Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01) | Apply Online

Opportunity Summary:

The NIH funding opportunity PAR 11 045, titled "Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01)," supports Research Project Grant (R01) applications focused on improving how treatment effects are measured in clinical trials involving people with intellectual and developmental disabilities (IDD). The announcement is jointly issued by three NIH Institutes: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS). At its core, the FOA is aimed at a persistent bottleneck in IDD treatment research: many potential therapies, including pharmacologic approaches, are difficult to test rigorously because the field lacks outcome measures that are sufficiently sensitive, reliable, and clinically meaningful for these populations.

The main purpose of the grant is to encourage projects that develop new outcome measures, or that validate and calibrate existing ones, so they can be used confidently in clinical trials. In practical terms, this means creating or refining tools that can detect meaningful changes over time, distinguish treatment effects from normal developmental variation, and perform well across the range of functioning often seen in IDD. The emphasis on "informative" outcome measures reflects the expectation that the resulting tools will be more than simply easy to administer; they should produce data that is interpretable for clinical decision-making and for regulatory-grade trial design, particularly in areas where outcome measurement has been a neglected but essential foundation for therapy development.

A major theme in the FOA is its relevance to pharmacological treatment development. Drug trials in IDD frequently struggle because standard endpoints may not translate well to IDD populations, may show floor or ceiling effects, or may fail to capture changes that matter to individuals and families. By funding measurement-focused research, the NIH is signaling that better endpoints are a prerequisite for determining whether interventions truly work, which in turn influences whether promising treatments move forward in the development pipeline. The FOA is positioned as a way to concentrate clinical and translational research effort on this measurement gap, which can affect the success of both behavioral and biomedical interventions.

This is a discretionary grant program using the R01 mechanism, meaning it is intended for substantial, hypothesis-driven research projects with a defined plan for method development and evaluation. The funding activity category is listed under Health, Income Security and Social Services, and it is associated with multiple CFDA program numbers: 93.242 (Mental Health Research Grants), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and 93.865 (Child Health and Human Development Extramural Research). No cost sharing or matching is required, which is typical for many NIH research grants and lowers the barrier for a wide range of applicants.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, small businesses and other for-profit organizations, and multiple levels of government (state, county, city or township, special district governments, independent school districts, and public housing authorities/Indian housing authorities). The FOA also explicitly includes tribal entities (federally recognized tribal governments and other tribal organizations), U.S. territories or possessions, and a range of mission-serving institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations. It also allows foreign organizations and regional organizations, as well as eligible federal agencies, reflecting NIH's interest in drawing on the best measurement science wherever it is located.

The opportunity was originally posted on November 23, 2010, later archived in 2013, with key dates in the record including an original closing date of May 7, 2013, a current closing date listed as April 25, 2013, and an archive date of May 25, 2013. While this listing is archival, the program description remains useful as a statement of research priorities and as a template for similar NIH measurement-development initiatives.

The FOA also notes a related, simultaneously issued announcement that may interest some applicants: PAR 11 038, "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)." Taken together, the pairing underscores a broader NIH strategy at the time: strengthen both preclinical predictors of treatment response and the clinical trial endpoints needed to evaluate therapies in real-world IDD populations.

For applicants seeking the full details, the archived NIH Guide entry is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-11-045.html (spacing and punctuation may need to be corrected if copying from older records). Technical issues accessing the announcement were directed to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV, reflecting standard NIH support channels for archived funding announcements.

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