Request for Proposals

The USC-Yale Roybal Center for Behavioral Interventions in Aging seeks proposals for research projects that study mechanisms of behavior change and involve randomized controlled trials (RCTs) (see LOI guidance and application found here.) For the upcoming year, we will support 2 projects with a maximum direct cost of $200,000 per project that, if approved for funding by the National Institute on Aging (NIA), would receive funding during the period of June 1, 2025, through May 31, 2026. Although a 12-month timeline is typical for these projects, we will consider longer timelines of up to 18 months. Eligible projects will propose to study a health outcome or behavior that promotes a better health outcome and must be adequately statistically powered to detect meaningful treatment effects.

Proposals will be evaluated for research design, innovation, feasibility, scalability, and timeliness using the following Proposal Evaluation Criteria. Projects must propose to test mechanisms of behavior change (factors that mediate or moderate an effect) that can inform scalable interventions with the potential to improve health- related outcomes from midlife to older adults. Projects must specify the development stage according to the NIH Stage Model for Behavioral Intervention Development.

Responsiveness criteria:

1. Projects must include an evaluation of mechanisms of behavior change.

Proposals should focus on careful testing of mechanism-driven interventions to contribute to an understanding

of causal drivers and/or mediators (psychological processes that explain how an intervention leads to change)

and moderators (factors that influence the magnitude or probability of behavior change) to help identify how an intervention works, for whom, and in which contexts, helping to identify heterogeneous subgroup effects or

variations on intervention design.

This includes intervention and study designs that apply and test specific principles of behavioral economics to improve individual or institutional decisions and processes. Examples include investigating the ways in which defaults help to address causal drivers of health disparities; how different choice architectures impact decision support tools; and messenger effects on the promotion of preventive care.

2. Projects must be an NIH-defined clinical trial

To be an NIH-defined clinical trial that studies mechanisms, the answers to the following four questions must be “YES”:

1. Does the study involve human participants?

2. Are the participants prospectively assigned to an intervention?

3. Is the study designed to evaluate the effect of the intervention on the participants?

4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

Studies must be prospective to be eligible for support. The project must comply with all NIH clinical trial policies.

3. Projects must address health-related behavior

Participants are encouraged to propose trials at their own institutions or coordinate with our partner organizations, the Roybal Implementation Network, which includes Contra Costa Health, Geisinger Health, Keck Medicine of USC, Northwestern Medicine, and Yale University. Potential topics of interest for RCTs identified by our partner sites include (but are not limited to):

• Preventable readmissions

• Equity of care

• Care transitions

• Addressing social determinants of health or health-related social needs

• Prescribing/Deprescribing/Polypharmacy

• Vaccination

• Operational optimization (throughput, no-show, scheduling)

• Preventive screening

• Overuse/inappropriate use of emergency medicine

• Advanced care planning

• Medication adherence

• Social services

• Overuse of diagnostic services

• Mobility/Fall prevention (inpatient and outpatient)

• Mood metrics (depression screening)

• Advanced care at home

  
  

The sustainability and scalability of intervention modalities will be considered, including using email, SMS, phone, clinical decision support, dashboards, and existing programs that are aligned with operational resources and priorities.

4. Proposed projects must have adequate statistical power to test mechanisms of behavior change and/or efficacy of the intervention.

Proposals must include a power calculation to demonstrate that the study design can adequately answer the research questions, test the proposed hypotheses, and provide interpretable results.

Next steps / How to apply:

• This Fall: The USC-Yale Roybal Center team is available to discuss proposal ideas or answer related questions from potential applicants. Please email knight@usc.edu to schedule a time.

• By Friday, January 10, 2025: Submit a brief description of your project using the LOI guidance and application found HERE.

• By Friday, January 31, 2025: We will tell you if you are invited to submit a full application.

• By Friday, March 7, 2025: Using templates and instructions we will provide, submit your Specific Aims,

  2-page Research Design, Human Subjects Questionnaire, Planned Inclusion Enrollment Report(s),

  Budget, Biosketch, and Other Support.

• During March 2025: Review and approve your Human Subjects System record, which we will help to

  draft. Complete applicable USC-Yale Roybal Center and NIH administrative requirements.

