Evaluating Screening Adherence Between Moment for Parents App and Attention Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Mental Health Screening Adherence
研究概览
简要总结
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.
详细描述
This study is a 12-week, two-arm pilot randomized controlled trial (RCT) designed to evaluate whether an interactive mobile application, the Moment for Parents app, improves adherence to routine mental health screening among pregnant and postpartum women. Perinatal mood and anxiety disorders (PMADs) are prevalent, impactful on maternal and infant health, and often remain undetected due to stigma, inconsistent clinical screening practices, and limited engagement with healthcare systems. Digital screening embedded within a consumer-facing app may address these barriers by normalizing emotional check-ins, reducing self-presentation concerns, and enabling repeated screening opportunities over time.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are:
- •Pregnant or up to 1 year postpartum
- •Age 18 years or older
- •Lives in Michigan
- •Owns a smartphone with internet access
- •Proficient in English
排除标准
- •Not female
- •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
研究组 & 干预措施
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.
干预措施: Perinatal Psychoeducation Articles (Behavioral)
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.
干预措施: Chatbot-Guided Journaling (Behavioral)
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.
干预措施: Perinatal-Focused Meditations (Behavioral)
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.
干预措施: Themed Perinatal Learning Pathways (Behavioral)
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.
干预措施: Perinatal Psychoeducation Articles (Behavioral)
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.
干预措施: Bi-weekly Perinatal Mental Health Screening (Behavioral)
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.
干预措施: Bi-weekly Perinatal Mental Health Screening (Behavioral)
结局指标
主要结局
Mental Health Screening Adherence
时间窗: From enrollment to 12 weeks post-enrollment
Mental health screening adherence will be measured as the total number of completed PHQ-9 and GAD-7 screenings delivered through the Moment for Parents app during the 12-week study period. Screening opportunities occur bi-weekly and are recorded passively by the application backend, allowing precise tracking of whether a participant completed each scheduled screening. Adherence will be compared across study arms using count-based analysis methods to determine whether the interactive chatbot increases screening adherence relative to the attention control condition.
次要结局
- App Engagement(From enrollment to 12 weeks post-enrollment)
- App Retention(From enrollment to 12 weeks post-enrollment)
- Baseline Predictors of Screening Adherence(From enrollment to 12 weeks post-enrollment)
- Patterns of Mental Health Screening Behavior(From enrollment to 12 weeks post-enrollment)
- Perceived Value of the Moment for Parents App(From 1 week after enrollment through 12 weeks after enrollment)
- Thematic Insights from User Experience Interviews(From 1 week after enrollment through 3 months after enrollment)