Evaluating Screening Adherence Between Moment for Parents App and Attention Control
Phase: NA
Conditions: Mental Health Screening Adherence
Sponsor: Poisera, Inc.

 
Study Title: Evaluating Screening Adherence Between Moment for Parents App and 
Attention Control 
Unique Protocol Id: R43MH130293 
 
Protocol Version: 1.0 
Version Date: December 4, 2025 
 
Principal Investigators: 
Marianna Kerppola 
Poisera, Inc. 
CEO 
team@momentforparents.com 
(734) 210-1120 
 
Dr. Maria Muzik 
University of Michigan 
Professor of Psychiatry and Obstetrics & Gynecology 
mmuzik@umich.edu 
734-764-0231 
 
Sponsor / Funding Agency 
National Institute of Mental Health (NIMH) 
SBIR Phase I Grant Number: R43MH130293 
 
 

Background: 
Problem to be Solved Maternal mood and anxiety disorders (MMADs) are the number one 
complication of pregnancy. Depression symptoms appear in 16-37% of pregnant women1,2 and 
anxiety symptoms in 14-54%.3-5 Pregnant women with untreated MMADs are at higher risk for 
maternal morbidity, preterm birth, and postpartum MMAD.6-9 Adverse outcomes for their children 
include low birth weight, developmental delays, and psychiatric disorders.8-11 Further, 
postpartum MMADs contribute to adverse childhood experiences,11-13 including suboptimal 
parenting13,14 and maternal suicide.7 Untreated MMADs lead to 115,000 additional days spent in 
the hospital, 85,000 emergency department visits, and 72,000 missed well-child visits each 
year.15 Overall, undetected and untreated MMADs have a high health burden. 
Current MMAD Screening Practices Pregnant women are inadequately screened with 50-65% 
of women with MMAD symptoms never diagnosed.16,17 The American College of Obstetrics and 
Gynecology (ACOG) recommends at least one screening in the perinatal period.18 Yet one in 
five pregnant women report never being screened by a healthcare clinician.19 Even when 
screened, MMADs remain undetected because mothers do not trust clinicians due to fear of 
judgment, stigma, or even loss of parental rights.20-22 
Current MMAD Treatment Practices MMADs are temporary and treatable3,30 with therapy, 
such as cognitive behavioral (CBT), interpersonal (IPT), acceptance and commitment (ACT), 
and dialectical behavior (DBT) therapies, and medications. Yet women with MMAD symptoms 
face multiple barriers to treatment. Mental health stigma and provider distrust prevent 
help-seeking behavior,31 particularly for Black and Latina women, who are half as likely to 
receive MMAD treatment than white women.32,33 Further, obstetric clinicians are inadequately 
trained about treatment options20,34,35 and inconsistent in their treatment practices.35,36 
 
Perinatal Access Programs (PAPs), established in over 30 states, increase access to MMAD 
treatment by employing behavioral health clinicians (BHCs) to deliver immediate psychiatric 
care and coordinate long-term treatment via phone.37,38 MC3 Perinatal (MC3), the Michigan PAP, 
successfully reduced MMAD scores by 50% for 103 women, according to preliminary MMAD 
symptom analysis. As with other PAPs,37 MC3 improved access to MMAD treatment with 57% 
percent meeting MMAD clinical criteria; 47% were African-American and 53% on public 
insurance. Yet PAPs have not eliminated underdiagnosis. Even Massachusetts Child Psychiatry 
Access Program for Moms, the first established PAP, reaches less than 10% of the presumed 
women with MMADs.37 
Gap in Knowledge The US Preventive Services Task Force identified MMAD monitoring as an 
urgent unmet need.39,40 Women who could benefit from PAPs and other existing effective MMAD 
interventions41–43 cannot be identified because individual risk profiles are unknown,40 and MMAD 
onset spans from pregnancy to 36 months postpartum.44–46 Without longitudinal MMAD 
monitoring, treatment cannot be delivered to women who need it. 
 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
2 

Given 95% of 18-49-year-old women own a smartphone,47 mobile health (mHealth) apps can 
affordably deliver health interventions at scale, including to marginalized individuals, when 
developed with inclusive design practices.48,49 Twelve commercially available mHealth apps 
claim to address MMADs, yet none have been scientifically validated to effectively monitor or 
treat MMADs.50,51 Another 22 academia-developed mHealth apps either prevent, screen, or treat 
MMADs, some proving to be feasible and acceptable by samples of <100 perinatal women.52,53 
Yet none are proven to engage mothers beyond 3 months, a small fraction of the MMAD risk 
timeframe. Evidence is required to validate that mothers will adhere to longitudinal MMAD 
monitoring.  
Research Questions: 
●​ Does the Moment for Parents app and chatbot experience increase mental health 
screening adherence over three months? 
●​ What patterns (e.g., demographic, sociographic, etc) exist among the users who engage 
with the app longitudinally? 
 
Purpose: This study will evaluate if pregnant and postpartum women complete mental health 
screening while engaging with the fully developed Moment for Parents app and chatbot. We will 
conduct a two-arm pilot RCT to evaluate screening adherence between the Moment for Parents 
intervention (n=80) and control (n=80) over 3 months. Findings will inform the design in a fully 
powered randomized controlled trial (RCT) in Phase II SBIR study. 
 
