, we 
conducted a series of pilot studies to inform the proposed JITAI. First, we developed an 
ecological momentary assessment app called SARA, which integrates gamification via an 
aquarium with scalable engagement strategies. A pilot micro-randomized trial (MRT) of SARA 
among 74 EAs with substance use showed excellent acceptability and 30-day engagement (M 
daily surveys=18.1, SD=9.2) despite much lower financial incentives (M=$6.24, SD=$3.83, 
range: $1-13) compared to previous daily self-report studies; further, inspirational messages 
increased daily survey completion.29 Second, we integrated feedback from SARA into a 
prototype JITAI, and obtained acceptability data among 39 substance-using EAs, establishing a 
blueprint for future refinement of the MiSARA JITAI. 
 
2. Objectives 
 
Given that cannabis use peaks among EAs and changing norms and policies have led to 
increases in availability and reductions in perceived risks of cannabis use,30, 31 we aim to 
develop a JITAI to reduce cannabis use among non-treatment seeking EAs who use cannabis 
thrice weekly. Using a transdisciplinary approach, the JITAI will integrate empirically based 
intervention strategies for reducing substance use (e.g., motivational interviewing and 
mindfulness) with engagement strategies grounded in areas such as basic psychology, human 
computer interaction (HCI), and marketing, which are necessary for efficacious mHealth 
interventions.32-34 
 
In this study, we will innovatively build on the results from our prior MRT optimizing app 
engagement (SARA) and prior feasibility/acceptability pilot of a prototype JITAI (MiSARA JITAI). 
In Aim 1, based on participant feedback, we will refine the MiSARA JITAI app environment to 
improve engagement by increased interactivity and personalization to maintain novelty 
throughout the intervention period. Then, we will test the feasibility, acceptability, and 
preliminary efficacy of a person specific JITAI called MiWaves for reducing cannabis use in this 
critically important EA population.   
 
3. Project Aims 
 
The specific aims of this project are to: 
 
Aim 1: Refine the MiSARA JITAI to reduce cannabis use among EAs. 
 
Aim 2: Conduct a pilot trial to test the feasibility and acceptability of MiWaves, a 2nd 
generation MiSARA JITAI with continually optimized population-based decision rules. 
 
The achievement of the proposed aims addresses a significant public health problem, namely 
the increases in cannabis use among EAs. The innovation is grounded in the development of a 
real-time, real-world, personalized, and scalable intervention approach to reduce substance use 
among EAs. This work is highly innovative since, despite promising results, evidence based 
JITAIs for cannabis use among EAs are lacking. Reducing cannabis and other drug use among 
EAs could have a major public health impact by preventing adverse health consequences (e.g., 
injury), development of SUD, and associated risky behaviors (i.e., drugged driving).  
 
4. Methods 
 
Aim 1: Refine the MiSARA JITAI to reduce cannabis use among EAs.  

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This aim does not include human subjects. Instead, it includes the development of (a) 
therapeutic content and (b) engaging content and human computer interfaces. Using a 
participatory action approach, we will integrate EA feedback from our formative studies with 
consultation from a new EA advisory board to create the MiWaves JITAI app.  
Refinements may include:  
• 
increased interactivity and personalization of the app,  
• 
integration of data into personalized feedback graphs,  
• 
personalization of messages based on behavioral trends to increase novelty, and 
• 
archiving intervention content in a virtual toolbox and creating ‘on-demand’ pulls for 
additional messages.   
 
A collection of empirically- and theoretically-grounded therapeutic content will be identified and 
developed by multiple intervention experts to maximize engagement. Therapeutic content will 
harness a variety of mediums and may include: a) messages (targeting goals, strengths; 
benefits to change, tools to address motives); b) brief videos (e.g., focusing on goal setting and 
attainment, protective behavioral strategies, safe driving, overdose prevention, other strategies); 
and c) life-insights visualizations -- feedback capitalizing on Ecological Momentary Assessments 
(EMAs) to visually integrate information about behaviors, risk and protective factors. Intervention 
content will be reviewed by an advisory board of EAs and selected based on fit with evidenced-
based intervention content (e.g., motivational interviewing) and appropriateness (e.g., no 
images glamourizing use, offensive jokes). Intervention experts on our team will collaborate with 
engagement experts, machine-learning experts and HCI experts to further develop and refine 
various types of visualizations to specifically address cannabis use related risk.  
 
