The Patient-Centered Outcomes Research Institute (PCORI) seeks 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). 

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 in 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. Mental health disparities among those with IDD may be especially pronounced for individuals belonging to racial and ethnic minority groups. Broad evidence gaps exist around mental health treatment in individuals with IDD, and stakeholders have identified a pressing need for more research on interventions for those with both IDD and mental health conditions.  

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, collaborative care, 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, 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.  

Please note: The PCORI Cost Principles state that PCORI will not cover costs for study interventions that constitute the procedures, treatments, interventions, or other standard clinical care (“patient care”) that is being proposed for comparison in the research project (“patient care costs”).

However, for the Cycle 2 2021 Intellectual and Developmental Disabilities PFA, PCORI will pilot consideration of funding support for meritorious applications providing well-supported and justified requests to cover patient care costs related to mental health conditions. This may include the intervention being studied as well as clinical personnel costs for those providing the care related to mental health conditions. For additional information on the conditions for such coverage, see the Coverage of Intervention Costs section in the funding announcement. Applicants should submit a realistic budget and timeline reflecting the proposed study’s scope and requirements.

Reminder: The primary institution’s Administrative Official must review, authorize, and submit the full application by 5 pm ET on August 31, 2021. 

Download Full Announcement

Key Dates

Online System Opens
May 4, 2021, 12:00 AM
Letter of Intent Deadline
June 1, 2021, 12:00 AM
Application Deadline
August 31, 2021, 12:00 AM

Funds and Project Period

Funds Available Up To

$40 million

Total Direct Costs

Up to $3 million

Maximum Project Period

3 years


Award Types