BabySTEPs: Supportive Texts to Empower Parents
Phase: NA
Conditions: Alcohol Drinking
Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

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BabySTEPs: Supportive Texts to Empower Parents 
NCT04719390 
 
Study Protocol and Statistical Analysis Plan 
Document Approved: July 2023 
 

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Please Note: This protocol pertains to Aim 3: Pilot Micro-Randomized Trial, as detailed below. 
 
STUDY PURPOSE AND AIMS 
 
 
The purpose of this study is to develop and pilot test a theory-driven, adaptive text messaging 
intervention (TMI) for heavy episodic drinking (HED) in postpartum women. HED is prevalent among women of 
childbearing age, with 35% of women ages 18-25 and 28% of women ages 26-44 reporting past month binge 
drinking. The postpartum period is a time of high risk for relapse, as more than half of women who reduce their 
drinking during pregnancy return to pre-pregnancy levels within the first 3 months postpartum. Postpartum 
HED is associated with poor mother-baby bonding, increased risk for child abuse and neglect, and poor long-
term child outcomes. The majority of adults who engage in HED do not seek treatment. Postpartum women 
may be especially unlikely to seek formal treatment due to stigma, fears of child removal, and barriers to 
accessing treatment. Text messaging is a promising strategy for reaching non-treatment-seeking risky 
drinkers, with research supporting the impact of motivational and behavioral TMIs on reducing drinking. This 
approach may be particularly suitable for postpartum women, as it is convenient and anonymous. The TMI 
literature suggests that to maximize efficacy, TMIs should be theory-driven, incorporate evidence-based 
interventions, and adapt in the moment to fluctuating levels of risk factors. Few existing TMIs for HED meet 
these criteria, and there is no existing TMI for HED that is specifically designed for postpartum women. To fill 
this important gap, the proposed TMI will be based on relapse prevention theory, an empirically supported 
framework for treatment of alcohol use that targets coping skills and motivation to avoid drinking in the 
presence of context-specific triggers. Triggers specific to the postpartum context include poor sleep and baby 
irritability, which increase vulnerability to three established risk factors for HED: stress, negative mood, and 
lowered self-efficacy. Consistent with relapse prevention theory, the proposed TMI will include evidence-based 
cognitive-behavioral and motivational interviewing intervention messages aimed at strengthening adaptive 
coping skills and bolstering motivation to resist the urge to drink in the presence of poor sleep and baby 
irritability leading to higher stress and negative mood and lower self-efficacy.  
 
 
The study has three primary aims: 
 
Aim 1: Test and refine the proposed theoretical model via Ecological Momentary Assessment (EMA).  This aim 
will refine the theoretical model underlying the TMI that specifies the impact of the proposed intervention 
components on the theoretical risk factors for postpartum RD, as well as decision rules for adaptive tailoring. 
Aim 1 work will include cellphone-based data collection using EMA with 30 women for 14 days to determine 
patterns and fluctuations of stress, negative mood, and self-efficacy in response to perceived sleep quality and 
baby irritability, and their impact on motivation, coping, and drinks per day. 
 
Aim 2: Develop the components of an adaptive TMI aimed at reducing postpartum risky drinking. This aim will 
develop content and decision rules for adaptive tailoring that are consistent with Aim 1 results. TMI 
components will be based on evidence-based motivational and behavioral interventions for alcohol use and will 
be adaptively tailored to individual fluctuations in stress, negative mood, and self-efficacy. Components will be 
refined via iterative cycles of user feedback collected via focus groups with 30 women. 
 
Aim 3: Conduct a pilot micro-randomized trial (MRT) to assess feasibility of design and methods in preparation 
for a future fully powered optimization trial. We will conduct a pilot MRT with 50 postpartum women with the 
primary goal of demonstrating feasibility and acceptability of MRT methods and the secondary goal of 
providing proof-of-concept data on the comparative impact of maternal-focused and drinking-focused 
messages on proximal (motivation, self-efficacy, and self-regulation) and distal (daily drinking) outcomes. 
 
 
To achieve these aims, the study will apply the Multiphase Optimization Strategy (MOST) framework. 
Study activities comprise the Preparation Phase of MOST, and will proceed in three phases to achieve the 
three study aims. Phase 1 (Aim 1) (10 months) will include EMA with 30 women for 14 days aimed at refining 
the conceptual model and evaluating EMA feasibility. Phase 2 (Aim 2) (10 months) will develop TMI 
components, including message content and decision rules to guide adaptive tailoring of the TMI via an 

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iterative user-centered design process with 30 women. Phase 3 (Aim 3) (11 months) will consist of a pilot MRT 
with 50 women to examine feasibility of the MRT design and preliminary effects of the TMI components on the 
proximal and distal outcomes. 
 
PARTICIPANTS AND RECRUITMENT 
Participants 
 
We will recruit 50 participants via social media. To be eligible for study enrollment, participants must 
meet the following criteria: (1) adult women ages 18-45 years who gave birth to an infant within the past 4 
weeks that will remain in their care; (2) English-speaking; (3) own a smartphone with internet access; (4) report 
a score of 2 or higher on the T-ACE alcohol risk screener  OR having 8 or more standard drinks in a week in 
the 12 months prior to becoming pregnant OR drinking 4 or more drinks at one time once a month or more in 
the 12 months prior to becoming pregnant.  
  
Recruitment 
We will advertise the study on several social media sites, including Facebook, Instagram, Reddit, 
NextDoor, BabyCenter, and TikTok. If an individual clicks on a study ad on one of the social media sites, they 
will be directed to the study website, where they can learn more about the study, and complete eligibility 
screening and informed consent either online or via phone with the study RA. Facebook is the social network 
with the highest number of users among adults and well-suited for recruiting study participants. Recruitment of 
participants for medical research via Facebook has been shown to produce samples similar to traditional 
recruitment methods and is an efficient recruitment strategy for addiction research, yielding research samples 
with high severity of SUDs. Research also supports the use of Reddit, NextDoor, and BabyCenter for 
recruitment of similar populations. Our Co-I Dr. Thrul is experienced in using online recruitment techniques, 
including Facebook and Instagram and Reddit, to recruit hundreds of participants for substance use studies. 
In addition to the click-to-website ads, we will use two other types of advertising on Facebook only, that 
will allow interested individuals the opportunity to connect directly with the study team to get more information 
on the study. In Facebook lead ads, clicking on the ad will immediately open a form in which an individual can 
enter their first name and cell phone number to allow the study RA to contact them directly. Additionally, we will 
employ ads that link directly to Facebook Messenger, so that when an individual clicks on the ad, it 
immediately opens up Facebook Messenger, so that the person can send a message to the study team to 
indicate their interest in learning more.  
 
