JMIR Publications

ABSTRACT

Background:

The digital therapy of attention-deficit/hyperactivity disorder (ADHD) based on “self-adaptive multitasking training paradigm” has been developed to improve the cognitive functional impairments and attention deficits of ADHD children. However, the efficacy and safety of such treatment for Chinese patients remain untested.

Objective:

To preliminarily evaluate the actual intervention effects of a video-game-like training software (ADHD-DTx) for ADHD children aged 6-12 years as the first national 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 TOVA (Test of Variables of Attention), 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 API (Attention Performance Index) exhibited statistically significant improvement (from -4.15±0.32 to -1.70±0.30, p = 7.20×10-14); the population total/AD/HD/ODD scores of SNAP-IV all significantly improved (total: from 1.33±0.05 to 1.09±0.05, p = 6.88×10-7; AD: from 1.71±0.06 to 1.44±0.06, p = 2.42×10-5; HD: from 1.38±0.07 to 1.05±0.06, p = 4.21×10-8; ODD: 0.84±0.05 to 0.75±0.05, p = 0.014); for WFIRS results, domains of “family” and “social activities” showed significant population improvement (family: from 0.75±0.05 to 0.65±0.04, p = 0.005; social activities: from 0.56±0.05 to 0.45±0.05, p = 0.036); for PSQ results, domains of “conduct problem”, “learning problem”, “psychosomatic problem”, “impulsivity-hyperactivity”, and “hyperactivity index” showed significant improvement (conduct problem: from 0.82±0.05 to 0.74±0.05, p = 0.042; learning problem: from 1.72±0.06 to 1.57±0.06, p = 0.016; psychosomatic problem: from 0.40±0.03 to 0.32±0.03, p = 0.008; impulsivity-hyperactivity: from 0.94±0.06 to 0.80±0.06, p = 0.013; hyperactivity index: from 1.06±0.05 to 0.92±0.05, p = 0.004). No device-related adverse event (AE) or severe adverse event (SAE) 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 digital therapy using ADHD-DTx, with satisfying safety outcomes.