Autism Spectrum DisorderNCT07898787
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
A study testing Quantum-Inspired Intervention (QII) in people with Autism Spectrum Disorder and Autism Spectrum Disorder (ASD, run by BlissBot, Inc.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism Spectrum Disorder (ASD, ASD
- What is being tested?
- Quantum-Inspired Intervention (QII)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Planned initiation of a new treatment, therapy, or medication change during the study period.
- Unstable medical conditions, including uncontrolled seizures, that are likely to require treatment changes during the study.
- Concurrent participation in another interventional clinical trial.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
- STUDY RATIONALE AND OBJECTIVES Autism Spectrum Disorder (ASD) 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. 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. This global multicenter confirmatory study is designed 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).
- CONCEPTUAL FRAMEWORK AND OPERATIONAL WORKFLOW Grounded in a quantum-inspired conceptual framework aimed at addressing foundational adaptive processing rather than superficial behavior management, QII integrates AI-enabled, fine-grained characterization of each child's needs with a proprietary quantum-inspired intervention protocol delivered by trained practitioners. All randomized participants, in both the experimental and waitlist control arms, complete the identical workflow described below; the QII protocol itself is delivered only to the experimental arm during the study period, and to the waitlist control arm following completion of the primary analysis. The procedural workflow and operational division of responsibilities across the trial follow a standardized five-stage cycle:
- Caregiver Intake and Structured Data Collection: Participating caregivers access a secure, web-based digital portal to submit multidimensional behavioral and developmental inputs regarding their child. Caregivers complete structured questionnaires covering functional communication, social responsiveness, and emotional stability, alongside qualitative observations via text, voice, or video logs documenting daily communication attempts, emotional regulation difficulties, sleep routines, and behavioral patterns.
- AI-Enabled Processing and High-Granularity Synthesis: The platform's AI pipeline operates in an administrative, analytical, and coordination support capacity. It transcribes audio/video submissions, indexes observational records, and performs fine-grained characterization across expansive behavioral domains. This automated pipeline synthesizes the complex developmental inputs into structured data profiles to accelerate clinical review while maintaining strict procedural consistency.
- Pattern Identification, Developmental Report, and Family Alignment: Trained practitioners review the synthesized data profiles to identify one to two primary focal dysregulation targets or dominant developmental priorities (e.g., expressive communication initiation or emotional volatility). The practitioner generates an individualized Developmental Report delineating these target intervention points and shares it directly with the family. The caregiver reviews, confirms, and formally signs off on the alignment plan, ensuring mutual agreement on the targeted developmental objectives prior to protocol initiation.
- Application of Standardized QII Protocol: Upon formal alignment, trained practitioners deliver the proprietary quantum-inspired intervention (QII) protocol. The intervention is conducted entirely remotely without requiring the family or child to travel to physical clinical sites. It imposes no added physical or labor-intensive training demands on the family; participating households simply maintain their normal daily living routines and lifestyle patterns. The protocol operates as a standardized, non-invasive, and non-contact regulatory methodology designed to stimulate foundational adaptive processing and functional improvement.
- Continuous Monitoring and Standardized Post-Intervention Reassessment: Throughout the 3-month intervention window, caregivers may voluntarily submit periodic observational notes or behavioral reflections through the portal. At the conclusion of month 3, a formal reassessment is conducted: caregivers complete the exact same structured intake questionnaire and data collection battery administered at baseline. Platform-generated profiles are used for intervention planning and process documentation only; formal efficacy endpoints are evaluated independently by blinded assessors, as described in Section 4.
- STUDY TIMELINE AND CLINICAL PHASING The overall clinical trial is conducted over a comprehensive 12-month operational timeline across participating sites, encompassing multicenter patient recruitment, standardized intervention delivery, blinded endpoint assessment, and statistical data lock:
- Screening and Enrollment (Months 1-2): Multicenter participant recruitment, diagnostic verification of ASD, informed consent acquisition, and eligibility confirmation.
- Preparation Phase (Month 3): Caregiver intake and structured data collection, AI-enabled fine-grained characterization, preparation of individualized Developmental Reports, and formal caregiver alignment and sign-off.
