Related Announcements

PAR-21-129 – Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01)

PAR-21-130 – Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-21-131– Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 -Clinical Trial Required)

PAR-21-132– Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required)

PAR-21-316 – Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

PAR-22-082 - Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

PAR-21-291 – Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R01 Clinical Trial Required)

PAR-21-292 – Pilot Studies to Test the Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R34 Clinical Trial Required)

RFA-MH-21-110 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R01 Clinical Trial Optional)

RFA-MH-21-111 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R34 Clinical Trial Optional)

RFA-MH-21-112 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/44 Clinical Trial Optional)

PA-20-183 – Research Project Grant – (Parent R01 Clinical Trial Required)

PA-20-185 – Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-21-110 – Pilot and feasibility studies in preparation for substance use prevention trials (R34 – Clinical Trial Optional)

PA-21-180 – Pilot health services and economic research on the treatment of drug, alcohol, and tobacco use disorders (R34 – Clinical Trial Optional)

PA-20-194 – NIH exploratory/developmental research grant program (Parent R21 Clinical Trial Required)

PA-20-195 – NIH exploratory/developmental research grant program (Parent R21 Clinical Trial Not Allowed)

Issued by

National Institute of Mental Health (NIMH)

National Institute on Drug Abuse (NIDA)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Purpose

The National Action Alliance for Suicide Prevention's (Action Alliance) Crisis Services Task Force summarized needed crisis services for suicide prevention in their 2016 report, Crisis Now: Transforming Services is Within Our Reach. The report describes effective crisis care as a systematic approach, optimized when delivered with the following characteristics: Regional or statewide crisis call centers that use technology to support real-time coordination across a system of care; centrally deployed mobile crisis outreach and support on a 24/7 basis; and crisis services that can diagnose and provide short term stabilization. In addition to their therapeutic value for the individual in crisis, effective crisis systems that support individuals in suicide distress have been reported to be successful diversions from law enforcement by supporting emergency care that reduces avoidable hospital admissions, arrest, and incarceration.

Since NOT-MH-19-025, Priority Research Opportunities on Suicide Prevention Crisis Services, was issued, evidence-based crisis services have become an even greater priority with the National Suicide Hotline Designation Act of 2020. The Act designates "9-8-8" as the universal telephone number in the United States for the national suicide prevention and mental health and substance use crisis hotline system. Built upon the National Suicide Prevention Lifeline (NSPL), 988 will be a nationally available toll-free portal. It will be a centralized number that builds on the current National Suicide Prevention Lifeline. It holds the potential for an effective system that can also dispatch local mobile crisis response if needed, and/or refer to a crisis receiving center or hospital emergency department. Fully realized, a 988 behavioral health crisis response line would also have follow-up protocols to maintain continued contact until the crisis is resolved. The new number must be launched and operational nationwide by July 2022. It is anticipated that the broader scope of 988—including mental health (MH) and substance use (SU) crises—along with a simplified number, will greatly expand the call demand, and crisis service needs.

In anticipation of those needs, SAMHSA published an online compendium, Crisis Services: Meeting Needs, Saving Lives that contains best practice toolkits and related papers that address crisis services, homelessness, technology advances, substance use, legal issues impacting crisis services, financing crisis care, diverse populations, children and adolescents, rural and frontier areas, and the role of law enforcement to help localities plan, build or improve their suicide prevention activities, and to better address mental health and substance use crisis services. In November 2020, the Action Alliance launched the Mental Health & Suicide Prevention National Response to COVID-19, which includes action steps to remedy long-standing needs for alternatives to criminal justice responses to mental and substance use crises. SAMHSA has issued grants in support of increasing access to quality community crisis services. For example, the Certified Community Behavioral Health Clinics (CCBHCs) Expansion Grants require that crisis services be included in the array of services the CCBHC grants support. The more than 430 CCBHCs in operation are required to provide comprehensive 24/7 access to community-based mental and substance use disorder services; treatment of co-occurring disorders; and physical healthcare in one single location. Additionally, CMS has issued planning grants to 20 State Medicaid agencies to provide qualifying community-based mobile crisis intervention services.

