Key Dates

Related Announcements

PAR-20-070 - Research Infrastructure Development for Interdisciplinary Aging Studies (R21/R33 - Clinical Trial Optional)

PAR-20-139 - Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)

PA-20-183- Research Project Grant (Parent R01 Clinical Trial Require

PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PAR-20-266 - Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional)

PAR-21-099 - Music and Health: Understanding And Developing Music Medicine (R21 Clinical Trial Optional)

PAR-21-100 - Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional)

PAR-21-307 - Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required)

PAR-21-308 - Pragmatic Trials for Dementia Care and Caregiver Support (R61/R33 Clinical Trial Required)

PAR-21-359 - Early and Late Stage Clinical Trials for the Spectrum of Alzheimers Disease/Alzheimers Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)

PAR-21-360 - Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)

PAR-22-077 - NIA Renewal and Revision Cooperative Agreements in AD/ADRD Research (U54 Clinical Trial Optional)

PAR-22-093 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

PAR-22-094 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Optional)

PAR-22-362 - NIA Renewal and Competing Revision Cooperative Agreements in Aging Research (U01 Clinical Trial Optional)

PAR-21-190 Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

PAR-21-341 Exploratory Grants in Cancer Control (R21 Clinical Trial Optional)

PAR-21-035 Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

NOT-OD-21-087 Notice of Special Interest (NOSI): Developing and Testing Multilevel Physical Activity Interventions to Improve Health and Well-Being

PAR-21-317 - NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

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

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PAR-22-105 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

PAR-22-109 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

Issued by

Office of Behavioral and Social Sciences Research (OBSSR)

National Institute on Aging (NIA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Purpose

Purpose

To achieve more potent strategies to promote sustained health-related behavior change, there is a need for intentional and methodical translation of foundational behavioral and social science discoveries into new or improved interventions. The Office of Behavioral and Social Sciences Research (OBSSR) and participating ICOs are issuing this Notice to highlight interest in the systematic development of original health-related behavioral interventions that test hypotheses that draw on basic behavioral and social sciences research (bBSSR) findings that posit causal or processual mechanisms of action of healthier behavior change. This includes research that focuses on use-inspired bBSSR, understanding of mechanisms of action underlying initial and sustained behavior change, and systematic development and testing of health-related behavioral interventions and their components.

Background

There have been many important prevention and treatment advances based on behavioral and social science research; nevertheless, even the most robust interventions work only in a subset of those intervened upon and changes can be difficult to sustain over time. There is a need for research in intervention development that bridges basic and applied (interventional) behavioral sciences, in which insights from basic research about the mechanisms and moderators of human behavior are used to develop more effective, efficient, and enduring interventions for health-related behavior change.

Research Objectives

This Notice encourages behavioral intervention research that integrates basic behavioral and social science, that create, refine, and test innovative interventions focused on the initiation, cessation, or maintenance of behaviors associated with improved health or disease mitigation.

The behavioral, emotional, cognitive, and/or social targets for interventions being developed and tested in response to this NOSI, should be based on insights from basic science about mechanisms that underlie health-related behavior change. Interventions may target the individual (e.g., cognitive or psychological processes), the immediate social environment (e.g., dyadic or family relationships), and/or broader social, organizational or environmental systems (e.g., worksites, schools, healthcare delivery, or neighborhood features).

Outcomes may include clinical indicators or health-related behaviors measured at the individual level or shifts in behavior or health indicators that are measured at an aggregate/population level.

Applicants are encouraged to employ innovative study designs for building, adapting, and optimizing behavioral interventions. Interdisciplinary project teams are also encouraged.

The use of an intervention development framework to inform the research plan is encouraged. Examples include, and are not limited to, the NIH Stage Model for Behavioral Intervention Development (https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development), and the Obesity Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development (https://cancercontrol.cancer.gov/brp/hbrb/translational-research.html). The experimental medicine approach, successfully demonstrated through the NIH Common Fund Science of Behavior Change initiative (https://commonfund.nih.gov/behaviorchange) is a research design that is compatible with both of these intervention development frameworks, as it is intended to help to determine the mechanisms through which an intervention exerts its effects.

Intervention creation and refinement require iterative and systematic testing of intervention features and components. Study timelines should include clear research steps, goals and milestones (go/no-go decision points). It is understood that during the intervention development process, timeline deviations may occur based on study results; for example, findings at one step may require a return to an earlier step to further refine an intervention or better understand the mechanism of action. As such, applicants should include a plan for dealing with unexpected results before proceeding to the next step of the intervention development refinement and testing plan.

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will not be considered 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.