Retention Strategies 
To maximize retention of participants in the Aim 3 MRT, we will employ strategies that have been used 
in other EMA studies, including those conducted by co-I Thrul. These strategies include participant training 
prior to beginning the TMI, which will ensure that participants are fully informed of the nature of the program 
and the level of responsivity that is required, personal contact with study personnel via phone prior to 
enrollment and upon completion of the TMI, tailored feedback on EMA completion rates sent via text or email 
(depending on participant preference) at the end of every week of the 4-week TMI period, and bonus 
incentives for compliance.  In addition, we will monitor compliance with EMA every 3 days during the Aim 1 
EMA data collection and the 4-week pilot MRT, and for those clients who do not respond to any EMA surveys 
in a 3-day period, the RA will send reminder text messages.  
 
Eligibility Screening 
 
Participants will complete eligibility screening online via a secure Qualtrics survey that contains the 
eligibility screen.  
 
 
Technology Platforms for Data Tracking, EMA and TMI Implementation 
 
We will use Partnership to End Addiction’s JITAI Master Platform for tracking participants through the 
study. For EMA and MRT data collection, we will use MetricWire’s data collection app, Catalyst. Developed by 
MetricWire Inc., the MetricWire EMA system will collect the study’s EMA survey data through the Catalyst EMA 
study app. Catalyst is secure and HIPAA compliant and does not have any associated conflicts of interest. 
Participants will install the Catalyst app on their own smartphones. Data on the participant’s smartphone are 

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synced (encrypted in-transit) to the server and wiped from the mobile device when a connection is available. 
When the participant’s device is not connected to the internet, data are stored (encrypted) on the device. When 
offline, the app/server periodically checks for a connection in the background and performs the sync/wipe of any 
response data. This allows triggers and data collection to occur offline while minimizing the amount of time data 
are stored on the device.  
 
All participant generated data are stored in production information systems in hosted (cloud) environments and 
are not permitted to be stored on locally managed electronic devices such as MetricWire workstations. 
 
User Identification 
• All critical Information systems require a unique and valid User Login ID and password for each individual 
user. 
• Shared accounts for critical Information Systems are prohibited. 
• All critical Information systems require Two-Factor Authentication (2FA) to prevent account 
Sharing. 
 
Encryption And Decryption 
• MetricWire critical Information systems use symmetric AES-256-CBC for data encryption at the 
database level, with a random, unique initialization vector for each operation. 
• Authentication is performed using HMAC-SHA-256 and HMAC-SHA-512. 
• Encryption Keys are stored on a NIST FIPS 140-2 Certified Key Management Server 
• All participant generated data are encrypted in transit using 4096-bit RSA keys 
 
• Data are encrypted end to end through the entire application. 
• Encryption keys and machines that generate keys are managed by MetricWire, protected from 
unauthorized access and encryption keys are regenerated after 365 days. 
• MetricWire monitors the transmission activity of critical information systems automatically 
• Information system owners review logs on a weekly basis and in accordance with quarterly risk 
assessments. 
 
The MetricWire system will not store any PII. We will assign participant IDs as login information for study 
participants instead of their names, email addresses, or other contact information.  
 
Once study data collection is completed, all data will be downloaded from the MetricWire backend server, 
stored on Partnership’s secure server, and deleted from the MetricWire server. Data download from the 
MetricWire backend server will be done via an encrypted HTTPS protocol. 
Only the research team at Partnership to End Addiction will have access to the participant data. 
 
PILOT MICRO-RANDOMIZED TRIAL (MRT) 
 
Purpose of Pilot MRT 
The goals of the Aim 3 pilot MRT are to (1) evaluate feasibility and acceptability of MRT methods and 
messages, and (2) collect proof-of-concept data on the comparative impact of maternal-focused and drinking-
focused messages on proximal (motivation, self-efficacy, and self-regulation) and distal (alcohol use) 
outcomes. An MRT design is recommended for optimizing text messaging interventions because it provides an 
empirical basis for decisions about delivery of intervention components1. In an MRT, participants are re-
randomized at each decision point, allowing for the examination of causal time-varying effects of intervention 
components on proximal outcomes with a smaller number of participants, thus maximizing efficiency2. The 
proposed study will pilot the MRT design to test the TMI for postpartum HED. Results will include feasibility and 
acceptability and preliminary main effects estimates to inform a fully-powered MRT in a future study. 
 
Sample and Power 
MRT participants will include 50 postpartum women who meet study eligibility criteria recruited following 
procedures described above (see Participants and Recruitment). In line with published recommendations for 

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Decision 
point
 EMA
R
Maternal 
Message
Drinking 
Message
No 
Message
Proximal 
Outcome 
EMA
Random time interval (15, 45, 60, or 90 
min) 
.40
.40
.20
Stage I intervention development research3,4,5 the primary goal of the pilot MRT is to assess feasibility and to 
generate provisional evidence of efficacy to inform planning a fully powered MRT, which will be conducted in a 
future study. Thus, our sample size of 50 was selected to balance recruitment feasibility with the goal of obtaining 
sufficient data to generate provisional evidence of main effects of intervention components5, and is consistent 
with other studies using MRT in the early stages of intervention development6. Given the small sample, we will 
interpret results based on effect size rather than statistical significance. Stage I studies are not required to 
demonstrate adequate power to detect significant effects3; thus, a formal power analysis was not conducted.  
 
