Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial
BackgroundAttention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence, with a prevalence of 5% and associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice. Howev...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2024-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e53191 |
| _version_ | 1827344547265380352 |
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| author | Marina Martin-Moratinos Marcos Bella-Fernández Maria Rodrigo-Yanguas Carlos González-Tardón Aaron Sújar Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla |
| author_facet | Marina Martin-Moratinos Marcos Bella-Fernández Maria Rodrigo-Yanguas Carlos González-Tardón Aaron Sújar Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla |
| author_sort | Marina Martin-Moratinos |
| collection | DOAJ |
| description |
BackgroundAttention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence, with a prevalence of 5% and associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice. However, sometimes treatment can be insufficient or have drawbacks.
ObjectiveThis study protocol aims to demonstrate the effectiveness of cognitive training through the serious video game The Secret Trail of Moon (MOON) in improving emotional regulation in people with ADHD.
MethodsThis is a prospective, unicenter, randomized, unblinded, pre- and postintervention study. The groups will be randomized (MOON vs control) via an electronic case report form. The MOON intervention will be performed 2 times per week for 10 weeks (30 minutes per session). The first 5 weeks (10 sessions) will be conducted face-to-face at the Puerta de Hierro University Hospital, and the remaining weeks will be conducted via the internet at the participants’ homes. The total sample consists of 152 patients aged between 7 and 18 years. All participants have a clinical diagnosis of ADHD under pharmacological treatment. Data collection will be used to obtain demographic and clinical data. The data will be recorded using REDCap. Measures will be made through clinical scales for parents and objective tests of cognitive functioning in patients. Additional information on academic performance will be collected. The study has a power greater than 80% to detect differences. Student t test, 2-factor analysis of variance (ANOVA), and Mann-Whitney analyses will be performed according to each variable’s characteristics.
ResultsThe study was approved by the Research Ethics Committee of the Puerta de Hierro University Hospital on December 14, 2022. As of September 26, 2023, we have enrolled 62 participants, and 31 participants have completed the study. This clinical trial was funded by the Comunidad de Madrid (IND2020/BMD-17544). The approximate completion date is March 2024.
ConclusionsSerious video games such as MOON can be motivational tools that complement multimodal treatment for ADHD.
Trial RegistrationClinicalTrials.gov; NCT06006871; https://clinicaltrials.gov/study/NCT06006871
International Registered Report Identifier (IRRID)DERR1-10.2196/53191 |
| first_indexed | 2024-03-07T22:48:43Z |
| format | Article |
| id | doaj.art-a347d1b84c6643d69eff1b5e93dfcfdc |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-07T22:48:43Z |
| publishDate | 2024-02-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-a347d1b84c6643d69eff1b5e93dfcfdc2024-02-23T13:45:51ZengJMIR PublicationsJMIR Research Protocols1929-07482024-02-0113e5319110.2196/53191Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical TrialMarina Martin-Moratinoshttps://orcid.org/0000-0003-1328-1369Marcos Bella-Fernándezhttps://orcid.org/0000-0001-6621-0199Maria Rodrigo-Yanguashttps://orcid.org/0000-0001-6118-2395Carlos González-Tardónhttps://orcid.org/0000-0001-9433-0577Aaron Sújarhttps://orcid.org/0000-0002-7891-6137Chao 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 BackgroundAttention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence, with a prevalence of 5% and associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice. However, sometimes treatment can be insufficient or have drawbacks. ObjectiveThis study protocol aims to demonstrate the effectiveness of cognitive training through the serious video game The Secret Trail of Moon (MOON) in improving emotional regulation in people with ADHD. MethodsThis is a prospective, unicenter, randomized, unblinded, pre- and postintervention study. The groups will be randomized (MOON vs control) via an electronic case report form. The MOON intervention will be performed 2 times per week for 10 weeks (30 minutes per session). The first 5 weeks (10 sessions) will be conducted face-to-face at the Puerta de Hierro University Hospital, and the remaining weeks will be conducted via the internet at the participants’ homes. The total sample consists of 152 patients aged between 7 and 18 years. All participants have a clinical diagnosis of ADHD under pharmacological treatment. Data collection will be used to obtain demographic and clinical data. The data will be recorded using REDCap. Measures will be made through clinical scales for parents and objective tests of cognitive functioning in patients. Additional information on academic performance will be collected. The study has a power greater than 80% to detect differences. Student t test, 2-factor analysis of variance (ANOVA), and Mann-Whitney analyses will be performed according to each variable’s characteristics. ResultsThe study was approved by the Research Ethics Committee of the Puerta de Hierro University Hospital on December 14, 2022. As of September 26, 2023, we have enrolled 62 participants, and 31 participants have completed the study. This clinical trial was funded by the Comunidad de Madrid (IND2020/BMD-17544). The approximate completion date is March 2024. ConclusionsSerious video games such as MOON can be motivational tools that complement multimodal treatment for ADHD. Trial RegistrationClinicalTrials.gov; NCT06006871; https://clinicaltrials.gov/study/NCT06006871 International Registered Report Identifier (IRRID)DERR1-10.2196/53191https://www.researchprotocols.org/2024/1/e53191 |
| spellingShingle | Marina Martin-Moratinos Marcos Bella-Fernández Maria Rodrigo-Yanguas Carlos González-Tardón Aaron Sújar Chao Li Ping Wang Ana Royuela Pilar Lopez-Garcia Hilario Blasco-Fontecilla Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial JMIR Research Protocols |
| title | Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial |
| title_full | Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial |
| title_fullStr | Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial |
| title_full_unstemmed | Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial |
| title_short | Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial |
| title_sort | effectiveness of a serious video game moon for attention deficit hyperactivity disorder protocol for a randomized clinical trial |
| url | https://www.researchprotocols.org/2024/1/e53191 |
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