- Baseline Assessment and Randomization (Month 4): Blinded baseline endpoint assessments by independent assessors, followed by randomization to the experimental or waitlist control arm.
- Active Intervention Phase (Months 5-7): Standardized multi-cycle delivery of the proprietary QII protocol to the experimental arm over a 3-month intervention period, while the waitlist control arm continues the identical procedural workflow without receiving QII. Caregivers may report adverse events or safety concerns at any time through the study portal and may request to discontinue the intervention at any time.
- Data Verification and Consolidation (Months 8-9): Finalization of multicenter data collection, data cleaning, and independent monitoring verification.
- Statistical Analysis and DMC Review (Months 10-11): Primary statistical analysis and independent Data Monitoring Committee review of safety and data integrity.
- Results Reporting (Month 12): Trial closeout and regulatory registry reporting.
- Waitlist Control Extension Phase (from Month 12): Following completion of the primary analysis, participants in the waitlist control arm will be offered the QII protocol, provided that no safety concerns have been identified by the DMC. Outcomes from this phase will be reported as exploratory.
- OUTCOME MEASURES AND ENDPOINT SPECIFICATIONS The trial employs validated, objective clinical instruments to evaluate tangible gains in adaptive communication, emotional self-regulation, and overall clinical response: Primary Outcome Title：Clinical Global Impression-Improvement (CGI-I) Score for the Primary Intervention Target Description：CGI-I rated by a blinded independent clinician on a 7-point scale (1 = very much improved; 7 = very much worse), assessing improvement relative to baseline in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline. Time Frame：End of the 3-month intervention period Secondary Outcome Title：Change from Baseline in Aberrant Behavior Checklist-Irritability Subscale (ABC-I) Score Description：ABC-I subscale (15 items; score range 0-45; higher scores indicate greater irritability), completed by caregivers under the administration of a blinded assessor. Time Frame：Baseline and end of the 3-month intervention period
- Independent Blinded Outcome Assessment: To ensure objectivity, all efficacy endpoints are assessed by independent, licensed clinicians at participating partner hospitals who are external to the sponsor and the intervention team. Outcome assessors are blinded to participants' group allocation and have no involvement in intervention delivery, Developmental Report preparation, or practitioner-family communication. Assessments are conducted at baseline and at the conclusion of the 3 months intervention period. The CGI-I is rated by the blinded assessor, and the ABC-I is completed by caregivers under the assessor's administration. Caregivers are instructed not to disclose intervention-related information to assessors.
- Safety Endpoints: Incidence, severity, and potential causality of adverse events (AEs), reported by caregivers at any time through the study portal and systematically recorded at the mid-point review and end-of-intervention assessment. Caregivers may request to discontinue the intervention at any time without affecting their child's access to other care.
- ETHICAL OVERSIGHT AND DATA GOVERNANCE The trial is conducted in full compliance with Good Clinical Practice (GCP) guidelines and international ethical standards for pediatric research. An independent Data Monitoring Committee (DMC) conducts scheduled reviews of safety and data integrity. All digital interactions, AI-supported data processing, and clinical records are handled via secure, encrypted, HIPAA-compliant cloud architectures.
- STUDY DESIGN A randomized, parallel-group design evaluating the efficacy and safety of the Quantum-Inspired Intervention (QII) protocol compared to a waitlist control arm over a 3-month intervention period. The target sample size of 80 participants (40 per arm) provides 90% power to detect a difference in CGI-I response rates (defined as a CGI-I score of 1 or 2) of 40% in the QII arm versus 10% in the waitlist control arm, using a two-sided test at a significance level of 0.05, and maintains greater than 85% power allowing for a 10% dropout rate.