• Summer 2025: We will learn if your study has been approved by the NIH. Depending on the risks

  associated with your study, the NIH may require your study to receive Data & Safety Monitoring Board

  (DSMB) and/or Safety Officer (SO) approval before recruitment can begin.

• For as long as your study continues: Update us quarterly on your progress and be available for

  Center meetings as needed. If applicable, update the DSMB and/or SO periodically and submit monthly enrollment data to NIA. Help us to maintain your CROMS, ClinicalTrials.gov and Human Subjects System records.

Click here to see full funding announcement

Behavioral RCT Funding Announcement

Each year, millions of Americans who experience serious health events such as heart attacks, strokes, or cancer diagnoses develop severe anxiety, depression, and even PTSD, and all too often, these individuals do not follow recommendations for health behaviors such as exercise, diet, or taking medications even though they are essential to recovery and prognosis.

The Columbia Roybal Center for Fearless Behavior Change, funded through the National Institute on Aging (NIA), is dedicated to advancing behavioral interventions that reduce psychological distress and improve health behaviors in these patients, with the ultimate goal of advancing effective behavioral interventions with the potential to be routinely implemented into clinical practice.

We are excited to announce our new call for proposals to fund randomized clinical trials (RCTs) that test behavioral interventions. These trials should seek to test interventions that are designed to reduce psychological distress and/or improve health behaviors in diverse midlife and older adults who have suffered serious health events. Studies that test implementation strategies for increasing the uptake of effective behavioral interventions into practice will also be eligible. Interventions should be designed with consideration of mechanisms of behavior change and health equity. Relevant study populations include, but are not limited to, patients with stroke, myocardial infarction, cardiac arrest, COPD, heart failure, respiratory failure, or recent diagnosis of cancer or end-stage renal disease. Relevant behavioral outcomes include, but are not limited to, measures of quality of life or psychological distress such as depression, anxiety, or PTSD and of health behaviors such as medication adherence, physical activity, or sleep.

Applicants must demonstrate how they will follow the mechanism-driven approach to intervention development promoted by the Science of Behavior Change. This involves testing the effect of the intervention not only on the target health behavior (e.g., medication adherence or physical activity), but also on the proximal mechanism that explains how the intervention works (e.g., reducing fear of recurrent cardiovascular events). Applicants are also expected to explain how the current trial will help advance the intervention along the NIH Stage Model and what the next step in intervention development will be if they are successful. (See NIH Stage Model for nomenclature onstage of behavioral intervention development).

Early-stage studies that are limited to assessing the feasibility of behavioral interventions (i.e., Stage I on the NIH Stage Model) are not eligible.

Award Amount

Up to $300,000 in total costs over a two-year period, contingent on institutional IC rates. The second year of funding will be dependent on achieving milestones from Year 1.  

Investigators will also receive support from the Columbia Roybal Center with finalizing the study protocol including selecting robust measures of behavioral mechanisms and health behaviors (e.g., actigraphy, electronic pill bottles); consultations on data management and analysis; planning for data and safety monitoring; and advice on integrating implementation outcomes into their research plan. Investigators will also gain mentorship from experienced behavioral trialists involved in the Columbia Roybal Center as well as opportunities for disseminating their study findings. Applicants are also encouraged to inquire about the possibility of applying for co-funding from other Centers in the Roybal Network.

Duration

Up to 2 years, with an anticipated project period June 01, 2025 – May 31, 2027.

Number of Awards

Up to 1 award per year.

Eligibility

Applicants can be post-doctoral research fellows or faculty of any rank but must show evidence of being able to complete the trial within two years. Applicants from groups that are underrepresented in behavioral medicine research are particularly encouraged to apply. Applicants are not required to be affiliated with Columbia University; however, all applicants must be directly affiliated with a domestic, US-based institution. This project does not currently support foreign/international components or foreign/international institutions.

Deadline

Applications are now being accepted. Applications must be submitted by Monday, December 16, 2024.

Trial Selection

Applicants will be notified of the outcome of their application by Monday, January 20, 2025. All submissions will receive feedback from the review committee. Applications that are not selected may resubmit their application the following year. Selected projects will then coordinate with the Roybal research team to formally submit a proposal for broader NIH approval, with an anticipated project period of June 01, 2025 – May 31, 2027, pending NIA and IRB approval.

