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

Call for Applications: Interventions for Elder Mistreatment

The Roybal Center for Elder Mistreatment Intervention Research is pleased to announce a call for applications for projects aimed at advancing research on interventions for elder mistreatment (EM), including (a) interventions to prevent EM and (b) interventions to prevent the negative health and mental health consequences of EM. The Center is designed to overcome crucial barriers that have historically prevented significant, impactful progression of EM intervention development research, and to assist investigators in building sustainable EM research programs.

Application due:  February 12, 2025

Background

EM, including financial exploitation, neglect, self-neglect, and various forms of abuse, affects a significant portion of older adults living in the community (over 15%) and an even greater number of persons living with Alzheimer’s Disease and Related Dementias (over 50%). Despite the negative outcomes associated with EM, evidence-based guidelines for prevention and management are lacking. The UTHealth Roybal Center for Elder Mistreatment Intervention Research aims to address this lack of available interventions by supporting innovative projects that advance the field of EM research through mechanisms-focused interventions.

Eligibility

We invite proposals from new and new-to-the-field investigators who intend to develop or adapt evidence-based interventions from related fields that target known EM risk factors or outcomes through a clearly defined mechanism. Interventions can target either the caregivers at risk for engaging in EM or the older adults at risk for experiencing EM. Eligible applicants must be independent researchers with faculty appointments at the time the award will be made. Applicants must also include a letter of support from their department chair confirming their availability of release time if funded.

Proposals must focus on stages 0-2 of the NIH Stage Model of Behavioral Intervention Development and must be supported by a clearly defined mechanism. All proposed projects must be a clinical trial with adequate statistical power to test mechanisms of behavior change and/or the efficacy of the intervention. We understand that not all scientists get extensive training in trial design and power analysis, which can be a barrier to submitting a proposal. However, we don’t want this to be a barrier for you. We can connect you with experts who can assist you with these elements of your proposal. 

Research Focus  

We encourage applications that address:

• Adaptation of evidence-based interventions to target known EM risk factors or outcomes.

• Development and initial testing of behavioral intervention mechanisms.

• Innovative approaches to real-world testing and collaboration with service providers.

Applicants will be judged as non-responsive if:

• They do not have a primary focus on behavioral and/or social intervention development.

• They are not focused on supporting community-dwelling older adults or their caregivers in the prevention or reduction of EM and its outcomes. Proposals focused on long-term care settings are outside the scope of this solicitation.

• They do not address stage 0-2 of the NIH Stage Model of Behavioral Intervention Development.

• Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.

Funding Details

• Amount: The Center intends to commit $300,000 in total costs each year to fund 1-3 awards.

• Duration: The Center will consider projects that are up to 2 years in length.

• Indirect costs: All project budgets should be inclusive of indirect costs. We strongly encourage applicants to seek IDC waivers to maximize the direct costs available to projects.

• Format: Proposals must adhere to the R03 grant format guidelines.

• Support Requirements: If your project involves university cores, services, or external recruitment sites (e.g., bioinformatics support for electronic health record data), please include appropriate letters of support.

  
  

Mentorship and Support

To ensure the progression of successful interventions, the selected project proposals will benefit from guidance provided by the UTH Roybal Cores, the Evaluation Committee, and the External Advisory Committee. This will include help working with service providers such as Adult Protective Services, securing testing sites, and navigating IRB requirements. A formal mentor or training plan is not required.

Submission Instructions

Please submit a one-page specific aims page directly to Drs. Acierno and Cannell (contact information below or at right) before submitting a full application.

Applications should be submitted electronically to the School of Nursing grants management office. Proposals must adhere to the R03 format guidelines and include all necessary letters of support.

Click here to see full funding announcement

Funding-Announcement.pdf

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Call for Clinical Trial Proposals

The NBER Roybal Center for Behavior Change in Health seeks proposals for research projects that involve randomized controlled trials (RCTs) or other NIH-defined clinical trials, and that, if approved for funding by the National Institute on Aging (NIA), would receive support during the period June 1, 2025 through May 31, 2026. Eligible projects must explore some aspect of the relationship between health and human behavior and must be adequately powered to detect meaningful treatment effects. Potential project funding is likely to fall in the range of $175,000 to $260,000 of direct costs.

Is your project an NIH-defined clinical trial? 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?

   
   

Proposals will be evaluated by the Center co-PIs (Marcella Alsan and Joseph Doyle) and Advisory Committee for research design, relevance, feasibility, scalability, and timeliness. We look for projects that propose to test scalable interventions with the potential to broadly improve population health as people and prioritize those with the potential to advance through the NIH Stage Model for Behavioral Intervention Development. Projects that evaluate mechanisms of behavior change are of particular interest.

To be eligible for support, subject recruitment for the study may not have started yet, and it must be possible to delay recruitment until after formal NIH approval.  The project must comply with all NIH clinical trial policies.

We welcome proposals from affiliates and non-affiliates, junior researchers, and scholars who are members of groups that are under-represented in the economics profession.

Please direct questions to the Associate Director of the NBER Roybal Center, Sarah Holmes Berk (sholmes@nber.org, 617-588-1445). 

Next steps / How to apply: 

• This summer/fall:  Reach out to us about potential project ideas and determine suitability for an application.

• By Monday, January 6, 2025: Submit a brief description of your project (including power calculations) and anticipated budget needs. Upload a PDF with this information here.

• By Friday, January 24, 2025: We will tell you if we are able to include your project.

• By Monday, February 24, 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 draft. Complete applicable NBER 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 periodically on your progress. If applicable, update the DSMB and/or SO periodically and submit monthly enrollment data to NIA. Help us maintain your ClinicalTrials.gov and Human Subjects System records.

• The University of Illinois Chicago (UIC) Midwest Roybal Center for Health Promotion and Translation seeks to advance the science, translation, and practice of health promotion programs for underserved older adults at risk of Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) in order to improve the functioning and quality of life of this growing segment of our population.

Click here to see full funding announcement