Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 28, 2023
Date Accepted: Jan 11, 2024
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Efficacy of The Secret Trail of Moon (MOON) a personalized treatment video game for children and adolescents with ADHD based on cognitive training and emotional regulation: Protocol for a randomized clinical trial.
ABSTRACT
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. Clinical Trial: NCT06006871
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