Expanding the observer-reported communication ability (orca) measure: measuring the communication ability of individuals with rare, neurodevelopmental disorders
Active Cooperative Agreement Awarded Last action
- Award ID
- UH3FD007304
- Recipient
-
Duke University UEI TP7EK8DZV6N5
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $1,813,576
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date 91% complete
- Originally
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Durham, NC 27705, USA
Award details come from USAspending.gov.
Description
- Abstract
- Children with neurodevelopmental disorders (ndds) typically have severe deficits in domains of daily functioning like communication, which families consistently list as one of their top clinical priorities. However, existing clinical outcome assessments (coas) have major limitations, including the inability to discriminate among individuals with low communication ability and/or are primarily nonverbal. Further, there are no current caregiver-reported measures designed for clinical trials that have high quality validity evidence for individuals with ndds. To address this critical need, our team designed the observer-reported communication ability (orca) measure to assess expressive, receptive, and pragmatic forms of communication, regardless of the modalities used by a child (e.g., vocalizations, gestures, assistive devices). Qualitative and quantitative evidence support its validity for individuals with angelman syndrome, and excitingly, the orca is likely to be generalizable to other NDD populations. This proposed study will allow US to use rigorous development methods to expand the orca measure to a broad range of NDD populations and, using existing coas, provide investigators with a comprehensive set of tools to evaluate changes in communication ability in NDD populations in pediatric clinical trials. Our study team includes experts in COA development, communication, clinical trials, and neuropsychology. Importantly, the team also includes a stakeholder engagement group (SEG) consisting of 16 leaders in the field; 12 parents/patient advocates and 4 clinicians who will provide access to 13 distinct NDD populations for the studies planned in this proposal. An external technical advisory committee (etac) will provide additional guidance and consists of clinicians, methodologists, speech-language pathologists, industry experts, and patient advocates. In the 2-year UG3 planning phase, we will conduct qualitative interviews with 8-12 parents for each of our 13 ndds and with 8-12 communication experts to identify the core concepts of communication for each of the ndds (aim 1). We will use the results from the qualitative interviews and data collected in seven ongoing natural history studies to develop targeted plans for the UH3 implementation phase to expand and validate the orca measure for each of the 13 ndds (aim 2). In the 3-year UH3 phase, we will expand the orca measure and conduct, as needed, additional qualitative interviews and longitudinal quantitative studies to evaluate the reliability, validity and responsiveness of the orca measure alongside other communication coas (aim 3). Finally, we will have approximately 1500 caregivers of typically developing children from birth to
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $1,049,722 | |
| Original award | $763,854 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Combinedbrain, Inc. | $538,233 |
Quick answers
Who received award UH3FD007304?
UH3FD007304 was awarded to Duke University by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on May 1, 2021.
How much is award UH3FD007304 worth?
$1,813,576 has been obligated on UH3FD007304.
Which agency awarded UH3FD007304?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded UH3FD007304, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
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