Abstract
Difficulties in emotional regulation are often observed in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Innovative complementary treatments, such as video games and virtual reality, have become increasingly appealing to patients. The Secret Trail of Moon (MOON) is a serious video game developed by a multidisciplinary team featuring cognitive training exercises. In this second randomized clinical trial, we evaluated the impact of a 20-session treatment with MOON on emotional regulation, as measured by the Strengths and Difficulties Questionnaire. We hypothesize that patients with ADHD using MOON will show improvements in (1) emotional regulation, (2) core ADHD symptoms, (3) cognitive functioning, and (4) academic performance, compared to a control group; additionally, we anticipate that (5) changing the platform (from face-to-face using virtual reality to the web) will not affect emotional regulation scores; and (6) the video game will not cause any clinically significant side effects. This was a prospective, unicentric, randomized, unblinded, pre- and postintervention study with block-randomized sequence masking. Participants included individuals aged between 7 and 18 years who had a clinical diagnosis of ADHD and were receiving pharmacological treatment. They were randomized into 2 groups using an electronic case report form: the MOON group, receiving standard pharmacological treatment plus personalized cognitive training via a serious video game, and the control group, receiving standard pharmacological treatment. We provided both the groups with psychoeducational support on ADHD. Analysis was conducted using the Student 2-tailed t test and 2-factor ANOVA. An independent monitor supervised the study. A total of 76 patients with ADHD participated in the trial, with an equal randomization (MOON: n=38, 50% and control: n=38, 50%) and a total dropout rate of 7. The primary hypothesis, a 3- or 4-point reduction in the global Strengths and Difficulties Questionnaire score, was not met. However, significant improvements were observed in material organization (P=.03), working memory (P=.04), and inhibition (P=.05), particularly among patients more engaged with the MOON treatment. Serious video games, when integrated into a multimodal treatment plan, can enhance outcomes for symptoms associated with ADHD. ClinicalTrials.gov NCT06006871; https://clinicaltrials.gov/study/NCT06006871. RR2-10.2196/53191.
Published Version
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