Evaluating Screening Adherence Between Moment for Parents App and Attention Control
NCT ID: NCT07322042
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2026-01-12
2026-08-31
Brief Summary
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This study will test whether a mobile app called Moment for Parents can help pregnant and postpartum women complete mental health screenings more regularly. The app includes educational articles, guided reflections, and mood check-ins that help women explore their feelings in a private, supportive environment. The app also includes a chatbot that guides them through short lessons about motherhood, stress, relationships, and emotional well-being. These conversations are designed to feel friendly and relatable, like talking with a knowledgeable companion rather than filling out a medical form. The investigators expect that this more personal experience may make it easier for women to notice and track changes in their mental health and encourage them to complete regular screeners.
The study will enroll 160 women who are pregnant or within the first year after giving birth. Participants will be randomly assigned to one of two groups:
Intervention group: Uses the full Moment for Parents app, including the interactive chatbot.
Control group: Uses a simplified version of the app with weekly articles but no chatbot.
Both groups will receive mental health screenings through the app over a 12-week period. These screenings include standard, widely used questionnaires that measure symptoms of depression and anxiety.
If a participant's answers show signs of concerning symptoms, such as depression, anxiety, or thoughts of self-harm, the study team will connect her to licensed mental health professionals for support. This offers more rapid help than the current standard of care, which often screens women only once during pregnancy.
The investigators hypothesize that women who interact with the chatbot version of the Moment for Parents app will complete mental health screenings twice as often as women using the app without the chatbot. In other words, the investigators believe the chatbot will increase regular screening by creating a more engaging and supportive experience.
Increasing the number of completed mental health screenings could help identify emotional struggles earlier, when treatment is most effective. If this study shows that the Moment for Parents app improves screening and engagement, it could guide the design of a larger study and help shape future care for pregnant and postpartum women nationwide. Overall, this research aims to make mental health support more accessible, less stigmatizing, and easier to use.
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Detailed Description
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Participants will be randomized 1:1 to either (1) the Moment for Parents chatbot intervention arm or (2) an attention control arm. Randomization will occur automatically at enrollment using permuted block randomization with a fixed block size to ensure balanced allocation across key baseline characteristics (e.g., race, gestational age, mental health history). Because all data are collected through the app platform, independent assessor blinding is not required.
The intervention arm receives the fully developed Moment for Parents application, which includes interactive chatbot-guided lessons, reflective prompts, mood check-ins, and optional audio-based meditations. These components are organized into topic-based "Journeys," each composed of short lessons designed to be completed in approximately five minutes. The chatbot integrates validated mental health screeners (PHQ-9 and GAD-7) within regular mood check-ins, allowing screening to be delivered contextually rather than as a standalone questionnaire. Participants receive daily push notifications encouraging continued engagement.
The control arm receives a modified version of the Moment for Parents app that omits the chatbot and interactive lesson structure. Instead, users receive weekly push notifications linking to educational articles describing expected changes during pregnancy and postpartum, including infant development and maternal physical and emotional adjustments. Like the intervention arm, mental health screening is administered via the app algorithm at regular intervals, ensuring both groups receive equivalent exposure to screening opportunities.
The primary focus of the trial is to compare screening adherence trajectories between arms. Both the timing and frequency of PHQ-9 and GAD-7 administration exceed current clinical norms, which typically involve only one screening during the perinatal period. Screening and engagement metrics are passively captured through the app backend, allowing complete ascertainment of screening adherence without missing data due to participant attrition.
Participants who exceed clinical cutoffs for depression, anxiety, or suicidality will be automatically flagged via an application programming interface (API) that alerts a licensed behavioral health team affiliated with the MC3 Perinatal Program. This clinical escalation pathway includes structured risk assessment and, when indicated, facilitated linkage to psychiatric care. These clinical procedures are not part of the research intervention itself and are governed by independent IRB oversight within the MC3 program.
In addition to comparing screening adherence between arms, the study will evaluate user engagement behaviors, identify participant-level predictors of engagement, and explore patterns of app utilization over time. Quantitative app usage data, such as screens completed, content viewed, and activities initiated, will be analyzed alongside qualitative interview data from participants demonstrating high product affinity. These findings will inform optimization of the intervention and guide sample stratification strategies for a future, fully powered Phase II randomized trial.