As states and localities build, increase, and/or improve their existing crisis service systems, it will be critical to understand which approaches are most effective. Across the continuum of crisis services, measurement-based care approaches to determine cost effectiveness, quality, and outcomes of crisis services will be needed to demonstrate intervention effectiveness and identify areas for further improvement. As such, the National Institutes of Health seeks research conducted in real-world settings, where a wide range of clinical presentations, psychosocial factors, age-related (e.g., youth; adult; older adult), geographic (rural/remote settings), cultural considerations, and health disparities influence the types of care that are provided. Examples of NIMH and NIDA studies that are encouraged through this Notice address the continuum of crisis service systems. Applications that include crisis services for children and under-resourced populations are encouraged. Topics of research interest span the crisis care continuum, including the effectiveness of these components: call center capabilities to address distress and coordinate care, deployed mobile crisis outreach and support, and crisis services that can diagnose and provide short term stabilization. These areas include, but are not limited to the following:

Treatment and Services Interventions

• Clinical trials that test innovative approaches to rapidly decrease distress and facilitate connection to appropriate service setting based upon clinical presentation and severity of risk.
• Clinical trials testing the preliminary effectiveness of therapeutic intervention strategies to de-escalate clinical emergencies, facilitate safety assessments, and coordinate indicated risk reduction actions (e.g., safe storage of lethal means) and appropriate referral based on severity of presentation.
• Apply adaptive design methodology (e.g., sequential multiple assignment randomized trials, factorial designs) to optimize intervention components of mobile crisis response teams.
• Determine effective culturally responsive crisis services, including optimal approaches to measure the effectiveness of culturally competent services (e.g., fewer dropouts in the continuum of care; improved individual outcomes).

Triage, Dispatch, and other Forms of Decision Support

• Studies to develop and test effective assessment strategies and decision-making aides (e.g., predictive algorithms) that incorporate demographic, clinical (e.g., intoxication, agitation, psychosis, trauma exposure), and contextual data (e.g., access to a weapon, presence of interpersonal support) about the caller and the crisis situation to guide tailored strategies for resolution of distress, referral, and engagement in appropriate follow-up services.
• Determining effective approaches such as decision aids, for dispatching/coordinating in-person response and transportation (mobile crisis teams, EMS, law enforcement) that take existing resources into consideration.
• Test approaches among crisis facilities (peer respite, day hospitals, inpatient psychiatric beds, sobering units) to reduce future or repeated crises by successfully linking to appropriate mental health and/or substance use services, including their acceptability and uptake by crisis service users.
• Testing strategies to optimize the interface/coordination between crisis call lines, other local, regional, or national crisis related call lines, crisis service bed registries, 911, and poison control.
• Testing enhanced training, staffing models, and procedures used by crisis call centers, 911, and poison control centers to improve outcomes that are measurable over time, particularly for under-served communities (language interpretative services; access to culturally specialized crisis services).

Strategies to Promote Service Engagement/Continuity, and Quality of Care, Including Studies Focused on:

• Testing effective strategies and protocols (timing, frequency, and content) that crisis facilities can implement to promote engagement and continuity of care post-crisis (e.g., transitions from mobile crisis teams, law enforcement, or EMS; transitions to community treatment for non-acute care; transfers to local acute (short-term) crisis care or detoxification facilities; transfers to available regional or state inpatient psychiatric crisis beds).
• Testing effective mobile technology enhancements for continuity and outcomes of care interventions initiated by crisis calls, to crisis care, to ongoing non-acute mental health (MH) and substance use (SU) services (e.g., cell phone apps and/or other telephonic monitoring; digital interventions to improve engagement; follow up caring contacts).
• Determining effective training approaches, including technology-assisted strategies, for crisis response teams for initial competency and sustained fidelity in the use of evidence-based assessments, interventions, and outcomes that are measurable and can be tracked over time.
• Determine effective approaches, including staffing compositions, for crisis response system collaborations among various crisis responders that may entail MH and SU services, peer supports, and public safety organizations in various communities (e.g., urban, rural, tribal, college campuses).
• Using current models (e.g., LOCUS) to determine the optimal level of crisis care across the care continuum (e.g., county-level, state-level, healthcare system-level), and examine how well do those models work with crisis services for the variety of persons served (e.g., persons with psychosis; substance use withdrawal), potentially building on existing management systems (e.g., psychiatric bed availability systems).
• Identify effective ways to test the value of specific crisis services in the context of alternatives, including comparative effectiveness and cost-effectiveness analyses, to promote implementation of high value services
• Assess strategies for sustainability of services determined to be of high value (quality of outcomes relative to cost).
• Examine how longitudinal real-world data can be leveraged to assess client and service use characteristics and evaluate the impact of the crisis care service continuum on outcomes at multiple levels, including individual, system, and regional (e.g., indicators of service quality, cost benefit, return on investment, reduced criminal justice involvement, 911 vs 988 on mental health/substance use status).
• Test the effectiveness of reimbursement/payment models along the continuum of crisis response services, that have the potential for widespread sustainability of implementation; this would include assessments of positive and negative elements of these payment models.

