Digital Therapeutics as a Complementary Approach for ADHD Treatment: Five Key Factors for Clinical Validation, Says Dr. Yang Li of Peking University Sixth Hospital
Attention-Deficit/Hyperactivity Disorder (ADHD), commonly known as hyperkinetic disorder, is a neurodevelopmental disorder that onsets in childhood and is primarily characterized by inattention, hyperactivity, and impulsivity that are inconsistent with developmental levels. Core symptoms include inattention, hyperactivity, and impulsivity. Children with ADHD are like cars with malfunctioning brakes and accelerators: at times speeding or losing control, and at other times slowing down or even stalling. The brains of children with ADHD function similarly; they exhibit impairments in self-monitoring and self-regulation, rendering them unable to adjust their behavior according to environmental demands. When the environment is novel and engaging, their brains become impulsive and absorbed—operating at high speed but with low accuracy. Conversely, when external stimuli are monotonous and dull, such as during tasks involving rote memorization, their brains enter a “stalled” state, leading to drowsiness and lethargy.
China is home to 23 million individuals with ADHD. Given the country’s large population base, the number of pediatric ADHD patients is substantial. Determining how to provide these patients with better and more tailored treatment plans remains a key question for every relevant clinician. With the rapid development of digital therapeutics, the answer to this challenge is becoming increasingly clear. In light of this, VCBeat interviewed Researcher Yang Li from the Child Psychology Center at Peking University Sixth Hospital to gain deeper insights into her perspectives and expectations regarding digital therapeutics for ADHD.
Yang Li, Researcher at Peking University Sixth Hospital; Deputy Director of the Child Psychology Center, Peking University Sixth Hospital; Vice Chair of the World Federation of ADHD
Yang Li, Researcher at Peking University Sixth HospitalVCBeat reports that digital therapeutics have undergone more than a decade of development. In recent years, with advancements in AI, VR, and other technologies, ADHD digital therapeutic products based on these emerging technologies have continued to emerge. These products offer advantages such as ease of use, intelligence, engagement, and minimal side effects, garnering widespread attention.
Digital therapeutics for ADHD are particularly well-suited for two specific populations. The first comprises individuals who respond poorly to pharmacological treatment. At least one-third of patients with ADHD experience suboptimal therapeutic efficacy or intolerance, leading to residual symptoms or adverse drug reactions, thereby necessitating the combination of non-pharmacological interventions. The second group includes those with low acceptance of medication. Some parents of children with ADHD have concerns regarding pharmacotherapy; in such cases, non-pharmacological interventions can provide timely initial support for the child.
Professor Yang Li stated that currently, only a very small number of ADHD digital therapeutics products abroad have received approval and entered clinical application. These approved products have all undergone rigorous clinical efficacy studies and validation, and the market entry pathway for domestic products must follow suit. For instance, Fangcun Doctor has subjected the entire process—from determining the direction of its ADHD digital therapeutics product and designing training protocols to finalizing the product—to strict and meticulous review and validation.
The evaluation metrics for clinical trials of digital therapeutics are quite similar to those for drug clinical trials. They require rigorous, strictly controlled randomized, double-blind studies to observe efficacy, side effects, adherence, and other factors. For therapies targeting mental and psychological disorders, it is also necessary to obtain input from various informants to assess improvements in children’s core symptoms and make a comprehensive judgment.
In this regard, Fangcun Doctor is conducting rigorous clinical trials. Clinical experience with patient usage has shown favorable acceptance of digital therapeutics and positive feedback on efficacy. Professor Yang Li expressed strong interest in seeing the final clinical evaluation results, hoping that these therapies can provide genuinely beneficial treatment supplements for patients who are unable to undergo pharmacological therapy or behavioral training.
Regarding the selection of digital therapeutics products by hospitals and physicians, Professor Yang Li also provided several reference dimensions.First, therapeutic efficacy.Only treatment tools that have been clinically validated as effective possess clinical value.Second, interest.Only when children are interested in the product can they adhere to treatment and achieve therapeutic efficacy.Third, accessibility.Cognitive behavioral training requires repeated, and even high-frequency, sessions. If the therapeutic environment is confined to hospital settings, it may limit parents’ and children’s use of the product; therefore, expanding the scenarios in which the product can be used is crucial.Fourth, cost-effectiveness.If the cost of digital therapeutics is prohibitively high, making them unaffordable for families, it will significantly deter parents from choosing such products.Fifth, Treatment Feedback from Parents and Children. Physicians will certainly evaluate how both parents and children use the product; only when they are willing to adhere to the treatment and derive genuine benefit can physicians’ recognition of the product be consistently reinforced.
Recently, Fangcun Doctor has established in-depth collaborations with top-tier medical institutions in China, including Peking University Sixth Hospital, Beijing Anding Hospital, Peking Union Medical College Hospital, West China Hospital of Sichuan University, and Beijing Huilongguan Hospital. Fangcun Doctor’s digital therapeutic product for adjunctive ADHD treatment (FocusPro1) has entered the phase of multi-center, multi-item clinical trials across China and is expected to obtain Class II medical device certification from the National Medical Products Administration (NMPA) within the year.
In addition, Professor Yang Li expressed her anticipation for the integration of digital therapeutics with in-person behavioral training. In principle, digital therapeutics can serve as a complementary approach to such training.Digital therapeutics is a cognitive enhancement training., and implement targeted interventions to address the child’s areas of deficit, such as attention, memory, and self-control.Offline behavioral intervention is a compensatory training,Due to limitations in training intensity and frequency, the improvement in cognitive function is modest; however, it can help children acquire daily living skills, such as packing their school bags. Theoretically, combining these two approaches—enhancing cognitive function on one hand and providing essential life skills on the other—can yield better rehabilitation outcomes.
Regarding the direction for improving digital therapeutics, Professor Yang Li believes that current ADHD digital therapeutic products have largely succeeded in digitizing and systematizing traditional pen-and-paper training, making the training more efficient and precise—a significant advancement. However, these interventions typically rely on children receiving visual information through video content, which is processed by the brain to generate feedback; this process is repeatedly reinforced to improve neural function, yet it remains limited to sensory input. With the rapid development of neuroscience, there is an expectation for the emergence of more innovative products based on brain-computer interaction technology, enabling deeper modulation of brain function to achieve better therapeutic outcomes.
We are confident that in the near future, digital therapeutics will reach every patient in need. A more extensive and in-depth exploration of digital therapeutics requires the joint efforts of enterprises and physicians. Let us wait and see what the future holds.