|This PCORI Funding Announcement will open on Tuesday, May 4, 2021, with more information about the funding opportunity.|
Notice of Upcoming PCORI Funding Announcement
The Patient-Centered Outcomes Research Institute (PCORI) plans to release a Targeted PCORI Funding Announcement (tPFA) on May 4, 2021, seeking to fund randomized controlled trials (RCTs) and/or observational studies that focus on comparative effectiveness of interventions targeting mental health conditions in individuals with intellectual and developmental disabilities (IDD). This tPFA preannouncement is provided to allow potential applicants additional time to identify collaborators; obtain stakeholder input on potential studies; and develop responsive, high-quality proposals.
PCORI’s 2019 reauthorizing legislation specifies IDD as a research priority. There are approximately 7–8 million people in the United States with IDD, representing about 3 percent of the population. While people with IDD often have co-occurring conditions, mental health conditions in particular are common, with prevalence estimates ranging from 37 percent to 55 percent in those with IDD and up to 65 percent in adolescents with IDD. There is a high degree of heterogeneity for symptom presentation and unique sets of needs across the lifespan for those with IDD and co-occurring mental health concerns, and these factors contribute to care complexity. Broad evidence gaps exist around mental health treatment in individuals with IDD, and stakeholders have identified more research on interventions for those with both IDD and mental health conditions as a priority.
PCORI’s tPFA will solicit applications that respond to the following question:
What is the comparative effectiveness of evidence-based approaches (e.g., specific pharmacologic and behavioral interventions) that address mental health conditions in individuals with IDD?
Proposed studies should compare the effectiveness of pharmacological, behavioral, other nonpharmacological or combination interventions administered via appropriate delivery modalities (e.g., telehealth, family-based, group or individual). Comparison of different healthcare delivery models for this population is also acceptable. Interventions must be evidence-based and/or in widespread use and reproducible. Standard interventions with established efficacy (e.g., cognitive behavioral therapy vs. selective serotonin reuptake inhibitors for depression), those that target relevant psychological domains (e.g., dialectical behavior therapy or acceptance and commitment therapy targeting emotion dysregulation), or mental health interventions developed or adapted for those with IDD may be acceptable.
PCORI is interested in studies focused on pediatric, transitional age, and adult individuals with mild to moderate IDD-related impairment, as well as those with more severe impairment due to IDDs. Underrepresented groups and other underserved populations (e.g., individuals in rural settings) are of particular interest.
Applicants should consider the following outcomes: symptom severity, functional impairment, quality of life, adverse events, health resource utilization, and relevant caregiver outcomes. Measures validated in the IDD population of interest are preferred, but alternative measures may also be acceptable if accompanied by a strong rationale for their use. Length of follow-up should be determined based on appropriateness for the intervention/design.