Procedures 
Study participants will be recruited via social media, as described above (Participants and Recruitment). 
After signing informed consent, participants will proceed through the following steps.  
Step 1: Baseline Assessment. Participants who sign informed consent will be asked to complete a 
Baseline Assessment via Qualtrics. Participants will be sent a secure link to the Qualtrics survey via text or email. 
The Baseline will take approximately 30 minutes to complete and will include questions about demographics, 
parenting, mental health, stress and coping, motivation, and drinking and other substance use.  
Step 2: Catalyst Training. Following completion of the Baseline, participants will participate in a one-on-
one 15-minute training session with the RA via Zoom to provide training on how to download and use the Catalyst 
app. In order to avoid fraudulent participants, participants will be asked to turn on their camera for 1 minute of 
the training, after which they will be allowed to turn off their cameras for the remainder of the training if that 
makes them more comfortable. Participants who complete both the baseline survey and the Catalyst training 
session will receive a $25 Amazon gift card upon completion of the Catalyst training session.   
Step 3: 28-day MRT. After completing the training, the TMI sequence of EMAs and TMI text messages 
will begin as described below and will last for 28 days. 
 
TMI Sequence and Randomization 
Upon completion of the Catalyst training, the TMI sequence of EMAs and TMI component delivery will 
begin (see Figure 2).  
Figure 2. TMI Sequence 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
There will be two decision points per day. Decision points will be randomly selected within a 12 hour window 
starting at the participant’s pre-selected start time. There will be at least 4 hours between the two decision points. 
At each decision point, participants will receive the “decision point EMA.” Upon completion of the decision point 
EMA, participants will be randomized to one of three options: (1) a maternal-focused message (.40 probability); 
(2) a drinking-focused message (.40 probability); or (3) no message (.20 probability). Fifteen minutes after 
randomization, participants will receive the “proximal outcome EMA.” This sequence will repeat 2 times per day, 
at each decision point. Participants will also be sent a “morning survey” each morning within 30 minutes of their 
selected start time that will ask questions about the prior day. After each survey prompt, the survey will be 
15 min 

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available for up to 60 minutes, with 2 reminder prompts sent (every 20 minutes). Surveys that are not completed 
within the 60 minute window will expire.  
Additionally, an optional “nighttime sequence” will become available nightly at 10 PM. The nighttime 
sequence will be optional with no prompt sent to avoid disturbing participants during the night. The reason for 
the nighttime sequence is to enable data collection and message receipt during the night when participants may 
be awake with their baby, which may be times of high risk for new mothers.  
The questions asked in each survey are shown in Tables 4-6 below. Completion of the morning survey 
should take approximately 2 minutes. Completion of each EMA survey should take approximately 1 minute. 
We will use the following procedures to encourage and monitor compliance: (1) one-on-one training prior 
to the start of data collection; (2) availability of technical support; (3) daily reminders to complete surveys; (4) 
bonus incentives; (5) outreach to participants who did not complete any EMA surveys 3 days in a row. If 3 days 
pass without any EMA responses, participants will receive an automated text message reminding them to 
complete the surveys. The reminder message will be sent once per day for 5 days. If there is still no response, 
the participant will be considered dropped from the study. 
In order to ensure participants are adequately supported during the study, we will provide information on 
how to obtain additional support for drinking (support hotlines). This information will be available within the 
Catalyst app at all times for participants to access if needed; (3) provide all participants with a list of local 
resources at the outset of the study. 
 
MRT Measures 
 
Baseline Assessment: 
 
Construct 
Measure 
Demographics 
Questions developed for study 
Drinking Self-efficacy  
 
Drinking Refusal Self-Efficacy Questionnaire-Revised7  
Alcohol and Drug Use 
history 
NIDA modified ASSIST8 
NIAAA Recommended Alcohol Questions9 
Alcohol and Drug Use 
Timeline Follow Back10 
Motivation/Readiness 
for Change 
Maternal Motivation Scale11 
Postpartum 
Depression 
Beck Depression Inventory12  
Maternal Self-efficacy 
Karitane Parenting Confidence Scale13  
Trauma History 
ACE 10 item Questionnaire14  
Maternal Attachment 
Infant Bonding Scale15  
Fatigue 
Fatigue Assessment Scale16  
Stress 
Perceived Stress Scale-417  
Drinking Motives 
Drinking Motives Revised Questionnaire18  
Coping self-efficacy 
Coping Self-Efficacy Scale19  
Social Support 
SSQ620  
Digital Literacy 
Media and Technology Usage and Attitudes Scale21  
 
Feasibility and Acceptability. Feasibility and Acceptability Outcomes: 
Drawing from other EMA feasibility studies22-27, feasibility outcomes will include the percent of EMA 
surveys completed each day, each week, and at the end of the 14-day period; the percentage of each EMA 
measure completed; and the percentage of respondents who completed 50% and 80% of EMA surveys22,23. 
Acceptability measures will be collected via a short text-based survey at the end of the 14-day EMA period and 
will include assessment of technical challenges, burden, emotional response, and overall satisfaction, using 
Likert-scale items from other EMA studies 24-27.   
 
Morning Survey Measures: 
[Sent daily at participant-selected wakeup time.] 
Construct 
Items 
EMA Burden/ 
Acceptability 
questions [include 
Retrospective questions 1=not at all, 7= very much 
Burden:  
1. 
Answering to the questions disrupted my everyday life 

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in final daily diary 
at end of study] 
2. 
The questionnaires on the phone stopped me from doing my usual activities 
3. 
I found it embarrassing when the alarm sounded around other people 
4. 
I enjoyed using the app 
5. 
I found it stressful to use the app 
6. 
Did your motivation to respond to the notifications decrease during the weeks? 
7. 
How tiring was it to take part in this study? 
8. 
Did the questionnaire become boring during the day? 
9. 
Did you get irritation while filling in the questionnaire? 
Ease of use 
1. 
The questionnaires on the phone were easy to complete/ 
2. 
At times I had to rush to complete the questionnaire on the phone on time 
3. 
I found it easy to remember to carry the phone with me during the time of the study 
How much time did 
you spend with 
your baby 
yesterday? 
1. 
Most or all of the day 
2. 
About half of the day 
3. 
Less than half of the day 
4. 
Evening and night only  
5. 
None 
6. 
Other  
a. 
For "how much time did you spend with your baby yesterday" you selected 
other. Please write in your response below. 
 
