%0 Journal Article
%@ 2291-9279
%I JMIR Publications
%V 13
%N 
%P e59124
%T 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
%A Martin-Moratinos,Marina
%A Bella-Fernández,Marcos
%A Rodrigo-Yanguas,María
%A González-Tardón,Carlos
%A Li,Chao
%A Wang,Ping
%A Royuela,Ana
%A Lopez-Garcia,Pilar
%A Blasco-Fontecilla,Hilario
%+ Health Sciences and School of Doctoral Programs, International University of La Rioja, Avda de la Paz, 137, Logroño, 26006, Spain, 34 910149575, hilariomanuel.blasco@unir.net
%K attention-deficit/hyperactivity disorder
%K ADHD
%K emotional regulation
%K serious video games
%K virtual reality
%K cognitive training
%K music
%K chess
%D 2025
%7 8.1.2025
%9 Original Paper
%J JMIR Serious Games
%G English
%X 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 
%R 10.2196/59124
%U https://games.jmir.org/2025/1/e59124
%U https://doi.org/10.2196/59124