The efficacy and implementation of AKL-T01 digital therapeutic in management of attention-deficit/hyperactivity disorder (ADHD) in children: A rapid review of recent evidence
Keywords:
Attention-Deficit/Hyperactivity Disorder, Digital Therapeutics, Video Games, Therapeutic Uses, ReviewAbstract
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder, often inadequately addressed by conventional treatments. Digital therapeutics (DTx) like AKL-T01 (EndeavorRx), a video game-based intervention, have emerged as innovative alternatives for improving attentional control. This rapid review synthesizes recent evidence on the efficacy and implementation of AKL-T01 in managing ADHD across diverse populations.
METHODS: This rapid review involves a systematic search of PubMed, Scopus, and Web of Science (2020-2023) which identified 127 records, with 122 excluded during screening (78 irrelevant, 44 non-English/non-peer-reviewed). Five studies evaluating AKL-T01 were included. Outcomes included attentional performance [Test of Variables of Attention (TOVA) Attention Performance Index (API)], ADHD symptoms, and usability metrics.
RESULTS: Across 1516 participants, AKL-T01 demonstrated significant improvements in objective attention measures [mean TOVA effect size: ~0.5 standard deviation (SD) versus methylphenidate’s: ~1.0 SD], particularly in pediatric populations. Parent-reported outcomes showed mixed results. Compliance rates averaged 83%-96%, with minimal adverse effects.
CONCLUSION: AKL-T01 shows promise as a safe, adjunctive DTx for pediatric ADHD. Ethical considerations (e.g., data privacy, neurodiversity-affirming frameworks) and long-term efficacy require further study.
References
Bokor G, Anderson PD. Attention-Deficit/Hyperactivity Disorder. J Pharm Pract. 2014; 27(4): 336-49.
De La Fuente A, Xia S, Branch C, Li X. A review of attention-deficit/hyperactivity disorder from the perspective of brain networks. Front Hum Neurosci. 2013; 7: 192.
Saccaro LF, Schilliger Z, Perroud N, Piguet C. Inflammation, Anxiety, and Stress in Attention-Deficit/Hyperactivity Disorder. Biomedicines. 2021; 9(10): 1313.
De Crescenzo F, Cortese S, Adamo N, Janiri L. Pharmacological and non-pharmacological treatment of adults with ADHD: a meta-review. Evid Based Ment Health. 2017; 20(1): 4-11.
Serrano-Troncoso E, Guidi M, Alda-Díez J. Is psychological treatment efficacious for attention deficit hyperactivity disorder (ADHD)? Review of non-pharmacological treatments in children and adolescents with ADHD. Actas Esp Psiquiatr. 2013; 41(1): 44-51.
Biederman J, Spencer T. Non-stimulant treatments for ADHD. Eur Child Adolesc Psychiatry. 2000; 9 Suppl 1: I51-9.
Fridman M, Banaschewski T, Sikirica V, Quintero J, Chen KS. Access to diagnosis, treatment, and supportive services among pharmacotherapy-treated children/adolescents with ADHD in Europe: data from the Caregiver Perspective on Pediatric ADHD survey. Neuropsychiatr Dis Treat. 2017; 13: 947-58.
Hong JS, Wasden C, Han DH. Introduction of digital therapeutics. Comput Methods Programs Biomed. 2021; 209: 106319.
Heusser AC, DeLoss DJ, Cañadas E, Alailima T. Leveraging machine learning to examine engagement with a digital therapeutic. Front Digit Health. 2023; 5: 1063165.
Aapro M, Bossi P, Dasari A, Fallowfield L, Gascón P, Geller M, et al. Digital health for optimal supportive care in oncology: benefits, limits, and future perspectives. Support Care Cancer. 2020; 28(10): 4589-612.
Cho CH, Lee HJ. Could Digital Therapeutics be a Game Changer in Psychiatry? Psychiatry Investig. 2019; 16(2): 97-8.
Montani V, De Filippo De Grazia M, Zorzi M. A new adaptive videogame for training attention and executive functions: design principles and initial validation. Front Psychol. 2014; 5: 409.
Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, et al. Video game training enhances cognitive control in older adults. Nature. 2013; 501(7465): 97-101.
Maple A, Palko L, Cañadas E, Jina A. STARS Adjunct Trial: Evidence for the Effectiveness of a Digital Therapeutic as Adjunct to Treatment With Medication in Pediatric ADHD. CNS Spectr. 2023; 28(2): 215-6.
Kollins SH, DeLoss DJ, Cañadas E, Lutz J, Findling RL, Keefe RSE, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020; 2(4): e168-e78.
Stamatis CA, Heusser AC, Simon TJ, Ala'ilima T, Kollins SH. Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01. Transl Psychiatry. 2024; 14(1): 328.
Stamatis CA, Farlow DN, Mercaldi C, Suh M, Maple A, Savarese A, et al. Two single arm trials of AKL-T01, a digital therapeutic for adolescents and adults with ADHD. Npj Ment Health Res. 2024; 3(1): 30.
Sareban M, Treff G, Smeddinck JD, Hussein R, Niebauer J. Opportunities and barriers for reimbursement of digital therapeutics in Austria: Findings From expert interviews. Digit Health. 2025; 11: 20552076241299062.
Borges do Nascimento IJ, Abdulazeem H, Vasanthan LT, Martinez EZ, Zucoloto ML, Østengaard L, et al. Barriers and facilitators to utilizing digital health technologies by healthcare professionals. NPJ Digit Med. 2023; 6(1): 161.
Rahsepar Meadi M, Sillekens T, Metselaar S, van Balkom A, Bernstein J, Batelaan N. Exploring the Ethical Challenges of Conversational AI in Mental Health Care: Scoping Review. JMIR Ment Health. 2025; 12: e60432.
Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD. BMC Public Health. 2024; 24(1): 1195.
Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021; 4: 58.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
Faraone SV, Biederman J, Spencer TJ, Aleardi M. Comparing the efficacy of medications for ADHD using meta-analysis. Med Gen Med. 2006; 8(4): 4.
Faraone SV, Buitelaar J. Comparing the efficacy of stimulants for ADHD in children and adolescents using meta-analysis. Eur Child Adolesc Psychiatry. 2010; 19(4): 353-64.
Zhang S, Faries DE, Vowles M, Michelson D. ADHD Rating Scale IV: psychometric properties from a multinational study as a clinician-administered instrument. Int J Methods Psychiatr Res. 2005; 14(4): 186-201.
Gazzaley A, Rosen LD. The distracted mind: Ancient brains in a high-tech world. Cambridge, MA: Mit Press; 2016.
Ioannidis JP. Why most published research findings are false. PLoS Med. 2005; 2(8): e124.
Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlström K, et al. Computerized training of working memory in children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2005; 44(2): 177-86.
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