FDA approves 'prescription video game' for kids with ADHD

• 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

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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.

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