NIH/NIMH/NIAAA – Development and Optimization of Tasks and Measures for Functional Domains of Behavior (R01 Clinical Trial Not Allowed)

October 1, 2018 by School of Medicine Webmaster

The purpose of this Funding Opportunity Announcement (FOA) is to support the development and optimization of tasks and/or measures for constructs pertaining to functional domains of behavior or cognitive/affective processes, for use in laboratory or population-based studies and clinical trials outcomes. This FOA encourages research that will result in the availability of tasks and measures of constructs that demonstrate: (1) good validity as a measure of a specific construct; (2) robust measurement properties; and (3) suitability for use with individuals who vary widely in age, ability, and/or severity of disorder. Because there are some constructs for which there are well-validated tasks/measures already available and others for which there are few standardized tasks/measures, ?candidate tasks/measures should be selected based on an analysis of the existing tools for assessing the construct(s) of interest and an assessment of the methodological and psychometric issues that are in need of further empirical work. Highest priority will be given to applications that target constructs with the greatest need for optimized measurement tools. In addition to the inherent value of having validated and psychometrically sound measurements, the tasks and measures will be evaluated for their potential to serve as common data elements for sharing and harmonizing data across multiple studies and data sets.

Research Objectives and Scope

This FOA encourages research projects to develop new tasks and measures or to optimize existing tasks and measures for functional behavioral constructs. Tasks and measures could include self-report tools, behavioral tasks, physiological measures, or neuroimaging protocols. Their properties should allow use with diverse research participants in a consistent manner. Optimally, tasks should provide a behavioral output, but for some constructs, a physiological or neuroimaging paradigm that does not involve behavioral responses may be appropriate. A single task/measure may yield multiple outputs or data elements, which may be associated with different constructs or units of analysis. It is important, however, that the specific relationship between individual outputs or data elements and the constructs be defined and determined. Because the development status of different tasks and measures varies, the nature and scope of proposed projects is expected to vary, with some projects focused on early stage development of novel tasks/measures and other focused on optimizing existing tasks. The intended use of the test should be considered in designing research projects; some tasks may be intended for use in high-throughput phenotyping or screening purposes, and others may require specialized equipment and procedures. Stages of measurement development covered in this announcement include validation, assessment of measurement characteristics, standardization of administration procedures/parameters, and collection of normative data.

Given the primary importance of validity in assessment methods, applications must provide either a review of existing evidence of strong validity for the task as a measure of an indicated construct or should include plans to test the construct validity of the task. This may be accomplished by tests of convergent, divergent, concurrent, and/or predictive validity. Evidence of validity can also be provided by data from relevant clinical populations, imaging studies with normal and clinical samples, and/or pharmacological or behavioral manipulation studies involving animal or human models.

Task parameters should be empirically tested in order to optimize measurement characteristics (i.e., psychometric properties), including such considerations as internal reliability, test-retest reliability, alternate forms reliability, stability, practice effects, ceiling/floor (i.e., range) effects, and optimal task length and difficulty. The degree to which these characteristics vary in clinical versus healthy populations is also relevant.

Standardization of administration procedures and parameters (e.g., number of trials, stimulus characteristics) enables examiners in diverse settings to implement tasks in a consistent manner. Applicants should address any administration and scoring difficulties that may limit usability. The standardization process should include considerations of burden and practicality and may include establishing specific stimulus or item sets and administration procedures including response options and presentation parameters, with appropriate attention to potential variation needed as a function of population, setting, or stimulus presentation hardware. Any modifications needed to allow use of tasks across different age groups and ability levels should be standardized. Documentation and ?instructions should allow implementation of the task(s) by new users.

Normative data are necessary for the interpretation of performance/scores across administration settings. For the purposes of establishing normative data, the participant sample should be diverse with regard to age, gender, ethnicity, education, and socioeconomic status. In particular, applicants should power studies to evaluate sex differences and sex-specific effects, in accord with current NIH priorities on sex as a biological variable (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html).

Successful applications will identify a true gap in measurement tools for a specific construct or ?constructs. Applications proposing to study a measure for a construct that already has several useable tasks will not be considered high priority for funding. Applicants should explain the details of the gap in available methods and how the proposed work will address the shortcoming. This should be accompanied by specific descriptions of the data that will be collected and what criteria will be used to evaluate if the characteristics are considered robust enough for use. An application may focus on a single task/measure or more than one task/measure.

Interests of Participating NIH Institutes, Centers and Offices

NIMH

The National Institute of Mental Health (NIMH) is interested in applications that pertain to the Research Domain Criteria (RDoC) initiative (https://www.nimh.nih.gov/research-priorities/rdoc/index.shtml ). The RDoC matrix includes five major domains of function (Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Systems for Social Processes, and Arousal/Regulatory Systems), each with several inter-related constructs (https://www.nimh.nih.gov/research-priorities/rdoc/constructs/rdoc-matrix.shtml ). There are some constructs for which standardized tasks and measures have been identified and others for which no standardized task or measure exists. A workgroup of the National Advisory Mental Health Council (NAMHC) was convened in April, 2016 to evaluate tasks and measures for each RDoC construct (see the workgroup’s final report, https://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/rdoc_council_workgroup_report_153440.pdf ). While this document is not a comprehensive review of RDoC-related tasks and measures, it does contain information regarding the gaps in the current recommendations for tasks and measures, as well as specific examples of tasks that require further evaluation. Applicants to this FOA are encouraged to consult the report as they formulate their research plans.

