Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required)

This R61/R33 concept complements NIMH's suite of clinical trial NOFOs by supporting feasibility and infrastructure development (R61) followed by well-powered clinical trials (R33) to test the effectiveness of system interventions and strategies for improving the organization, delivery, coordination, and clinical and functional outcomes of mental health services. System interventions - which may span structural, policy, organizational, and interpersonal domains - attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical and functional outcomes. The focus of system interventions may include a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems. This phased mechanism allows researchers to first establish feasibility and develop necessary infrastructure in the R61 phase before conducting fully-powered effectiveness trials in the R33 phase.