Description

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.

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.