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Background Attention 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. Objective This 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. Methods This 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. Results The 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. Conclusions Serious video games such as MOON can be motivational tools that complement multimodal treatment for ADHD. Trial Registration ClinicalTrials.gov; NCT06006871; https://clinicaltrials.gov/study/NCT06006871 International Registered Report Identifier (IRRID) DERR1-10.2196/53191
Background Attention 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. Objective This 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. Methods This 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. Results The 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. Conclusions Serious video games such as MOON can be motivational tools that complement multimodal treatment for ADHD. Trial Registration ClinicalTrials.gov; NCT06006871; https://clinicaltrials.gov/study/NCT06006871 International Registered Report Identifier (IRRID) DERR1-10.2196/53191
BACKGROUND Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice; however, sometimes treatment can be insufficient or have some drawbacks. OBJECTIVE To demonstrate the effectiveness of cognitive training through the serious video game “The Secret Trail of Moon” (MOON) in improving emotional regulation of people with ADHD. METHODS Design: prospective, unicenter, randomized, unblinded, PRE-POST intervention study. Randomization of the groups (MOON vs. Control) will be performed by electronic CRD. The MOON intervention will be performed 2 times per week for 10 weeks (30 minutes per session). The first five weeks (10 sessions) will be conducted face-to-face in Puerta de Hierro University Hospital; the remaining weeks will be conducted online at the participants' home. The clinical trial was registered in Clinical Trials NCT06006871. Sample: 152 patients aged between 7 and 18 years. All participants had a clinical diagnosis of ADHD (CGI between 3 and 6) under pharmacological treatment. Evaluation: Data collection will be used to obtain demographic and clinical data. The data will be recorded with an electronic CRD (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. Statistical power analysis: The study has a power greater than 80% to detect differences. Statistical analysis: Classical statistics: T student, 2-factor ANOVA and Mann Whitney analyses will be performed according to the characteristics of each variable. Ethics: The study was approved by the Research Ethics Committee of the Puerta de Hierro University Hospital on December 14th, 2022. The authorization of the Spanish Agency of Medicines and Health Products was February 14th, 2023. Informed consent will be requested from legal guardians and minors protecting their personal data to the provisions of the Organic Law 3/2018 of 5 December, on Personal Data Protection and guarantee of digital rights. RESULTS To September 26, 2023, we have enrolled 62 participants. Thirty-one participants have completed the study. This clinical trial has been funded by the Comunidad de Madrid (Spain) IND2020/BMD-17544. The approximate completion date is March 2024. CONCLUSIONS Serious video games such as MOON can be motivational tools that complement multimodal treatment in ADHD. CLINICALTRIAL NCT06006871
Critical neuropsychological capabilities such as working memory, cognitive flexibility, and processing speed are foundational to many daily activities. For children, such skills are essential for school success. Thus, children who demonstrate weaknesses in these abilities may experience impaired academic performance; this is especially true for students identified with learning differences who often exhibit less developed cognitive abilities. The purpose of this project was to examine the efficacy of a cognitive training program implemented during the school day to improve abilities predictive of academic achievement. Ninety-five children completed two training activities that were counterbalanced across participants. Analyses of baseline working memory, cognitive flexibility, and processing speed performance relative to those following training showed a strong treatment effect. Moreover, there is notable evidence of greater intervention efficacy with extended engagement with the training program. Implications for neuropsychological research and practice are discussed.
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