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DDT-COA-000-163 Accelerating the FDA COA Qualification Package for thePSYCHS as a ClinRO measure

Award Number: U01FD008650
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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DDT-COA-000-163 Accelerating the FDA COA Qualification Package for thePSYCHS as a ClinRO measure - ABSTRACT The Clinical High-Risk Syndrome for Psychosis (CHR-P) is a DSM-5-recognized condition affecting youth and young adults who experience attenuated delusions, hallucinations, and thought disturbances that, while subthreshold for full psychosis, are distressing and impair daily functioning. Attenuated Psychosis Syndrome (APS), listed under Conditions for Further Study in DSM-5, affects approximately 1.7% of the general youth population and nearly 20% of youth presenting to psychiatric services, yet remains under-recognized and poorly served by qualified assessment tools. Current clinical outcome assessments (COAs) for APS include the Structured Interview for Psychosis-Risk Syndromes (SIPS) and the Comprehensive Assessment of At-Risk Mental States (CAARMS). Differences between these instruments have historically hindered harmonization across research and clinical trials. In response, the National Institute of Mental Health led a harmonization effort that resulted in the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS), a semi-structured ClinRO instrument designed to assess 15 distinct attenuated positive symptoms organized into three general concepts: attenuated delusions, hallucinations, and thought disorder. There are currently no FDA-qualified COAs for measuring APS severity in CHR-P clinical trials, presenting a major obstacle to drug development. The PSYCHS is now implemented in the FNIH-funded AMP SCZ observational study and will be further evaluated in the upcoming ProCAN randomized controlled trial, which includes PSYCHS assessments, blinded raters, and ecological momentary assessment. These data provide a unique opportunity to establish the PSYCHS as a reliable and valid ClinRO for use in regulatory trials. The objective of this project is to develop a comprehensive Full Qualification Package (FQP) for the PSYCHS. We aim to: (a) engage the FDA to refine our Qualification Plan through ongoing consultation; (b) systematically evaluate content validity using input from clinicians, researchers, patients, and trainers; and (c) conduct preliminary qualitative and quantitative studies to assess test–retest reliability, recall periods, clinically meaningful change, and within-patient thresholds. The FQP will integrate data from previous studies, ongoing observational research, and a forthcoming clinical trial to support regulatory qualification of the PSYCHS instrument.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	1	1/15/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $250,000 )
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	1	9/10/2025	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $250,000

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DDT-COA-000-163 Accelerating the FDA COA Qualification Package for thePSYCHS as a ClinRO measure

Award Number: U01FD008650

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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