- Conditions
- Autism Spectrum Disorder, Autism Spectrum Disorder (ASD, ASD
- Being tested
- Quantum-Inspired Intervention (QII)
- Keywords
- Quantum-Inspired Intervention, QII, StarHealing, Novel Neurodevelopmental Intervention, Non-Invasive Intervention, Autism, ASD, Social Communication, Emotional Stability, Emotional Regulation, Adaptive Functioning, AI-Enabled Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Communication, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum-Inspired Intervention (QII)Other
Quantum-Inspired Intervention (QII) is an investigational, non-pharmacological, non-invasive, and non-contact protocol delivered entirely remotely by trained practitioners over 3 months. It follows a standardized workflow: (1) Caregiver intake: caregivers submit structured questionnaires and observations (text, voice, or video) via a secure web portal, covering communication, emotional regulation, social responsiveness, sleep, and behavior. (2) AI-supported profiling: an AI pipeline transcribes, organizes, and synthesizes inputs into structured developmental profiles. (3) Practitioner review and family alignment: practitioners identify one to two primary developmental priorities in an individualized Developmental Report, which caregivers review and confirm. (4) QII delivery: practitioners deliver the standardized non-contact protocol; no travel or added training is required, and families maintain their usual routines.
| Study group | Role | What they receive |
|---|---|---|
| Quantum-Inspired Intervention (QII) | Experimental | Participants receive the proprietary Quantum-Inspired Intervention (QII) protocol over a 3-month intervention period. Delivery is conducted entirely remotely by trained practitioners without requiring on-site visits or added labor burden for the family. Following caregiver intake, AI-enabled developmental profiling, and caregiver-confirmed Developmental Report alignment, standardized non-contact protocol sessions are administered. Participants continue their usual care throughout the study. Efficacy endpoints are assessed by blinded independent assessors at baseline and at the end of the 3-month intervention period. Receives: Other: Quantum-Inspired Intervention (QII) |
| Waitlist Control (Delayed QII) | No intervention | Participants complete the identical procedural workflow as the experimental arm, including caregiver intake, AI-enabled developmental profiling, and Developmental Report alignment, and continue their usual care, but do not receive the QII protocol during the 3-month intervention period. Efficacy endpoints are assessed by blinded independent assessors at the same time points. Following completion of the primary analysis, participants are offered the QII protocol, provided that no safety concerns have been identified by the Data Monitoring Committee (DMC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Improvement (CGI-I) Score for the Primary Intervention Target
CGI-I rated by a blinded independent clinician on a 7-point scale (1 = very much improved; 7 = very much worse), assessing improvement relative to baseline in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline. Response is defined as a CGI-I score of 1 (very much improved) or 2 (much improved).
Measured: End of the 3-month QII intervention period
Secondary outcomes (1)
Change from Baseline in Aberrant Behavior Checklist-Irritability Subscale (ABC-I) Score
ABC-I subscale (15 items; score range 0-45; higher scores indicate greater irritability), completed by caregivers under the administration of a blinded assessor.
Measured: Baseline and end of the 3-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to one of two parallel groups: an intervention group receiving QII over a 3-month intervention period, and a waitlist control group. Both groups complete the identical procedural workflow, including caregiver intake, AI-enabled characterization, and Developmental Report alignment; only the intervention group receives QII during the study period. Participants in the waitlist control group will be offered QII following completion of the primary analysis, provided that no safety concerns have been identified by the DMC. Design details may be further refined following consultation with regulatory authorities.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlissBot, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Yujia Wang, Principal investigator, BlissBot, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898787
- Sponsor's protocol ID
- SH-ASD-001
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published primary and secondary outcome results, including baseline and end-of-intervention CGI-I and ABC-I scores, will be shared. Audio, video, and free-text caregiver submissions will not be shared.
