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.

ABSTRACT:

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 wer

SUBMITTER: Bao M 

PROVIDER: S-EPMC12817042 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature