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

Attention Deficit Hyperactivity Disorder Clinical Trial

— MOON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006871
• Other study ID #: PI 106/22
• Secondary ID: IND2020/BMD-1754
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

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

Drug:
• Usual treatment for ADHD
All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Locations

Country	Name	City	State
Spain	Puerta de Hierro University Hospital	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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 R — View 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 — View 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 Ser — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impression Scale (CGI) for clinicians	Symptom severity will be measured with the Clinical Global Impression Scale (CGI) approximately 1 minute duration. ADHD symptomatology severity based on clinician-assessed CGI score (between 3-6) for inclusion criteria	3 months
Primary	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	The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents	The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The SNAP IV is a scale for the assessment of ADHD symptoms. It's an 18-item questionnaire with a Likert scale of 0-4 (approximately 5 minutes long) of which 9 assess attention deficit and another 9 assess hyperactive-impulsive component. The cut-off points for attention deficit are 1.78 for parents. For hyperactivity-impulsivity they are 1.44 for parents.	3 months
Secondary	The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents	The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The Conners scales are a set of scales for the assessment of patients with ADHD. CPRS-HI is a 10-item questionnaire with a Likert scale of 0-3 (approximately 2 minutes long). This revised and abbreviated version of the Conners scale is designed to be answered by parents of children ages 6-18. It consists of 10 items with a Likert type response: 0= not true at all/never; 1= just a little true/occasionally; 2= Pretty much true/often; 3=very much true/very often.; The cut-off points are divided by gender. For children, a score above 16 is suspected ADHD. While for girls, a suspected diagnosis of ADHD is from 12 points	3 months
Secondary	Clinical Global Impression Scale (CGI) for parents	Symptom severity will be measured with the Clinical Global Impression Scale (CGI) adaptation for parents of approximately 1 minute duration, consisting of a "thermometer" with a Likert scale of 1-10.	3 months
Secondary	The Sleep Disturbance Scale for Children (SDSC) for parents	Sleep difficulties will be measured with the Sleep Disturbance Scale for Children (SDSC). It is a 26-item questionnaire with a Likert scale of 1-5 (1: never; 5: always) with an approximate duration of 5 minutes (Bruni et al., 1996)	3 months
Secondary	Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents	Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. The subjective test for parents will be performed with the Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire.The BRIEF-2 is a questionnaire designed for the evaluation of executive functions in children and adolescents. It is made up of 63 items with three answer options (never, sometimes and frequently). Its correction provides four general indexes: emotional regulation, cognitive regulation, behavioral regulation and global index of executive function.	3 months
Secondary	Conners Continuous Performance Test 3rd Edition (CPT-3) for patients with ADHD	Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Conners Continuous Performance Test-3 (CPT-3) is a task that is usually used to screen for ADHD in addition to measuring sustained attention, impulse control and processing speed. The Conners CPT-3 is a computerized, standardized, and validated application test for different age and gender groups. The test consists of pressing a button each time a letter (target) appears on the screen, except for the letter X (non-target), which should not be pressed. The duration is approximately 14 minutes and the presentation interval between letters is variable (1, 2 and 4 seconds). The test provides results on hits, error of omission (undetected target) and errors of commission (reacted non-target), which are considered a measure of impulsivity. In addition, CPT3-3 provides information on mean reaction time and reaction time variability of hits.	3 months
Secondary	Corsi Cubes for patients with ADHD	Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Corsi Cubes to measure visuospatial working memory (Corsi, 1972; Kessels et al., 2000)	3 months
Secondary	Comprehensive Trail-Making Test Second Edition (CTMT-2) for patients with ADHD	Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Comprehensive Trail-Making Test Second Edition (CTMT-2) to measure cognitive flexibility, with three indexes: inhibitory control, task switching and total index.	3 months
Secondary	Game Addiction Scale for Adolescents (GASA) for patients with ADHD	Game Addiction Scale for Adolescents (GASA) is a 7-item questionnaire to assess video game addiction (Lemmens et al., 2009)	3 months
Secondary	Academic notes	Information about academic performance will be obtained with grades.	3 months
Secondary	"Clinical Examinations Questionnaire"(UKU) for patients with ADHD	UKU is a tool designed to evaluate possible secondary symptoms that happen during the week. This scale is not included in the assessment phases. Only the MOON with VR group should complete the scale after each cognitive training session.	3 months