Efficacy and Safety of a Video Game–Like Digital Therapy Intervention for Chinese Children With Attention-Deficit/Hyperactivity Disorder: Single-Arm, Open-Label Pre-Post Study

Background The digital therapy of attention-deficit/hyperactivity disorder (ADHD) based on a “self-adaptive multitasking training paradigm” has been developed to improve the cognitive functional impairments and attention deficits of children with ADHD. However, the efficacy and safety of such treatment for Chinese patients remain untested. Objective This study aimed to preliminarily evaluate the actual intervention effects of a video game–like training software (ADHD-DTx) for children with ADHD aged 6-12 years as the first nationally certified digital therapeutics medical device for ADHD in China. We performed a single-arm, open-label efficacy and safety study. Methods This is a single-arm, open-label, pre-post efficacy and safety study. A total of 97 participants were included in the analysis. Participants received digital therapy (ADHD-DTx) and basic behavioral parent training for 4 weeks (25 min/day, ≥5 times/week) without medication. The efficacy outcomes included the Test of Variables of Attention (TOVA), Swanson, Nolan, and Pelham Questionnaire, version 4 (SNAP-IV), Weiss Functional Impairment Rating Scale (WFIRS), and Conner’s Parent Symptom Questionnaire (PSQ). Safety-related events were monitored during and after the trial. Results From day 0 (baseline) to day 28, the population TOVA Attention Performance Index exhibited statistically significant improvement (from mean –4.15, SE of the mean [SEM] 0.32 to mean –1.70, SEM 0.30; t94=–8.78; n=95; P