A Preliminary Study on the Efficacy and Safety of a Novel Digital Therapeutic Device: A Randomized Clinical Trial in South Korean Pediatric Patients With Attention-Deficit/Hyperactivity Disorder

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. As digital therapeutics (DTx) emerge as adjuncts to traditional ADHD treatment, we evaluated the efficacy and safety of a novel game-based DTx (ADAM-101) in pediatric ADHD. We hypothesized that adding ADAM-101 to pharmacotherapy would improve ADHD symptoms and attention more than pharmacotherapy alone. This study represents one of the first multicenter DTx trials conducted in South Korea. METHODS: This prospective, multicenter, open-label randomized clinical trial enrolled 54 children aged 7-12 years with ADHD. Participants were assigned to an intervention group (pharmacotherapy+ADAM-101) or a control group (pharmacotherapy only). The intervention group used ADAM-101 for 25 minutes per session, five times a week, for 4 weeks. Primary outcomes were the Korean ADHD Rating Scale (K-ARS) and the Advanced Test of Attention (ATA). Clinical Global Impressions (CGI) scales were used as secondary outcome measures. Safety was assessed via vital signs, electrocardiography, and adverse event reporting. RESULTS: Compared with control, the intervention group showed significantly greater improvement in parent-rated K-ARS (Cohen's d=1.07) and the auditory ATA Sensitivity Index (d=0.61). No significant differences were observed in visual ATA measures. CGI scales also favored the intervention group (CGI-Improvement d=1.57; CGI-Severity d=1.05). No serious adverse events were reported. CONCLUSION: ADAM-101 as an adjunct to pharmacotherapy showed preliminary benefits in clinician- and parent-rated symptom severity and auditory attention, without significant safety concerns. Larger confirmatory trials are warranted.