The ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention

The ROSE Scale-Up Study, a large pragmatic trial designed to inform whether the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) program should be implemented as universal postpartum depression (PPD) prevention. ROSE is a brief, five-session educational intervention deliverable by non-mental health providers that has previously prevented approximately half of PPD cases in trials of at-risk populations. The ROSE Scale-Up Study addresses a critical gap identified by the United States Preventive Services Task Force: prior evidence and recommendations focused on selective or indicated prevention for those at elevated risk, leaving open whether universal prevention, offering ROSE to all pregnant people, would be more equitable, scalable, cost-beneficial, and effective across the full population of pregnant people, including those who screen negative for PPD risk.

This trial will enroll 2,320 pregnant people and randomize all participants to either the ROSE intervention or enhanced care as usual. Participants will be assessed using commonly available PPD risk prediction tools and characterized by multiple operationalizations of risk, including Medicaid enrollment, Cooper Survey Questionnaire (CSQ) scores, past major depressive episode assessed via SCID-5, past MDE identified through electronic health record diagnoses, and baseline elevated depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS). The study's design allows simultaneous evaluation of ROSE as universal prevention (offered to everyone), selective prevention (offered only to those identified as at risk), and indicated prevention (offered to those with elevated baseline symptoms). By embedding randomization across the full population and stratifying by risk assessment methods, the investigators can compare outcomes across prevention strategies within a single, efficient trial.

Primary and secondary objectives extend beyond traditional efficacy endpoints. Effectiveness outcomes include prevention of PPD cases and improvements in functioning. The study also explicitly evaluates cost-benefit, comparing the costs of screening and targeted delivery to the costs and outcomes of universal delivery, noting that previous implementation experience suggests the economic consequences of missed cases may far exceed per-pregnancy delivery costs. Equity is a key focus: the trial quantifies PPD cases prevented by universal prevention that would not be prevented under selective or indicated approaches, with explicit comparisons between minority and non-Hispanic white participants to assess whether universal delivery reduces disparities. The trial further examines scalability using quantitative and qualitative data drawn from 98 agencies previously implementing ROSE, employing measures such as the Intervention Scalability Assessment Tool (ISAT) and provider perceptions. Mechanistic questions how ROSE works across different risk levels are integrated into the evaluation.

This protocol positions the ROSE Scale-Up Study as the largest PPD prevention trial to date and as the first randomized effort to directly compare universal, selective, and indicated prevention strategies in the same population. The pragmatic, implementation-focused design aims to produce actionable guidance for clinicians, health systems, and policymakers about the trade-offs among effectiveness, equity, cost, and scalability when considering ROSE as a universal prenatal offering. Findings are intended to inform decisions about broad adoption of ROSE to prevent postpartum depression across diverse real-world settings.