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

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

National Institute on Drug Abuse (NIDA)

NIDA is interested in research to evaluate behavioral treatments for substance use disorders (SUDs); produce treatments that are implementable and self-sustaining; and develop optimal behavioral strategies to promote medication adherence and other outcomes for SUDs. These efforts include:

• Research to elucidate purported mechanism of action and targets of behavioral interventions at multiple levels of analysis. This includes determination of underlying biological and/or neurobiological mechanisms (e.g., as measured by imaging methodologies, skin conductance, or other biological/physiological indices) of the interventions associated with the behavioral, cognitive, affective, or social mechanisms of interventions.
• Research that uses innovative technologies (digital therapeutics, including mobile applications and other platforms, virtual reality, wireless monitoring and biofeedback, imaging tools for biofeedback) to develop, improve and systematically measure behavioral interventions including the use of imaging methods to predict outcomes from behavioral interventions.
• Research that incorporates genetic/epigenetic methodologies to help understand the variability in outcomes as result of therapeutic interventions.
• Research that evaluates the use of medications to improve the potency of behavioral interventions.
• Research on the essential components of a behavioral treatment, adherence or therapist training intervention.
• Treatment development research aimed at facilitating the implementation of an intervention, testing behavioral interventions within primary care settings
• Research to promote adherence to pharmacotherapies, such as buprenorphine, methadone, depot naltrexone, lofexidine, naloxone, or HAART, in substance abuse treatment populations.
• Studies that develop safe and effective psychosocial interventions to improve the outcomes of pharmacotherapies for SUDs including OUD and overdose reversal.
• Research on tobacco harm reduction strategies such as switching from combustibles to e-cigarettes.

NIDA FOA’s for this NOSI include the following or their subsequent reissued equivalents:

National Institute on Aging (NIA)

The National Institute on Aging (NIA) is interested in preliminary (Stage I, II, and III) behavioral intervention development research for mid-life and older individuals that capitalizes on and integrates basic research to inform the development of efficacious interventions, defined by their governing principles in accordance with the NIH Stage Model. (please see https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development. Interventions may be focused on individuals, dyads, families, communities, organizations, or systems.

The purpose of the interventions to be developed may be, for example, to promote health and well-being, including emotional/behavioral well-being, (e.g., in caregivers of individuals with dementia), promote behaviors associated with health and well-being (e.g., exercise), establish and maintain high quality and nurturing close relationships, cope with age-related disorders, cope with stress, decrease pain, improve sleep hygiene, promote independence, help older individuals with declining memory improve their memory, prevent disease or disease progression, and prevent cognitive decline.

NIA is also interested in supporting Alzheimer’s disease Alzheimer’s disease-related dementias (AD/ADRD)-focused research on interventions for care providers and also preliminary behavioral interventions focused at increasing long-term adherence to lifestyle interventions, such as diet and physical activity, that might delay the onset and progression of AD/ADRD. Applications focused on behavioral intervention development for people living with AD/ADRD and/or their care partners are encouraged to submit to PAR-21-307 or PAR-21-308.

NIA is particularly interested in mechanism-focused intervention development research on underrepresented minorities, with the goal of determining the underlying principles of interventions that improve their health and well-being and serve to reduce health disparities.

Applicants are also encouraged to consider the ultimate scalability of interventions and may conduct preliminary research to adapt/modify interventions to streamline interventions, optimize the ability to deliver interventions with fidelity and/or improve real-world ease of implementation.

NIA’s FOA’s for this NOSI include the following or their subsequent reissued equivalents:

National Cancer Institute (NCI)

The National Cancer Institute (NCI) seeks to support and catalyze research on the discovery, development, testing, and implementation of effective strategies to promote healthy lifestyle behaviors for cancer prevention and control. Early-phase (basic-to-clinical) behavioral translation studies (e.g., Phase I or Phase II studies, as defined by the ORBIT model for behavioral treatment development (see http://www.ncbi.nlm.nih.gov/pubmed/25642841) are of particular interest, including research that elucidates the causal factors related to cancer risk behaviors, identifies potential targets for intervention, and/or involves the design and optimization of interventions to promote and sustain healthy behaviors related to cancer prevention and control.

Research in response to this Notice can involve any aspect of the cancer control continuum (e.g., prevention, detection/diagnosis, treatment, survivorship). Cancer-related behavioral risk factors of interest to NCI include tobacco use; diet; energy balance and obesity; physical activity and sedentary behavior; sun safety/UV-protective behaviors and tanning; alcohol use; sleep and circadian function; adherence to cancer-related medical and behavioral regimens; cancer screening; vaccinations to prevent cervical cancer (HPV vaccination); and avoidance of environmental carcinogens (e.g., radon).

The following are of special interest:

• Use of the ORBIT model for behavioral treatment development (seehttp://www.ncbi.nlm.nih.gov/pubmed/25642841) to guide the aims, study designs and methods proposed, with a focus on Phase I and/or Phase II of the ORBIT model;
• New and innovative research designs, alone or in combination, including (but not limited to) mixed-methods, qualitative and user-centered methods; single-case and N-of-1 designs; dose-finding methods; proof-of-concept studies; full and fractional factorial (e.g., as used in Multiphase Optimization Strategy [MOST]) designs; adaptive interventions (e.g., using SMART, JITAI and microrandomized trials);
• Interventions, including those involving natural experiments, targeting the built, sociocultural, communication, and policy environments that affect cancer risk and behavioral risk factors;
• New and existing data collection systems (e.g., smart phone-based, sensor data, electronic health records) and integrated datasets;
• Multi-level interventions, including combinations of at least two levels of analysis (e.g., community and clinical settings) that are hypothesized to produce both independent and joint effects and that address complex behaviors;
• Multi-behavior interventions (e.g., targeting bundles or clusters of behavioral risk factors) including combinations of at least two behaviors, with innovations in the combination of behaviors, the intervention approach, or both;
• Developing and preliminary testing of interventions prior to, during or following cancer treatment that aim to improve symptom management, cancer risk, recurrence, and quality of life;
• Using systems-level methods (e.g., agent-based modeling, system dynamics) to identify drivers of cancer-related risk behaviors and points of entry for interventions.

NCI FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR prioritizes behavioral and social science intervention research that includes rigorous empirical tests of putative mechanisms of action, across the translational continuum. As such, high priority projects will draw on knowledge from basic behavioral and social science to develop behavioral interventions and accompanying mechanistic hypotheses that address current challenges or opportunities related to dental, oral, and craniofacial (DOC) health. NIDCR supports a broad range of DOC intervention research projects, for participants of any age or developmental stage; for any DOC condition with public health significance (e.g., dental caries, periodontal disease, craniofacial anomalies, oral cancers, salivary gland dysfunctions, oral mucosal diseases, orofacial pain); for a range of outcomes (e.g., direct intervention with patients to improve DOC outcomes, intervention with practitioners to improve DOC care, intervention on health systems to improve continuity of care); for stakeholders from different sectors (e.g., patients, families, social networks and communities, practitioners, care-delivery systems, professional organizations, policy-makers); and for DOC intervention research at all stages, from early intervention development (e.g., Stage I) through implementation and health services research (Stages IV/V).

NIDCR FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest to NINR

NINR FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Center for Complementary and Integrative Health (NCCIH)

NCCIH is committed to the rigorous investigation of promising mind and body behavioral interventions. These mind and body approaches are widely used by the public, and they are increasingly recognized to provide a non-pharmacological approach to symptom management (e.g., chronic pain, mild depression, anxiety, etc.). These approaches can be utilized by individuals to help prevent, treat, or self-manage various conditions (e.g., chronic pain, headache, anxiety, promote wellness), as well as being complementary to treatment offered by conventional health care. Mind and body interventions include various mind-based approaches (e.g., mindfulness, hypnosis, guided imagery), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), meditative movement approaches (e.g., yoga, tai chi, qi-gong), music and art therapy approaches, or a combination of these approaches (e.g., meditation and yoga, or mindfulness-based stress reduction MBSR).

NCCIH is interested in research to develop and test mind and body behavioral interventions for the following high priority topic areas: symptom management - particularly for chronic pain syndromes; reduction of prescription drug (opioid) use or abuse in patients with chronic pain; enhancement of medication adherence; treatment or prevention of post-traumatic stress (disorder), traumatic brain injury, sleep disorders or disturbances, anxiety, depression, obesity, and smoking; promotion of psychological resilience or wellbeing; and promotion of healthy eating and physical activity. For more details on NCCIH’s approach to funding clinical trials, including a description of our available FOA s, please see https://nccih.nih.gov/grants/funding/clinicaltrials.

NCCIH FOAs for this NOSI include the following or their subsequent reissued equivalents:

Application and Submission Information

This notice applies to due dates on or after June 5, 2019 and subsequent receipt dates through September 8, 2022.

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.

• PA-19-055 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-091 NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

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-IC-19-XXX (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

The Office of Behavioral and Social Sciences Research (OBSSR) facilitates this Notice on behalf of the participating NIH Institutes and Centers (ICs). As OBSSR cannot accept assignment of applications or directly fund or manage awards, contact one of the IC-based officials below regarding the suitability of the proposed project for this FOA and the IC's research portfolio.

Lisa Onken, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: lisa.onken@nih.gov

Jill Mattia, PhD
Director, Behavioral and Social Sciences Research Program
National Institute Of Dental & Craniofacial Research (NIDCR)
E-mail: jill.mattia@nih.gov

Will Aklin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5909
Email: aklinwm@nida.nih.gov

Karen Kehl, PhD, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-8010
Email: karen.kehl@nih.gov

Lanay Mudd, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov>;

Susan Czajkowski, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5871
Email: susan.czajkowski@nih.gov