NCT Number: NCT07552909
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.
Interested in participating?
Request Info7 year–11 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200092, China
Location status: Recruiting
Jingjun Liu, Master
PRINCIPAL_INVESTIGATOR
Meihui Qiu, Master
PRINCIPAL_INVESTIGATOR
Sixun Zou, Master
PRINCIPAL_INVESTIGATOR
Weiping Xia, PhD
CONTACT
Xuan Cao, Master
PRINCIPAL_INVESTIGATOR
Yiting Wu, Master
PRINCIPAL_INVESTIGATOR
CONTACT
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.
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.
Randomized Controlled Study.
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.
Exclusion criteria
include:
Home-based digital therapy with ADHD brain-controlled games.
Primary Outcome Measure: ADHD SNAP-IV subscale scores (Inattention/Hyperactivity-Impulsivity).
Secondary Outcome Measure: Executive Function (BRIEF) questionnaire scores.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Weiping Xia, PhD
CONTACT
Yiting Wu, Master
CONTACT
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Other
Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games
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