Objectives: (1) evaluate screening adherence differences between the two arms, (2) understand 
Moment for Parents app engagement and feedback patterns among participants; (3) use this 
information to determine if a chatbot can longitudinally engage pregnant women to facilitate 
continuous MMAD symptom monitoring. 
Methods: 
Eligibility 
Inclusion criteria: 
●​ Women who are pregnant or up to 1 year postpartum 
●​ Age 18 years or older 
●​ Lives in the United States 
●​ Owns a smartphone with internet access 
●​ Proficient in English 
 
Exclusion criteria: 
●​ Not female 
●​ Not currently pregnant or more than 1 year postpartum 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
3 

●​ Younger than 18 years old 
●​ Does not live in Michigan 
●​ Does not own a smartphone with internet access 
●​ Not proficient in English 
Design 
This is a pilot randomized control trial to evaluate if the Moment for Parents app motivates 
higher mental health screening compared to a control version of the app.  
Participants in the chatbot intervention arm will use the Moment for Parents app with the 
chatbot as developed in Aim 1. In this arm, participants will read articles and engage in chatbot 
conversations about pregnancy, motherhood, and mental health. When a participant starts using 
the app, she will choose a “Journey” to support her emotional well-being. Journeys are 
composed of an average of 8 lessons. Each lesson includes an article, a chatbot-guided 
reflection, and occasionally, a meditation. Lessons take about 5 minutes to complete. Women 
rate lesson satisfaction on a 5-point Likert scale. Journeys cover topics such as: 
●​ Cultivating resilience 
●​ Enhancing social support networks 
●​ Improving communication with clinicians 
●​ Increasing mindfulness, non-judgment, and acceptance of feelings 
●​ Strengthening the mother-child bond 
●​ Decreasing feelings of isolation, depression, and anxiety 
●​ Establishing self-care patterns 
●​ Increasing knowledge around parenting and child development 
●​ Preparing for labor and delivery 
Each day, the app will send a push notification inviting the participant to continue the next lesson 
in the Journey. When the user clicks on the push notification, it will initially ask the participant 
about her mood. Then, it will offer different ways to process the selected mood (e.g., venting, 
meditating, or journaling). If the user selects one of these activities the app guides them through 
completing the activity. 
If it’s time for the user to complete a mental health screening, the app algorithm will incorporate 
the PHQ-9 and GAD-7 questions into the mood check-in. including sensitive topics, such as 
trauma history, mental illness, and social support. 
The Moment for Parents chatbot does not use the PHQ-9 and GAD-7 results in its algorithms 
in selecting topics delivered to the user. As such, the Moment for Parents app does not 
serve as an intervention for any possible MMAD symptoms. It does not claim to prevent, 
diagnose, or treat any medical conditions. Instead, it provides general wellness information 
in an interactive, conversational form that feels like talking to a well-informed friend. 
The Moment for Parents chatbot is an innovative approach to overcome social desirability and 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
4 

self-presentation biases by turning sensitive conversations into validating, empathetic 
experiences for women. The chatbot conversations provide psychosocial support for perinatal 
women, while simultaneously monitoring for MMAD symptoms. These chatbot conversations 
yield an interactive and personalized experience. We hypothesize that this interactive and 
personalized experience will engage women more often, thereby giving more opportunities to 
deliver the mental health screenings. 
Participants in the attention control arm will use a modified Moment for Parents app without 
the chatbot. Weekly push notifications invite participants to read an article about what’s 
happening during their current week of pregnancy and/or postpartum. These articles focus on 
baby development and general advice about what symptoms to expect at each stage of 
pregnancy and postpartum. As in the chatbot intervention arm, the app algorithm will deliver the 
weekly mental health screening within the chatbot conversation. 
In both arms, the PHQ-9 and GAD-7 mental health screeners will be used. Participants in both 
arms will be prompted to complete a PMD screen more frequently than in the current standard 
of care (i.e., only once perinatally).  
Positive Screening Procedures 
When a participant screens positively for symptoms of depression, anxiety, and/or suicidality via 
PHQ-9 and GAD-7 in either arm, a Moment for Parents Application Programing Interface (API) 
will immediately alert MC3 Perinatal and the UM study team (i.e., Dr. Muzik (PI), a perinatal 
psychiatrist and Medical Director of the MC3 Perinatal Program, and Dr. Menke, the behavioral 
health consultant and licensed clinical psychologist on the MC3 Perinatal team) via secure 
email, including contact information for the participant with possible symptoms (i.e., first names, 
email, phone number, address and emergency contact if available). 
If the participant endorsed suicide risk, Dr. Menke will immediately contact (M-F 9-5) the 
participant for safety assessment, conduct a state-of-the-art suicide risk assessment (i.e., Safety 
Planning Intervention) and, if appropriate, facilitate immediate psychiatric care based on 
standard suicide protocol (i.e., patient monitored by family or staff and brought to emergency 
services). In such cases, the participant will not be left unsupervised until seen in the psychiatric 
emergency room. Dr. Menke will report back to the PI, Dr. Muzik, a perinatal psychiatrist and 
Medical Director of the MC3 Perinatal Program, who can further support the psychiatric 
disposition. Dr. Muzik will be continuously accessible via a pager system and cell phone. Should 
the participant refuse hospitalization, and it is deemed necessary, the clinicians will engage 
police and authorities in ensuring safe transport to the nearest psychiatric emergency room for 
further in-person assessment. If it is deemed that the participant is not an imminent suicide risk, 
the participant will complete an intake and be offered services in the MC3 Perinatal program.  
If the participant screened positively for depression and/or anxiety, a MC3 Perinatal BHC will 
contact the participant within 24 hours (M-F 9-5) of screening and be offered services in the 
MC3 Perinatal program. If the participant is interested, The BHC describes the program to the 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
5 

participant, thus engaging her, and then completes an assessment. The assessment includes a 
standard psychiatric assessment (including re-evaluation of presence/absence of suicidality, 
psychosis, and coherent thinking and behaviors), and subsequent disposition to short-term 
evidence-based practices, or connection to long-term care depending on the severity of 
presentation, and participants’ preference. Types of evidence-based interventions provided 
include Cognitive Behavioral Therapy (CBT), Dialectic Behavioral Therapy, Acceptance and 
Commitment Therapy, Interpersonal Therapy, Motivational Interviewing, Early Relational Health, 
and Infant Mental Health principles.  
The Moment for Parents platform will connect to MC3 Perinatal programming, an existing 
clinical program. MC3 Perinatal is not a component of the Moment for Parents app. MC3 
Perinatal procedures and/or operations will not be a part of the research or data analysis. MC3 
Perinatal are monitored by an existing IRB. 
Study Diagram 
The following diagram illustrates the relationship between the Moment for Parents app, the 
mental health screening, and MC3 Perinatal. 
 