Aim 2: Conduct a pilot trial to test the feasibility and acceptability of MiWaves, a 2nd 
generation JITAI with continually optimized population-based decision rules. 
 
This aim includes human subjects. Specifically, it includes the following: a) conduct EA 
enrollment and obtain feedback, and b) software refinement. Based on prior work and Aim 1 
feedback from EA advisors, the MiWaves app will be iteratively refined among a total of 150 
EAs (ages 18-25). Participants who report cannabis use three or more times per week in the 
past month (see Inclusion/Exclusion criteria below for more information) will be recruited online 
to use the MiWaves JITAI for 30 days. Enrollment will occur in multiple waves, with the first two 
waves beta testing proposed trial procedures with small groups of n≈10 participants and n≈20, 
and the final wave(s) involving a pilot trial with up to 150 EAs. Feasibility will be defined by the 
percentage of participants who consent to the study who ultimately download the MiWaves app. 
 
Participants 
 
The subject population comprises of emerging adults ages 18-25 years-old, residing in the US, 
who use cannabis, and report motivation to change their cannabis use habits. 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 represent 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 one race.  
 
Recruitment  
 

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We will employ a variety of recruitment sources on this project. Recruitment options may include:  
1. We may use social media ads (e.g., Facebook, Instagram, Snapchat, X [Twitter]) to target 
18–25-year-olds in the United States. When users click on our ad, they will be redirected 
to the online (Qualtrics) screening informed consent (with waiver of documentation of 
consent and waiver of parental consent requested for states where the age of majority is 
over 18). 
2. We may recruit potential participants through flyers displayed within the community (at 
locations such as coffee shops, gyms, community centers, clinics, restaurants, libraries, 
stores or small businesses, pharmacies, churches, etc.).  
3. We may recruit potential participants through a page on UMHealthResearch.org, a 
website hosted by the Michigan Institute for Clinical and Health Research (MICHR).  
Participants who learn of the study through UMHealthResesearch.org may be redirected 
to the study website and/or the direct link to the screening survey through the study’s 
description. If someone with a UMHealthReserach.org account finds the study and 
expresses interest in participating, they may be contacted by research staff by phone or 
email. 
4. We may partner with third-party recruitment companies (e.g., BuildClinical) to generate 
additional leads for our study staff to follow up with. 
5. With appropriate regulatory approval from the necessary IRBs, we may contact 
participants from other studies that consented to recontact for future research 
participation. In these situations, we will receive approval from that study’s investigative 
team and IRB, and list the IRB number in section 8-1.1 of our application. 
6. We may provide sample emails with recruitment resources to distribute to venues (with 
appropriate approval) such as the UM Registrar email list or other community Listservs. 
7. We may recruit potential participants through a study specific website, which may include 
an embedded eligibility survey. 
8. We also may contact interested participants via email or in person with appropriate follow-
ups. 
 
Participants will be invited to print or save a copy of the informed consent before moving on to the 
screening survey. After giving online screening consent and completing a CAPTCHA to protect 
against bots, participants will complete a 2-3-minute eligibility survey. Following determination of 
eligibility (see eligibility requirements outlined in inclusion and exclusion criteria section below), 
negative screens will receive a thank you page ending their participation. No identifying 
information will be collected from those participants who are not eligible for the study.  
 
Inclusion/Exclusion Criteria  
 
Individuals will be eligible to continue if they: 1) reside in the US; 2) speak and read English; 3) 
are 18-25 years of age; 4) have a smartphone on which the app can be downloaded; 5) screen 
positive for cannabis use 3 or more times each week over the past month; 6) report motivation 
to change cannabis use as a 1 or higher (using a scale of 0-10); and 7) meet study verification 
criteria (i.e., use of CAPTCHA, IP address checks, repeat attempts, social media checks).  
 
Participants may be excluded if they report current medical marijuana use and/or fail identity 
verification procedures (see prior study1) based on IP addresses, survey time completion, repeat 
attempts, social media checks or survey responses. Potential participants may also be excluded 
based on participant best interest (e.g., if the participant has plans to travel outside of the 
country during the app use period, or if study staff know the participant or their family personally, 
in order to fully ensure participant privacy), with PI approval. 

