Effectiveness of a Virtual Reality Serious Video Game (The Secret Trail of Moon) for Emotional Regulation in Children With Attention-Deficit/Hyperactivity Disorder: Randomized Clinical Trial.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: Serious video games, when integrated into a multimodal treatment plan, can enhance outcomes for symptoms associated with ADHD.

Trial Registration: ClinicalTrials.gov NCT06006871; https://clinicaltrials.gov/study/NCT06006871.

International Registered Report Identifier (irrid): RR2-10.2196/53191.