Clinical Research Directory

Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study

Sponsor: BlissBot, Inc

Summary

The purpose of this global multicenter confirmatory study is to evaluate the clinical efficacy and safety of Quantum-Inspired Intervention (QII), a novel non-invasive neurodevelopmental protocol, in children diagnosed with Autism Spectrum Disorder (ASD). Autism Spectrum Disorder involves complex neurodevelopmental dynamics characterized by challenges in emotional regulation and adaptive functioning. Existing clinical paradigms primarily rely on pharmaceuticals for secondary symptom control or behavioral methods aimed at external behavioral modification, while interventions targeting core functional shifts remain limited. Grounded in a quantum-inspired conceptual framework aimed at addressing foundational adaptive processing, QII integrates AI-enabled, fine-grained characterization of each child's needs with a proprietary quantum-inspired intervention protocol delivered by trained practitioners. While fully elucidating the fundamental mechanisms will require extended scientific timelines, the urgent needs of individuals and families make confirming tangible, real-world functional efficacy the paramount priority. Preliminary case reports of the QII protocol observed encouraging signals in emotional stabilization and spontaneous communication. Building on these initial findings, this study systematically evaluates the efficacy of QII at scale in an expanded, multicenter cohort. Eligible participants will be randomized to receive either the standardized QII protocol over a defined period or a waitlist control, with the waitlist control arm offered QII following completion of the primary analysis. The primary endpoint evaluates improvement in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline, as measured by the Clinical Global Impression-Improvement (CGI-I) scale; changes in irritability and behavioral dysregulation, as measured by the Aberrant Behavior Checklist-Irritability Subscale (ABC-I), are evaluated as a secondary endpoint.All efficacy endpoints are assessed by independent clinicians blinded to group allocation. Caregivers may report any adverse event or safety concern at any time and may request to stop the intervention at any time; adverse events are also recorded at scheduled study assessments.

Official title: A Multicenter, Global Confirmatory Study Evaluating the Efficacy and Safety of Quantum-Inspired Intervention (QII), a Novel Neurodevelopmental Intervention, for Improving Emotional Stability and Social Communication in Children With Autism Spectrum Disorder

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