Evaluating Screening Adherence Between Moment for Parents App and Attention Control

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Poisera, Inc.
Study ID
NCT07322042
Status
Recruiting

Conditions

  • Mental Health Screening Adherence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Perinatal Psychoeducation Articles — BEHAVIORAL
    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.
  • Bi-weekly Perinatal Mental Health Screening — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

Mental health challenges, such as depression and anxiety, are the most common medical complications during pregnancy and after childbirth. Many women experience these symptoms, yet half are never screened, let alone diagnosed. When mental health concerns go unnoticed, they can affect a mother's well-being, her birth experience, and her child's development. When identified early, these conditions are treatable. However, current healthcare practices often fail to screen women consistently, and many women do not feel comfortable discussing emotional struggles with healthcare providers. 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.

Key Dates

Start date
Feb 5, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Mental Health Screening Adherence [ Time Frame: From enrollment to 12 weeks post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Remote/Virtual ParticipationAnn ArborMichigan48109
Marianna Kerppola
734-210-1120‬

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