Randomization Procedure 
Randomization will be achieved using permuted block randomization, which allows us to 
randomly allocate participants into arms, while maintaining balance between arms (i.e., race, 
mental health history, race, gestational age). We will use a block size of 10. Randomization will 
be automatically assigned at the enrollment website and will avoid possible bias due to 
knowledge of block size. Since all data is collected through a website or app, no blinding of 
assessors is necessary. 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
6 

Survey Procedure 
One week after a participant downloads the app (both arms), we will contact them via in-app 
message, email, and SMS, inviting them to complete a four-question survey. The questions are 
adapted from a product-market fit survey developed by Sean Ellis.54 The questions are:​
 
1.​ How would you feel if you could no longer use Moment for Parents? 
a.​ Very disappointed 
a.​ Somewhat disappointed 
a.​ Not disappointed 
2.​ What type of people do you think would most benefit from Moment for Parents? 
3.​ What is the main benefit you receive from Moment for Parents? 
4.​ How can we improve Moment for Parents for you? 
 
Participants who do not respond to the survey will receive weekly reminders until the end of the 
study period. 
Interview Procedure 
We will identify participants who respond “Very disappointed” to Question 1, as this group is 
most likely to represent individuals who find the app highly valuable. Then, we will contact these 
participants via e-mail and SMS, inviting them to participate in a virtual interview about their 
experience with the Moment for Parents app. We will offer participants a $30 e-gift card 
incentive for completing the interview. 
The goal of these interviews is to better understand who is engaging most meaningfully with the 
app and why. We aim to explore whether there are shared characteristics, experiences, or 
needs among participants who report high satisfaction with the app. By identifying patterns in 
who is benefiting most, we hope to gain insight into what drives deeper engagement and 
perceived value. 
We are intentionally focusing on this subset of participants rather than interviewing all users. In 
Aim 1, when we invited all participants to interview, we found that interviews with disengaged 
users often yielded limited insight, as the majority had not used the app enough to provide 
meaningful feedback. This targeted approach allows us to more effectively explore the factors 
contributing to positive user experiences. 
Interviews will take place remotely and be conducted via Zoom. These will be single-session 
interviews without any follow-up. All women will have the option to decline participation in the 
interview. We will record and transcribe each interview using Fathom and then use inductive 
thematic analysis to code each interview. After confirming the accuracy of the interview 
transcription, we will delete the audio recording and any identifying information in Fathom. 
Participants who complete the interview will receive a $30 gift card to Amazon via email or SMS. 
At the beginning of each interview, the interviewer will request the following for safety purposes: 
●​ The participant's current location 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
7 

●​ The participant's emergency contact 
This information will be recorded in a temporary document, so it is available should the 
interviewee require crisis support during the interview (see Crisis Protocol for more details on 
these procedures). The information will be deleted at the end of the interview. 
Recruitment and Consent Process 
Pregnant women will be recruited from: 
●​ obstetric clinics 
●​ partnerships with doula agencies, prenatal yoga studios, birth education classes, and 
other providers supporting perinatal women 
●​ public spaces, such as libraries and coffee shops 
●​ internet-based strategies (e.g., email/newsletters, social media, community postings). 
 
Only research personnel will be communicating with interested women via email. A research 
personnel email contact will be provided for study-specific questions. 
 
All promotional materials will include a URL and/or QR code directing women to an enrollment 
website informing them about the study. Women will self-recruit by downloading the Moment for 
Parents app and entering their: 
●​ First name 
●​ Email address 
●​ Phone number 
●​ Due date (confirming she is <24 weeks of gestation) 
●​ Month and year of her birthday (confirming she is <18 years old) 
●​ County and zip code (confirming she lives in Michigan) 
●​ Race 
●​ Ethnicity 
●​ Annual income 
●​ Household size 
●​ Mental health history 
Downloading the app and entering this information demonstrates that she owns a smartphone 
with internet access and is proficient in English. 
Next, the app will prompt the user to allow location permissions on their phone. This is the 
prompt provided to the user about location permissions: 
You can get mental health support during this study if you need it. Because this support 
is limited to individuals living in Michigan, we request that you turn on your location 
permissions to confirm that you are eligible for these services. 
We are requesting “approximate location”, which does not track the user’s precise location, but 
rather triangulates the user’s proximity to cell towers. This allows us to confirm that the 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
8 

participant is physically in Michigan. We are requesting “foreground access”, which means that 
the user’s location will only be tracked “while using the app.” When location permissions are 
activated, our backend will collect their latitude and longitude, along with a timestamp. If the 
user denies location access, the individual is not eligible for this study. 
If an individual is eligible for the study, she will be directed to an electronic consent document 
form within the app. Individuals who want to participate must select “I agree to participate.” 
Completing this step is considered the end of the enrollment process. 
If an individual does not meet enrollment criteria, she will be directed to a screen explaining she 
is ineligible for the study. 
Incentives 
Participants who complete the interview will receive a $30 e-gift card. E-gift cards will be 
provided through Tango card, where participants can choose their preferred gift card. Here is a 
list of e-gift card options available through Tango card: 
https://www.tangocard.com/reward-catalog?rewardcategory=gift+card. Gift cards will be 
provided within 48 hours of completing the survey or interview. 
 
