03 July 2020

FDA approves 'prescription video game' for kids with ADHD

EndeavorRx is the first game-based non-drug treatment for ADHD authorised by the FDA.

  • A video game for kids with ADHD is the first game-based treatment for any condition approved by the FDA
  • The device is a non-drug way to alleviate ADHD symptoms in children 
  • The game will probably appeal to parents and children alike, but it is still uncertain how effective it really is


The first video game to help treat kids with attention-deficit/hyperactivity disorder (ADHD) has been approved by the US Food and Drug Administration.

EndeavorRx is a prescription-only game designed to help improve attention in eight- to 12-year-olds with ADHD who have confirmed attention problems.

It is the first game-based treatment authorised by the FDA for any condition.

The game from Akili Interactive is meant to be part of a treatment plan that may include healthcare provider-directed therapy, medication and/or education, according to the FDA.

No serious side effects

"The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics," Dr Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

Approval of the device follows several studies that included a total of 600 children. The studies evaluated whether the game led to improvements in areas such as attention and school performance.

No serious side effects were reported. The most common ones were frustration, headache, dizziness, emotional reaction, and aggression, according to the FDA.

Dr Andrew Adesman, chief of developmental and behavioural paediatrics at Cohen Children's Medical Center in New Hyde Park, New York, said the device seems promising and is likely to appeal to parents of kids with ADHD. But the jury is still out on its effectiveness, he added.

Diagnosis by a professional

"Presently, many parents of children with ADHD have difficulty accessing appropriate counselling services and are reluctant to consider treatment with medications that have proven effectiveness," Adesman said. "To the extent that this product is only available by prescription, it is unclear to what extent insurance companies will cover the cost of this treatment approach."

He said the video game is likely to be most effective in conjunction with other treatments.

ADHD is a common disorder that begins in childhood and affects about four million six- to 11-year-olds in the United States.

ADHD should be diagnosed by a professional based on symptoms such as inattention, hyperactivity, and impulsivity that interfere with functioning or development, according to the US Centers for Disease Control and Prevention.

Image credit: iStock


Ask the Expert

ADHD Expert

Dr Renata Schoeman has been in full-time private practice as a general psychiatrist (child, adolescent and adult psychiatry) since 2008, currently based in Oude Westhof (Bellville). Renata also holds appointments as senior lecturer in Leadership (USB) and as a virtual faculty member of USB Executive Development’s Neuroleadership programme. She serves on the advisory boards of various pharmaceutical companies, as a director of the Psychiatric Management Group (PsychMG) and is the co-convenor of the South African Society of Psychiatrist (SASOP) special interest group for adult ADHD, and co-founder of the Goldilocks and The Bear Foundation ( She is passionate about corporate mental health awareness and uses her neuroscience background to assist leaders in equipping them to become balanced, healthy and dynamic leaders that take their own and their team’s emotional, intellectual, social health and physical needs into account. Renata is academically active and enjoys research and collaborative work, has published in many peer-reviewed journals, and has presented at local and international congresses. She is regularly invited to present at conferences and to engage with the media. During her post-graduate studies, she trained at Harvard, Boston in neurocognition and neuroimaging. Her awards include, amongst others, the Young Minds in Psychiatry award from the American Psychiatric Association, the Discovery Foundation Fellowship award, a Thuthuka award from the NRF, and a MRC Fellowship. She also received the Top MBA student award and the Director’s award from USB for 2015. She was a finalist for the Businesswomen’s Association of South Africa’s Businesswoman of the Year Award for 2016, and received the Excellence in Media Work award from SASOP during 2016.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules