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Attention Deficit Hyperactivity DisorderPhase 3MOONNCT06006871

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

A Phase 3 study testing The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game and Usual treatment for ADHD in people with Attention Deficit Hyperactivity Disorder, run by Puerta de Hierro University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game and Usual treatment for ADHD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSpain
Study dates
9 May 2023to 15 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Puerta de Hierro University Hospital

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

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

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.

Read more

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.

Being tested
The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game, Usual treatment for ADHD
Keywords
ADHD, ADD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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).

  • Usual treatment for ADHDDrug

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

Study groups in NCT06006871
Study groupRoleWhat they receive
The Secret Trail of Moon (MOON): Cognitive training with Serious Video GameExperimentalThe 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.
Receives: Behavioral: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game; Drug: Usual treatment for ADHD
Control GroupActive comparatorThis 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.
Receives: Drug: Usual treatment for ADHD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (11)

  1. 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.

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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)

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 3 months

  7. 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)

    Measured: 3 months

  8. 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.

    Measured: 3 months

  9. 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)

    Measured: 3 months

  10. Academic notes

    Information about academic performance will be obtained with grades.

    Measured: 3 months

  11. "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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start9 May 2023
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06006871
Sponsor's protocol ID
PI 106/22
Other IDs
IND2020/BMD-17544, Expte. 1061/22/EC-R.
Acronym
MOON
Status last verified
Feb 2024
First submitted
7 May 2023
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34370610

  • 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.

    PubMed 34468332

  • 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.

    PubMed 37093628

  • 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.

    PubMed 35916694

  • 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.

    PubMed 36877328

  • 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.

    PubMed 39773848

  • 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.

    PubMed 38393773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game and Usual treatment for ADHD in people with Attention Deficit Hyperactivity Disorder, run by Puerta de Hierro University Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Strenghts and difficulties questionnaire (SDQ) for parents (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06006871, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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