Publications
Wang SY. Beyond Symptom Scores: A High-Resolution Caregiver-Integrated Framework for Measuring Developmental Progress in Autism. OSF; 2026. doi:10.17605/OSF.IO/9CERB
Wang SY. Sustained Milestone Breakthroughs in Autism: Longitudinal Follow-Up Evidence from the StarHealing QII Framework. OSF; 2026. doi:10.17605/OSF.IO/5HF2W
Wang SY. A Neuro-Cognitive and Quantum-Inspired Framework for Autism Support: Early Evidence from AI-Augmented Family-Based Intervention. OSF; 2026. doi:10.17605/OSF.IO/APZKW
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07898787
- Acronym / sponsor ID
- SH-ASD-001
- Conditions
- Autism Spectrum Disorder, Autism Spectrum Disorder (ASD, ASD
- Keywords
- Quantum-Inspired Intervention, QII, StarHealing, Novel Neurodevelopmental Intervention, Non-Invasive Intervention, Autism, ASD, Social Communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BlissBot, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- STUDY RATIONALE AND OBJECTIVES Autism Spectrum Disorder (ASD) 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. 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. This global multicenter confirmatory study is designed 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).
- CONCEPTUAL FRAMEWORK AND OPERATIONAL WORKFLOW Grounded in a quantum-inspired conceptual framework aimed at addressing foundational adaptive processing rather than superficial behavior management, QII integrates AI-enabled, fine-grained characterization of each child's needs with a proprietary quantum-inspired intervention protocol delivered by trained practitioners. All randomized participants, in both the experimental and waitlist control arms, complete the identical workflow described below; the QII protocol itself is delivered only to the experimental arm during the study period, and to the waitlist control arm following completion of the primary analysis. The procedural workflow and operational division of responsibilities across the trial follow a standardized five-stage cycle:
- Caregiver Intake and Structured Data Collection: Participating caregivers access a secure, web-based digital portal to submit multidimensional behavioral and developmental inputs regarding their child. Caregivers complete structured questionnaires covering functional communication, social responsiveness, and emotional stability, alongside qualitative observations via text, voice, or video logs documenting daily communication attempts, emotional regulation difficulties, sleep routines, and behavioral patterns.
- AI-Enabled Processing and High-Granularity Synthesis: The platform's AI pipeline operates in an administrative, analytical, and coordination support capacity. It transcribes audio/video submissions, indexes observational records, and performs fine-grained characterization across expansive behavioral domains. This automated pipeline synthesizes the complex developmental inputs into structured data profiles to accelerate clinical review while maintaining strict procedural consistency.
- Pattern Identification, Developmental Report, and Family Alignment: Trained practitioners review the synthesized data profiles to identify one to two primary focal dysregulation targets or dominant developmental priorities (e.g., expressive communication initiation or emotional volatility). The practitioner generates an individualized Developmental Report delineating these target intervention points and shares it directly with the family. The caregiver reviews, confirms, and formally signs off on the alignment plan, ensuring mutual agreement on the targeted developmental objectives prior to protocol initiation.
- Application of Standardized QII Protocol: Upon formal alignment, trained practitioners deliver the proprietary quantum-inspired intervention (QII) protocol. The intervention is conducted entirely remotely without requiring the family or child to travel to physical clinical sites. It imposes no added physical or labor-intensive training demands on the family; participating households simply maintain their normal daily living routines and lifestyle patterns. The protocol operates as a standardized, non-invasive, and non-contact regulatory methodology designed to stimulate foundational adaptive processing and functional improvement.
- Continuous Monitoring and Standardized Post-Intervention Reassessment: Throughout the 3-month intervention window, caregivers may voluntarily submit periodic observational notes or behavioral reflections through the portal. At the conclusion of month 3, a formal reassessment is conducted: caregivers complete the exact same structured intake questionnaire and data collection battery administered at baseline. Platform-generated profiles are used for intervention planning and process documentation only; formal efficacy endpoints are evaluated independently by blinded assessors, as described in Section 4.
- STUDY TIMELINE AND CLINICAL PHASING The overall clinical trial is conducted over a comprehensive 12-month operational timeline across participating sites, encompassing multicenter patient recruitment, standardized intervention delivery, blinded endpoint assessment, and statistical data lock:
- Screening and Enrollment (Months 1-2): Multicenter participant recruitment, diagnostic verification of ASD, informed consent acquisition, and eligibility confirmation.
- Preparation Phase (Month 3): Caregiver intake and structured data collection, AI-enabled fine-grained characterization, preparation of individualized Developmental Reports, and formal caregiver alignment and sign-off.
