Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Introduction: 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 it can be insufficient or have some drawbacks.

      Objective: To demonstrate the effectiveness of cognitive training through the video game 'The
      Secret Trail of Moon' (MOON) in improving emotional regulation of ADHD in people aged 7 to 18
      years.

      Hypotheses: H1: ADHD patients using MOON improve their emotional regulation more than the
      control group; H2: ADHD patients using MOON improve in symptomatology with respect to the
      control group; H3: ADHD patients using MOON improve their cognitive abilities than the
      control group; H4: ADHD patients using MOON improve in academic performance with respect to
      the control group; H5: The change of platform (face-to-face, online) does not entail
      differences in emotional regulation; H6: There are no side effects associated with the video
      game.

      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/week for 10 weeks (30 minutes/session). The first five
      weeks (10 sessions) will be conducted face-to-face; the remaining weeks will be conducted
      online at the participants' home.

      Sample: 152 patients with a clinical diagnosis of ADHD (CGI between 3 and 6) with
      pharmacological treatment.

      Evaluation: a data collection notebook will be used to obtain demographic and clinical data.
      The data will be recorded with electronic CRD (REDCap). Measures to answer the hypotheses
      will be made through clinical scales for parents and objective tests of cognitive abilities
      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 Hospital Universitario
      Puerta de Hierro 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.
    


Intervention name(s): The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game; Usual treatment for ADHD
Intervention type(s): Behavioral; Drug
Intervention description(s): Patients are pharmacologically stable and receive a cognitive intervention with our videogame twice a week in the hospital (10 sessions) and twice a week in their home with a computer video game (other 10 sessions).; All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single-center, randomized, unblinded, PRE-POST intervention study with concealment of the randomization sequence.
A randomization of 2 groups by blocks will be performed: Group 1: "The Secret Trail of Moon" (MOON): a personalized cognitive training with a face-to-face and online video game (n=76); Group 2: Passive control (TAU): usual treatment (pharmacological) without cognitive training intervention (n=76).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; ADD