The National Institute of Mental Health (NIMH) and National Institute on Drug Abuse (NIDA) encourage research that addresses Institute priorities and is aligned with these recommended areas. For research on the effectiveness of interventions or services, NIMH supports studies that employ an experimental therapeutics approach, whereby clinical trials are designed not only to test the intervention effects on outcomes of interest, but also to inform understanding of the intervention’s mechanisms of action. As such, applications to NIMH that propose to develop and/or test the efficacy/ effectiveness of preventive, therapeutic, or services interventions must include specification of the intervention target(s)/mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcome. In the case of services interventions, targets/mechanisms might involve mutable consumer- or provider-behaviors, or organizational-/system-level factors that are intervened upon in order to improve access, continuity, quality, equity, and/or value of services. Studies adapting existing preventive, therapeutic, or services interventions to specifically target customers in employment and training settings should provide a justification for the unique targets to be tested. Research generating new information about factors causing/reducing disparities in outcomes is strongly encouraged as it may inform other intervention areas. See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated Funding Opportunity Announcements (FOAs) for NIMH clinical trials research support.

Given the focus on scalable, sustainable approaches, NIMH and NIDA encourage interventions that can readily be integrated into community practice, that can be delivered using existing service platforms/ personnel/resources, and that incorporate features that are specifically designed to prevent threats to implementation fidelity. Strategies that might be used to enhance sustained implementation and scalability include but are not limited to consumer-facing technology (e.g., self-administered content) and responder -facing technology (e.g., technology to provide responder support, training and sustained implementation with fidelity), MH or SU specialty consultation via existing resources or other sustainable means (e.g., on the spot video consultation; telehealth, collaborative care approaches); or other robust design features that promote responder/provider competence and sustained implementation fidelity. To facilitate the translation into practice, this initiative is intended to support research that reflects a deployment-focused model of intervention and services design and testing that considers the perspective of key stakeholders (e.g., service users, crisis responders, providers, administrators, payers) and the characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) in the community settings where optimized prevention strategies are intended to be implemented.

NIH Office of Research on Women's Health (ORWH)

As part of the NIH Office of the Director, ORWH works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. Across the crisis services continuum, women have historically faced inequities including unique risk factors for exposure, barriers to reproductive and mental health care, and inadequate pathways for escaping victimization. Global events such as the COVID-19 pandemic, climate emergencies and conflict-related displacements magnify gaps in crisis services for women and girls already experiencing health inequities. With this in mind, ORWH is interested in co-funding research to directly address women's barriers to care and providing support through bolstering the integration of trauma-informed, contextually relevant, and gender-sensitive responses within crisis service systems. Projects focused on groups of women and girls who are understudied, underrepresented, and underreported in research, exploring sex and gender differences, considering intersectionality and multidimensional frameworks, and intervening across multiple levels in partnership with diverse stakeholders are highly encouraged. ORWH is additionally interested in supporting research aiming to reduce stress for crisis hotline workers, many of whom are women. For additional guidance on areas of interest to the ORWH, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).

IC Specific Application and Submission Information:

Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

The National Institute of Mental Health (NIMH) accepts applications to the following or their subsequent reissued equivalents:

The National Institute on Drug Abuse (NIDA) accepts applications to the following or their subsequent reissued equivalents:

Application and Submission Information

This notice applies to due dates on or after June 5, 2022 and subsequent receipt dates through May 8, 2025.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

The National Institute of Mental Health (NIMH) accepts applications to the following or theirsubsequent reissued equivalents:

• PAR-21-129 – Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01
• PAR-21-130 – Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)
• PAR-21-131 – Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 -Clinical Trial Required)
• PAR-21-132 – Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required)
• PAR-21-316 – Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)
• PAR-22-082 - Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)
• PAR-21-291 – Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R01 Clinical Trial Required)
• PAR-21-292 – Pilot Studies to Test the Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R34 Clinical Trial Required
• RFA-MH-21-110 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R01 Clinical Trial Optional)
• RFA-MH-21-111 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R34 Clinical Trial Optional)
• RFA-MH-21-112 – Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/44 Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) accepts applications to the following or their subsequent reissued equivalents:

• PA-20-183 – Research Project Grant – (Parent R01 Clinical Trial Required)
• PA-20-185 – Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-21-110 – Pilot and feasibility studies in preparation for substance use prevention trials (R34 – Clinical Trial Optional)
• PA-21-180 – Pilot health services and economic research on the treatment of drug, alcohol, and tobacco use disorders (R34 – Clinical Trial Optional)
• PA-20-194 – NIH exploratory/developmental research grant program (Parent R21 Clinical Trial Required)
• PA-20-195 – NIH exploratory/developmental research grant program (Parent R21 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-MH-22-110” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Stephen O'Connor, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-8366
Email: stephen.o'[email protected]

Julia Zur, Ph.D.
National Institute of Drug Abuse (NIDA)
Telephone: 301-402-3869
Email: [email protected]

Damiya Whitaker, PsyD, MA
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-8206
Email contact [email protected]