A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
ID: NCT07552909
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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.
Read Full Scientific Objectives & Methods
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.
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.
Treatment Arms Description
Control group: Participants will receive standard clinical care, with treatment strategies determined by the clinician based on their clinical experience, professional knowledge, and the specific condition of the school-aged child with ADHD. This includes outpatient guidance and ADHD health education from the doctor. No study-specific interventions will be applied during this period, and participants will be followed up at predetermined time points.
For children in the intervention group, the entire training process will be completed at home. Each training session will last for 30 minutes, and a total of 30 sessions will be completed within 2 months of enrollment. All training frequency and duration will be presented in a quantifiable format.
- 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
- 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.
Primary Outcome Measures
- Inattention — Time Frame: The first week after the intervention
Assess using the Inattention subscale scores from the parent version of the Swanson, Nolan, and Pelham-IV (SNAP-IV) 47-item Rating Scale. The Inattention subscale consists of the first 9 items of the parent version of the 47-item SNAP-IV scale, directly corresponding to the DSM-5 diagnostic criteria for inattentive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much). The subscale score is calculated as the mean of items 1-9 (range 0-3). Higher scores indicate greater symptom severity. Based on established clinical norms (Swanson, 2001), a mean score of ≥ 1.67 is defined as the threshold for a "positive" symptomatic response (clinical significance) for Inattention. Previous studies have demonstrated that this subscale possesses exceptional psychometric properties, with internal consistency (Cronbach's α) reported as high as 0.95 in recent clinical evaluations (Enemuo et al., 2022; Hall et al., 2020).
- Hyperactivity-Impulsivity — Time Frame: The first week after the intervention
Assess using the Hyperactivity-Impulsivity subscale scores from the parent version of the SNAP-IV questionnaire. The Hyperactivity-Impulsivity subscale consists of items 10-18 of the parent version of the 47-item SNAP-IV scale, corresponding to the DSM-5 criteria for hyperactive and impulsive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much).The subscale score is calculated as the mean of items 10-18 (range 0-3). Higher scores reflect increased severity of hyperactivity and impulsivity. According to standardized norms, a mean score of ≥ 1.50 is used as the cut-off point to determine a "positive" symptomatic status (clinical significance) for Hyperactivity-Impulsivity. Extensive psychometric evaluations have reported exceptional reliability for this subscale, with a Cronbach's α coefficient reported as high as 0.92 to 0.94 in clinical samples (Bussing et al., 2008; Hall et al., 2020).
View Secondary Outcome Measures (1)
- executive function — Time Frame: The first week after the intervention
Executive function will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al., 2000). The Parent-Report form consists of 86 items rated on a 3-point Likert scale(1 = Never, 2 = Sometimes, 3 = Often). The inventory yields two primary indexes: the Behavioral Regulation Index (BRI: Inhibit, Shift, Emotional Control) and the Metacognition Index (MI: Working Memory, Plan, Organize, Monitor), which combine into the Global Executive Composite (GEC). Raw scores will be converted into standardized T-scores (M=50,SD=10) using age- and gender-appropriate norms. Higher T-scores reflect greater dysfunction, with T≥65 indicating clinical significance. The BRIEF is a well-validated instrument; according to the technical manual and prior clinical studies (Gioia et al., 2000; Donders et al., 2002), the Cronbach's α for the GEC exceeds 0.90, ensuring robust reliability for evaluating intervention efficacy.
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View Official Medical/Scientific Title
Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games