Key Dates

Related Announcements

• September 26, 2023 - Health and Health Care Disparities Among Persons Living with Disabilities (R01 - Clinical Trials Optional). See NOFO PAR-23-309.

Issued by

National Institute of Mental Health (NIMH)

Purpose

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. NIMH’s 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:

• Studies examining how stigma, discrimination, structural barriers, or other stressors associated with disabilities may increase onset and severity of psychopathology, especially in the context of stress regulation pathways and conceptual frameworks for assessing the interaction of multiple sources of stress in persons with disabilities who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status.
• Investigations of how structural barriers in home, school, work, and community environments may impact cognitive and emotional function and increase risk for or severity of mental health symptoms in persons with disabilities who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status.
• Studies examining mental health protective and resilience factors associated with adaptive environments and disability-related accommodations, and evidence for better mental health outcomes in persons with disabilities who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status.
• Studies examining the generalizability and accessibility of mental health diagnostic tools or need for adaptation of measurement tools to be inclusive of persons with disabilities, including those who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status, (e.g., materials and testing modalities that are adapted for individuals with disabilities; elimination of ableist language in mental health surveys; culturally and linguistically appropriate tools).
• Investigations of social determinants of health (e.g., financial security, housing and food stability, experience of discrimination, language and literacy skills) for individuals with disabilities who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status, and impact on mental health.
• Investigations of biological, behavioral, environmental, or social measures or pathways that may be targets for prevention and treatment development or mechanisms of pathophysiology of mental health conditions in persons with disabilities who are members of one or more other populations that experience health disparities, including those based on race and ethnicity and socioeconomic status.

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:

• Develop and test new mental health interventions, or interventions to prevent and treat functional impairments, that lead to the experience of disability.
• Develop and test strategies for providing access to and engagement with effective, high quality, evidence-based mental health treatments, in a broad range of settings in which mental health services are provided.
• Investigate whether and to what extent financing mechanisms, policies, regulations, and health care system rules optimize person-level outcomes that can improve mental health outcomes for persons with disabilities.

All applications that propose clinical trials testing treatment or preventive interventions should follow the NIMH’s 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 intervention’s 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.

Inquiries

Please direct all inquiries to:

Beshaun Davis, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-5098
Email: beshaun.davis@nih.gov