A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based digital therapy with brain-controlled games.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder (ADHD). Basic parameters: 7 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games
Overview
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.
Detailed description
1. Research Title
A Randomized Controlled Study on the Efficacy of Home-Based Digital Therapy with Brain-Controlled Games for School-Aged Children with Attention Deficit Hyperactivity Disorder. 2. Research Objective
To explore the efficacy of brain-controlled games as an intervention for school-aged children with mild to moderate ADHD, with the aim of providing a new evidence-based method to intervene in the core symptoms of ADHD. 3. Study Design
Randomized Controlled Study. 4. Total Cases 5. Case Selection
Inclusion Criteria: Children aged 7 years, 0 months to 11 years, 11 months who are diagnosed by a physician with at least the rank of attending physician in pediatric psychiatry as meeting the diagnostic criteria for ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), have a full-scale Wechsler IQ higher than 85, and are outpatient children with ADHD who have not received any intervention (newly diagnosed within the last month or have not taken medication for at least 4 weeks). Informed consent will be obtained from the patient/guardian and from participants aged 8 years and older. 6. Exclusion Criteria
Exclusion criteria include: 1. Auditory or visual diseases or disorders. 2. Inability to use the software, such as color blindness, or hand function defects or disabilities. 3. Comorbidities with other neurodevelopmental disorders such as oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, Tourette's syndrome, etc. 4. Patients with other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders. 5. Attention deficit disorder caused by organic diseases of the nervous system or other organic diseases. 6. Previous history of ineffective regular ADHD medication as prescribed by a doctor. 7. Past or present game addiction. 8. Previous similar brain-controlled game interventions like Neurotest. 9. Previous physical therapy such as magnetic stimulation. 7. Treatment Protocol
Home-based digital therapy with ADHD brain-controlled games. 8. Efficacy Assessment
Primary Outcome Measure: ADHD SNAP-IV subscale scores (Inattention/Hyperactivity-Impulsivity).
Secondary Outcome Measure: Executive Function (BRIEF) questionnaire scores. 9. Statistical Methods
The differences in evaluation results between the intervention group and the control group will be analyzed using a repeated measures analysis of variance from a general linear model. Missing data will be handled using the Last Observation Carried Forward (LOCF) method. The study will control for inter-group bias through measures such as random assignment, consistent training of evaluators, and blind evaluation where the evaluators are unaware of the subjects' treatment status.
Interventions
- Device Home-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 persona
Primary outcome measures
- Inattention [Time frame: The first week after the intervention]
- Hyperactivity-Impulsivity [Time frame: The first week after the intervention]
Secondary outcome measures (1)
- executive function [Time frame: The first week after the intervention]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Weiping Xia — Shanghai
Identifiers
NCT: NCT07552909 · XH-25-007