Promoting Healthy Children and Youth Topical PCORI Funding (US)

Applications proposing interventions that involve parents and caregivers are acceptable. Studies that propose to evaluate interventions targeting parents or caregivers that do not include a primary outcome measure of child and youth health or well-being will be considered nonresponsive to the funding announcement. Applicants may propose comparative effectiveness studies of prevention, screening, diagnostic, treatment and management approaches, and pharmacologic, no pharmacologic, and or combination therapies, as appropriate.

Applicants are strongly encouraged to assess issues of intervention implementation to facilitate widespread uptake of findings after completion of the study. Toward that end, hybrid type 1 and hybrid type 2 trials may be appropriate. Hybrid type 3 trials, as well as strict implementation or dissemination studies, will not be considered responsive, nor will studies focused on the development of research methods.

Topics

• The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing one of the below SAEs should identify the area that is best associated with their research approach.
  • Prevention and treatment of obesity: Obesity is a complex disease associated with sequelae that can impair a child’s well-being and quality of life during a critical time for growth and development. Rates of pediatric obesity remain high in the United States and disproportionally affect Black and Hispanic or Latino youth and those from low-income households.
  • Addressing social determinants of health/social needs to improve health outcomes: Children and youth constitute the poorest segment of the U.S. population. Poverty, and its associated social and structural drivers are significant upstream causes of child morbidity and mortality.
  • Targeted prevention of substance misuse through identified risk factors: Adolescence is a critical period for physical and psychological development and is also a susceptible time for the initiation of substance misuse. Timely targeted prevention approaches are imperative to avoid and address substance misuse as early as possible and mitigate associated negative outcomes.

Funding Information

• PCORI has allotted up to approximately $100 million under this PFA to fund high-quality, patient centered comparative clinical effectiveness studies that respond to research questions of interest. The proposed budget for studies under this initiative can include up to $12 million in direct costs.

Eligibility Criteria

• In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the federal government, nonprofit and for profit research organizations, and colleges and universities.
• Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions: abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract; comply with the PCORI methodological standards adopted by the Board of Governors; consult, as appropriate, with the expert advisory panels for clinical trials and rare disease; deposit de-identified data from the original research into a PCORI designated repository to facilitate data sharing, as appropriate; have appropriate processes in place to manage data privacy and meet ethical standards for the research; comply with the requirements of PCORI for making the information available to the public; and comply with other terms and conditions determined necessary by PCORI to carry out the research project.

For more information, visit PCORI.