Application Process Overview

Applicants will be required to submit a 3-page research strategy describing the significance, innovation, approach, and expertise of the study team, statistical analysis plan, preliminary budget, and biosketches of all co-investigators.

Review Process

Reviewers, including patient stakeholders, will score proposals from 1-9 for overall impact, broadly mirroring the NIH approach to grant review. Reviewers will judge each application on the basis of significance, innovation, expertise of the applicant and formation of diverse multidisciplinary teams inclusive of patient stakeholders, rigor of the scientific approach including its consideration of mechanisms of behavior change, likelihood that study activities can be completed on time, potential impact on health equity, potential to lead to subsequent funding, and alignment with goals of the Columbia Roybal Center. Early-stage investigator status will be viewed favorably when prioritizing applications for funding.

At least two independent reviews will be obtained for each proposal. A “study section” will be convened in December 2024 at which the top ranked proposals will be discussed. One proposal will be selected for funding in the upcoming year.

Applicants are encouraged, but not required, to attend pre-application office hours with our Center’s directors to ask questions about how to be responsive to the RFP.

Interested applicants may choose to write a brief letter of intent (no more than one page) to Co-Directors, Dr. Ian Kronish, ik2293@cumc.columbia.edu, and Dr. Nathalie Moise, nm2562@cumc.columbia.edu, if they wish to schedule a consultation. 

Contact

For any questions about the scientific content, contact: Dr. Ian Kronish and Dr. Nathalie Moise, Directors, Columbia Roybal Center, ik2293@columbia.edu (212) 342-1335 and nm2562@cumc.columbia.edu

For any questions about the application process and format, contact: Robin Cumella, rmc2203@cumc.columbia.edu. 

Click here to see full funding announcement

Behavioral Intervention Trials

ASU Roybal Center seeks applications to conduct NIH Stage I-III randomized clinical trials that will develop and test mechanisms of behavioral change (MoBC)-driven and technology-enabled behavioral and lifestyle interventions for older adults living alone with cognitive decline.

These trials should test the ASU Roybal Center’s Conceptual Framework (Exhibit 1) with rigorous design to secure future funding (e.g.,NIH R01) to advance to the next Stage. We will award two trials at $150,000

total (direct + indirect) each year for two years, starting June 1, 2025 (pending NIA approval). Applicants

are strongly encouraged to seek IDCwaivers from their own institutions to maximize the direct costs for trials.

One-year no-cost extension may be considered.

Eligibility

The awards are for Early Stage Investigators (ESIs) as defined by the NIH, mid-career and established investigators across the U.S. Collaboration with experts in behavioral and lifestyle interventions, including with Center faculty, is encouraged but not required. The award selection process will adhere to the ASU Advancing Inclusion and Culture (AIC) guidelines. 

Evaluation criteria

Applications will be evaluated on six criteria:

1. significance of the problem for older adults living alone with cognitive decline

2. ability to test ASU Roybal Center’s Conceptual Framework

3. methodological rigor

4. strength and novelty of the intervention

5. potential to advance to the next Stage and future funding

6. qualifications of the investigator team

   
   

Application Process

Step 1: Submit a Letter of Intent (LOI) to ASURoybalCenter@asu.edu by 11:59pm PST on 2/18/2025 in one PDF document containing the following in order:

1. General Information Form

   1. Cover page with project title

   2. Name of Principal Investigator and project team

   3. Contact information including mailing address, email, and telephone

2. Research Strategy (maximum 2 single-spaced pages with one-inch margins) describing: 

   1. significance of the problem as it relates to older adults living alone with cognitive decline

   2. Test of an operationalized model of ASU Roybal Center’s Conceptual Framework (see Figure 1)

   3. Enablement of behavior and lifestyle intervention by technology 

   4. Methods including design, setting, sample and sample size, control (if applicable), outcome(s), and timeline

   5. Plan to advance to next Stage research and its NIH funding mechanism(s)

   6. Qualifications of the investigator team

3. NIH Biosketch for the PI(s) and all Co-Is. Please follow biosketch instructions and examples.

Step 2: Consult with ASU Roybal Center Behavioral Intervention Development (BID) Core.

Step 3: Submit full application (1-page Specific Aims & 6-page Research Strategy). PIs who are invited to submit will receive notification by Friday, February 28 with instructions for full application submission which is due by 11:59pm PST on 3/31/2025.

Click here to see full funding announcement