The purpose of this Funding Opportunity Announcement (FOA) is to support multi-site clinical trials in geographically diverse school settings to test the efficacy or effectiveness of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) to promote mental, emotional, and behavioral (MEB) health and prevent MEB disorders among youth.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, U.S. Virgin Islands, Guam, American Samoa, Commonwealth of the Northern Mariana Islands
Type of Grant: Grant
Deadline: 10/28/2022
Size of the Grant: $500,000
Grant Duration: 5 years
Details:
The overall goal of this FOA is to provide support for a set of multisite trials to improve the evidence base of complementary and integrative health approaches that can be delivered in a school-based setting or with students to address the youth mental health crisis. Awards made under this FOA will support a milestone-driven planning phase (UG3) for one year with possible transition to a study conduct phase (UH3) of up to an additional four years. Total duration of the award will be a maximum of 5 years. Only UG3 projects that meet the scientific milestones and feasibility requirements will transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application describing both phases and instructed in this FOA.
The proposed trials must meet all the following criteria:
- The project must include a complementary or integrative health intervention
- The project must study MEB in youth in school settings or identify youth at schools and then provide after school or telehealth delivered intervention for youth.
- The project must test an intervention, or coordinate several interventions (which can be treatments, preventive actions, or organizational changes) that are robust, apply to the prevention or treatment of MEB in youth and are suitable for use in school settings, with the broad goal of determining whether the intervention(s) is efficacious or effective.
- The intervention(s) must be well-characterized and available such that it could be reliably delivered in school settings.
- The intervention(s) must be reasonably simple and not require a complex structure for implementation or monitoring.
- The outcome measure(s) must be related to MEB and clinically meaningful and important to stakeholders including youth, parents, teachers, and school administrators.
- The project design must incorporate rigorous controls, prospectively identified, preferably by randomization. The design may incorporate novel randomization approaches, such as by cluster or timing of implementation. If another method is used to generate the comparison group, perhaps by staged assignment or staged implementation of the intervention, it should provide comparable rigor.
- Proposed analytic plans for projects that proposed cluster-randomized trials must address adequacy of sample size and study power and employ analytic strategies relevant for such trial designs. Applicants are strongly encouraged to consult Collaboratory Biostatistical Guidance documents.
- The project must enroll youth based on broad eligibility criteria to maximize diversity, and minimize intentional or unintentional exclusions based on risk, health literacy, demographics, or expected adherence.
- Milestones for proposed trials must be appropriate (i.e., relevant, measurable, achievable, result-focused, and timebound) and a contingency plan must be provided in the event UG3 and/or UH3 milestones are not achieved.
Funding Information
- The application budget for the one-year UG3 phase is limited to $500,000 in direct costs.
- The maximum period of funding for the UG3 phase is one year and the maximum period of funding of the UH3 phase is up to four years, for a total of up to five years for the entire UG3/UH3 award.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.