MSSc, MAPS, MCCLP, AFHKPS | Clinical Psychologist
Breathe-n-Smile Psychology, Essendon North, Footscray and Victoria telehealth
In brief
- A digital therapeutic is regulated medical software, not a general focus or wellness app.
- ENDEAVORRIDE is used in Japan as an adjunctive treatment for paediatric ADHD. EndeavorRx has FDA authorisation for specified paediatric patients in the United States.
- A controlled trial found improvement on an objective attention measure. That result should not be read as proof of broad improvement for every child or adult with ADHD.
- These products do not replace individual assessment, medication review, therapy, school support, or workplace adjustments.
A prescription video game can sound similar to an ordinary brain-training app, but the two are not interchangeable. Digital therapeutics are software-based medical devices intended to prevent, manage, or treat a health condition. Their claims and supply are regulated.
This article looks at ENDEAVORRIDE and EndeavorRx, two versions of technology developed for ADHD. Breathe-n-Smile Psychology does not prescribe or provide either product.
What is a digital therapeutic?
The Therapeutic Goods Administration describes digital therapeutics as evidence-based software products that deliver a medical intervention. In Australia, a digital therapeutic generally needs to be included in the Australian Register of Therapeutic Goods before it can be supplied, unless an exclusion or exemption applies.[1]
This distinguishes a digital therapeutic from a general meditation, productivity, or brain-training app. A wellness app may still be useful to someone, but it has not necessarily been assessed for a medical purpose.
What are ENDEAVORRIDE and EndeavorRx?
ENDEAVORRIDE is a software-based medical device for paediatric ADHD. It received manufacturing and marketing approval in Japan in February 2025 and was launched there on 5 June 2026 as an adjunctive treatment. Adjunctive means that it is used alongside usual care rather than as a complete replacement.[2]
EndeavorRx uses the same underlying technology in the United States. The US Food and Drug Administration granted De Novo authorisation in 2020 and later cleared an updated indication. The current FDA documents specify the intended patient group and conditions of use.[3]
What did the controlled trial find?
The STARS-ADHD trial included 348 children aged 8 to 12 who were not taking ADHD medication during the study. Participants used either AKL-T01, the earlier name for the technology, or a digital control for about 25 minutes a day, five days a week, over four weeks.[4]
The primary outcome was performance on the Test of Variables of Attention. The AKL-T01 group improved more than the control group on that objective attention measure. Reported treatment-related adverse events were mild and included frustration and headache. The study was sponsored by the product developer.
What the result does not establish: one trial on an attention test does not show that a prescription game will improve every ADHD symptom, school result, work difficulty, relationship concern, or daily task. It also does not show that an ordinary commercial game has the same effect.
Does digital training change the brain?
Learning and repeated practice can be associated with changes in performance and brain activity. However, phrases such as “rewiring the brain” or “training the prefrontal cortex” can make the evidence sound more certain and general than it is.
For this product, the clearest claim is narrower: the intervention was designed to challenge attention and cognitive control, and controlled research found improvement on a specific objective attention measure. Whether that translates into useful day-to-day change depends on the person and the outcome being measured.
Are ADHD digital therapeutics available in Australia?
The TGA requires digital therapeutics to meet Australian medical-device requirements before supply unless an exclusion or exemption applies.[1] Do not assume that overseas authorisation makes a product available or approved for supply in Australia. Check the current ARTG record and speak with an appropriate prescriber or health professional if you are considering a regulated product.
Breathe-n-Smile Psychology does not prescribe or provide ENDEAVORRIDE or EndeavorRx. For practical, non-product-specific ideas, you may prefer our guides on background stimulation and ADHD focus or ADHD habit pairing.
How this fits with broader ADHD care
ADHD support may involve environmental adjustments, skills work, therapy, medication prescribed by a medical practitioner, or a combination. The mix depends on assessment, goals, health considerations, and individual response.
If you are still working out where to begin, read whether to see a psychologist or psychiatrist for ADHD, what happens in an adult ADHD assessment, or what may happen after an adult ADHD diagnosis.
Would you like to ask about ADHD therapy or assessment?
Call 0431 828 769 or email [email protected]. You can also use the contact form for a general enquiry, or check appointment availability.
Please avoid including sensitive clinical information in ordinary email or website messages.
Frequently asked questions
Is a digital therapeutic the same as a wellness app?
No. A digital therapeutic is intended for a medical purpose and is regulated as software-based medical technology. A general wellness or productivity app may not have been assessed for the same purpose.
Can a prescription game replace ADHD medication?
It should not be treated as an automatic replacement. ENDEAVORRIDE is described as an adjunctive treatment in Japan. Medication decisions require discussion with an appropriately qualified medical practitioner.
Do ordinary video games have the same evidence?
No. Evidence about a specific regulated product and protocol cannot be transferred to ordinary commercial games.
Does Breathe-n-Smile Psychology provide these products?
No. Breathe-n-Smile Psychology does not prescribe or provide ENDEAVORRIDE or EndeavorRx.
References
- Therapeutic Goods Administration. Digital therapeutics. Updated 30 January 2026. TGA digital therapeutics guidance.
- Shionogi & Co., Ltd. ENDEAVORRIDE digital therapeutic app for adjunctive treatment of paediatric ADHD launched in Japan. 5 June 2026. Shionogi launch notice.
- US Food and Drug Administration. De Novo classification request DEN200026, EndeavorRx. Decision date 15 June 2020. FDA device classification record.
- Kollins SH, DeLoss DJ, Cañadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD: a randomised controlled trial. Lancet Digital Health. 2020;2(4):e168-e178. https://doi.org/10.1016/S2589-7500(20)30017-0.
Clinical disclaimer: This article provides general educational information and does not constitute medical advice. Product availability, regulation, and indications can change. Breathe-n-Smile Psychology does not prescribe or provide ENDEAVORRIDE or EndeavorRx.