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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study 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

Primary outcome measure(s)

• Inattention — 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 — 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).

Trial sites (1)

More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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