Slots: No more than two applications are allowed per institution. If two applications are submitted then the 2 awards must address the NIH Stage Model as it relates to behavioral interventions to address a different aspect of healthy aging.
Deadlines
Internal Deadline: Monday, August 19th, 2024, 5pm PT Contact RII.
LOI: September 6, 2024
External Deadline: October 8, 2024
Award Information
Award Type: Grant
Estimated Number of Awards: 2
Anticipated Award Amount: $756,000
Who May Serve as PI:
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
NIA encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set that will enhance the research education program. The PD(s)/PI(s) must be able to provide both administrative and scientific leadership to the development and implementation of the proposed program. In addition to relevant clinical psychological science expertise in behavioral intervention development, PD(s)/PI(s) may have broader expertise in clinical and/or basic psychological science relevant to intervention development. To achieve the program goals, PD(s)/PI(s) and/or key personnel also may include individuals with experience in mentoring, program evaluation, or university administration. Any of the PD(s)/PI(s) may serve as the contact PD/PI.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-25-029.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#. Please have this material prepared before beginning this application.
Purpose
A major goal of the National Institute on Aging (NIA) is to promote the health and well-being of older adults to “extend the healthy, active years of life.” To realize this goal, NIA supports research on behavioral interventions to promote healthy aging and prevent illness (e.g., improve memory, increase physical activity, improve mood, support stress management, encourage good sleep hygiene), improve care, foster disease management (e.g., promote adherence to medical regimens, support caregivers, improve healthcare system practices), assist with end of life decision-making and care, and support the needs of the growing older adult population. The term behavioral intervention is used broadly here, to include a variety of non-pharmacological interventions for individuals, dyads, families, groups, communities, organizations, and societies. NIA’s behavioral intervention development research program is guided by the NIH Stage Model, which is a six-stage intervention development framework that encourages a focus on understanding “how and why” interventions exert their effects. An understanding of how and why interventions work, sometimes called the principle(s) or mechanisms of behavior change (MoBCs) of an intervention, is often helpful, and may be critical to the creation of potent interventions that can be implemented efficiently in the settings where they are needed. Of course, interventions must be culturally competent to work, and understanding how and why an intervention will —or will not—work for particular groups of individuals is crucial to developing culturally competent interventions. So, ascertaining MoBCs to facilitate the development of culturally competent interventions is viewed as essential and is an inherent part of the NIH Stage Model.
NIH Stage Model
The following are the six Stages of the NIH Stage Model:
- Stage 0: Basic Behavioral Science: Questions separate from but related to the MOBC(s) of the intervention being developed are basic behavioral science questions that can be addressed in Stage 0 research. Basic science research questions—research on mechanisms of change—is an integral part of all other stages of intervention development. Such research involves asking basic science questions about behavior change within the context of intervention development studies. Questions of mechanisms of behavior change are relevant to every Stage of behavioral intervention development.
- Stage I: Creation, Adaptation, Modification & Pilot-Testing (CAMP) of the full interventions, including procedures for teaching providers to deliver the intervention correctly:
- CAMP of the Intervention: All studies that seek to create or change (adapt, modify, tailor or refine) and pilot test the feasibility and acceptability of an intervention are Stage I studies. Stage I studies can be conducted in controlled research settings or in community settings.
- CAMP of a Training Procedure: Training procedures may be needed to ensure an interventionist (e.g., a, nurse, peer counselor, psychotherapist, social worker, physician, etc.) can deliver the intervention correctly (with “fidelity”), and the testing of training procedures can be considered interventions in their own right. The development and pilot feasibility and acceptability testing of provider-friendly training procedures (and associated materials) are included in Stage I studies.
- Stage II: Traditional Efficacy Testing. Stage II studies test efficacy under highly controlled ideal conditions (e.g., in a research setting), where internal validity is maximized.
- Stage III: Efficacy in the “Real World:” Like Stage II, Stage III studies test efficacy. However, Stage III studies involve the delivery of the intervention by an individual, or a group of individuals, in a real-world context, and are conducted with as high internal validity as possible within this real-world setting:
- Stage III efficacy testing of an intervention consists of the experimental testing of an intervention while maintaining as high a level of control as possible in a real-world setting, with community-based interventionists/providers.
