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<.001); the population total, inattention (AD), hyperactivity/impulsivity (HD), and oppositional defiant disorder (ODD) scores of SNAP-IV all significantly improved (total: from mean 1.33, SEM 0.05 to mean 1.09, SEM 0.05; t96=5.32; P<.001; AD: from mean 1.71, SEM 0.06 to mean 1.44, SEM 0.06; t96=4.44; P<.001; HD: from mean 1.38, SEM 0.07 to mean 1.05, SEM 0.06; t96=5.96; P<.001; ODD: mean 0.84, SEM 0.05 to mean 0.75, SEM 0.05; Z=2.47; P=.03; n=97); for WFIRS results, domains of "family" and "social activities" showed significant population improvement (family: from mean 0.75, SEM 0.05 to mean 0.65, SEM 0.04; Z=2.80; P=.01; social activities: from mean 0.56, SEM 0.05 to mean 0.45, SEM 0.05; Z=2.91; P=.01; n=97); for PSQ results, domains of "learning problem," "psychosomatic problem," "impulsivity-hyperactivity," and "hyperactivity index" showed significant improvement (learning problem: from mean 1.72, SEM 0.06 to mean 1.57, SEM 0.06; Z=2.42; P=.03; psychosomatic problem: from mean 0.40, SEM 0.03 to mean 0.32, SEM 0.03; Z=2.66; P=.02; impulsivity-hyperactivity: from mean 0.94, SEM 0.06 to mean 0.80, SEM 0.06; Z=2.49; P=.03; hyperactivity index: from mean 1.06, SEM 0.05 to mean 0.92, SEM 0.05; Z=2.90; P=.01; n=97). No device-related adverse event or severe adverse event was observed or reported during or after the intervention. CONCLUSIONS: This study preliminarily suggested the significant improvements of ADHD symptoms and attention function after 4 weeks of ADHD-DTx digital therapy combining basic behavioral parent training with satisfying safety outcomes.