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.
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 mobile application designed to improve sensory processing abnormalities and cognitive deficits by means of mobile assessments, neuroplasticity-based social cognitive training exercises and closed-loop algorithms.