- Stage III studies testing the efficacy of training materials for real-world providers are often necessary to ensure an intervention can be delivered with fidelity prior to progression to Stages IV and V.
- Stage IV: Effectiveness Testing: Stage IV research tests the effectiveness of an intervention. Stage IV tests intervention effectiveness, where the intervention is delivered in community settings by community interventionists (e.g., under actual conditions in the “real world”). Stage IV research strives for maximal external validity.
- Stage V Research: Dissemination & Implementation: Stage V research is focused on strategies to disseminate and implement interventions, rather than modifying or testing the intervention itself. Specifically, Stage V seeks to create, modify, and test implementation and dissemination strategies, to achieve an understanding of the principles (or mechanisms) that govern effective dissemination and implementation strategies. Stage V research testing an implementation strategy is sometimes combined with Stage IV effectiveness testing. This is sometimes referred to as a “Type 2 Hybrid.”
Because dissemination and implementation strategies and approaches are behavioral interventions in and of themselves, the intervention development process for implementation strategies can also be conceptualized using the relevant Stages of intervention development (e.g., Stage I [within Stage V], Stage III [within Stage V], etc.).
Henceforth, the six Stages of the NIH Stage Model will be referred to as “the Stages” or the “six Stages.”
The NIH Stage Model goal is to develop maximally potent and implementable interventions defined by the principles through which they work. However, the NIH Stage Model is nonprescriptive. It accommodates intervention research wherever it is in its development. It integrates basic and applied science by encouraging research designs that seek to understand the principles or MoBCs of an intervention, wherever possible in all Stages of intervention development. Consideration of ease of implementation is encouraged as early as possible and as often as necessary, but the Model does not prescribe how this should be accomplished. The Model also does not dictate the use of any particular theory, research design, measure, or statistical analytic approach. It can be used for the development of single or multi-component interventions, and for interventions designed to target mechanisms of change at any level –or multiple levels–of a socioecological model (e.g., the Health Disparities Framework, The Social-Ecological Model: A Framework for Prevention, etc.). The pathway taken through the Stages is also non-prescriptive, except that any pathway proposed requires a scientifically justifiable rationale and a rigorous approach.
The NIH Science of Behavior Change (SOBC) Program shares with the NIH Stage Model a goal of understanding of mechanisms of behavior change. The SOBC mechanism-focused, experimental medicine approach is a methodology that is compatible with the NIH Stage Model. It encourages a clear a priori specification of the intended mechanistic target(s) of an intervention and methods that test causal hypotheses about the degree to which an experimental manipulation or intervention engages those targets. Within the experimental medicine approach to behavior change, intervention targets may include mechanisms or processes at any level of analysis (e.g., environmental, social, contextual, interpersonal, behavioral, psychological, and/or neurobiological). The SOBC program established the expectation that behavior change interventions are designed to explicitly test hypotheses about mechanisms of action, and that they incorporate appropriate measures to enable such tests. This includes testing hypotheses about which components of an intervention are responsible for change in a target mechanism or process, as well as hypotheses about whether changes in that mechanism result in a change in the relevant outcome. The SOBC website provides valuable resources to researchers, including information on the experimental medicine approach, as well as a measures repository, to help achieve this goal.
The National Advisory Council on Aging (NACA) Review of NIA’s Division of Behavioral and Social Research advised that intervention research be conducted using the NIH Stage Model, with a focus on careful testing of mechanisms of behavior change and for mechanism-based intervention research that aims to reduce health disparities. This NOFO is intended to provide resources for short courses on the NIH Stage Model to help researchers acquire expertise in this Model to achieve these goals, and to foster the creation of potent, scalable interventions that promote healthy aging among all people and support the needs of the growing older adult population.
Short Course Curriculum
This NOFO will support development of a curriculum that must include instruction in the following 6 broad topics. The sub-bullets are recommended sub-topics for each broad topic.
- NIH Stage Model Goals – Understanding the overarching goals of the NIH Stage Model:
- Developing interventions that are defined by their principles (MoBCs).
- Identifying principles that allow for an intervention to be maximally potent, scalable and culturally competent.
- Contributing to behavioral intervention development as a cumulative science.
- Stages – Understanding each of the six Stages of intervention development:
- Mechanisms – Understanding mechanisms, moderators, and mediators of behavior change across the Stages of intervention development:
- Distinctions between mechanisms, moderators, and mediators of behavior change.
