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Research on the Mechanism of Sensory Excitement Inhibition Imbalance in Autism Based on Brain Computer Interface: A Randomized Controlled Trial of Collaborative Adversarial Cognitive Regulation Training Based on Brain Computer Interface and Artificial Intelligence Technology for Social Intervention in Children with Autism Spectrum Disorder

Research on the Mechanism of Sensory Excitement Inhibition Imbalance in Autism Based on Brain Computer Interface: A Randomized Controlled Trial of Collaborative Adversarial Cognitive Regulation Training Based on Brain Computer Interface and Artificial Intelligence Technology for Social Intervention in Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113506
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum disorder

Interventions

Control group 2: waiting intervention group
:Treatment as usual
Intervention group:Intervention group: Dyadic Parent-Child Intervention Using Brain-Computer Interface and Artificial Intelligence (BCI-AI) Neurofeedback
Control Group 1:Control Group 1: Dyadic Parent-Child Intervention Using Brain-Computer Interface and Sham Neurofeedback

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Inclusion criteria for children and adolescents with autism spectrum disorder: (1) Diagnose autism, Asperger's syndrome, and non-specific pervasive developmental disorder based on DSM-IV, or diagnose autism spectrum disorder based on DSM-V. The diagnosis was validated through the Autism Diagnostic Observation Scale (ADOS). (2) Passing the Wechsler Intelligence Test Fourth Edition with a total IQ greater than 70 points. Among them, the IQ for language comprehension needs to be greater than 70; (3) Age range: 8 to 17 years old; (4) Can understand Mandarin. (5) Normal or corrected visual and auditory abilities. (6) Prior to the start of the experiment, no BCI based mindfulness meditation intervention or attention training was conducted. (7) Ensure that there is a fixed parent who can participate in collaborative intervention and that the parent also meets the inclusion criteria. (8) No history of brain injury, cerebral palsy, or severe metabolic disorder; 2.Inclusion criteria for parents of children and adolescents with autism spectrum disorder who primarily care for one parent: (1) Age between 23-50 years old; (2) No head injury or surgery has been performed; (3) Can understand Mandarin. (4) Normal or corrected visual and auditory abilities. (5) Prior to the start of the experiment, no BCI based mindfulness meditation intervention or attention training was conducted. (6) Willing to participate and assist children or adolescents throughout the intervention process. (7) No history of brain injury, cerebral palsy, or severe metabolic disorders.

Exclusion criteria

Exclusion criteria: 1.Children and adolescents with autism spectrum disorder who meets the following criteria will be excluded: (1) Children or adolescents with schizophrenia, bipolar disorder, or substance dependence; (2) Children with uncontrolled epileptic seizures (>= 1 in the past 6 months) or severe self harm behavior; (3) The family will be away from Guangzhou for more than one week at the follow-up time. 2.Parents of children and adolescents with autism spectrum disorder who meets the following criteria will be excluded: (1) Parents with schizophrenia, bipolar disorder, or substance dependence; (2) Parents have uncontrolled epileptic seizures (>=1 in the past 6 months) or serious self harm behavior;

Design outcomes

Primary

MeasureTime frame
Depression, Anxiety and Stress Scales - 21;Score of the Quality of Life Scale for Children;Autism Spectrum Quotient;

Secondary

MeasureTime frame
Social Response Scale score;EEG indicators;Mindful Attention Awareness Scale Chid and adult version;Pittsburgh Sleep Quality Index;Parenting Stress Scale score;Emotional Expression in the Family Adjective Checklist;

Countries

China

Contacts

Public ContactHuilin Zhu

The Third Affiliated Hospital Sun Yat-sen University

zhuhlin6@mail.sysu.edu.cn+86 13416150019

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026