April 24, 2024
National Institute of Mental Health (NIMH)
This Notice informs potential applicants of the National Institute of Mental Health (NIMH) participation, effective immediately, in the Notice of Funding Opportunity (NOFO) PAR-23-309, "Health and Health Care Disparities Among Persons Living with Disabilities (R01 - Clinical Trials Optional)".
The following text has been added to reflect the NIMH's participation in this NOFO:
Part 1. Overview Information
Components of Participating Organizations
National Institute of Mental Health (NIMH)
Assistance Listing Number(s)
93.242
Part 2. Section I. Funding Opportunity Description
Specific Areas of Research Interest for Participating Organizations:
NIMH Areas of Interest:
The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. People with disabilities experience higher prevalence of mental health conditions and disparities in mental health services. Individuals with serious mental illnesses (SMI), other mental health conditions, and autism may experience functional impairment that meets the ADA definition of disability and disability-associated disparities in mental health outcomes, mental health services, and autism services. NIMH is interested in applications that support the NIMH Strategic Plan for Research relevant to the specific priorities described in this NOFO.
Translational research at NIMH is aimed at translating knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental disorders and developing novel and improved interventions. NIMHs Division of Translational Research is interested in intersectional research on the risk, onset, and trajectories of mental health conditions in persons with disabilities and other marginalized identities (e.g., based on race and ethnicity, sexual orientation and gender identity, low socioeconomic status, and rural setting).
Examples of translational research of particular interest include, but are not limited to:
For the purposes of this NOFO, the Division of Services and Intervention Research (DSIR) is particularly interested in disability research that is focused on members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status. DSIR is particularly interested in (but not limited to) projects that explicitly align to Goals 3.2, 3.3, and 4 of the NIMH Strategic Plan for Research and:
All applications that propose clinical trials testing treatment or preventive interventions should follow the NIMHs experimental therapeutics approach to intervention development and testing (see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml). That is, the scope of work, if focused on intervention development or efficacy testing, should include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the interventions outcomes. In effectiveness trials, this includes confirming that modifications to interventions with known efficacy, or deployment to novel populations, still engage the interventions intended target. In this manner, the results of the trial should advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).
Applications involving clinical trials that test services interventions, policy interventions, and/or implementation strategies should employ methods that seek to understand how, why, for whom, and/or in what circumstances the intervention is effective. That is, methodology should go beyond assessing just whether an intervention is effective (or not). Potential approaches include but are not limited to mediation analyses (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, and partial or full factorial designs. For multi-component interventions, other methods to examine the direct effects of each of the intervention components on the ultimate intervention outcome (versus modelling such effects through target/mediator variables) could also be employed. In this manner, the study results may be informative regardless of the primary outcomes (e.g., in the event of overall negative results, it may be informative to examine whether the intervention was effective in certain circumstances or for certain populations).
NIMH encourages a deployment-focused model of intervention design and testing that takes into account the perspective of relevant end-users (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows). To this end, NIMH strongly encourages meaningful inclusion of end-users in the research (e.g., member of an advisory panels and/or inclusion as key personnel). This attention to end-user perspectives is intended to help ensure the research findings will have clear utility to communities, practices, and/or policy makers who may benefit from those findings.
Adaptations or augmentations of efficacious preventive, therapeutic, or services interventions should only be undertaken if there is (a) an empirical rationale for the adaptation/augmentation target (i.e., a clear association of the adaptation/augmentation with non-response, partial response, patient non-engagement, or relapse), (b) a clear hypothesis and plan to address the mechanism by which the adapted intervention or augmentation will enhance outcomes, and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings. Clinical trials that are not responsive to these guidelines will not be reviewed.
Part 2. Section VII. Agency Contacts
Scientific/Research Contact(s)
Beshaun Davis, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-5098
Email: beshaun.davis@nih.gov
Financial/Grants Management Contact(s)
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov
All other aspects of the NOFO remain the same.
Please direct all inquiries to:
Beshaun Davis, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-5098
Email: beshaun.davis@nih.gov