All participants will be entered into a raffle to win one of 4 $50 e-gift cards (also from Tango). We 
will draw the raffle winners once all 160 participants have completed the study, then email the 
winners with a link to the gift card. 
Outcome Measures 
Measures 
a.​ PHQ-9 and GAD-7 screening adherence over 3 months 
a.​ Responses to product-market fit survey questions described above 
b.​ Qualitative feedback via interviews 
Statistical Design and Power 
This 3-month pilot randomized controlled trial (RCT) tests the hypothesis that women using the 
Moment for Parents app will adhere to screening at twice the rate of those in the control arm. It 
will also help determine the optimal design of a Phase II RCT.  
In this pilot RCT, we will (1) test differences between PHQ-9 and GAD-7 screening adherence in 
both arms and (2) examine baseline predictors of retention and patterns of engagement in both 
arms. Knowledge of baseline predictors of retention will determine other factors to manipulate in 
assigning women to groups, e.g. oversampling women with a history of mental illness or 
elevated baseline symptoms.  
The pilot RCT sample size (Moment for Parents intervention, n=80 and attention control, n=80) 
was determined by logistical concerns, such as time available to recruit and enroll participants, 
yet it will allow us to detect large differences in screening adherence between groups. 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
9 

 
1. Evaluating screening adherence in Moment for Parents intervention and 
control arms 
We will examine if women in the Moment for Parents arm complete more PHQ-9 and GAD-7 
screenings than the control. We will count the total number of PHQ-9 and GAD-7 screenings 
completed during the study while ignoring the timing of the responses. We will test differences 
between the arms, using Poisson regression with the number of PHQ-9 and GAD-7 screenings 
completed as the dependent variable and chatbot arm as the main predictor, controlling for age 
of the participant, race, mental health history, gestational age, and annual income. We expect 
that women in the chatbot arm will respond to the PHQ-9 and GAD-7 at twice the rate of those 
in the control arm. Using a two-sided Type I error of 0.05, a total of 160 women randomized 1:1 
to chatbot intervention (n=80) or attention control (n=80) will have 84% power to detect a 
doubling in the response rate based on Poisson regression methods (G*Power version 
3.1.9.7).89 We will also explore different distributions, including negative binomial and 
zero-inflated Poisson, and choose the distribution that best fits the data. We will present 
adjusted response rates and the difference between the two groups with 95% confidence 
intervals (CI) and p-value. Unlike other studies where dropping out of the study results in 
missing data, collecting data through the Moment for Parents app will be complete because we 
will know at each time point if a screen was completed.  
Next, we will estimate the length of time that women adhere to PHQ-9 and GAD-7 screens in 
chatbot and control arms, using survival analysis. The starting point for the survival analysis will 
be when the participant enrolls in the study and completes the first PHQ-9 and GAD-7 screen, 
and the endpoint will be when she completes her final PHQ-9 and GAD-7 screen. There will be 
no censoring because, as explained above, we will know at each timepoint whether the screen 
was completed. We will examine survival curves in each group with the Kaplan-Meier method 
and report median survival times with 95% CI for each group. 
 
2. Examining baseline predictors of retention and patterns of engagement 
between Moment for Parents intervention and control arms 
Understanding predictors of engagement will inform the optimal design for the Phase II RCT. 
We will use Cox proportional hazards regression to examine predictors, including mental health 
history and baseline PHQ-9 and GAD-7 score. As above, the starting point will be when the 
participant enrolls in the study and completes the first PHQ-9 and GAD-7 screen, and the 
endpoint will be when she completes her final PHQ-9 and GAD-7 screen. The proportional 
hazards assumption will be tested for each predictor by including the interaction between the 
predictor and time. If the interaction term is significant, we will include it in the final model to 
account for the non-proportional hazards. For each predictor, we will report the odds ratio with 
95% CI. 
Next, we will use a generalized linear mixed-effects model with a logit link for the binary 
outcome of whether the participant completed the PHQ-9 and GAD-7 at each of the 12 weeks 
of the study. Due to the exploratory nature of the study, we will use graphical techniques to 
examine the data, by plotting the fitted model over time.88 First, we will plot the fitted model for 
the overall sample. Next, we will plot fitted models for chatbot and control arms and other 
relevant groups (e.g., those with positive baseline PHQ-9 and GAD-7 score vs. those without 
and those with a history of mental illness vs. those without). Plots will be examined for group 
differences. Through this graphical analysis, we expect to find groups of users with different 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
10 

patterns of use. For example, there could be an “early adopters” group who complete screens 
for the first few weeks and then drops out. Other possible patterns are “infrequent responders”, 
who will complete screens less frequently, but continue throughout the study. In addition, there 
will be “compliers” who complete screens every week throughout the study. We will be able to 
detect relationships between groups based on mental health history and baseline mental health 
scores if they are strongly associated with these groups.  
Data Management 
Moment for Parents will obtain the following app usage data from participants who enroll in the 
study: 
●​ Demographics, including week of gestation, age, race, ethnicity, annual income, 
household size, and previous mental health history 
●​ Number of chats started and completed 
●​ Number of meditations opened and played 
●​ Number of articles opened and read 
●​ PHQ-9 and GAD-7 screening results 
●​ Number of chats, meditations, and or articles saved, indicating content that users found 
helpful 
●​ Engagement rate, which measures the average number of activities completed in the 
app (e.g., chats, meditations, and/or articles) per active user over daily, weekly, or 
monthly intervals. 
●​ Retention rate, calculated as the proportion of active users relative to the total number of 
enrolled users. 
●​ Total number of enrolled users of the Moment for Parents app. 
●​ Total number of active users, defined as those who have completed at least one activity 
in the app (i.e., chat, meditation or article) in the past seven days. 
Data Sharing (collection and analysis) 
Moment for Parents will store de-identified data in a password-protected cloud-based system 
(i.e., Google Drive) only accessible to research personnel. Women’s and Infant’s Mental 
Health/Zero to Thrive (WIMH/Z2T) research personnel will only have access to de-identified 
data.  
Data Storage 
App Usage and PHQ-9 and GAD-7 Data: App usage data will be obtained via the Moment for 
Parents app. Data collected via the Moment for Parents app will be stored securely in a 
HIPAA-compliant data warehouse on Amazon Web Services (AWS) that was developed by 
Moment for Parents. Backend app usage data will be obtained by Moment for Parents from the 
AWS data warehouse. When a participant screens positively for symptoms of depression, 
anxiety, and/or suicidality, Moment for Parents will automatically send participant contact 
information (first name, email, phone number, and emergency contact info) and which 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
11 

