Clinical trial NCT06006871: Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD
Official title: The Secret Trail of Moon (MOON): a Personalized Treatment Video Game for Children and Adolescents With ADHD Based on Cognitive Training and Self-regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
ADD
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 76
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age 7-17 years (could turn 18 during the study)
* Clinical diagnosis of ADHD in any presentation.
* With pharmacological treatment for ADHD.
* Ability to follow verbal instructions
* Ability to play a video game (not necessary to play regularly).
* Clinically stable. ADHD symptomatology severity based on clinician-assessed CGI score (between 3-6).

Exclusion Criteria:

* Severe patients (\> or equal to 5 CGI) or very mild patients (CGI \< or equal to 1)
* Patient at risk of suicide (according to the clinical judgment of the professional in charge of the patient)
* Motor difficulties that prevent playing the videogame
* Participation in other similar studies
* Intention to initiate any psychotherapeutic treatment (including cognitive-behavioral therapy) in the next 3 months of the course of participation in the clinical trial.

Primary outcomes:
measure: Strenghts and difficulties questionnaire (SDQ) for parents
timeFrame: 3 months
Secondary outcomes:
measure: The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents
timeFrame: 3 months
measure: The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents
timeFrame: 3 months
measure: Clinical Global Impression Scale (CGI) for parents
timeFrame: 3 months
measure: The Sleep Disturbance Scale for Children (SDSC) for parents
timeFrame: 3 months
measure: Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents
timeFrame: 3 months
measure: Conners Continuous Performance Test 3rd Edition (CPT-3) for patients with ADHD
timeFrame: 3 months
measure: Corsi Cubes for patients with ADHD
timeFrame: 3 months
measure: Comprehensive Trail-Making Test Second Edition (CTMT-2) for patients with ADHD
timeFrame: 3 months
measure: Game Addiction Scale for Adolescents (GASA) for patients with ADHD
timeFrame: 3 months
measure: Academic notes
timeFrame: 3 months
measure: "Clinical Examinations Questionnaire"(UKU) for patients with ADHD
timeFrame: 3 months
Other outcomes:
measure: Clinical Global Impression Scale (CGI) for clinicians
timeFrame: 3 months
Locations:
city: Majadahonda
country: Spain
facility: Puerta de Hierro University Hospital
state: Madrid
Study officials:
References:
citation: Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Blasco-Fontecilla H. A Virtual Reality Serious Videogame Versus Online Chess Augmentation in Patients with Attention Deficit Hyperactivity Disorder: A Randomized Clinical Trial. Games Health J. 2021 Aug;10(4):283-292. doi: 10.1089/g4h.2021.0073.
citation: Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Royuela A, Blasco-Fontecilla H. A Virtual Reality Game (The Secret Trail of Moon) for Treating Attention-Deficit/Hyperactivity Disorder: Development and Usability Study. JMIR Serious Games. 2021 Sep 1;9(3):e26824. doi: 10.2196/26824.
citation: Rodrigo-Yanguas M, Martin-Moratinos M, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Bella-Fernandez M, Blasco-Fontecilla H. Effectiveness of a Personalized, Chess-Based Training Serious Video Game in the Treatment of Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial. JMIR Serious Games. 2023 Apr 24;11:e39874. doi: 10.2196/39874.
citation: Sujar A, Martin-Moratinos M, Rodrigo-Yanguas M, Bella-Fernandez M, Gonzalez-Tardon C, Delgado-Gomez D, Blasco-Fontecilla H. Developing Serious Video Games to Treat Attention Deficit Hyperactivity Disorder: Tutorial Guide. JMIR Serious Games. 2022 Aug 1;10(3):e33884. doi: 10.2196/33884.
citation: Bella-Fernandez M, Martin-Moratinos M, Li C, Wang P, Blasco-Fontecilla H. Differences in Ex-Gaussian Parameters from Response Time Distributions Between Individuals with and Without Attention Deficit/Hyperactivity Disorder: A Meta-analysis. Neuropsychol Rev. 2024 Mar;34(1):320-337. doi: 10.1007/s11065-023-09587-2. Epub 2023 Mar 6.