Prior night sleep28 
1. 
How well did your baby sleep last night (0 = poor to 7 = excellent) 
2. 
How well did you sleep last night [0 = poor to 7 = excellent] 
Mastery-
Parenting29 
1. 
Yesterday, I was good at feeding my baby 
a. 
Strongly disagree 
b. 
Disagree 
c. 
Agree 
d. 
Strongly agree 
 
2. 
Yesterday, I was good at soothing my baby when they became upset 
a. 
Strongly disagree 
b. 
Disagree 
c. 
Agree 
d. 
Strongly agree 
 
3. 
Yesterday, I was good at reading my baby’s cues 
a. 
Strongly disagree 
b. 
Disagree 
c. 
Agree 
d. 
Strongly agree 
 
4. 
Yesterday, my baby responded well to me 
a. 
Strongly disagree 
b. 
Disagree 
c. 
Agree 
d. 
Strongly agree 
Baby fussiness30 
1. 
Yesterday, how easy or difficult was it for you to calm or soothe your baby when they were 
upset? [1 to 7: 1 = very easy; 7 = difficult]. 
2. 
Yesterday, how much did your baby cry and fuss in general? [1 to 7: 1 = very little/much 
less than the average baby; 7 = a lot/much more than the average baby] 
Social support31 
How often was support available to you when you needed it yesterday? 
a. 
None of the time 
b. 
Little of the time 
c. 
Some of the time 
d. 
Most of the time 
Drinking 
1. 
Did you consume any alcohol yesterday? Yes/no 
2. 
If yes, how many drinks did you consume? 
3. 
If yes, select all time periods when you drank yesterday [morning, lunchtime, afternoon, 
evening, during the night] 
Alcohol 
motivations18 
If you drank yesterday, why did you drink: 
1. 
Because it makes social gatherings more fun 
2. 
To forget about your problems 
3. 
Because it gives you a pleasant feeling 
4. 
To be liked 
 
Mastery-Drinking 
1. 
How strong was your urge to drink yesterday? 1= very low, 7=very high 

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Look at this in relation to actual drinking. 
2. 
To what extent did you feel that you overcame your urge to drink yesterday? 
1=not at all, 7= to a very great extent 
Drinking cues32 
1. 
Was alcohol available to you yesterday (yes/no) 
2. 
Were other people in your household drinking yesterday (yes/no) 
Discrimination 
1. 
At any time yesterday did you feel that you were treated unfairly? (yes/no) 
2. 
What was the main reason(s) for the unfair treatment that you experienced yesterday? 
(check all that apply) 
a. 
Your age 
b. 
Your gender 
c. 
Your race 
d. 
Your ethnicity or nationality 
e. 
Your religion 
f. 
Your height or weight 
g. 
Some other aspect of your appearance 
h. 
A physical disability 
i. 
Your sexual orientation  
j. 
Your drinking 
k. 
Your smoking  
l. 
Your other substance use 
m. Being poor 
n. 
Being a mother 
o. 
Other  
i. For "What was the main reason(s) for the unfair treatment that you 
experienced yesterday?" you selected other. Please write your response 
below: 
 
3. 
Who treated you unfairly yesterday? (check all that apply) 
a. 
Family member 
b. 
Partner 
c. 
Stranger 
d. 
Acquaintance  
e. 
Employer 
f. 
Health care provider 
g. 
Other social service provider 
h. 
Other ____ 
i. For "Who treated you unfairly yesterday?" you selected other. Please 
write in your response below: 
 
Decision Point/Daily EMA 
[sent 2x daily] 
 
Construct 
Items 
 
1. 
Were you with your baby since the last survey you completed? Yes/no [IF NO: Skip Baby 
Fussiness] 
2. 
Will you be with your baby in the next hour? Yes/no [IF NO: Skip Maternal SE] 
Maternal SE 
How confident are you that you will be able to meet your baby’s needs (such as needs to be fed, 
changed, soothed, or entertained) over the next hour? 
[Not at all confident to extremely confident 1-7] 
Drinking SE33 
How confident are you that you can avoid drinking for the next hour? [1 = not at all confident to 7 = 
extremely confident] 
Stress34 
Rate your overall stress level right now 1-7, very low to very high. 
 
Mood 
1. 
What is your overall feeling right now [very unpleasant to very pleasant 1-7] 
2. 
What is your overall energy level right now [very low to very high 1-7] 
3. 
What is your anxiety level right now [very low to very high 1-7] 
Fatigue16 
1. 
How physically exhausted are you right now? 
2. 
How mentally exhausted are you right now? 
[not at all to extremely 1 -7] 
Baby Fussiness35 
1. 
Since your last assessment, how many times did your baby fuss, cry, or seem upset? 
[0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more times] 
2. 
How many of these times were you able to successfully soothe your baby? [all of them, 
most of them, some of them, a few of them, none of them] 
Intent to Drink33 
How committed are you to not drink in the next hour? [1 = not at all to 7 = extremely] 
Urge to Drink 
How strong is your urge to drink right now? 1= very low, 7=very high 

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Drinking 
4. 
Did you consume any alcohol in the past hour? Yes/no 
5. 
If yes, how many drinks did you consume? 
 
 
Proximal Outcome EMA 
 
Construct 
Items 
Maternal SE 
How confident are you that you will be able to meet your baby’s needs (such as needs to be fed, 
changed, soothed, or entertained) over the next hour? 
[Not at all confident to extremely confident 1-7] 
Drinking SE33 
How confident are you that you can avoid drinking for the next hour? [1 = not at all confident to 7 = 
extremely confident] 
Intent to Drink33 
How committed are you to not drink in the next hour? [1 = not at all to 7 = extremely] 
Urge to Drink 
How strong is your urge to drink right now? 1= very low, 7=very high 
 
Drinking 
6. 
Did you consume any alcohol since the last survey you received? Yes/no 
7. 
If yes, how many drinks did you consume? 
 
