Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) | PAR 23 256

FAQs: NIH PAR-23-256 (R34) - Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging

What is PAR-23-256?

PAR-23-256 is a National Institutes of Health (NIH) funding opportunity titled "Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)." It supports early-stage, proof-of-concept clinical trials that test music-based interventions for brain disorders commonly associated with aging.

What is the main purpose of this funding opportunity?

The main purpose is to fund feasibility studies that generate the practical and scientific groundwork needed before launching a larger, more definitive clinical trial. Projects are expected to produce pilot data strong enough to support a later clinical efficacy, effectiveness, or pragmatic clinical trial application.

What kind of studies does this opportunity support?

This opportunity supports early-stage feasibility clinical trials (proof-of-concept) that test music-based interventions in populations affected by brain disorders of aging, with a strong emphasis on feasibility, acceptability, safety, implementability, and measurement approaches that will translate into a later larger trial.

Is a clinical trial required under this opportunity?

Yes. The mechanism is R34 and the opportunity specifies "Clinical Trial Required," meaning funded projects must include a clinical trial component.

What does "feasibility trial" mean in the context of this opportunity?

In this context, a feasibility trial is designed to de-risk and prepare for a subsequent, larger trial by testing whether the intervention and trial procedures can be carried out in the target population and realistic settings. It typically focuses on operational and methodological questions (for example, recruitment, retention, adherence, fidelity monitoring, and practicality of control conditions), and on whether outcome measures and procedures are workable and informative for a future trial.

What is the NIH Music-based Interventions (MBI) Toolkit and how must it be used?

The NIH MBI Toolkit is a set of principles intended to guide how music-based interventions are designed, delivered, and evaluated. Under PAR-23-256, projects are expected to be explicitly guided by the toolkit, using its principles as a central framework rather than treating it as optional background. A key expectation is that results will help validate or refine those guiding principles.

What conditions or populations are in scope for this funding opportunity?

The focus is on brain disorders of aging. Examples listed include (but are not limited to) Alzheimer's disease and Alzheimer's disease-related dementias, Parkinson's disease, and stroke.

What types of music-based interventions are expected to be tested?

The opportunity supports music-based interventions, with the specific expectation that the intervention is designed, delivered, and evaluated in alignment with the NIH MBI Toolkit principles. The provided information does not list specific intervention formats, but it emphasizes using toolkit-guided methods.

What kinds of evidence should a feasibility trial produce for this opportunity?

The feasibility trial is expected to generate operational and scientific evidence reviewers typically look for when considering a full-scale study. Examples include recruitment and retention performance in older or neurologically impaired populations, adherence over time, fidelity monitoring for the music-based protocol, the practicality of the control or comparison condition, and preliminary signals that selected outcomes are sensitive and appropriate.

What does it mean that the study should address "scientific or methodological gaps"?

It means applicants are expected to use the feasibility trial to tackle key uncertainties that currently prevent confident large-scale testing in the field. The project should go beyond asking whether the intervention can be delivered and should also determine whether it is acceptable, safe, implementable in realistic settings, and measurable in ways that translate cleanly into a later, larger trial.

Is the goal to prove efficacy in this R34 feasibility trial?

The emphasis is on feasibility and building a credible foundation for a later trial rather than running a definitive efficacy test. The trial may look for preliminary signals to help select outcomes and procedures, but it is primarily meant to support a subsequent, larger clinical trial application.

What types of outcomes or trial features are emphasized for feasibility?

Feasibility-relevant features highlighted include recruitment and retention, adherence to the intervention, fidelity monitoring, practicality of the control/comparison condition, and whether outcomes and procedures are appropriate and sensitive enough to carry forward into a later larger trial.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations and governmental entities. Eligible applicants include: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside higher education); for-profit organizations other than small businesses; and small businesses.

Are minority-serving institutions and community-based organizations eligible?

Yes. The opportunity highlights additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are listed among the additional eligible applicant types.

Can federal government agencies apply?

Yes. Eligible federal government agencies are listed among the additional eligible applicant types.

Are non-U.S. (foreign) organizations eligible to apply?

No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply under this opportunity.

Can a U.S. organization include non-U.S. components in its application?

Non-domestic components of U.S. organizations are not eligible. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning certain foreign elements may be included if they meet NIH's definition and requirements for a foreign component.

What type of grant is this?

This is an NIH discretionary grant opportunity using the R34 mechanism, which is commonly used for clinical trial planning and feasibility work. The opportunity specifically requires a clinical trial.

What are the CFDA numbers associated with this opportunity?

The opportunity is listed under CFDA numbers 93.213 and 93.866.

When was this opportunity created and what was the listed closing date?

The opportunity was created on August 7, 2023. The original closing date listed in the provided information is December 21, 2023.

Is the award ceiling or expected number of awards provided?

No. The provided source data does not specify an award ceiling or the expected number of awards.

Where should applicants look for budget expectations, project period norms, and review considerations?

Because the provided information does not include those details, applicants would typically consult the full NOFO and any linked NIH Institute or Center guidance for budget expectations, project period norms, and review considerations.

What is the expected trajectory after completing an R34 feasibility trial under this program?

The expected trajectory is that the feasibility trial will produce pilot data and operational evidence to support a later, competitive application proposing a larger clinical trial (for example, an efficacy, effectiveness, or pragmatic clinical trial).

How should applicants think about control or comparison conditions in the feasibility trial?

The feasibility trial is expected to examine the practicality of the control or comparison condition so it can be carried forward into a later larger trial. This includes determining whether the comparison approach is workable in realistic settings and acceptable to participants.

What is meant by fidelity monitoring for the music-based protocol?

Fidelity monitoring refers to assessing whether the music-based intervention is delivered as intended according to the protocol. The opportunity highlights this as an important feasibility element to test before scaling to a larger trial.

What makes this opportunity distinct from music and health research that is not toolkit-guided?

A defining feature of this opportunity is the expectation that the study is explicitly guided by the NIH MBI Toolkit. The toolkit is meant to shape intervention design, delivery, and evaluation, and the feasibility results are expected to help validate or refine the toolkit principles rather than treating the toolkit as merely informational.