RecruitingNot ApplicableNCT07552909

A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children

Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

146 participants

Start Date

Aug 24, 2025

Study Type

INTERVENTIONAL

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Summary

Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children.

Eligibility

Min Age: 7 YearsMax Age: 11 Years

Inclusion Criteria5

Children aged 7 years 0 months to 11 years 11 months
Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above
Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85
Children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks)
Informed consent must be obtained from the patient/guardian and from participants

Exclusion Criteria9

Auditory or visual illness or disorder
Inability to use software (e.g., color blindness, impaired hand function, or disability)
Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders
Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders
Attention deficit disorder caused by organic neurological diseases or other organic diseases
Previous regular ADHD medication use as prescribed by a doctor, but without efficacy
Past or present gaming addiction
Previous neurofeedback-like "brain control game" interventions
Previous physical therapy such as magnetic stimulation.

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Interventions

DEVICEHome-based digital therapy with brain-controlled games

Home-based brain-controlled training for children with ADHD is completed in a home environment. The training session lasts for 30 minutes daily, with a total of 30 sessions to be completed within a 2-month period. All training frequency and duration are presented in a quantifiable format. The training process incorporates engaging game elements. AI technology is used to provide real-time monitoring and difficulty adjustments, ensuring that each child's training intensity and content are personalized and optimized based on their individual needs. Eye-tracking technology is integrated into the game training to further enhance the training effects on visual attention and cognitive control, making the training more comprehensive and multi-faceted.