Dr. Ke Xiaoyan, Director of Nanjing Brain Hospital: Digital Therapeutics for ADHD Must Prioritize Rigorous Efficacy Validation and Long-Term Health Outcomes
Attention-Deficit/Hyperactivity Disorder (ADHD), commonly known as hyperactivity disorder, is a neurodevelopmental disorder that onset in childhood and is primarily characterized by attention deficits, 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 they speed or lose control, while at other times they slow down or even stall. The brains of children with ADHD function in this manner; their self-monitoring and self-regulation capabilities are impaired, preventing them from adjusting 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 knowledge retention, their brains enter a stalled state, leading to drowsiness.
In China, over 20 million children and adolescents are currently affected by ADHD; however, there are no more than 500 specialized child psychiatrists, with high-quality practitioners predominantly concentrated in large tertiary Grade A hospitals in first- and second-tier cities. Furthermore, the consultation rate for ADHD is less than 20%, and only about one-third of patients receive standardized treatment.
Overall, the current landscape of ADHD diagnosis and treatment is characterized by uneven distribution of medical resources, a severe imbalance between supply and demand, and significant limitations in existing therapeutic options, leaving substantial room for future exploration and development. Therefore,Can the emergence of digital therapeutics fill these gaps? What innovations and medical value have they actually brought? What are the future development trends of the industry? What are the perspectives and judgments of frontline medical experts?
An in-depth exclusive interview with Dr. Ke Xiaoyan, Director of the Child Mental Health Institute and Chief Physician at Nanjing Brain Hospital, as well as Director of the WHO Collaborating Center for Research and Training in Child Mental Health, on the efficacy validation of digital therapeutics
Ke Xiaoyan, Director of the Child Mental Health Research Center and Chief Physician at Nanjing Brain Hospital; Director of the WHO Collaborating Center for Research and Training in Child Mental Health
Director Ke Xiaoyan introduced that, regarding ADHD, parents generally have a basic level of awareness when seeking medical care. However, they often struggle to distinguish whether a child’s hyperactivity should be classified as a medical condition, a behavioral disorder, or an educational issue. Without relevant experience, it is difficult for them to truly understand the disease and make accurate judgments. Therefore, patient education should go beyond mere knowledge dissemination; it also requires more families affected by the condition to share their personal experiences.
In terms of treatment, even if parents accept the diagnosis, they may not necessarily adhere to the prescribed treatment or complete the full treatment regimen, particularly pharmacological therapy. Many parents exhibit poor acceptance, and even among those who do accept it, long-term medication adherence is often challenging. Therefore, patient education must be implemented at all stages. Parents’ perspectives may fluctuate repeatedly, making this a process that requires sustained, gradual engagement over the long term.
In response to this, particularly following the outbreak of the pandemic in 2019, the Child Mental Health Research Center at Nanjing Brain Hospital, with platform support from Dr. Fang Cun, launched a series of online parent education classes. This initiative aimed to address the limitation of insufficient time for comprehensive health education during outpatient consultations. The series comprises three main modules—ADHD, Tic Disorders, and Autism Spectrum Disorder—and has achieved high acceptance and engagement rates among parents, providing tangible assistance to many families feeling lost and helpless.
Regarding the currently popular digital therapeutics, Director Ke Xiaoyan stated that digital therapeutics have garnered attention because their remote nature enhances healthcare accessibility, and some studies have demonstrated their efficacy with low adverse effects. However, Director Ke believes that whether conclusions drawn from small-sample studies can be generalized to ADHD patient populations with different phenotypes and subtypes still requires rigorous clinical trials in the Chinese population for validation. Only with support from evidence-based medical data can the effectiveness of digital therapeutics be ensured.
Director Ke Xiaoyan has repeatedly emphasized that the product development and clinical validation of digital therapeutics must be conducted with greater rigor. Only in this way can products possess genuine viability. If rigor is lacking from the outset, the product’s efficacy will face substantial skepticism, potentially leading stakeholders to dismiss the entire offering due to such doubts—a trade-off not worth making. It is preferable to proceed at a measured and steady pace, clearly defining the specific age groups and types of neuropsychological impairments for which the intervention is effective.
Director Ke Xiaoyan pointed out that it is necessary to replicate and validate foreign digital therapeutics research, conduct localized development and design, and carry out clinical studies targeting specific age groups. The more narrowly the target population is defined, the more rigorous the study, the stronger its reproducibility, and the greater the likelihood of widespread acceptance. Special attention should be paid to preschool children, for whom pharmacological treatment is not generally recommended as the first-line option in clinical practice; instead, parent education and behavioral management are prioritized. Furthermore, children at this stage exhibit heightened neuroplasticity and functional adaptability, making them well-suited for intervention with digital therapeutics.
However, the prerequisite is not only to verify the short-term efficacy of digital therapeutics but also to observe their long-term effects. A therapy should not merely be harmless or achieve improved scores on training tests; rather, it must be genuinely effective in delivering functional improvements, which constitutes the true clinical treatment goal. Meanwhile, Director Ke Xiaoyan also cautioned against parents developing a preference for certain therapies due to concerns about medication, without considering actual clinical circumstances, as this may compromise treatment outcomes. It is also essential to prevent products with unverified efficacy from being prematurely introduced into clinical practice or commercialized, thereby avoiding adverse consequences.
Professor Ke Xiaoyan also emphasized that primary healthcare in China is a critical component that cannot be overlooked. There is a need for scalable solutions that reduce reliance on specialized personnel. She expressed hope that innovative products based on computer and internet technologies, such as digital therapeutics, can genuinely help enhance the accessibility of high-quality medical services, alleviate the clinical dependence on specialized staff, and promote greater equity in healthcare delivery. This should be the direction of our collective efforts.
Recently, Fangcun Doctor has entered into in-depth collaborations with leading medical institutions in China, including Beijing Anding Hospital, Peking Union Medical College Hospital, Peking University Sixth Hospital, West China Hospital of Sichuan University, Beijing Huilongguan Hospital, and Wuhan Children’s Hospital. Fangcun Doctor’s digital therapeutic product for adjunctive treatment of ADHD (FocusPro1) has also entered the phase of multi-center clinical trials across China and is expected to obtain Class II medical device certification from the National Medical Products Administration (NMPA) within the year.