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Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

Award Number: R43MH124542
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/18/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2023

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Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS) - PROJECT SUMMARY The goal of the current project is to elaborate upon, reconstruct and advance to pivotal trial readiness CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum)—a clinician-assisted, closed-loop technology, mobile application for adolescents with Autism Spectrum Disorder (ASD). Via ten mobile assessments CICADAS will capture data on sensory processing abnormalities and associated cognitive deficits. These data will populate a machine learning algorithm that will tailor the delivery of ten neuroplasticity-based social cognitive training (NB-SCT) exercises targeting sensory processing abnormalities. This individualized assessment and treatment approach is posited to induce adaptive long-term learning about social-emotional events, thus maximizing the impact and generalizability of psychological Evidence Based Treatments targeting social skills and relational strategies, including PEERS (Program for the Education and Enrichment of Relationship Skills). In particular, we posit that CICADAS-induced enhancement of processing and cognition will facilitate the application of PEERS skills in the environment of adolescents with ASD, thus improving their real- world functioning. In this project, we will build upon promising results obtained from two studies in anxiety and psychosis, leverage pilot data collected in adolescents with Autism Spectrum Disorder (ASD), and accumulate preliminary evidence for CICADAS to function as 1) a stand-alone treatment; 2) a primer for PEERS; 3) an enhancer for PEERS. In Specific Aim 1, we will finalize development, ensuring that assessment data correctly populate the closed- loop algorithm and correctly guide the delivery of individualized NB-SCT. Next, we will involve three adolescents with ASD and two PEERS clinicians in three focus groups that will be organized to refine CICADAS. Once decisions regarding app design are made, the three adolescents will be involved in a 2-week trial run to verify that CICADAS is detecting and improving sensory processing abnormalities and cognitive deficits. At the end of this test run, each stakeholder will be asked to rate enjoyment, ease of use, product quality, and perceived usefulness. Finally, we will submit these data from the trial run to our consultant to confirm that CICADAS is suitable for evaluation in the feasibility trial. In Specific Aim 2, we will conduct a three-arm randomized crossover trial with 48 adolescents with ASD to document the acceptability of CICADAS and evaluate its potential as a stand-alone treatment, as a primer for PEERS, or as a treatment enhancer of PEERS. At the completion of this project we will have usability data sufficient to support an efficacy trial in Phase II designed to establish medical claims. At the completion of Phase II, we will be able to complete the FDA regulatory pathway and have the opportunity to improve the lives of people suffering from this condition.


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: 2024 ( Subtotal = $0 )
2024	2021	POSIT SCIENCE CORP	160 PINE ST STE 200	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Mental Health Research Grants	000	2	4/8/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $260,345 )
2021	2021	POSIT SCIENCE CORPORATION	160 PINE ST STE 200	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Mental Health Research Grants	001	2	8/6/2021	NON-COMPETING CONTINUATION	$260,345
2021	2021	POSIT SCIENCE CORPORATION	160 PINE ST STE 200	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Mental Health Research Grants	002	2	8/31/2021	NON-COMPETING CONTINUATION	$0
2021	2020	POSIT SCIENCE CORPORATION	160 PINE ST STE 200	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Mental Health Research Grants	000	1	8/3/2021	NEW	$0
														Subtotal = $260,345

Issue Date FY: 2020 ( Subtotal = $360,194 )
2020	2020	POSIT SCIENCE CORPORATION	160 PINE ST STE 200	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Mental Health Research Grants	000	1	9/18/2020	NEW	$360,194
														Subtotal = $360,194

Grand Total All Awards = $620,539

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Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

Award Number: R43MH124542

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/18/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2023

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