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Baseline Assessment 
 
Eligible participants will be notified of their eligibility and sked to provide contact information. 
Following completion of the screening assessment, participants will be verified for authenticity.  
We have experience with methods related to identification and handling of fraudulent cases using 
internet-based research via use of a Completely Automated Public Turing test to tell Computers 
and Humans Apart (CAPTCHA) and checking for duplicate IP addresses. 
 
Once verified, eligible participants will be redirected to an online baseline consent housed in 
Qualtrics (waiver of documentation and waiver of parental consent requested for states where the 
age of majority is over 18).  After giving online baseline consent and completing a CAPTCHA to 
protect against bots, eligible participants will complete a 25-35 minute baseline survey and 
another contact information form in Qualtrics. In the rare event and at the participant’s request, 
participants may also have the option to complete the consent and surveys over the phone where 
the research assistant will read the questions and record responses.       
 
 
After completion of the baseline assessment, eligible participants will receive information about 
how to download and enroll into the MiWaves app. Eligible participants will have one month from 
screening consent to complete the baseline assessment and download the MiWaves app. To 
begin the 30-day pilot trial, participants will be activated to begin receiving notifications. After this 
step, participants will be enrolled in the study and begin the pilot trial.   
 
 
 
Pilot Trial 
 
As part of the pilot trial, participants will interact with the app for a 30-day period. During this 
intervention period, participants will be asked to complete four short (5-10 minutes) weekly 
surveys online and brief (1-3 minutes) twice-daily surveys within the app. Participants will 
receive daily push notification reminders about completing surveys which will not include 
sensitive information (e.g., about substance use) or other information that may identify the 
individual as a study participant. The MiWaves app can also passively collect data regarding 
participants’ interaction with the app, movement, context, and may also collect GPS location. 
Beta testing will occur in the first two waves of n=10 per wave to aid in the development of the 
app and algorithm creation. Participants involved in beta testing waves will interact with the app 
for only 10 days including the twice-daily surveys during those 10 days and then complete only 
one weekly survey.  
 
Since novelty is well understood to enhance user engagement with technology35, additional 
features of the app can be intermittently turned on to maintain participant engagement during 
the intervention period. These features may include: 1) life insights feedback, or graphs of 
survey responses/app engagement over a window of time; 2) inspirational messages which 
harness the theory of reciprocity to encourage survey completion; 3) financial incentives of 
varied amounts which are tied to survey completion; and 4) active tasks, which are brief games 
that capture cognitive performance (e.g., reaction time, spatial memory). In instances where the 
app is not able to display how many surveys have been completed and how much money 
participants have earned during the pilot trial (e.g., due to technical difficulties), participants will 
receive a message each week from the study team that informs them: 1) how many 

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assessments they completed during the past week; and 2) the total amount of money earned to 
date.  
 
Participants will likewise receive therapeutic content via the app during the pilot trial. Twice per 
day (morning and afternoon), intervention messages may be delivered. MiWaves will use 
reinforcement learning algorithms to learn whether and in which context it is best to deliver 
these messages for each EA. The message will target content areas such as daily goals to 
reduce use, upstream factors (e.g., coping with negative affect), reasons and tools to reduce 
use, potential consequences of use, and identification of alternative activities. Messages will 
vary by the amount of effort required by the EA to engage with the content (e.g., messages with 
a ‘pick’ list or text entry box will be considered higher effort, whereas messages with only visual 
content will be considered lower effort), as a potential moderator of intervention effects.  
Furthermore, harm reduction messages can be delivered when the EA enters a high-risk 
location (e.g., dealer’s/dispensary location). These high-risk locations will be prespecified during 
app set-up. Note that all content participants receive directly on their phone as push notifications 
will not contain any confidential information. All intervention messages will include user ratings 
(e.g., thumbs up/down, star rating) to inform future content refinement.     
 
Post-Test and Follow-Up Assessments  
 
At the end of the 10-day or 30-day intervention period, all participants will be invited to complete 
a 20-25 minute post-test about their experience using the app, feedback about intervention 
content, and recent cannabis use (with questions mirroring those asked in earlier surveys).  
 
Then, two months after the start of the app intervention, all pilot trial participants will be invited 
to complete a 25-35 minute follow-up assessment containing questions that mirror those asked 
in the screening, baseline, weekly and daily surveys. Participants will have the option to 
complete both assessments online or over the phone with a RA if preferred.  
 
