Clinical study on the intervention effect of digital therapy on children with attention deficit hyperactivity disorder (ADHD).

To evaluate the efficacy and safety of digital therapy for children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD). From January to March 2023, 52 children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD) from Wuhan Children's Hospital, Hubei Province, China were selected for intervention using the "MindPro1" attention training software developed by Jiangsu Ruinao Qizhi Medical Technology Co., Ltd. Before the intervention, the children were in a stable treatment state, and no modifications were made to the original treatment plan during the MindPro1 intervention. Subjects with severe mental illness or other conditions that may affect the implementation and evaluation of disease treatment were excluded. Subjects completed the planned 4-week intervention, and changes in attention-related variables were assessed using the Test of Attention Variables (TOVA) and the parent version of the 18-item SNAP-IV scale (Swanson, Nolan, and Pelham, version IV scale) before and after the intervention. After 4 weeks of intervention, the lower limit of the 95% confidence interval of the response rate of the 18-item SNAP-IV-Parent scale, which was ≥ 30% improvement from baseline, was higher than 27.5% (better than similar products on the market); the SNAP-IV parent score improved (P < 0.001), with statistical significance; the TOVA-ACS score improved (P < 0.05), with statistical significance. The acceptance rate of parents of children was 100%, and the average compliance rate was 95%. There were 4 cases (7.69%) of adverse reactions that may be related to the device in this trial, which recovered spontaneously within 2 days of discontinuation, and no serious adverse events occurred. After 4 weeks of treatment with ADHD auxiliary treatment software, the objective attention assessment data and attention function assessment scale were significantly improved. Parents had a high acceptance of the software, the average compliance rate of participants was high, and the incidence of related adverse events was low and mild.