Effectiveness of a Virtual Reality Serious Video Game (MOON) for emotional regulation in Attention-Deficit/Hyperactivity Disorder: A randomized clinical trial. (Preprint)

BACKGROUND Emotional regulation difficulties are often observed in children and adolescents with 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 (SDQ). OBJECTIVE We hypothesize that ADHD patients 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 web-based) will not affect emotional regulation outcomes; and (6) the video game will not cause any clinically significant side effects. METHODS This was a prospective, unicentric, randomized, unblinded, pre- and post-intervention study with block-randomized sequence masking. Participants included clinically diagnosed ADHD patients aged 7 to 18 years, under pharmacological treatment. They were randomized into two groups using an electronic case report form (eCRF): the MOON group, receiving standard pharmacological treatment plus personalized cognitive training via a serious video game; and the control group, receiving standard pharmacological treatment. Both groups were provided with psychoeducational support on ADHD. Analysis was conducted using Student's t-test and two-factor analysis of variance (ANOVA). Approval was granted by the Research Ethics Committee of Puerta de Hierro University Hospital on December 14, 2022, and by the Spanish Agency of Medicines and Health Products on February 14, 2023 (1061/22/EC-R). An independent monitor supervised the study. RESULTS A total of 76 ADHD patients participated in the trial, with an equal randomization (MOON=38; control=38) and a total dropout rate of 7. The primary hypothesis, a 3- or 4-point reduction in the global SDQ score, was not met. However, significant improvements were observed in material organization (p=0.03), working memory (p=0.04) and inhibition (p=0.05), 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. CLINICALTRIAL International Registered Report Identifier (IRRID): DERR1-10.2196/53191; ClinicalTrials.gov; NCT06006871; https://clinicaltrials.gov/study/NCT06006871 INTERNATIONAL REGISTERED REPORT RR2-10.2196/53191