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
BackgroundDifficulties 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. Th...
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JMIR Publications
2025-01-01
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Series: | JMIR Serious Games |
Online Access: | https://games.jmir.org/2025/1/e59124 |
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author | Marina Martin-Moratinos Marcos Bella-Fernández María Rodrigo-Yanguas Carlos González-Tardón Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla |
author_facet | Marina Martin-Moratinos Marcos Bella-Fernández María Rodrigo-Yanguas Carlos González-Tardón Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla |
author_sort | Marina Martin-Moratinos |
collection | DOAJ |
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BackgroundDifficulties 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.
ObjectiveWe 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.
MethodsThis 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.
ResultsA 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.
ConclusionsSerious video games, when integrated into a multimodal treatment plan, can enhance outcomes for symptoms associated with ADHD.
Trial RegistrationClinicalTrials.gov NCT06006871; https://clinicaltrials.gov/study/NCT06006871
International Registered Report Identifier (IRRID)RR2-10.2196/53191 |
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institution | Kabale University |
issn | 2291-9279 |
language | English |
publishDate | 2025-01-01 |
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spelling | doaj-art-0785c44a5a3248df84251498c8a0fb202025-01-08T16:30:35ZengJMIR PublicationsJMIR Serious Games2291-92792025-01-0113e5912410.2196/59124Effectiveness of a Virtual Reality Serious Video Game (The Secret Trail of Moon) for Emotional Regulation in Children With Attention-Deficit/Hyperactivity Disorder: Randomized Clinical TrialMarina Martin-Moratinoshttps://orcid.org/0000-0003-1328-1369Marcos Bella-Fernándezhttps://orcid.org/0000-0001-6621-0199María Rodrigo-Yanguashttps://orcid.org/0000-0001-6118-2395Carlos González-Tardónhttps://orcid.org/0000-0001-9433-0577Chao Lihttps://orcid.org/0000-0002-0240-5170Ping Wanghttps://orcid.org/0000-0003-2377-2751Ana Royuelahttps://orcid.org/0000-0003-1665-081XPilar Lopez-Garciahttps://orcid.org/0000-0002-5474-6719Hilario Blasco-Fontecillahttps://orcid.org/0000-0002-2864-6298 BackgroundDifficulties 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. ObjectiveWe 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. MethodsThis 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. ResultsA 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. ConclusionsSerious video games, when integrated into a multimodal treatment plan, can enhance outcomes for symptoms associated with ADHD. Trial RegistrationClinicalTrials.gov NCT06006871; https://clinicaltrials.gov/study/NCT06006871 International Registered Report Identifier (IRRID)RR2-10.2196/53191https://games.jmir.org/2025/1/e59124 |
spellingShingle | Marina Martin-Moratinos Marcos Bella-Fernández María Rodrigo-Yanguas Carlos González-Tardón Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla 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 JMIR Serious Games |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
url | https://games.jmir.org/2025/1/e59124 |
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