Stress coping  
1. 
Since the last survey you completed, did you use any strategies to cope with negative 
feelings or stress? 
a. 
I didn’t experience negative feelings or stress since the last survey 
b. 
I drank alcohol 
c. 
I changed my thinking 
d. 
I changed my current situation to cope with negative feelings or stress 
e. 
I found something else to do 
f. 
I sought advice or support 
g. 
I came up with a plan to cope with negative feelings or stress 
h. 
I set a goal or kept track of my progress towards my goal 
i. 
I directly communicated my needs to others 
j. 
I tried to relax 
k. 
I took medication 
l. 
I pushed negative feelings or stress away 
m. I used another strategy 
n. 
I didn’t use any strategies to cope with negative feelings or stress 
2. 
In the previous question you indicated that you took medication to cope with negative 
feelings or stress. Was this medication intended for the purpose of managing negative 
feelings or stress/for the purpose of managing alcohol cravings? 
a. 
Yes 
b. 
No 
3. 
Was this medication prescribed to you by your healthcare provider? 
a. 
Yes 
b. 
no 
8. 
You selected "I used another strategy to cope with stress". Please describe what you did 
below: 
Drink Coping  
1. 
Since the last survey you completed, did you use any strategies to manage the urge to 
drink alcohol?  
a. 
I didn’t experience an urge to drink alcohol since the last survey 
b. 
I changed my thinking 
c. 
I changed my current situation to cope with negative feelings or stress 
d. 
I found something else to do 
e. 
I sought advice or support 
f. 
I came up with a plan to cope with negative feelings or stress 
g. 
I set a goal or kept track of my progress towards my goal 
h. 
I directly communicated my needs to others 
i. 
I tried to relax 
j. 
I made an effort to stay safe and avoid risks while drinking alcohol 
k. 
I took medication 
l. 
I pushed negative feelings or stress away 
m. I used another strategy 
n. 
I didn’t use any strategies to cope with negative feelings or stress 
2. 
In the previous question you indicated that you took medication to cope with the urge to 
drink alcohol. Was this medication intended for the purpose of managing negative feelings 
or stress/for the purpose of managing alcohol cravings? 
a. 
Yes 

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b. 
No 
3. 
Was this medication prescribed to you by your healthcare provider? 
a. 
Yes 
b. 
No 
You selected "I used another strategy to cope with the urge to drink alcohol". Please describe what 
you did below: 
 
 
MRT Data Analysis 
Given that this is a pilot MRT and not powered to detect statistically significant effects, our primary focus 
in interpretation of findings is to assess feasibility of this design for a future fully-powered optimization trial. 
Feasibility analysis will include: (1) Recruitment Feasibility: We will evaluate length of time to recruit 50 MRT 
participants and demographic and clinical characteristics of those who enroll vs. those who decline enrollment; 
(2) Engagement Feasibility: We will examine paradata collected automatically by the TMI platform, including 
number of EMAs responded to, number of messages viewed, and number of days of engagement; (3) Retention 
Feasibility: We will track retention rates and predictors of retention using logistic regression analyses. We will 
follow the general recommendations of Klasnja and colleagues for analysis of MRT data to inform JITAI36 
optimization. Multilevel mixed effects models will be the primary analytic approach, and will account for nesting 
of observations within participant37. To test main effects of TMI components on the proximal outcomes, we will 
first examine models that include only the intercept and a term for the TMI component. The coefficient associated 
with TMI component represents the mean difference in proximal outcome between person times when the 
component is delivered and person times when it is not delivered, averaged across the study period. We will 
compute the standardized effect size for all main effects following the recommendations of Luers et al1.  
 
PARTICIPANT INCENTIVES 
 
Study participants will receive incentives to participate in the study. Incentives will be received in the form 
of gift cards to Amazon. Incentives will be provided for completion of the Aim 3 baseline assessment and Catalyst 
training, and the Aim 3 follow-up survey and qualitative interview. Reimbursement for the Aim 3 baseline 
assessment and Catalyst training will be provided upon completion of the Catalyst training. Reimbursement for 
the Aim 3 EMAs (as part of the MRT) will be provided at the end of the four-week testing period of the TMI, and 
reimbursement for the follow-up survey and qualitative interview will be provided upon completion of each survey. 
Gift cards will be provided via email or text. Participants who withdraw from the study prematurely will receive 
reimbursement for all study components they completed. Participants will receive $25 for completing the baseline 
and training, $25 for the follow-up, and $25 for the qualitative survey. Participants will receive $0.50 for each 
EMA survey they complete, plus a $20 bonus for completing 50% of surveys and a $30 bonus for completing 
80% of surveys.The bonus incentives for completing 50% and 80% of required EMA surveys are used routinely 
in EMA studies to boost compliance, and have been used in EMA studies with postpartum women (for example: 
38), and are not thought to be coercive given the relative low amount of money provided. Johannes Thrul (study 
Co-I) has used these methods in prior studies of young adult smokers, with bonus incentive rates up to $60 (see 
22,32,39. Due to an increase in fraudulent participants, we have added language to the consent form that states 
that participants who are determined to have entered the study fraudulently will not be compensated and will be 
unenrolled from the study. 
 
RISKS AND BENEFITS 
 
Potential Risks for Participants 
 
This study presents no greater than minimal risk to participants. Potential risks for study participants 
include risks associated with assessment questions, general risks associated with confidentiality, mandated 
reporting of child abuse and neglect, and specific risks associated with the use of cell phones to deliver an 
intervention for risky drinking. Each of these risks is described in the following sections. 
 
Assessment Risks. There is some risk that participants will feel uncomfortable answering questions 
about drinking and other sensitive topics in the EMA as well as the baseline and follow-up assessments. No 
side effects have been noted in the literature in association with any of the assessment tools used in this study, 
although, as with many assessment batteries, some people may experience mild fatigue or momentary 
concern about their ability to do well. It is unlikely that participants will experience more than minor discomfort. 
Our past experience with many of the assessment tools to be used in this study indicates that these measures 
are largely acceptable to participants. 

