Novel video game approved by FDA could potentially help children with ADHD

The Food and Drug Administration (FDA) recently approved the first therapeutic video game for children with Attention Deficit and Hyperactive Disorder (ADHD). EndeavorRX, created by Akili, is a game for children ages 8-12 who have trouble paying attention.

Experts say this approval will be a welcome relief for parents seeking options other than medication. They caution, however, that this is not a cure.

“There is a tremendous need for it because parents of kids with ADHD don’t usually like medication for various reasons, so there is a big societal demand for something besides medication to explore,” said Dr. Michael Bloch, assistant professor in the Child Study Center and Psychiatry at Yale University.

"I am open minded, but I'm rightfully a little skeptical about a video game treating ADHD," neuropsychologist Dr. Sanam Hafeez told ABC News. "We've spent years and years telling parents to decrease screen time because we feel it worsens ADHD."

Experts agreed that EndeavorRx should not be used to replace established and recommended treatments by the American Academy of Pediatrics (AAP), including behavioral therapy and medication management.

ADHD is a commonly diagnosed pediatric neurodevelopmental disorder that exerts a taxing burden on children and families, affecting over 4 million children aged 6 to 11 with symptoms including difficulties with paying attention or controlling behavior. According to the CDC, about 3 in 4 U.S. children with ADHD receive treatment.

A spokesperson for Akili told ABC News the video game is only available with a doctor's prescription. The FDA reviewed EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low to moderate risk devices of a new type.

After seven years of clinical studies on more than 600 children, researchers found that children receiving the EndeavorRx program had a significantly greater improvement on a computer-based test of attention compared to a control video game condition. Common side effects of the game include frustration, headache, dizziness, emotional reaction and aggression.

Although children had markedly better scores on a computer-based test of attention, parents shouldn't necessarily expect major changes in the children's behavior. According to a study published in the Lancet Digital Health Journal, parents did not rate their children's ADHD symptoms as "significantly" improved compared to a group that did not receive the game.

A company spokesperson said the video game is only approved to be used five days a week for up to 25 minutes per day.

"It’s designed as a monthly treatment that can be used repeatedly as directed by a child’s doctor,” the spokesperson said.

Another big question parents may have is if their kids will have improved attention at school after playing this game. According to the company spokesperson, clinical trials were not set up to answer that question.

Although EndeavorRx clinically has not been shown to be as effective as current treatments for ADHD, experts see it as a promising step for the future of ADHD treatment.

“You have a lot of kids who are socially isolating in the summer ... so maybe this game is better than playing other non-prescribed video games," Bloch said.

He added, “It’s great that the company is doing work to try to develop electronic interventions for ADHD in patients because they are urgently needed at the moment, as there is such a shortage in child psychiatrists and access to treatment is a major issue for a lot of areas of the U.S."

Doctors will be able to prescribe EndeavorRx to families within the next few months with costs expected to be on par with other prescription treatments for children with ADHD, according to the spokesperson.

ABC News' Zohreen Shah contributed to this report.

Ayodola Adigun, M.D., M.S., a fellow in child and adolescent psychiatry at Yale University and a contributor to the ABC News Medical Unit.