- Baseline Assessment and Randomization (Month 4): Blinded baseline endpoint assessments by independent assessors, followed by randomization to the experimental or waitlist control arm.
- Active Intervention Phase (Months 5-7): Standardized multi-cycle delivery of the proprietary QII protocol to the experimental arm over a 3-month intervention period, while the waitlist control arm continues the identical procedural workflow without receiving QII. Caregivers may report adverse events or safety concerns at any time through the study portal and may request to discontinue the intervention at any time.
- Data Verification and Consolidation (Months 8-9): Finalization of multicenter data collection, data cleaning, and independent monitoring verification.
- Statistical Analysis and DMC Review (Months 10-11): Primary statistical analysis and independent Data Monitoring Committee review of safety and data integrity.
- Results Reporting (Month 12): Trial closeout and regulatory registry reporting.
- Waitlist Control Extension Phase (from Month 12): Following completion of the primary analysis, participants in the waitlist control arm will be offered the QII protocol, provided that no safety concerns have been identified by the DMC. Outcomes from this phase will be reported as exploratory.
- OUTCOME MEASURES AND ENDPOINT SPECIFICATIONS The trial employs validated, objective clinical instruments to evaluate tangible gains in adaptive communication, emotional self-regulation, and overall clinical response: Primary Outcome Title：Clinical Global Impression-Improvement (CGI-I) Score for the Primary Intervention Target Description：CGI-I rated by a blinded independent clinician on a 7-point scale (1 = very much improved; 7 = very much worse), assessing improvement relative to baseline in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline. Time Frame：End of the 3-month intervention period Secondary Outcome Title：Change from Baseline in Aberrant Behavior Checklist-Irritability Subscale (ABC-I) Score Description：ABC-I subscale (15 items; score range 0-45; higher scores indicate greater irritability), completed by caregivers under the administration of a blinded assessor. Time Frame：Baseline and end of the 3-month intervention period
- Independent Blinded Outcome Assessment: To ensure objectivity, all efficacy endpoints are assessed by independent, licensed clinicians at participating partner hospitals who are external to the sponsor and the intervention team. Outcome assessors are blinded to participants' group allocation and have no involvement in intervention delivery, Developmental Report preparation, or practitioner-family communication. Assessments are conducted at baseline and at the conclusion of the 3 months intervention period. The CGI-I is rated by the blinded assessor, and the ABC-I is completed by caregivers under the assessor's administration. Caregivers are instructed not to disclose intervention-related information to assessors.
- Safety Endpoints: Incidence, severity, and potential causality of adverse events (AEs), reported by caregivers at any time through the study portal and systematically recorded at the mid-point review and end-of-intervention assessment. Caregivers may request to discontinue the intervention at any time without affecting their child's access to other care.
- ETHICAL OVERSIGHT AND DATA GOVERNANCE The trial is conducted in full compliance with Good Clinical Practice (GCP) guidelines and international ethical standards for pediatric research. An independent Data Monitoring Committee (DMC) conducts scheduled reviews of safety and data integrity. All digital interactions, AI-supported data processing, and clinical records are handled via secure, encrypted, HIPAA-compliant cloud architectures.
- STUDY DESIGN A randomized, parallel-group design evaluating the efficacy and safety of the Quantum-Inspired Intervention (QII) protocol compared to a waitlist control arm over a 3-month intervention period. The target sample size of 80 participants (40 per arm) provides 90% power to detect a difference in CGI-I response rates (defined as a CGI-I score of 1 or 2) of 40% in the QII arm versus 10% in the waitlist control arm, using a two-sided test at a significance level of 0.05, and maintains greater than 85% power allowing for a 10% dropout rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to one of two parallel groups: an intervention group receiving QII over a 3-month intervention period, and a waitlist control group. Both groups complete the identical procedural workflow, including caregiver intake, AI-enabled characterization, and Developmental Report alignment; only the intervention group receives QII during the study period. Participants in the waitlist control group will be offered QII following completion of the primary analysis, provided that no safety concerns have been identified by the DMC. Design details may be further refined following consultation with regulatory authorities.