11 
 
 
General Confidentiality Risks. Every effort will be made to keep all materials confidential and to protect 
the identities of participants. While we cannot guarantee absolute confidentiality, we believe that the risk of a 
confidentiality breach is extremely low for this study. Confidentiality breach may occur related to the data 
collected if an unauthorized person gains access to the data files and/or a participant’s identity is discovered. 
We will take the following precautions to minimize these risks as much as possible: No identifying information 
will appear on any data collection survey; all data will be coded by participant ID. All study data will be stored in 
databases on Partnership to End Addiction’s secure server, where all participant records will be coded and 
filed numerically according to a unique project identification number, with no names attached to the database. 
A master table linking participants to project ID codes will be kept in a separate secure file, with access 
restricted only to those members of the research team who require client contact information for the purposes 
of tracking and follow-up. For extra security, this file will be password-protected. Follow-up contacts will be 
made by project staff under explicit guidelines that preserve confidentiality when telephoning or emailing 
information to participants. Only the PI and RAs who recruit or follow the participants will have access to 
identifying information. Recordings of focus groups will be audio-only. These recordings will be stored on 
Partnership’s secure server, labeled only by Study ID. However, it is possible that due to the small sample 
size, an individual’s voice may be recognizable on the recording. Recordings will only be listened to by 
authorized study staff who will be required to keep all aspects of the recording confidential.    An additional 
confidentiality risk is possible within the focus groups.  It is possible that a focus group participant may break 
the confidentiality of the group. We will make every effort to prevent this from happening by respectfully 
requesting that all focus group participants keep the information discussed private.   
 
Mandated Reporting. There is some risk in this study that investigators may become aware of child 
abuse or neglect that would necessitate a report to child protective services. Given that the study is being 
conducted remotely, it is extremely unlikely that information requiring reporting would come to the attention of 
study staff. However, if study staff becomes aware that a child is in danger of abuse or neglect, a report to CPS 
would be required. The two ways study staff would become aware of harm to a child are (1) if a participant 
directly informs staff during a phone contact or focus group, or (2) staff witnesses a child being harmed during 
an online focus group in which a participant has her camera on. In either of these unlikely scenarios, we will 
make every effort to inform the family first before making a report to CPS. All project staff at Partnership to End 
Addiction are required to complete web-based training courses on identifying and reporting child abuse and 
neglect. These procedures have been followed in our two prior studies of pregnant and postpartum women in 
New Jersey home visiting programs. 
 
Risks Associated with Cell Phone Based EMA and Intervention Delivery. There is some risk of a breach 
of confidentiality concerning risky drinking behavior. It is possible that since participants will be receiving 
messages on their personal cell phones, another person may view a message specific to changing alcohol use 
from an unguarded phone. Messaging also holds the potential to trigger individuals who may use avoidant 
tactics to reduce alcohol use. In a prior study done by the Co-I (Muench) that was focused on developing a TMI 
for problem drinking, 12% reported being a little bit triggered by the messages, but only one person reported 
being extremely triggered by the messages. In that study, being triggered by messages had no impact on 
drinking outcomes and was not significantly negatively correlated with messages helping to reduce cravings. 
This suggests that a small number of people may be triggered by the messages, but they are able to control 
resulting cravings without drinking. Additionally, while unlikely, it is possible that there may be a breach of 
confidentiality if a participant’s cell phone number is obtained through the computerized database. There is a 
risk that a participant may receive a text message while driving, or in another situation in which reading or 
responding to a text message would be dangerous. To minimize the risk of participants reading or responding 
to text messages while driving or in otherwise dangerous situations, we will include in the baseline EMA and 
TMI training session information about risks associated with texting while driving and other situations in which 
texting would be dangerous. We will also develop a Training Guide for participants that will include information 
on the dangers of texting while driving. In every contact that study personnel has with participants (scheduling 
assessments, conducting baseline and follow-up assessments, troubleshooting EMA), we will ensure that 
participants are reminded that they should not read or respond to any text message while driving or in any 
other situation in which it would be dangerous to do so. Two additional risks associated with cell phone based 
intervention delivery include data use overage and text message security. Participants who do not have an 
unlimited text messaging plan may be charged for the text messages they send and receive in the study. As 
with any mobile phone, there is a risk that messages might be read by other people. We will ensure that 

12 
 
participants are fully aware of these risks before deciding whether to enroll in the study. There is also always 
the risk of technical difficulties resulting in failure to receive or send messages.  
 
Risks to Infants. If study participants are engaging in hazardous drinking and/or breastfeeding while 
drinking, their infant children may be at risk. To mitigate this risk, we will take the following steps, based on 
prior text-messaging research studies with high-risk populations. First, we will use the baseline training session 
to educate study participants on the risks associated with drinking and breastfeeding. The TMI will also include 
messages providing psychoeducation regarding the risks of drinking while breastfeeding.. At the beginning of 
the study, we will provide participants with a list of local treatment providers and support groups that they can 
access if they choose to. Drinking while breastfeeding is not reportable as child abuse. 
 
Potential Study Benefits 
 
Study participants may or may not benefit directly from participating in this study. It is possible that 
some participants may benefit from the supportive text messages they will receive because they may find the 
messages to be supportive and helpful. The primary benefit of the study will be in terms of the knowledge 
gained and the potential for improving reach to postpartum women who struggle with alcohol, an important and 
currently underserved group. The knowledge gained as a result of this study will be invaluable to future efforts 
to provide interventions directly to postpartum women to address risky drinking and other negative health 
behaviors. Postpartum women are a currently underserved population at high risk for negative consequences 
of drinking and are unlikely to be reached by the formal service system. Text messaging represents a potential 
low cost and low burden approach for reaching this population, with potential large impact in terms of reach 
and scalability. The risks to study participants are reasonable in relation to anticipated benefits. Procedures 
have been developed and will be in place throughout the study to minimize these risks to the greatest degree 
possible. These procedures have been successful in preventing risk in past studies using similar procedures. 
 
PROTECTIONS AGAINST RISK 
 
General Protections Against Study Risks 
 
If the baseline assessment indicates very severe substance use or psychiatric problems that would not 
be adequately served by the TMI provided as part of the proposed study, the participant will be referred to local 
inpatient or outpatient treatment providers or to another appropriate care facility. We will develop an 
information sheet with information on local treatment providers and support groups and provide this to 
participants at the beginning of the study, and again at the baseline assessment if the baseline assessment 
reveals substance use or psychiatric problems at the level that would not be adequately served by the TMI 
provided in the study.  Risks to infants, such as risks associated with drinking while breastfeeding, will be 
addressed through provision of psychoeducational information to participants during the baseline training 
session, as well as regularly throughout the intervention period via text message. 
 