Incentives 
 
Participants will be compensated $40 for completing the baseline assessment and downloading 
and enrolling in the MiWaves app. During the pilot trial, all participants can earn up to $60 for 
completing the four weekly surveys ($15/survey) and between $0.50 - $3.00 for each completed 
daily survey, with the possibility of earning up to $60 for completing all twice-daily surveys. All 
incentives earned for completing the daily surveys and weekly surveys will be disbursed at the 
end of the intervention period. Participants will then receive $40 for completing the post-test and 
$50 for completing the follow-up assessment. Over the course of the study, participants could 
receive up to $250 for completing study activities and assessments. Earned financial incentives 
will be disbursed electronically (e.g., via a gift card of the participant’s choice).  
 
Participant involved in the beta-testing waves will receive the above rates of compensation for 
the activities completed. Total potential compensation for beta testing participation is $117.  
 
Measures 
 
 
Self-administered measures are reliable and valid among emerging adults. Please see Table 1 
for more information about the domains queried at each assessment timepoint, the timeframes 
asked about for each domain at each timepoint, and references for the questions capturing each 

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domain. All the outcomes listed in Table 1 are exploratory, except for the bolded primary 
outcomes concerning feasibility and acceptability. 
 
Table 1. Overview of MiWaves Measures, Assessment Timepoints, and Question 
Timeframes 
Domain 
Assessment Timepoint 
Screen 
Baseline 
Weekly 
Daily 
Post-Test 
2M FU 
Background Characteristics 
Demographics36-47 
Current 
Current 
 
 
 
Current 
Cell phone characteristics48-50 
Current 
 
 
 
 
 
Substance Use Frequency, Quantity and Methods of Use 
Nicotine use47, 51-54 
1M 
1M 
 
 
1M 
1M 
Nicotine methods of use47, 51-54 
 
1M 
 
 
1M 
1M 
Alcohol use QxF55-61 
1M 
1M 
 
Yesterday 
1M 
1M 
Alcohol TLFB59, 60, 62, 63 
 
7D 
7D 
 
 
7D 
Cannabis use QxF39, 47, 59, 60, 62-67  
1M 
1M 
7D 
12h 
1M 
1M 
Cannabis TLFB59, 60, 62, 63 
 
7D 
7D 
 
 
7D 
Cannabis methods of use39, 47, 
64-67 
 
1M 
 
 
1M 
1M 
Illicit drug use47, 64, 68 
 
1M 
 
 
1M 
1M 
Prescription drug misuse45 
 
1M 
 
 
1M 
1M 
Precursors of Cannabis Use 
Cannabis use motives69-71 
 
Current 
 
12h 
 
Current 
Cannabis cravings72, 73 
 
Current 
 
Current 
 
Current 
Perceived risk of cannabis74 
 
Current 
 
 
 
Current 
Social influences45, 54 
 
Current 
 
 
 
Current 
Mood/Affect75, 76 
 
 
7D 
Current 
 
 
Stress76 
 
 
 
Current 
 
 
Energy76 
 
 
 
Current 
 
 
Readiness to Change Substance Use  
Importance rulers (nicotine, 
alcohol, cannabis)77  
Current 
Current 
 
 
Current 
Current 
Likelihood and confidence 
rulers (cannabis)78, 79 
 
Current 
 
 
 
Current 
Substance Use Outcomes and Consequences  
Marijuana Adolescent 
Consequences Questionnaire80 
 
1M 
 
 
1M 
1M 
Young Adult Driving 
Questionnaire81 
 
1M 
 
 
1M 
1M 
DSM Symptoms Checklist82 
 
1M 
 
 
1M 
1M 
Protective Factors  
Protective Behavioral 
Strategies for Marijuana83 
 
1M 
7D 
 
1M 
1M 
Social Support84 
 
Current 
 
 
 
Current 
Behavioral Economic Measures  
Cannabis Purchase Task85-88 
 
Current 
Current 
 
 
Current 
Activity Level Questionnaire89, 90 
 
1M 
 
 
1M 
1M 
Delayed Discounting Task91 
 
Current 
Current 
 
 
Current 
Brief Relative Reinforcement* 
 
 
7D 
 
 
 
