Korean study shows feasibility and scalability of game-based digital therapeutic device as adjunctive treatment for paediatric ADHD.A preliminary study from South Korea demonstrates the efficacy and safety of ADAM-101, a novel game-based digital therapeutic (DTx) device, in children with attention-deficit/hyperactivity disorder (ADHD).
“DTx devices have emerged as adjuncts to traditional treatment for ADHD,” the researchers said. “[In this study,] ADAM-101 showed preliminary benefits in clinician- and parent-rated symptom severity and auditory attention, without significant safety concerns.”
Compared with kids receiving pharmacotherapy only, those on pharmacotherapy and the adjunctive DTx device had significantly lower K-ARS* scores (total: mean change, –5.33 vs +1.52; p=0.001; inattention: mean change, –3.15 vs +0.82; p=0.005; impulsivity: mean change, –2.56 vs +1; p=0.002) and ATA** auditory sensitivity index (mean change, +0.58 vs –0.04; p=0.048) after 4 weeks of intervention. [Psychiatry Investig 2026;23:851-860]
“[The ATA auditory sensitivity index] reflects accuracy in distinguishing an auditory target from nontarget stimuli. This outcome may reflect differences in task characteristics and measurement sensitivity,” the researchers explained.
“Compared with visual attention tests that rely on stimulus discrimination based on visual cues, the auditory attention task requires participants to rely solely on auditory input, which can be inherently more demanding and potentially more sensitive to change, particularly in the paediatric ADHD population,” they continued.
Other outcomes
Compared with the control group, the intervention group also showed a significantly lower CGI-I*** score post-treatment (median, 2 vs 3; p<0.001), which indicates greater perceived improvement. A similar pattern was observed for CGI-S*** score (mean change, –0.52 vs –0.00; p<0.001).
There were no serious adverse events or device-related issues, supporting the clinical acceptability of the intervention, the researchers noted.
All but one participant in the intervention group completed more than 75 percent of the recommended sessions, indicating feasibility and high compliance.
Attractive for paediatric use
The CDC# considers ADHD as a chronic condition requiring long-term, family-centred care, and classifies affected youth as having special healthcare needs. [https://www.cdc.gov/adhd/index.html, accessed October 28, 2026] However, pharmacotherapies for ADHD in young children remains controversial due to concerns on side effects, medication adherence, and long-term outcomes. [Lancet Psychiatry 2018;5:727-738; CNS Drugs 2021;35:403-424]
“Considering these treatment challenges and unmet needs, DTx devices have emerged as promising adjuncts to traditional interventions,” the researchers said.
DTx devices are software-based tools designed to target particular symptoms, commonly through repetitive cognitive behavioural training. Their accessibility, scalability, and safety make them particularly attractive for early intervention in children. ADAM-101 is designed to boost cognitive control processes relevant to ADHD through adaptive, feedback-driven training within a gamified Go/No-Go paradigm, the researchers explained.
Fifty-four participants (mean age 9.8 years, 85 percent male) were assigned equally to pharmacotherapy either alone or with the DTx device. Participants in the intervention group were instructed to use the device for 25 mins per session, five times a week for 4 consecutive weeks.
Implications
“By incorporating both parent/clinician-rated scales and standardized neurocognitive measures, this study enabled a multidimensional evaluation of treatment effects from complementary clinical perspectives,” the researchers said.
The findings also align with evidence showing improved neural efficiency and task-related attentional control with gamified cognitive training in paediatric populations. [Lancet Digit Health 2020;2:e168-e178; J Affect Disord 2024;365:563-577]
“[Hence,] this game-based DTx device may represent a feasible and scalable adjunctive treatment option for paediatric ADHD within routine outpatient settings,” they added.
However, given the modest sample size and exploratory nature of the trial, the researchers called for larger studies to confirm the results and establish the clinical effectiveness of ADAM-101 in real-world paediatric settings.