The issues surrounding confidentiality are of supreme importance and sensitivity because highly 
personal clinical information will be obtained from participants. Participants will sign a statement that attests to 
their understanding that the information they provide will be held as confidential to the extent permitted by law. 
Consent forms will clearly state the right to refuse participation or to withdraw at any time.  
 
In order to address any concerns regarding coercion, clients will be informed that they are free to 
choose not to participate and may withdraw at any time (this is included in the consent form). In addition, the 
reimbursement rates of $25 per interview and $0.50 per EMA are moderate amounts that are appropriate for 
the time investment and not considered coercive. Individuals who are hesitant to consent or express the desire 
to withdraw will not be offered additional financial incentives to continue. 
 
Protection Against Risks Associated with Cell Phone Based EMA and Intervention Delivery 
 
All text messaging for the purposes of participant tracking will occur though Partnership to End 
Addiction’s JITAI Master Platform, which has been used in studies by Columbia University, NYU, Northwell 
Health and the American Cancer Society, and all EMA data collection will occur through Metricwire’s Catalyst 
app.  
Partnership’s Platform: The Platform uses an Internet Information Server (IIS) structure to authenticate 
and assign the proper groupings to the logins. At no point does the program ask clients for their name or 
contact information, other than phone number and email. The Platform Data Services and Web Application are 

13 
 
hosted in Amazon Web Services (AWS) in AWS HIPAA-compliant services. Industry-standard application 
architecture guidelines and principles are best practices including features such as: Route53-highly available 
and scalable cloud Domain Name System (DNS) web service, Elastic Beanstalk, Multi-AZ Remote Database 
Service, Guard duty – continuous security monitoring service that analyzes and processes the following data 
sources: VPC Flow Logs, AWS CloudTrail event logs, and DNS logs, and Inspector service that enables you to 
analyze the behavior of your AWS resources and helps you identify potential security issues. In addition, the 
platform includes best practices in HIPAA-compliant authentication and security (e.g., password restrictions, 2-
factor authentication, role based security, and audit logging and reporting).  
 
Participants will be informed of the risks of using their cell phone for research purposes, and informed 
that it is their responsibility to secure their phone at all times. They will be told that they can delete text 
messages after reading (and responding when necessary). They will also be reminded that while our 
databases are secure, all email and SMS communication is as secure as any other email or SMS message 
they may receive. We will reinforce this risk during recruitment and the consent process, and during the 
baseline training session. 
 
When a participant enters his/her phone number in the Platform, a unique data identifier will be created 
automatically. A separate database reference system will be created. All electronic files (e.g., database, 
spreadsheet, etc) containing identifiable participant information are password protected and restricted only to 
key study personnel who need access to this information for the purposes of tracking participants through the 
study. All computers hosting such files have a BIOS password to prevent access by unauthorized users. 
Research staff will have a secure login to access study data. 
 
Metricwire: We will take precautions to ensure that participants are aware of steps they can take to 
protect their privacy and include a number of built-in features to protect privacy while using the Catalyst app. 
Specifically, we will include the following features in EMA and TMI to protect participant security and privacy 
when using the smartphone app: 
(1) Participants will be provided information about ways to protect their privacy when using their 
smartphone. We will send a message that contains a link to a webpage with information about 
security steps participants can take to protect their privacy (http://www.techlicious.com/tip/9-ways-
to-secure-your-smartphone/). Steps may include setting a password to protect from others 
accessing their device and not using the app while connected to an unsecured wireless network. 
We will encourage participants to secure their entire smartphone with the built-in “screen lock.” This 
can use a variety of identification mechanisms (password, face recognition, or fingerprint) that the 
participant determines is most convenient. Generally, we will encourage participants to use the 
lock/password features, but we will not require it because it may act as a barrier to using the app 
(e.g., if participants forget their password or find it frustrating to enter their password each time they 
want to open the app).  
(2) We will not retain data on participants’ smartphones. Rather, data will be stored on the Metric Wire 
secure server, which is backed up on a continual basis. Data will be downloaded daily by the study 
team and stored on Partnership’s secure server. Data on participants’ smartphones will be deleted 
within several minutes after the information is captured to the server database.  
(3) All data will be transmitted directly between participants’ devices and the server. Transmissions will 
be encrypted and will not contain any personally identifiable meta-data.  
(4) At the beginning of the study, we will require all participants to “register” their phone (i.e., verify their 
credentials) to download the app and sync with the protected server. This will be a one-time event, 
but will ensure that only participants who pass the inclusion criteria and enroll in the study have 
access to the app. 
(5) Participants do not have the ability to see their data once it is submitted to the Metricwire secure 
server. For participant generated data, the EMA application interface functions in one direction only. 
This helps ensure that the participants’ submitted data remains secure even if the device is lost of 
stolen. In addition, Metricwire has the capability to prevent the participants’ version of the EMA 
application from connecting to the secure server in the event the phone is lost or stolen. 
All data collected using the Metricwire app is property of Partnership to end Addiction, and the agreement with 
the vendor explicitly specifies this.  
 
CONFIDENTIALITY 

14 
 
 
 
Regarding assessment data and other records, Partnership to End Addiction study investigators have 
an established set of procedures designed to ensure the confidentiality of study data. All staff at Partnership 
who participate in research with human subjects is required to complete CITI online training on the protection 
of human subjects, including confidentiality. Additionally, research staff will be trained on and strictly monitored 
for adherence to federal guidelines for maintaining the privacy and confidentiality of participants throughout the 
study. All assessment data will be collected via a computer administration platform. No identifying information 
will appear on any data collection survey; all data will be coded by participant ID. All study data will be stored in 
databases on Partnership to End Addiction’s secure server, where all participant records will be coded and 
filed numerically according to a unique project identification number, with no names attached to the database. 
All study databases will be stored in a secure folder on Partnership’s network, with access restricted only to the 
members of the research team. A master table linking participants to project ID codes will be kept in a separate 
secure file, with access restricted only to those members of the research team who require client contact 
information for the purposes of tracking and follow-up. For extra security, this file will be password-protected. 
Follow-up contacts will be made by project staff under explicit guidelines that preserve confidentiality when 
telephoning or emailing information to participants. Only the PI and RAs who recruit or follow the participants 
will have access to identifying information. 
 