The proposed research aims to address a major gap in perinatal mental health care by testing whether a mobile behavioral health tool can feasibly support sustained screening adherence outside of clinical environments. If successful, this approach may enable earlier identification of PMAD symptoms, reduce disparities in detection and treatment, and provide empirical evidence supporting digital engagement pathways for perinatal mental health monitoring at scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Moment for Parents Intervention
Participants in the intervention arm will use the full Moment for Parents mobile application, which includes an interactive chatbot that delivers brief lessons, mood check-ins, guided reflections, and optional mindfulness activities. Lessons are grouped into topic-based "Journeys," each consisting of short modules designed to support emotional well-being during pregnancy and postpartum. The app sends daily push notifications prompting users to continue their Journey or engage with mood-related activities. Standard mental health screening instruments (PHQ-9 and GAD-7) are integrated into these check-ins, allowing screening to occur naturally within regular app use. The intervention is designed to increase user engagement and create more opportunities for mental health screening completion than traditional perinatal care.
Perinatal Psychoeducation Articles
Participants access brief, evidence-based articles related to pregnancy, postpartum experiences, and infant development. Articles are designed to increase perinatal knowledge and normalize common emotional and physical changes during this period.
Weekly Perinatal Mental Health Screening
Participants complete validated mental health screening tools (PHQ-9 and GAD-7) integrated into a mobile app. This allows screening to occur in a non-clinical, routine format and increases opportunities for early symptom identification.
Chatbot-Guided Journaling
Participants interact with a conversational chatbot that guides them through mood reflection prompts, journaling activities, and emotional processing exercises. The chatbot personalizes the experience using user input and delivers supportive, non-clinical language to reduce barriers to disclosure.
Perinatal-Focused Meditations
Participants are provided optional audio-based mindfulness and self-regulation meditations tailored to pregnancy and postpartum stressors. These meditations support emotional regulation and help participants manage worry, fatigue, and distress.
Themed Perinatal Learning Pathways
Participants select topic-based curricula (called "Journeys") composed of brief lessons that include educational content, reflections, and optional activities. Each pathway focuses on a specific aspect of pregnancy or postpartum well-being (e.g., resilience, social support, communication with clinicians) and prompts sustained engagement through short, sequential modules.
Moment for Parents Attention Control
Participants in the attention control arm will use a modified version of the Moment for Parents mobile application that does not include the interactive chatbot or guided "Journey" lessons. Instead, the app sends weekly push notifications prompting users to read brief educational articles on pregnancy and postpartum topics, including infant development and common maternal experiences. The app delivers the same mental health screeners (PHQ-9 and GAD-7) at comparable intervals as the intervention arm. However, the screeners are not embedded within conversational features. This version of the app provides exposure to perinatal health information without the personalized engagement strategies present in the intervention condition.
Perinatal Psychoeducation Articles
Participants access brief, evidence-based articles related to pregnancy, postpartum experiences, and infant development. Articles are designed to increase perinatal knowledge and normalize common emotional and physical changes during this period.
Weekly Perinatal Mental Health Screening
Participants complete validated mental health screening tools (PHQ-9 and GAD-7) integrated into a mobile app. This allows screening to occur in a non-clinical, routine format and increases opportunities for early symptom identification.
Interventions
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Perinatal Psychoeducation Articles
Participants access brief, evidence-based articles related to pregnancy, postpartum experiences, and infant development. Articles are designed to increase perinatal knowledge and normalize common emotional and physical changes during this period.
Weekly Perinatal Mental Health Screening
Participants complete validated mental health screening tools (PHQ-9 and GAD-7) integrated into a mobile app. This allows screening to occur in a non-clinical, routine format and increases opportunities for early symptom identification.
Chatbot-Guided Journaling
Participants interact with a conversational chatbot that guides them through mood reflection prompts, journaling activities, and emotional processing exercises. The chatbot personalizes the experience using user input and delivers supportive, non-clinical language to reduce barriers to disclosure.
Perinatal-Focused Meditations
Participants are provided optional audio-based mindfulness and self-regulation meditations tailored to pregnancy and postpartum stressors. These meditations support emotional regulation and help participants manage worry, fatigue, and distress.
Themed Perinatal Learning Pathways
Participants select topic-based curricula (called "Journeys") composed of brief lessons that include educational content, reflections, and optional activities. Each pathway focuses on a specific aspect of pregnancy or postpartum well-being (e.g., resilience, social support, communication with clinicians) and prompts sustained engagement through short, sequential modules.
Eligibility Criteria
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Inclusion Criteria
* Pregnant or up to 1 year postpartum
* Age 18 years or older
* Lives in Michigan
* Owns a smartphone with internet access
* Proficient in English
Exclusion Criteria
* Not currently pregnant or more than 1 year postpartum
* Younger than 18 years old
* Does not live in Michigan
* Does not own a smartphone with internet access
* Not proficient in English
18 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
National Institute of Mental Health (NIMH)
NIH
Poisera, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marianna Kerppola, MBA, MSc
Role: PRINCIPAL_INVESTIGATOR
Poisera, Inc.
Maria Muzik, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Remote/Virtual Participation
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Study Recruitment and Enrollment Information
Other Identifiers
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