Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD

NCT06006871 | Completed Phase 3 DMC

• 3 other identifiers: PI 106/22IND2020/BMD-17544Expte. 1061/22/EC-R.
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; ADD

Outcome Measures

Primary Outcomes (1)

• Strenghts and difficulties questionnaire (SDQ) for parents

  This questionnaire has 25 items (duration of approximately 5 minutes). It mainly measures the scales 1) Emotional symptoms, 2) Behavioral problems, 3) Hyperactivity, 4) Problems with peers and 5) Prosocial behavior. A decrease of 3 to 4 points in the post-assessment visit (D70) with respect to the pre-assessment visit (D0) will be considered an improvement in emotional regulation (Goodman, 1977)

  3 months

Secondary Outcomes (11)

• The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents

  3 months

• The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents

  3 months

• Clinical Global Impression Scale (CGI) for parents

  3 months

• The Sleep Disturbance Scale for Children (SDSC) for parents

  3 months

• Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents

  3 months

Other Outcomes (1)

• Clinical Global Impression Scale (CGI) for clinicians

  3 months

Study Arms (2)

The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

EXPERIMENTAL

The Secret Trail of Moon is a therapeutic video game that has been created for the cognitive training of patients with ADHD. Five mechanisms have been designed to work on five cognitive functions that are deficient in ADHD: sustained attention, working memory, reasoning, planning and visuospatial ability. Aspects of rewards and music therapy have been added to this enhanced version of the game. In this second clinical trial, the impact has been extended to twice a week during 20 sessions. There are two platforms of the same version of the game: computer (7-11 years old) and virtual reality (12-18 years old). Patients have to come to the hospital twice a week for training sessions of about 20-30 minutes duration for 10 weeks. Subsequently, they are given the computer version of the video game on a USB so that they can play it at home for another 10 weeks (twice a week). Participants are monitored for possible difficulties and/or side effects.

Behavioral: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game; Drug: Usual treatment for ADHD

Control Group

ACTIVE COMPARATOR

This group corresponds to the control group (n=76). The control group continues with their prescribed pharmacological treatment without any cognitive intervention. The participants of this group are contacted by telephone once a week to follow up on possible difficulties and/or side effects.

Drug: Usual treatment for ADHD

Interventions

The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game BEHAVIORAL

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).

The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

Usual treatment for ADHD DRUG

All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Control Group; The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (7)

• 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.

  PMID: 34370610 BACKGROUND

• 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.

  PMID: 34468332 RESULT

• 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.

  PMID: 37093628 RESULT

• 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.

  PMID: 35916694 RESULT

• 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.

  PMID: 36877328 RESULT

• Martin-Moratinos M, Bella-Fernandez M, Rodrigo-Yanguas M, Gonzalez-Tardon C, Li C, Wang P, Royuela A, Lopez-Garcia P, Blasco-Fontecilla H. Effectiveness of a Virtual Reality Serious Video Game (The Secret Trail of Moon) for Emotional Regulation in Children With Attention-Deficit/Hyperactivity Disorder: Randomized Clinical Trial. JMIR Serious Games. 2025 Jan 8;13:e59124. doi: 10.2196/59124.

  PMID: 39773848 DERIVED

• Martin-Moratinos M, Bella-Fernandez M, Rodrigo-Yanguas M, Gonzalez-Tardon C, Sujar A, Li C, Wang P, Royuela A, Lopez-Garcia P, Blasco-Fontecilla H. Effectiveness of a Serious Video Game (MOON) for Attention Deficit Hyperactivity Disorder: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2024 Feb 23;13:e53191. doi: 10.2196/53191.

  PMID: 38393773 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child and adolescent psychiatrist

Model Details: 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).

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: August 23, 2023
• Study Start: May 9, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

ES (1)