We will obtain a Certificate of Confidentiality (COC) from NIH to provide an extra layer of protection to 
all data collected in conjunction with the proposed study. NIH routinely issues COCs to protect research 
information provided by study participants from compulsory legal demands such as subpoenas for identifying 
information. The COC can be used to avoid forced disclosures of information collected in the context of a 
research study and would thus protect against court subpoena of research data.  
 
PROCEDURES FOR OBTAINING INFORMED CONSENT 
 
 
Informed consent will be obtained online, via a secure Qualtrics form. Participants can complete 
informed consent either fully online, or via phone with the study RA. Procedures for both options are described 
below. 
 
Informed Consent by Phone with Study RA: Study participants will be recruited from Central Intake or 
social media (Facebook, Instagram, Reddit, NextDoor, BabyCenter) during the last trimester of pregnancy. For 
clients recruited from Central Intake, Central Intake (CI) providers will briefly introduce the study to potentially 
eligible clients using a script provided by the study team. If a client is interested, the CI provider will ask for 
permission to provide her contact information and due date to the study team. Within two weeks of the due 
date, the RA will contact interested clients by phone to screen for eligibility, describe the study, and obtain 
informed consent. Eligibility screening will include administration of the T-ACE alcohol risk screener with 
supplementary questions. At the end of eligibility screening, if the participant is eligible, the RA will ask the 
participant if they are interested in enrolling in the study. If the answer is yes, the RA will send the participant a 
link to the secure Qualtrics informed consent form via email or text (whatever the participant prefers). The RA 
will allow them a few minutes to read it, and then review the main points in each section and answer any 
questions the participant has.  The confidentiality that surrounds research studies will be discussed with 
clients, explaining that confidentiality is assured to the extent permitted by law. This means that the information 
they provide is confidential, except for the case of potential abuse of a child, or danger to their lives or the lives 
of others. Given the remote nature of the study, it is extremely unlikely that study staff would become aware of 
any information that would necessitate breaking confidentiality, such as child abuse or danger to themselves or 
others. The only way we would become aware of child abuse or neglect is if (1) a participant tells us directly 
during a phone contact or focus group, or (2) we witness a child being harmed during a zoom focus group in 
which a participant has their video camera on. Reports of drinking behaviors do not automatically rise to the 
level of child abuse reporting.  Participants will also be informed about the protections afforded by the 
Certificate of Confidentiality. Participants will be informed that information collected from the EMA, TMI, focus 
groups, and baseline follow-up assessments will be used only for research purposes and reported in aggregate 
form (i.e., the confidentiality of individuals will be maintained). Following review of the consent form, the RA will 
ask if the participant has any questions. If the participant would like to provide consent to enroll in the study, 
the RA will ask them to complete the questions in the Qualtrics form that assess understanding of the consent 
form and then click the box labeled “I consent to enroll in the study” to enroll. Participants who are recruited 

15 
 
from social media will also be provided the option to connect with the study RA via phone to complete eligibility 
screening and informed consent. For participants who select this option, the steps detailed above will be 
followed. 
 
Informed Consent Online: Participants who click on a social media ad will be directed to the study 
website, where they will view information about the study and will be prompted to click on a link to complete 
eligibility screening. Clicking on the link will take them to a secure Qualtrics survey that contains the eligibility 
screening questions. After answering the questions, eligible participants will be presented with an electronic 
consent form, in a secure Qualtrics form. The form will provide the name of the PI (Dr. Dauber) and her contact 
information and inform respondents that she, as the PI, has IRB approval to conduct the study. The consent 
form will contain a thorough description of the research project, including the procedures involved, the risks 
and benefits, compensation, the right to non-participation, and the Research Subject’s Bill of Rights. All 
information described above regarding confidentiality and mandated reporting will be included in the consent 
form. At the beginning of the consent Qualtrics form, there will be a link to a video that participants must view in 
order to complete the consent process. In the video, the study RA will review the consent form the same way 
they do with participants who complete the consent process via phone.  To assess understanding of the 
information provided in the informed consent, eligible participants will be asked a series of multiple-choice 
questions regarding the informed consent before being able to proceed with the study. Answers will be 
collected and any wrong answer will result in the potential participant being prompted to review the full consent 
document before attempting the consent questions again. Potential participants will not be enrolled in the study 
if they answer the questions incorrectly four times. After completing the questions correctly, participants will be 
asked to check a box to indicate whether they would like to enroll in the study. Participants who enroll will be 
prompted to enter their first name and cell phone number into the secure Qualtrics form to allow the study RA 
to contact them for the Baseline Assessment and EMA training. At any time during the online consent process, 
participants will have the option to text “BABY” to the study number to contact the study RA to ask questions 
and/or to complete the consent process via phone.   
 
DATA SHARING 
 
As an NIAAA-funded study, this study is bound by the requirement that all NIAAA-funded human 
subjects research studies participate in the NIAAA Data Archive. The purpose of the Data Archive is to 
promote data sharing across the scientific community. NIAAA requires that certain language be included in the 
informed consent forms to allow participants to make an informed decision about whether they agree to include 
their data in the Data Archive. Participants who do not agree to have their data included in the Data Archive 
can still participate in the study. Participants who initially agree to have their data included have the right to 
change their minds at any time during the study, as stipulated in the consent form. However, once a 
participant’s data is part of the NIAAADA, the study researchers cannot take back the study data that was 
shared before they were notified that the participant changed their mind. 
 
Participant information that is entered into the Data Archive is coded according to a "Global Unique 
Identifier" or "GUID." According to the NIAAA Data Archive, the GUID is a subject ID that allows for the linking 
of data from a unique individual across multiple studies, but does not expose any personally identifying 
information. The GUID is generated based on the following information: full name at birth, sex, date of birth, 
city of birth. All of this information is collected by the research team, who uses the NIAAA GUID Tool to create 
the GUID. The participant's study data is then submitted to the Data Archive along with the GUID. No 
identifying information about any study participant is submitted to the Data Archive at any time. 
 
 
 

16 
 
 
 
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