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===Digital interventions=== Several clinical trials have investigated the efficacy of digital therapeutics, particularly [[Akili Interactive Labs]]'s video game-based digital therapeutic AKL-T01, marketed as [[EndeavourRx]]. The pediatric STARS-ADHD randomised, double-blind, parallel-group, controlled trial demonstrated that AKL-T01 significantly improved performance on the [[Test of Variables of Attention]], an objective measure of attention and inhibitory control, compared to a control group after four weeks of at-home use.<ref name="STARS-ADHD">{{cite journal |vauthors=Kollins SH, DeLoss DJ, Cañadas E, Lutz J, Findling RL, Keefe RS, Epstein JN, Cutler AJ, Faraone SV |title=A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial |journal=[[The Lancet Digital Health]] |volume=2 |issue=4 |pages=e168–e178 |date=April 2020 |pmid=33334505 |doi=10.1016/S2589-7500(20)30017-0 |doi-access=free}}</ref> A subsequent pediatric open-label study, STARS-Adjunct, published in [[Nature Portfolio]]'s [[npj Digital Medicine]] evaluated AKL-T01 as an adjunctive treatment for children with ADHD who were either on stimulant medication or not on stimulant pharmacotherapy. Results showed improvements in ADHD-related impairment (measured by the Impairment Rating Scale) and ADHD symptoms after 4 weeks of treatment, with effects persisting during a 4-week pause and further improving with an additional treatment period.<ref name="STARS-ADHD-Adjunct">{{cite journal |vauthors=Kollins SH, Childress A, Heusser AC, Lutz J |title=Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD |journal=npj Digital Medicine |volume=4 |issue=1 |page=58 |date=March 2021 |pmid=33772095 |pmc=7997870 |doi=10.1038/s41746-021-00429-0 |ref=STARS-Adjunct}}</ref> Notably, the magnitude of the measured improvement was similar for children both on and off stimulants.<ref name="STARS-ADHD-Adjunct" /> In 2020, AKL-T01 received marketing authorisation for pediatric ADHD from the [[Food and Drug Administration|FDA]], becoming "the first game-based therapeutic granted marketing authorisation by the FDA for any type of condition."<ref name="FDA AKL-T01">{{cite web |title=FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD |url=https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd |website=Food and Drug Administration |date=17 June 2020 |publisher=United States Food and Drug Administration |access-date=19 April 2024 |ref=FDA}}</ref> In addition to pediatric populations, a 2023 study in the ''[[Journal of the American Academy of Child and Adolescent Psychiatry|Journal of the American Academy of Child & Adolescent Psychiatry]]'' investigated the efficacy and safety of AKL-T01 in adults with ADHD. After six weeks of at-home treatment with AKL-T01, participants showed significant improvements in objective measures of attention ([[Test of Variables of Attention|TOVA - Attention Comparison Score]]), reported ADHD symptoms (ADHD-RS-IV inattention subscale and total score), and reported quality of life (AAQoL).<ref name="STARS-ADHD-Adults">{{cite journal |vauthors=Stamatis CA, Mercaldi C, Kollins SH |title=A Single-Arm Pivotal Trial to Assess the Efficacy of Akl-T01, a Novel Digital Intervention for Attention, in Adults Diagnosed With ADHD |journal=[[Journal of the American Academy of Child and Adolescent Psychiatry]] |date=October 2023 |volume=62 |issue=10 |pages=S318 |doi=10.1016/j.jaac.2023.09.510 |url=https://www.jaacap.org/article/S0890-8567(23)01994-9/fulltext#%20 |access-date=22 April 2024}}</ref> The magnitude of improvement in attention was nearly seven times greater than that reported in pediatric trials.<ref name="STARS-ADHD-Adults" /> The treatment was well-tolerated, with high compliance and no serious adverse events.<ref name="STARS-ADHD-Adults" />
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