NIH – Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional)

Purpose

The purpose of this FOA is to encourage practice-based research aimed at testing developmentally-focused theory-based efficacious prevention interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness. The research should test prevention approaches that are both scalable and sustainable for implementation in pediatric serving primary care settings, including strategies that can be used to identify at-risk youth and match and deliver prevention interventions of appropriate intensity. This FOA seeks to support clinical trials to establish the effectiveness of prevention interventions when implemented in pediatric-serving primary care settings. Specifically, this initiative encourages research that leverages health care systems or other existing health services resources:

1. • As a platform for rapidly refining and pilot testing efficacious prevention interventions (e.g., for identifying, recruiting, delivering and assessing the outcome of interventions); AND
   • As a platform for ultimately delivering scalable interventions in a sustainable manner.

Background

Substantial progress has been made in the development and testing of efficacious theory-based developmentally focused prevention interventions designed to address modifiable proximal risk and protective factors with the goal of having an impact on distal mental health outcomes, including suicide behaviors and the occurrence of serious mental illness. Pediatric-serving primary care (including obstetrics/gynecological for pregnancy and post-partum, pediatric care, family practice, adolescent medicine) is a health care setting that holds potential for the implementation of mental health prevention interventions because it offers broad access and is non-stigmatizing. In addition, there is the potential for prevention interventions found to be efficacious in the primary care setting to be endorsed by the United States Preventive Services Task Force (USPSTF) and covered under insurance.

Because pediatric primary care offers broad access and is non-stigmatizing, it may be an appropriate setting for reaching populations who experience mental health disparities, including racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, or any other subgroup with documented disparities in prevalence of mental illnesses, mental illness trajectories, access to prevention services, and quality and outcomes of mental health care. Accordingly, this Funding Opportunity Announcement (FOA) encourages studies that involve diverse populations, including groups that might experience health disparities, and as appropriate, it encourages examination of whether prevention services in primary care can potentially reduce or eliminate disparities.

To date, many of the research-supported prevention interventions have been developed and tested in randomized controlled trials (RCTs) with children recruited for the study through academic centers and delivery of relatively intensive and complex interventions by study-hired and trained clinicians. Ultimately, sustainable approaches to prevention will require: 1) delivery in a system where youth who might benefit from prevention can be systematically identified and served; and 2) interventions that are matched in terms of intensity/dose to the severity/need, to the child’s/family’s tolerance, and to the capacity within the delivery setting, such that they can be delivered with fidelity by setting providers.

NIMH intends to fund an estimate 4 to 9 awards, corresponding to a total of $2 million for fiscal years 2020 and 2021 for this and the companion R34 announcement (RFA-MH-20-506).

Key Dates

Filed Under: Funding Opportunities