NCT07898787Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 1 Feb 2027
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- BlissBot, Inc
- Diseases
- Autism
- NCT number
- NCT07898787
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Feb 2027 to the primary completion date, 29 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned initiation of a new treatment, therapy, or medication change during the study period.
- Concurrent participation in another interventional clinical trial.
Other illness
- Unstable medical conditions, including uncontrolled seizures, that are likely to require treatment changes during the study.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Who the study is looking for
- Age 5 to 17 years at the time of enrollment.
- Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria, confirmed by a qualified clinician, with the diagnosis documented for at least 1 years.
- Caregiver able to access the web-based study portal and complete questionnaires in Chinese or English.
- Written informed consent provided by a parent or legal guardian, and assent from the child where developmentally appropriate.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.