symptoms were identified by the PHQ-9 and GAD-7 (i.e., depression, anxiety, and/or suicidality) 
to MC3 Perinatal via secure email. The secure email is sent using an application programming 
interface (API) developed by the Moment for Parents team, thus requiring no human handoff. 
The MC3 BHC can only access the secure email via password. 
 
Survey Data: The product market fit survey data will be collected in a Paperform survey linked to 
a participant’s enrollment ID and stored in Google Drive. Once data collection is complete, the 
survey data will be exported and enriched with user profile information from the AWS participant 
database, including: 
●​ Week of pregnancy 
●​ Age 
●​ Zip code 
●​ Race 
●​ Ethnicity 
●​ Number of children 
●​ Mental history 
●​ Annual income 
●​ Household size 
●​ Number of chats completed during 30-day period 
●​ PHQ-9 and GAD-7 scores during 30-day period 
Once the data above is incorporated, the participant ID will be deleted to de-identify the data. 
Interview Data: Interview data will be obtained through a Zoom interview audio recording 
conducted by Moment for Parents research personnel. Audio recordings will be transcribed via 
Fathom. All data will be de-identified by Moment for Parents to ensure confidentiality. Moment 
for Parents will store data in a password-protected cloud-based system (i.e., Google Drive) only 
accessible to research personnel. WIMH/Z2T research personnel will only have access to 
de-identified transcripts (i.e., WIMH/Z2T research personnel will not have access to audio 
recordings).  
 
Identifiable Information: This study will collect participant’s email and phone number, both 
considered individually identifiable sensitive data. This data is stored in a password-protected 
AWS database developed and maintained by the Moment for Parents team. 
Data Analysis 
Quantitative (e.g., descriptive statistics, correlations, regressions) and qualitative (e.g., thematic 
analysis) will be conducted. App usage and survey data will be analyzed by the Moment for 
Parents research personnel using R or comparable statistical software. Interview transcripts will 
be coded using inductive thematic analysis, a qualitative method where data patterns or themes 
are identified naturally, without preexisting codes. 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
12 

Risk to Subjects 
Level of Risk: This study involves no more than minimal risk to participants. 
●​ There is minimal risk of breach of confidentiality since identifiable information will be 
collected once a participant has agreed to the electronic consent form. 
●​ There is minimal risk of breach of confidentiality for those who participate in an interview. 
These participants will be audio recorded, so there is a risk of loss of confidentiality. 
●​ There is a small risk that topics and questions posed by the Moment for Parents chatbot, 
including the PHQ-9 and GAD-7 screening questions, could make a participant feel 
uncomfortable. 
●​ There is a small risk that participants who receive services from the MC3 Perinatal 
program may experience psychological discomfort answering questions or during 
assessment and therapy sessions. 
Risk Mitigation 
Personally identifiable information, including a participant’s name, email address, and phone 
number, is collected once a participant has agreed to the electronic consent form. This 
information is stored in a separate, encrypted database on AWS. WIMH/Z2T research personnel 
will only have access to de-identified data. 
 
Participants who participate in an interview agree in the consent form that their audio can be 
recorded. Only authorized research personnel on this application will be granted access to the 
data. 
 
Our study includes pregnant women who may experience a range of stressors, including mental 
health problems, socioeconomic challenges, relational problems, medical complications, and a 
variety of traumatic exposures. Uncomfortable emotions and/or issues may be surfaced through 
conversations with the chatbot. However, we believe this constitutes only minimal risk, as 
participants can skip any questions they do not want to answer or end the conversation with the 
chatbot at any time. The Moment for Parents app also offers strategies to engage in 
mindfulness, self-regulation, and self-care. 
Mental health symptoms may be surfaced through the PHQ-9 and GAD-7 screeners, and 
women may be made more aware of their distress. At any point in the research study, each 
woman has the option of not answering questions on the screener, as well as ending her study 
participation completely. These options are made explicit to women during the consent process. 
We believe that the provision of the PHQ-9 and GAD-7 screener constitutes only minimal risk in 
that it parallels current routine prenatal care practice, where standardly depression and anxiety 
screeners are given at the initial prenatal visit. 
Users may experience psychological discomfort answering questions or during MC3 Perinatal 
assessment and therapy sessions. WIMH/Z2T have selected tools that are standardly employed 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
13 

in the field, and these have been observed to be safe and have not elicited significant distress 
or discomfort among participants. We do not expect the discomfort to be greater than that 
experienced during routine psychological services. 
Potential Benefits to Subjects 
All women participating in the proposed research will receive more mental health screenings 
and more rapid treatment support than in the current standard of care, thereby improving the 
likelihood that they will get needed treatment for MMADs. Chatbot conversations are 
educational in nature. All women participating in the study will receive more educational material 
related to MMADs, which will improve help-seeking behavior. 
Dissemination of Results and Publication Policy 
All data will be de-identified. Quantitative data will be presented in its aggregate form and any 
direct quotes shared from interviews will be de-identified. Results will be used for publications, 
reports, grant applications, and to inform the next phase of the study. 
 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
14 