Mediators 
Social context of cannabis 
use92, 93 
 
7D 
7D 
 
 
7D 

9 
 
Domain 
Assessment Timepoint 
Screen 
Baseline 
Weekly 
Daily 
Post-Test 
2M FU 
Satisfaction with social events94  
 
 
 
Current 
 
 
Distress92, 95 
 
 
 
Current 
 
 
Positive outlook76 
 
 
 
Current 
 
 
Health Status, Outcomes and Service Utilization 
Service Utilization45 
 
Lifetime 
 
 
 
2M 
Mental Health 
 
 
 
 
 
 
   Global Measure94 
 
Current 
 
 
 
Current 
   PHQ-296 
 
2W 
7D 
 
2W 
2W 
   GAD-297 
 
2W 
7D 
 
2W 
2W 
   ASI-398 
 
Current 
 
 
 
 
   Mindfulness Attention  
   Awareness Scale99 
 
Current 
 
 
 
Current 
   PCL-5 short form100 
 
1M 
 
 
 
1M 
Physical Health 
 
 
 
 
 
 
 
   Global Measure94 
 
Current 
 
 
 
Current 
   Pain Intensity101 
 
7D 
 
 
 
7D 
   Pain Interference101, 102 
 
7D 
 
 
 
7D 
   Sleep Quality101, 103 
 
7D 
 
 
 
7D 
   Sleep* 
 
 
 
12h 
 
 
   Exercise104 
 
 
 
12h 
 
 
Acceptability and Feasibility (Primary Outcome Measures) 
Acceptability105,* 
 
 
 
 
Current 
 
Feasibility 
 
 
 
 
 
 
*Items were created for this study  
Notes: In the table above, 1M = Past Month, 2W = Past 2 weeks, 7D = Past 7 days, 12h = Past 12 hours. 
Bolded items indicate Primary Outcome Measures. All other outcomes are exploratory. 
Table cells which are blank indicate that the domain was not assessed at that timepoint. 
 
5. Analysis 
 
Quantitative data will be analyzed using a statistical software package (e.g., SAS, STATA, 
SPSS). Descriptive statistics (frequencies) will be employed to understand the distributions of 
question responses. Appropriate bivariate and multivariate techniques will be used to explore 
trends in the data. Open-ended responses will be analyzed manually and coded into themes 
and subthemes when possible. 
 
6. Human Use Considerations and Protections 
 
This research is covered by a Certificate of Confidentiality from the NIH. All hired members of the 
research team will complete training and receive certification in Human Subjects Research 
Protection and HIPAA regulations, including Good Clinical Practice, and the investigators will 
keep current certifications up to date.  
 
Aim 1. There will be no human subjects’ involvement in Aim 1 of this proposal as it is focused on 
app and content refinement.  
 
Aim 2. In this aim, we will conduct a pilot trial to test the feasibility and acceptability of a 2nd 
Generation just-in-time adaptive intervention (JITAI) with continually optimized population-based 
decision rules.  

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Identifiable Information. For each stage of the proposed research investigation, participants’ 
names and contact information will be stored in a secure database, separate from their study 
data. Names will be linked to individual ID numbers only in a study database, which will be kept 
in a restricted access location only accessible to study staff. All study devices will be password 
protected, use UM encryption (e.g., Hub) whenever possible, and only accessed by study staff. 
UM encryption enables safeguards against data compromise, malware, and ransomware and has 
a user portal to manage devices in case of theft, loss, or forgotten passwords. All information 
collected will be accessible only to research staff who have completed and maintain mandatory 
training in the protection of human subjects and good clinical practices.  
 
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  
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 in the context of an app-based 
study. Should information to this effect be shared as part of assessment data collection or study 
interactions (e.g., phone follow-up, reminder messages), we will provide appropriate referrals to 
national hotlines and follow standard reporting procedures. We will notify participants when/if we 
must make any mandatory reports based on information they disclose and 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. Also note in a study conducted 
by our team using mobile phone assessments of EAs’ illegal drug use, participants reported (98%) 
that they were well-informed about potential study risks and most used a password/code on their 
phone during the study, as advised.106   
 
Participants could also potentially experience emotional discomfort as a result of being asked 
personal questions or because of intervention content. Because the study takes place solely via 
mobile devices, participants will receive a national resource list. Our prior 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. 
 
