FDA Approves Prescription Video Game for ADHD

Kids playing video games.

Key Takeaways

  • On June 15th, the FDA approved marketing for the first game-based therapeutic.
  • EndeavorRx is a video game to be used as a drug-free treatment for kids with ADHD.

The FDA has officially granted marketing authorization to the first game-based therapeutic. Developed by Akili Interactive Labs, Inc. EndeavorRx, a video game, is a non-drug treatment option for children ages 8–12 years old who have been diagnosed with certain types of ADHD. 

The first-and-only prescription treatment of its kind, EndeavorRx has found a way to make treatment fun, accessible, and virtual, which is a game-changer for the mental health industry.

“I’m all for innovative interventions for all kinds of mental health conditions,” says Lindsay Israel, a Board Certified Psychiatrist and Chief Medical Officer at Success TMS. “It’s really nice to have a non-medication alternative just as a treatment tool in the arsenal, especially for parents who are looking for options that won’t harm their children.”

Expanding Treatment Options

Up until this month, behavioral therapy, educational programs, and medication (short-acting and intermediate-acting/long-acting stimulants) were the only FDA-approved treatment options for children diagnosed with ADHD. EndeavorRx is a new, welcomed alternative. 

The game-based treatment has been evaluated in over 600 children with ADHD across five clinical trials. Results from the medical study published in The Lancet Digital Health show that EndeavorRx (AKL-T01) can improve inattention in patients ages 8–12 who have been diagnosed with inattentive or combined-type ADHD. The study also shows there are minimal adverse reactions, which is a huge benefit. 

How It Works

Meant to be included in a therapeutic program (which may include therapy or medication), the EndeavorRX video game is part of the EndeavorRx Treatment System™ care program, which includes ADHD Insight™ behavior tracking app and Akili Assist™ support which gives parents or caregivers direct access to a trusted partner from Akili Interactive Labs, Inc. 

“People love games, so this option can improve treatment compliance (which can be a significant problem with young people),” says Nicole Arzt, licensed marriage and family therapist. “It can also help children feel more involved with their care, which can strengthen positive outcomes.”

The downsides of this treatment are minimal. EndeavorRx won’t negatively impact a child’s health the way many medications can. 

Dr. Israel believes one of the only issues parents might face is disengaging their child from the game itself, especially if it’s enticing. Otherwise, there is no known harm to the child.

More than 6.1 million children aged two to 17 years old have been diagnosed with ADHD. Studies show that two-thirds of children diagnosed with ADHD are on medication. Treating children with stimulants has been a long, controversial debate, with many arguing that children are too often overprescribed. 

“Stimulants have so many side effects. For one, they can be easily abused,” explains Arzt. “This can create long-term dependency problems, and these problems can be hard to treat because the prescriptions are legal. Furthermore, medication isn't designed to be a cure.”

Nicole Arzt, MS, LMFT

Many people believe drugs can and will ‘fix’ the problem, but mental illness doesn't work that way. Even with medication, most health experts recommend a behavioral therapy component.

— Nicole Arzt, MS, LMFT

EndeavorRx certainly offers hope that non-medicated treatment options are possible.

Benefits of Video Game Therapy

Though the new innovative treatment isn’t meant to replace medication, it’s a promising new development for those suffering from ADHD. The video game can be utilized at home, it doesn’t require the child to visit an office, and it’s more appealing than taking a pill every day. Video games are also kid-friendly and fun, so adding a mental health component is an added benefit to an already enjoyable activity.

Studies show that 91% of children ages 2-17 play video games, so chances are children will actually want to play this. According to Akili Interactive Labs, Inc.’s website, these games feel like high-end interactive action video games but target and treat cognitive impairments at their specific sources in the brain. Right now, the games target prefrontal cortex-based cognitive control, but even more brain-benefiting technologies are in development.

“It’s not that medicines are evil but it’s nice to have an alternative because not everyone can tolerate meds,” says Dr. Israel. “Now, parents can weigh the pros and cons and make an informed decision for their child.”

EndeavorRx has many benefits. It could minimize the need for higher doses and additional medications, explains Dr. Israel. It also utilizes what we know kids like and what keeps them engaged in a therapeutic way. Children with ADHD often have difficulty concentrating on homework or paying attention in school, but surprisingly, video games are not usually a problem for those battling ADHD.

The Future of Mental Health Care

“Society (and even mental health professionals) can be slow to change. It takes a while for people to integrate new treatments,” says Arzt. “That being said, we're all moving towards a space of trying to decrease pharmacological treatment in young children, so people are showing far more interest in alternative methods.”

Nicole Artz, MS, LMFT

Virtual reality is the future. I believe we're going to see more and more virtual treatment methods for all ages and all kinds of conditions.

— Nicole Artz, MS, LMFT

Dr. Israel has many hopes for this new product. She hopes that it will cater to children who have learning disabilities, so all children with ADHD can benefit. She also hopes we can build on this concept and extend the age range, eventually offering it to adults.

What This Means For You

Therapeutic video games are just the beginning of what’s possible. Other companies are working hard to bring innovative, technology-driven products to the forefront of the mental health field, giving patients more beneficial, and often safer, treatments, and thanks to the push from the FDA, more and more treatments are likely on the horizon. 

4 Sources
Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. FDA. FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD.

  2. Kollins S, DeLoss D, Cañadas E et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trialThe Lancet Digital Health. 2020;2(4):e168-e178. doi:10.1016/s2589-7500(20)30017-0

  3. Danielson ML, Bitsko RH, Ghandour RM, Holbrook JR, Kogan MD, Blumberg SJ. Prevalence of parent-reported ADHD diagnosis and associated treatment among U.S. children and adolescents, 2016J Clin Child Adolesc Psychol. 2018;47(2):199-212. doi:10.1080/15374416.2017.1417860

  4. Granic I, Lobel A, Engels R. The benefits of playing video gamesAmerican Psychologist. 2014;69(1):66-78. doi:10.1037/a0034857

By Sarah Sheppard
Sarah Sheppard is a writer, editor, ghostwriter, writing instructor, and advocate for mental health, women's issues, and more.