References 
1. ​
Woods SM, Melville JL, Guo Y, Fan MY, Gavin A. Psychosocial Stress during 
Pregnancy. Am J Obstet Gynecol [Internet]. 2010 Jan [cited 2020 Dec 
3];202(1):61.e1-61.e7. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2811236/ PMCID: PMC2811236 
2. ​
Lee AM, Lam SK, Sze Mun Lau SM, Chong CSY, Chui HW, Fong DYT. 
Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 
2007 Nov;110(5):1102–1112. PMID: 17978126 
3. ​
Yonkers KA, Vigod S, Ross LE. Diagnosis, pathophysiology, and management of 
mood disorders in pregnant and postpartum women. Obstet Gynecol. 2011 
Apr;117(4):961–977. PMID: 21422871 
4. ​
Vesga-López O, Blanco C, Keyes K, Olfson M, Grant BF, Hasin DS. Psychiatric 
disorders in pregnant and postpartum women in the United States. Arch Gen Psychiatry. 
2008 Jul;65(7):805–815. PMCID: PMC2669282 
5. ​
Rubertsson C, Hellström J, Cross M, Sydsjö G. Anxiety in early pregnancy: 
prevalence and contributing factors. Arch Womens Ment Health. 2014 Jun;17(3):221–228. 
PMID: 24442712 
6. ​
Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A 
meta-analysis of depression during pregnancy and the risk of preterm birth, low birth 
weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010 
Oct;67(10):1012–1024. PMCID: PMC3025772 
7. ​
Admon LK, Dalton VK, Kolenic GE, Ettner SL, Tilea A, Haffajee RL, Brownlee 
RM, Zochowski MK, Tabb KM, Muzik M, Zivin K. Trends in Suicidality 1 Year Before and 
After Birth Among Commercially Insured Childbearing Individuals in the United States, 
2006-2017. JAMA Psychiatry. 2020 Nov 18; PMCID: PMC7675215 
8. ​
Jarde A, Morais M, Kingston D, Giallo R, MacQueen GM, Giglia L, Beyene J, 
Wang Y, McDonald SD. Neonatal Outcomes in Women With Untreated Antenatal 
Depression Compared With Women Without Depression: A Systematic Review and 
Meta-analysis. JAMA Psychiatry. 2016 Aug 1;73(8):826–837. PMID: 27276520 
9. ​
McKee K, Admon LK, Winkelman TNA, Muzik M, Hall S, Dalton VK, Zivin K. 
Perinatal mood and anxiety disorders, serious mental illness, and delivery-related health 
outcomes, United States, 2006-2015. BMC Womens Health. 2020 Jul 23;20(1):150. 
PMCID: PMC7376899 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
15 

10. ​
Santos IS, Matijasevich A, Barros AJD, Barros FC. Antenatal and postnatal 
maternal mood symptoms and psychiatric disorders in pre-school children from the 2004 
Pelotas Birth Cohort. J Affect Disord [Internet]. 2014 Aug 1 [cited 2021 Jul 
20];164(100):112–117. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4051989/ PMCID: PMC4051989 
11. ​
Muzik M, Borovska S. Perinatal depression: implications for child mental health. 
Ment Health Fam Med. 2010 Dec;7(4):239–247. PMCID: PMC3083253 
12. ​
Turney K. Pathways of disadvantage: Explaining the relationship between 
maternal depression and children’s problem behaviors. Soc Sci Res. 2012 
Nov;41(6):1546–1564. PMID: 23017973 
13. ​
Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, 
Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: 
addressing the impact on mothers, fathers, and children. Issues Ment Health Nurs. 2012 
Jul;33(7):445–457. PMID: 22757597 
14. ​
Muzik M, Morelen D, Hruschak J, Rosenblum KL, Bocknek E, Beeghly M. 
Psychopathology and parenting: An examination of perceived and observed parenting in 
mothers with depression and PTSD. J Affect Disord. 2017 Jan 1;207:242–250. PMCID: 
PMC5107117 
15. ​
Luca DL, Margiotta C, Staatz C, Garlow E, Christensen A, Zivin K. Financial Toll 
of Untreated Perinatal Mood and Anxiety Disorders Among 2017 Births in the United 
States. Am J Public Health. 2020 Jun;110(6):888–896. PMCID: PMC7204436 
16. ​
Ko JY, Farr SL, Dietz PM, Robbins CL. Depression and treatment among U.S. 
pregnant and nonpregnant women of reproductive age, 2005-2009. J Womens Health 
2002. 2012 Aug;21(8):830–836. PMCID: PMC4416220 
17. ​
Byatt N, Levin LL, Ziedonis D, Moore Simas TA, Allison J. Enhancing 
Participation in Depression Care in Outpatient Perinatal Care Settings: A Systematic 
Review. Obstet Gynecol. 2015 Nov;126(5):1048–1058. PMCID: PMC4618720 
18. ​
American College of Obstetricians and Gynecologists’ Committee on Obstetric 
Practice. Screening for Perinatal Depression. Obstet Gynecol. 2018;132(5):5.  
19. ​
Bauman BL. Vital Signs: Postpartum Depressive Symptoms and Provider 
Discussions About Perinatal Depression — United States, 2018. MMWR Morb Mortal Wkly 
Rep [Internet]. 2020 [cited 2020 Dec 3];69. Available from: 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6919a2.htm 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
16 