Participants will be informed that we will take steps necessary to secure their data. Electronic data 
files will be stored in a restricted-access folder in a secure U-M web-based location (e.g., U-M 
Dropbox, U-M network) only accessible to study staff. Participants will be instructed at the close 
of each web-based survey (e.g., screening, baseline) of steps they can take to further protect their 
privacy (e.g., clear browser history). In the baseline consent, participants will be encouraged  not 
to leave their mobile devices or computers open/unlocked (i.e., they will be encouraged to use a 
passcode). 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, study contacts and reminders will not include sensitive information about 
substance use.  
 
Protections against risk. To minimize the risk of violating confidentiality, research staff 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 

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confidentiality of all information reported by research participants. Staff will maintain human 
subjects and confidentiality certifications through the UM Program for Education and Evaluation 
in Responsible Research and Scholarship system and will complete 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., app-based 
survey response logs) will be coded with this number, rather than with a name. Computer data 
files (e.g., screening/baseline/ follow-up data, survey logs,) will be saved with passwords in a 
restricted-access location, and will not contain birthdates, etc. For participant tracking, a list will 
be maintained linking participants’ ID numbers to their names. This list will be kept in a restricted 
access location and deleted after the study is completed.  We have also received 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.  
 
Research staff will be trained to handle (i.e., discuss and refer as needed) unexpected issues that 
may arise. Because this is an online, app-based study, participant contact with research staff is 
limited, but participants could disclose this information to staff who contact them for the phone-
based follow-up assessment or in response to reminder messages. 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 at UM will be informed of any incidents 
as appropriate (see Data and Safety Monitoring Plan).  
 
Because smartphone and app use are common among emerging adults, it is unlikely that others 
will know that the participant is in a research study just by seeing a new notification on their phone. 
We will instruct participants to interact with the in private and to consider using a 
password/passcode or other security features (e.g., biometrics, face recognition log in) on their 
phone. Participants will be informed that they still risk having content viewed by others if anyone 
else accesses their phone or has access to their MiWaves app account. Intervention content 
included in the MiWaves app pilot study will not directly mention details obtained from 
assessments about participants’ own reports of illegal behaviors, instead they will be theoretically 
grounded content based on MI behavior change (e.g., weighing pros/cons of cannabis use in 
relation to goals and motives). Furthermore, participants will be explicitly instructed during the 
consent process that in the event of a crisis they should call 911 or utilize the crisis resources in 
the resources page of the MiWaves app.  
 
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 during a phone-based follow-up assessment. 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 during some 
type of study interaction. If the participant discloses suicidality or homicidality during study 
interaction, staff will attempt to assess risk level and provide appropriate follow-up (e.g., suicide 
hotline numbers, 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 

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prior to completing the reporting process. We will always attempt to inform participants when we 
must make a mandatory report.   
 
Vulnerable subjects. We will enroll 18-25 year-old emerging adults with regular (3 times weekly 
or more) cannabis use. Per the NIH definition, children under 18 will not be enrolled; however, a 
few US states list the age of majority as 19, 20, or 21. For those states where age of majority is 
greater than 18 years, we have requested a waiver of parental consent and these participants are 
still considered adults, thus not vulnerable subjects, under NIH guidelines. The age range is 
critical for this research because rates of cannabis use peak during this developmental period, 
and interventions delivered during this time can potentially prevent future escalation and 
consequences associated with use, which could have enormous public health impact. It is 
important to study this vulnerable population because they are at risk for negative outcomes, and 
they could experience possible benefits if effective, accessible interventions can be developed.  
 
Potential Benefits of the Proposed Research to Human Subjects and Others. 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 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 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.106 In 
addition, participants may be helped by the intervention. In sum, potential benefits for the research 
outweigh the risks for the participants. With regard to benefits to others, in the event that the 
intervention tested in the present study is efficacious, the potential benefits to society involve 
reducing the public health burden associated with cannabis use by way of healthcare 
expenditures, reductions in impaired driving/motor vehicle crashes, etc.   
 
Importance of the Knowledge to be Gained. Given that cannabis 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 do not seek help for their 
cannabis use, the development of effective and targeted prevention interventions is clearly 
needed. Given the current penetration of smartphone usage into the lives of young people, the 
potential reach for interventions using this medium, and the ability 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 minimal 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 cannabis use among emerging adults.   
  
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