As RDoC is considered to be an evolving research framework that supports continual updating on the basis of new information, investigators are encouraged to submit applications intended to develop tasks/measures that assess current RDoC constructs or modified conceptions of current constructs. For modified constructs, applicants should provide supportive information consistent with the established criteria for developing RDoC constructs, i.e., (1) evidence for a functional dimension of behavior/cognition, (2) evidence for a neural circuit/system predominantly involved in implementing the behavior, and (3) relevance for psychopathology. These three construct criteria are particularly relevant for applications which will use computational approaches that employ data-driven methods to assess current or modified constructs.

Tasks/measures may be developed either for traditional laboratory/clinic settings, or for population-based studies that involve self-administration via mobile or web-based apps. Priority will be given to tasks for which versions can be developed that show potential validity in either type of setting, although applicants may focus on one or the other setting for initial task development.

The RDoC framework includes an emphasis upon neurodevelopmental factors that affect psychopathology, and also the broad range of environmental influences, both harmful and protective, that interact with neurodevelopment to confer risk or resilience. Given this emphasis, the development and/or validation of tasks/measures that can be scaled for appropriate use across a broad range of development, or that target critical periods of development, are of high priority. (For example, many measures in the NIH Toolbox, http://www.nihtoolbox.org/Pages/default.aspx , are standardized from ages 3 to 85.) However, it is recognized that for many RDoC constructs (e.g., for assessing fear or reward-related behavior), it is not possible to develop scaled version of the same task across age ranges; further, it is highly expensive to validate the scaling of a task across the entire life span. For these reasons, applicants may confine the focus of the research plan to a particular, justifiable age range. However, applicants should address the potential age range for which a task/measure might be scaled and address any future plans to expand the age range of validation. Development of tasks that target children of particular ages, or that could readily be scaled across the range of childhood, is particularly encouraged.

Relevant research topics include, but are not limited to:

  • Development of variants of existing task(s)/measure(s) that are optimized for use in a novel setting or for a new clinical research purpose; for example, development and testing of parallel versions of a task that can be used for high-throughput phenotyping for screening purposes and for intensive, lab-based research.
  • Development of tasks/measures for realms of behavior that are computationally definable, and conducted within the scope of a theoretical framework that is sufficiently precise to make quantitative predictions about how computational processes (neural and/or psychological) can result in particular aspects of behavior;
  • Direct comparisons of a range of administration parameters and analysis of the effects on the test’s measurement characteristics.
  • Development of standardized stimuli for an existing task in order to enhance usability across age groups or level of ability and/or as a repeated measure with psychometrically equivalent alternate forms.
  • The collection of normative data from a broad population and development of methods to convert raw scores into a common scale that can be interpreted in a standardized way. This stage of task development is most appropriate for tasks and measures for which reliability and validity have been established

Projects that would not be supported by NIMH under this announcement include:

  •  Development or optimization of tests that are only suitable for animal research; however, development of  tasks that have animal analogs is encouraged.
  • Applications that propose to modify the current structure of the RDOC matrix by suggesting new RDoC constructs, subconstructs, domains, or units of analysis. Please note that suggested changes to the RDoC matrix may be submitted to the RDoC Unit via RDocAdmin@mail.nih.gov and that investigators may submit investigator-initiated applications to study new constructs. Criteria for RDoC constructs are detailed here.
  • Applications that propose to study tests that are designed only for use with specific DSM or ICD diagnostic categories.
  • Projects that ONLY use existing data; while it would be appropriate, and encouraged, to include aims that involve aggregation and/or reanalysis of existing data, analysis of existing data should not be the sole focus of the application.

NIAAA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in tasks and measures of functional domains that are pertinent to alcohol use. NIAAA has established the Addictions Neuroclinical Assessment (ANA) as a package of tests and measures that are grounded in three neuroscience domains relevant for addictions, and which share significant overlap with RDoC. These domains comprise Incentive Salience, Negative Emotionality, and Executive Function. The NAMHC workgroup report described above identifies tasks that are relevant for these domains and for studying alcohol use disorder (AUD) and related constructs. For example, measures to assess Executive Function and Negative Emotionality overlap with Cognitive Systems and Negative Valence Systems, respectively. Because the NAHMC report did not include AUD, it does not identify aspects directly related to Incentive Salience, i.e., increased salience for alcohol and related cues. Thus, tasks that measure this domain are of specific relevance to the NIAAA.

In addition to measures focused on Incentive Salience, and the relevant research topics described under point 2 above, NIAAA is particularly interested in the following:

  • Projects focused on existing measures that have not been evaluated in patients with AUD and that test these measures in this population.  For example, there may be different clinical considerations or normative data for use among patients with AUD as compared to healthy volunteer groups or patients with psychotic disease.
  • Identification of tasks that may be used repeatedly over time, i.e., are less sensitive to practice effects, and which are relevant for understanding changes in the ANA domains during acute and protracted withdrawal and recovery from AUD.
  • Additional testing of tasks that may be used in different age groups, e.g., with children, adolescents, and finally, adults, to understand risk factors for development and maintenance of AUD as measured by the same tasks. If using the same tasks is not feasible, direct comparison of tasks that assess the same domains/subdomains of function, e.g., visuospatial functioning, hypohedonia, etc. in different age groups would also be useful.
  • Evaluation of measures that may be used to predict recovery and relapse among patients with AUD, and measures that may be used to determine clinical trials outcomes.

Deadlines:  January 5, 2019 (letters of intent); February 5, 2019 and then standard dates apply (full proposals)

URL:  https://grants.nih.gov/grants/guide/pa-files/PAR-18-930.html

Filed Under: Funding Opportunities