20. ​
Byatt N, Simas TAM, Lundquist RS, Johnson JV, Ziedonis DM. Strategies for 
improving perinatal depression treatment in North American outpatient obstetric settings. J 
Psychosom Obstet Gynaecol. 2012 Dec;33(4):143–161. PMID: 23194018 
21. ​
Kingston DE, Biringer A, Toosi A, Heaman MI, Lasiuk GC, McDonald SW, 
Kingston J, Sword W, Jarema K, Austin MP. Disclosure during prenatal mental health 
screening. J Affect Disord. 2015 Nov 1;186:90–94. PMID: 26233318 
22. ​
Dennis CL, Chung-Lee L. Postpartum depression help-seeking barriers and 
maternal treatment preferences: a qualitative systematic review. Birth Berkeley Calif. 2006 
Dec;33(4):323–331. PMID: 17150072 
23. ​
Kim JJ, Silver RK, Elue R, Adams MG, La Porte LM, Cai L, Kim JB, Gibbons RD. 
The experience of depression, anxiety, and mania among perinatal women. Arch Womens 
Ment Health. 2016;19(5):883–890. PMID: 27188618 
24. ​
Wenzel ES, Gibbons RD, O’Hara MW, Duffecy J, Maki PM. Depression and 
anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina 
women. Arch Womens Ment Health [Internet]. 2021 May 10 [cited 2021 Jul 15]; Available 
from: https://doi.org/10.1007/s00737-021-01139-y PMID: 33970310 
25. ​
La Porte LM, Kim JJ, Adams MG, Zagorsky BM, Gibbons R, Silver RK. Feasibility 
of perinatal mood screening and text messaging on patients’ personal smartphones. Arch 
Womens Ment Health. 2020 Apr;23(2):181–188. PMID: 31203440 
26. ​
Fayers P. Item Response Theory for Psychologists. Qual Life Res [Internet]. 2004 
Apr 1 [cited 2021 Sep 2];13(3):715–716. Available from: 
https://doi.org/10.1023/B:QURE.0000021503.45367.f2 
27. ​
Gibbons RD, Weiss DJ, Frank E, Kupfer D. Computerized Adaptive Diagnosis 
and Testing of Mental Health Disorders. Annu Rev Clin Psychol [Internet]. Annual Reviews; 
2016 Mar 28 [cited 2021 Jul 21];12(1):83–104. Available from: 
https://www.annualreviews.org/doi/10.1146/annurev-clinpsy-021815-093634 PMID: 
26651865 
28. ​
Gibbons RD, Weiss DJ, Kupfer DJ, Frank E, Fagiolini A, Grochocinski VJ, 
Bhaumik DK, Stover A, Bock RD, Immekus JC. Using computerized adaptive testing to 
reduce the burden of mental health assessment. Psychiatr Serv Wash DC. 2008 
Apr;59(4):361–368. PMCID: PMC2916927 
29. ​
Beiser D, Vu M, Gibbons R. Test-Retest Reliability of a Computerized Adaptive 
Depression Screener. Psychiatr Serv Wash DC. 2016 Sep 1;67(9):1039–1041. PMCID: 
PMC5033509 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
17 

30. ​
Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava 
M, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Trivedi MH, 
Rush AJ, STAR*D-Child Team. Remissions in maternal depression and child 
psychopathology: a STAR*D-child report. JAMA. 2006 Mar 22;295(12):1389–1398. PMID: 
16551710 
31. ​
Ward E, Wiltshire JC, Detry MA, Brown RL. African American Men and Women’s 
Attitude Toward Mental Illness, Perceptions of Stigma, and Preferred Coping Behaviors. 
Nurs Res [Internet]. 2013 [cited 2021 Jun 14];62(3):185–194. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4279858/ PMCID: PMC4279858 
32. ​
Kozhimannil KB, Trinacty CM, Busch AB, Huskamp HA, Adams AS. Racial and 
Ethnic Disparities in Postpartum Depression Care Among Low-Income Women. Psychiatr 
Serv [Internet]. 2011 Jun [cited 2024 Jan 22];62(6):619–625. Available from: 
http://psychiatryonline.org/doi/abs/10.1176/ps.62.6.pss6206_0619 
33. ​
Taylor J, Gamble CM. Suffering in Silence [Internet]. Center for American 
Progress. [cited 2021 Jun 14]. Available from: 
https://www.americanprogress.org/issues/women/reports/2017/11/17/443051/suffering-in-si
lence/ 
34. ​
Byatt N, Biebel K, Lundquist RS, Simas TAM, Debordes-Jackson G, Allison J, 
Ziedonis D. Patient, provider, and system-level barriers and facilitators to addressing 
perinatal depression. J Reprod Infant Psychol [Internet]. Routledge; 2012 Nov 1 [cited 
2020 Dec 3];30(5):436–449. Available from: 
https://doi.org/10.1080/02646838.2012.743000 
35. ​
Palladino CL, Fedock GL, Forman JH, Davis MM, Henshaw E, Flynn HA. OB 
CARES--The Obstetric Clinics and Resources Study: providers’ perceptions of addressing 
perinatal depression--a qualitative study. Gen Hosp Psychiatry. 2011 Jun;33(3):267–278. 
PMID: 21601724 
36. ​
Kim JJ, La Porte LM, Adams MG, Gordon TEJ, Kuendig JM, Silver RK. Obstetric 
care provider engagement in a perinatal depression screening program. Arch Womens 
Ment Health. 2009 Jun;12(3):167–172. PMID: 19277845 
37. ​
Byatt N, Straus J, Stopa A, Biebel K, Mittal L, Moore Simas TA. Massachusetts 
Child Psychiatry Access Program for Moms: Utilization and Quality Assessment. Obstet 
Gynecol. 2018 Aug;132(2):345–353. PMCID: PMC6059997 
38. ​
Lifeline4Moms Network Members [Internet]. UMass Chan Medical School. 2020 
[cited 2022 Mar 16]. Available from: 
https://www.umassmed.edu/lifeline4moms/Access-Programs/network-members-us/ 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
18 