| Arm | Type | Receives |
|---|---|---|
| Quantum-Inspired Intervention (QII) | Experimental | Other: Quantum-Inspired Intervention (QII)Participants receive the proprietary Quantum-Inspired Intervention (QII) protocol over a 3-month intervention period. Delivery is conducted entirely remotely by trained practitioners without requiring on-site visits or added labor burden for the family. Following caregiver intake, AI-enabled developmental profiling, and caregiver-confirmed Developmental Report alignment, standardized non-contact protocol sessions are administered. Participants continue their usual care throughout the study. Efficacy endpoints are assessed by blinded independent assessors at baseline and at the end of the 3-month intervention period. |
| Waitlist Control (Delayed QII) | No intervention | –Participants complete the identical procedural workflow as the experimental arm, including caregiver intake, AI-enabled developmental profiling, and Developmental Report alignment, and continue their usual care, but do not receive the QII protocol during the 3-month intervention period. Efficacy endpoints are assessed by blinded independent assessors at the same time points. Following completion of the primary analysis, participants are offered the QII protocol, provided that no safety concerns have been identified by the Data Monitoring Committee (DMC). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Planned initiation of a new treatment, therapy, or medication change during the study period.
- Unstable medical conditions, including uncontrolled seizures, that are likely to require treatment changes during the study.
- Concurrent participation in another interventional clinical trial.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantum-Inspired Intervention (QII)Quantum-Inspired Intervention (QII) is an investigational, non-pharmacological, non-invasive, and non-contact protocol delivered entirely remotely by trained practitioners over 3 months. It follows a standardized workflow: (1) Caregiver intake: caregivers submit structured questionnaires and observations (text, voice, or video) via a secure web portal, covering communication, emotional regulation, social responsiveness, sleep, and behavior. (2) AI-supported profiling: an AI pipeline transcribes, organizes, and synthesizes inputs into structured developmental profiles. (3) Practitioner review and family alignment: practitioners identify one to two primary developmental priorities in an individualized Developmental Report, which caregivers review and confirm. (4) QII delivery: practitioners deliver the standardized non-contact protocol; no travel or added training is required, and families maintain their usual routines. | Other | Quantum-Inspired Intervention (QII) |
Primary outcome
Clinical Global Impression-Improvement (CGI-I) Score for the Primary Intervention Target
Time frame: End of the 3-month QII intervention period
CGI-I rated by a blinded independent clinician on a 7-point scale (1 = very much improved; 7 = very much worse), assessing improvement relative to baseline in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline. Response is defined as a CGI-I score of 1 (very much improved) or 2 (much improved).
1 secondary outcome
Change from Baseline in Aberrant Behavior Checklist-Irritability Subscale (ABC-I) Score
Time frame: Baseline and end of the 3-month intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BackgroundWang SY. Beyond Symptom Scores: A High-Resolution Caregiver-Integrated Framework for Measuring Developmental Progress in Autism. OSF; 2026. doi:10.17605/OSF.IO/9CERB
- BackgroundWang SY. Sustained Milestone Breakthroughs in Autism: Longitudinal Follow-Up Evidence from the StarHealing QII Framework. OSF; 2026. doi:10.17605/OSF.IO/5HF2W
- BackgroundWang SY. A Neuro-Cognitive and Quantum-Inspired Framework for Autism Support: Early Evidence from AI-Augmented Family-Based Intervention. OSF; 2026. doi:10.17605/OSF.IO/APZKW
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published primary and secondary outcome results, including baseline and end-of-intervention CGI-I and ABC-I scores, will be shared. Audio, video, and free-text caregiver submissions will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Yujia Wang principal investigator
BlissBot, Inc
Questions about this trial
What is this clinical trial studying?
A study testing Quantum-Inspired Intervention (QII) in people with Autism Spectrum Disorder and Autism Spectrum Disorder (ASD, run by BlissBot, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Yujia Wang, Master in Applied Math (3479795658, sarah@blissbot.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-Improvement (CGI-I) Score for the Primary Intervention Target (time frame: End of the 3-month QII intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898787, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.