- The links between behavior change theory and hypothesized MoBCs, moderators, and mediators.
- Developing and testing hypotheses of the MoBCs of an intervention, based upon testable theories about behavioral, interpersonal, organizational, or systemic change.
- Measurement of hypothesized MoBCs, moderators, and mediators.
- Differentiating between adaptations/modifications/tailoring of intervention that are believed to change the hypothesized MoBCs of interventions vs. those that are not believed to change the hypothesized MoBCs.
- Fidelity – Understanding the role of intervention fidelity across the Stages of intervention development:
- Definition of fidelity in accordance with the NIH Stage Model: Fidelity is the degree of consistency with the (hypothesized or known) principles of the intervention.
- Understanding how to deliver an intervention with fidelity to its principles, while allowing flexibility (e.g., to respect participant’s language and values).
- Intervention fidelity activities in each Stage, including those related to training, calibrating, supervising/tracking, and re-training interventionists.
- Developing and testing fidelity methods (e.g., training and tracking procedures) appropriate for different types of interventionists, settings, and interventions. Developing guidance on fidelity methods for community interventionists is of particular interest.
- Ensuring that hypothesized MoBCs are reflected in intervention training and fidelity procedures.
- Clarifying the relationship of fidelity to the determination of MoBC: Implications of different intervention fidelity methods for testing MoBCs at each Stage.
- Methodology –Understanding research methods and designs appropriate for each Stage that clarify or test MoBCs:
- Methodologies and study designs appropriate for each Stage that contribute to understanding MoBCs (e.g., multi-component interventions, multi-site designs, adaptive interventions, N=1 interventions, etc.).
- Statistical considerations of research methodologies and designs at each Stage, and implications for conclusions about MoBCs.
- Scalability –Understanding how determining mechanism contributes to the creation of potent, scalable, culturally competent interventions:
- Differentiating between meaningful adaptations that affect the intervention’s hypothesized principles vs. flexible delivery methods devised to retain consistency with the hypothesized principles governing the intervention.
- Creating inherently personalized interventions that work across widely disparate groups of individuals who share a common characteristic or problem, amenable to remediation by an intervention that targets this specific characteristic or problem, minimizing the need for later adaptation.
- Simplifying interventions and their delivery, based upon knowledge of MoBCs.
As long as the curriculum addresses the required topics, short courses may be in any of a variety of formats, delivery modalities, length, and expected time to complete. Curricula should include at least some case studies or examples from aging-related behavioral intervention research, but others may be included too.
Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, investigators are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Further, applications must:
- Describe the evaluation or assessment process to determine whether the overall program is effective in meeting its mission and objectives, and whether the scientific research climate is inclusive, safe, and supportive of participant development.
- Detail the plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations.
Dissemination Plan. Candidates must provide a description of the strategy for dissemination of the short courses as it is critical that these courses reach a broad audience. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program (e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops).
Non-Responsiveness Criteria
The following types of applications will be considered non-responsive to this NOFO and will not be reviewed:
- Applications that do not develop an NIH Stage Model training curriculum that explicitly addresses the six required topics as described above, and as defined by the NIH Stage Model.
- Applications that do not include an evaluation plan for evaluating the activities supported by the award.
- Applications that do not include a dissemination plan describing how course materials will be made available nationally.
Additional Considerations
Candidates are encouraged to partner with existing NIH-funded or other federally funded resources and programs and leverage training activities from both federal and private-sector partners including, but not limited to, the following:
- Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging
- Resource Centers for Minority Aging Research (RCMAR)
- Claude D. Pepper Older Americans Independence Center (OAIC)
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving federal support. R25 programs may augment institutional research training programs (e.g., T32, T90), but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.
Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate, and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical and behavioral sciences (e.g., see the Notice of NIH’s of Interest in Diversity). For the purpose of this announcement, institutions are strongly encouraged to recruit participants who will enhance diversity on a national basis.
Consistent with existing NIH practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a participant or faculty candidate as an eligibility or selection criteria, and (2) NIH does not use the race, ethnicity, or sex of prospective participants, participants, or faculty in the application review process or funding decisions. Applicants and award recipients are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.