39. ​
US Preventive Services Task Force, Curry SJ, Krist AH, Owens DK, Barry MJ, 
Caughey AB, Davidson KW, Doubeni CA, Epling JW, Grossman DC, Kemper AR, Kubik M, 
Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. 
Interventions to Prevent Perinatal Depression: US Preventive Services Task Force 
Recommendation Statement. JAMA. 2019 Feb 12;321(6):580–587. PMID: 30747971 
40. ​
O’Connor E, Senger CA, Henninger M, Gaynes BN, Coppola E, Soulsby Weyrich 
M. Interventions to Prevent Perinatal Depression: A Systematic Evidence Review for the 
U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare 
Research and Quality (US); 2019 [cited 2020 Dec 3]. Available from: 
http://www.ncbi.nlm.nih.gov/books/NBK537819/ PMID: 30807060 
41. ​
Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K. 6-Month Outcomes from a 
Randomized Controlled Trial to Prevent Perinatal Depression in Low-Income Home Visiting 
Clients. Matern Child Health J [Internet]. 2014 May [cited 2021 Jul 20];18(4):873–881. 
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871944/ PMCID: 
PMC3871944 
42. ​
Zlotnick C, Tzilos G, Miller I, Seifer R, Stout R. Randomized controlled trial to 
prevent postpartum depression in mothers on public assistance. J Affect Disord. 2016 Jan 
1;189:263–268. PMCID: PMC4641029 
43. ​
Dimidjian S, Goodman SH, Felder J, Gallop R, Brown AP, Beck A. Staying Well 
during Pregnancy and the Postpartum: A Pilot Randomized Trial of Mindfulness Based 
Cognitive Therapy for the Prevention of Depressive Relapse/Recurrence. J Consult Clin 
Psychol [Internet]. 2016 Feb [cited 2021 Jul 20];84(2):134–145. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5718345/ PMCID: PMC5718345 
44. ​
Putnick DL, Sundaram R, Bell EM, Ghassabian A, Goldstein RB, Robinson SL, 
Vafai Y, Gilman SE, Yeung E. Trajectories of Maternal Postpartum Depressive Symptoms. 
Pediatrics. 2020;146(5). PMID: 33109744 
45. ​
Park M, Brain U, Grunau RE, Diamond A, Oberlander TF. Maternal depression 
trajectories from pregnancy to 3 years postpartum are associated with children’s behavior 
and executive functions at 3 and 6 years. Arch Womens Ment Health [Internet]. 
2018;21(3):353–363. Available from: https://doi.org/10.1007/s00737-017-0803-0 PMID: 
29340801 
46. ​
Ahmed A, Bowen A, Feng CX, Muhajarine N. Trajectories of maternal depressive 
and anxiety symptoms from pregnancy to five years postpartum and their prenatal 
predictors. BMC Pregnancy Childbirth. 2019 Jan 14;19(1):26. PMCID: PMC6332639 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
19 

47. ​
Demographics of Mobile Device Ownership and Adoption in the United States 
[Internet]. Pew Research Center: Internet, Science & Tech. [cited 2021 Jul 20]. Available 
from: https://www.pewresearch.org/internet/fact-sheet/mobile/ 
48. ​
Veinot TC, Mitchell H, Ancker JS. Good intentions are not enough: how 
informatics interventions can worsen inequality. J Am Med Inform Assoc JAMIA [Internet]. 
2018 May 16 [cited 2021 Jun 11];25(8):1080–1088. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646885/ PMCID: PMC7646885 
49. ​
López L, Green AR, Tan-McGrory A, King R, Betancourt JR. Bridging the digital 
divide in health care: the role of health information technology in addressing racial and 
ethnic disparities. Jt Comm J Qual Patient Saf. 2011 Oct;37(10):437–445. PMID: 
22013816 
50. ​
Zhang MW, Ho RC, Loh A, Wing T, Wynne O, Chan SWC, Car J, Fung DSS. 
Current status of postnatal depression smartphone applications available on application 
stores: an information quality analysis. BMJ Open [Internet]. 2017 Nov 14 [cited 2021 Aug 
6];7(11):e015655. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695478/ 
PMCID: PMC5695478 
51. ​
Feldman N, Back D, Boland R, Torous J. A systematic review of mHealth 
application interventions for peripartum mood disorders: trends and evidence in academia 
and industry. Arch Womens Ment Health [Internet]. 2021 Apr 30 [cited 2021 Aug 6]; 
Available from: https://doi.org/10.1007/s00737-021-01138-z PMID: 33929636 
52. ​
Hussain-Shamsy N, Shah A, Vigod SN, Zaheer J, Seto E. Mobile Health for 
Perinatal Depression and Anxiety: Scoping Review. J Med Internet Res [Internet]. 2020 
Apr 13 [cited 2021 Aug 6];22(4):e17011. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186872/ PMCID: PMC7186872 
53. ​
Dol J, Richardson B, Murphy GT, Aston M, McMillan D, Campbell-Yeo M. Impact 
of mobile health interventions during the perinatal period on maternal psychosocial 
outcomes: a systematic review. JBI Evid Synth. 2020 Jan;18(1):30–55. PMID: 31972680 
 
 
 
Evaluating Screening Adherence Between Moment for Parents App and Attention Control Protocol ID: 
R43MH130293 
Version 1.0 | Dec. 8, 2025 
20