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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.
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BACKGROUND: Compared with traditional approaches, gaming strategies are promising interventions for the treatment of attention-deficit/hyperactivity disorder (ADHD). We developed a serious game, The Secret Trail of Moon (TSTM), for ADHD treatment. OBJECTIVE: The main objective of this clinical trial was to demonstrate the effectiveness of an add-on, either TSTM or Therapeutic Chess (TC), in previously optimally drug-titrated, clinically stable patients with ADHD. METHODS: This study is a prospective, unicentric, randomized clinical trial in clinically stable patients with ADHD, aged 12 to 22 years. The TSTM (n=35) and TC groups (n=34) performed 12 weekly sessions of their respective treatments. The control group (CG) patients (n=35) were called by phone every week, but they received no cognitive intervention. The primary end point was the change from baseline to end point in the parent "Behavior Rating Inventory of Executive Function-2" (BRIEF-2; patients' parents) in the per-protocol population (31 serious videogame: 24 TC and 34 CG). RESULTS: Our study failed to probe clear-cut improvements in the global score of the BRIEF-2. However, the TC group showed improvements in measures of emotional control, emotional regulation, and inattention. The TSTM group showed improvements in measures of emotional regulation, inattention, and school context. CONCLUSIONS: TSTM and TC did not improve executive function symptoms, but they improved ADHD symptomatology related to emotional regulation. Further studies with bigger samples are required to confirm these preliminary findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04355065; https://clinicaltrials.gov/ct2/show/NCT04355065.
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Video game-based therapeutic interventions have demonstrated some effectiveness in decreasing the symptoms of attention deficit hyperactivity disorder (ADHD). Compared with more traditional strategies within the multimodal treatment of ADHD, video games have certain advantages such as being comfortable, flexible, and cost-efficient. However, establishing the most appropriate type(s) of video games that should be used for this treatment remains a matter of debate, including the commercial existing video games or serious video games that are specifically constructed to target specific disorders. This guide represents a starting point for developing serious video games aimed at treating ADHD. We summarize the key points that need to be addressed to generate an effective and motivating game-based treatment. Following recommendations from the literature to create game-based treatments, we describe the development stages of a serious video game for treating ADHD. Game design should consider the interests of future users; game mechanics should be based on cognitive exercises; and therapeutic mechanisms must include the control of difficulty, engagement, motivation, time constraints, and reinforcement. To elaborate upon this guide, we performed a narrative review focused on the use of video games for the treatment of ADHD, and were inspired by our own experience during the development of the game "The Secret Trail of Moon."
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Objective: To carry out a quasi-systematic review of the use of serious video games for health as a cognitive rehabilitative tool in patients diagnosed with attention-deficit hyperactivity disorder. Method: A quasi-systematic review of serious video games used as an evaluative and rehabilitative tool in patients with ADHD was conducted. It included behavioral patterns in the use of video games and addiction problems in this population. For its elaboration the PRISMA GUIDES were followed. The search was carried out in three PubMed databases, MEDLINE, and PsycInfo using the keywords: [game OR serious game OR computer game) AND (psychotherapy OR rehabilitation OR intervention OR mental disorders) AND (adhd)], [(adhd) AND (Video game addiction)]. All articles written in English, Spanish, or Portuguese from January 1970 to June 2021 were included: those in which reference was made to the use of video games and/or new technologies as a therapeutic and evaluative tool in children and adults diagnosed with ADHD, as well as those that referred to behavioral and clinical patterns in the use of video games. Results: We found 605 articles of which 128 were reviewed (44 observational studies, 26 quasi-experimental studies, 26 experimental studies, 8 systematic reviews, 9 narrative texts, 6 case reports, 7 pilot studies, 8 systematic reviews, and 2 meta-analyses). Serious video games can be used to ameliorate ADHD symptoms while improving adherence to treatment. Some serious video games show high accuracy properties assessing ADHD features. Conclusion: Serious video games for health are increasingly being used as a cognitive rehabilitation tool in patients with attention-deficit hyperactivity disorder (ADHD). Systematic Review Registration: [www.crd.york.ac.uk/prospero], identifier [CRD42021247784].
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BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) affects between 4% and 8% of children worldwide. The treatment of choice is multimodal treatment. Multimodal interventions for ADHD may be improved by incorporating new treatments, such as treatment via serious video games. The Secret Trail of Moon (TSTM) is a virtual reality serious video game that was designed for cognitive training related to core ADHD symptoms and executive dysfunction. OBJECTIVE: We aimed to describe the development and usability of TSTM. METHODS: The usability study included 37 children and adolescents who tested TSTM during the early usability stage (preinclusion) of a randomized controlled clinical trial for testing the effectiveness of TSTM. Chi-square tests were performed to compare patients with ADHD (ADHD combined subtype vs inattentive subtype) and to compare frequent and infrequent video game players in the second study. We used SPSS version 20 for Macintosh (IBM Corporation). RESULTS: A total of 31/37 (86%) and 30/37 (83%) of participants liked playing TSTM and wanted to continue playing TSTM, respectively. Further, 5/37 (14%) of participants reported that they experienced either perceived dizziness or virtual reality motion sickness. We found no statistically significant differences after comparing the ADHD combined subtype to the inattentive subtype and frequent video game players to infrequent video game players. CONCLUSIONS: Serious video games, such as TSTM, may complement the current multimodal approach for treating ADHD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04355065; https://clinicaltrials.gov/ct2/show/NCT04355065.
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Objective: Serious videogames and virtual reality (VR) have gained increasing interest for treating attention deficit hyperactivity disorder (ADHD). "The Secret Trail of Moon" (TSTM) study is a clinical trial devoted to testing the efficacy of TSTM, a VR serious videogame developed to train in five major cognitive skills usually compromised in patients with ADHD. This study is a three-arm nonequality trial comparing TSTM to online chess training and a control group (CG). This study aims to demonstrate that augmentation with either TSTM or online chess is efficacious in clinically drug-stable patients with ADHD. Materials and Methods: This study is prospective, unicentric, and randomized with a CG. One hundred five patients with ADHD, ages 12-22 years old, and pharmacologically stable were enrolled. Patients were randomized into three groups: TSTM group, online chess group (therapeutic chess [TC]), and CG. Objective and subjective measures of the patient and parents are included. Patient visits differ for each group. TSTM group patients have 15 face-to-face visits: preinclusion visit, inclusion visit, 12 training visits, and final visit. TC and CG patients have 3 face-to-face visits (preinclusion, initial visit, and final visit) and 12 e-mail or phone communications during training (TC) or follow-up (CG group). This study was approved by the local Institutional Review Board (IRB). Results: Not applicable. This is a study protocol. Conclusion: This is the first study testing an augmentation strategy using either a serious videogame or chess in clinically drug-treated patients with ADHD. Using VR serious videogames present with several advantages over traditional videogames. Trial Registration: NCT04355065.