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Attention Deficit Disorder With HyperactivityPhase 2NCT04355065

The Secret Trail of Moon (Serious Videogame) and Chess on ADHD: a Clinal Trial

A Phase 2 study testing Cognitive Traning with The Secret Trail of Moon and Cognitive Traning with Therapeutic Chess in people with Attention Deficit Disorder With Hyperactivity, run by Puerta de Hierro University Hospital at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Blackground: Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest. Especially, the use of Virtual Reality video games. Read more about this study

Who is it for?
Ages 12 to 22 years
What is being tested?
Cognitive Traning with The Secret Trail of Moon and Cognitive Traning with Therapeutic Chess
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteSpain
Study dates
9 Dec 2019to 22 Jan 2021
Phase
Phase 2
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 12 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents and young adults (male and female) between the ages of 12 and 22.
  • Diagnosis of Attention Deficit Hyperactivity Disorder.
  • Patients with stable pharmacological treatment for ADHD.
  • Signature of the informed consent by the patient and their parents.

Who cannot join

  • A diagnosis of ADHD comorbid with autism spectrum disorder or mental retardation.
  • Suffering from epilepsy.
  • Mobility plans in the next 3 months.
  • Plans to begin other psychological treatment, including cognitive-behavioral psychotherapy in the next 3 months.
  • Possibility of suicide risk as assessed by the clinician.

Trial locations and contacts

1 site in 1 country.

Hilario M Blasco-Fontecilla, ID contact

+34 655214857

hmblasco@yahoo.es

Spain1 site, 1 recruiting

  • Puerta de Hierro University Hospital

    Majadahonda, Madrid, 28222

    Hilario M Blasco-Fontecilla, ID, +34 655214857, hmblasco@yahoo.es

    Recruiting

Other trials in Spain

About this study

Official title: Randomized Study of Personalized Cognitive Training With Virtual Reality Technology (The Secret Trail of Moon) Versus Online Therapeutic Chess Cognitive Training Versus Usual Treatment (TAU) in Attention Deficit Hyperactivity Disorder (ADHD):a Clinical Trial"

Blackground:

Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest. Especially, the use of Virtual Reality video games. Our team has developed an innovative video game based on Virtual Reality, "The Secret Trail of Moon (TSTM) as a cognitive tool to train 5 main areas of deficit in patients with ADHD. It is superiority study comparing TSTM with therapeutic chess and control group.

Read more

Methods:

This study is prospective, unicentric, randomized with a control group. 105 patients diagnosed with ADHD and pharmacologically stable, aged between 12 and 22 years. These patients will be randomized intro three groups: TSTM group (The Secret Trail of Moon); TC group (Therapeutic Chess) and CG (Control Group). Objective and subjective measures of the patient, parents and teachers will be included. Patients´visit will be different for each group. The TSTM group will have 15 face-to face visits: pre-inclusion visit, inclusion visit, 12 training visits and final visit. CT and GC group patients will have 3 face-to- face visits (pre-inclusion, initial visit and final visit) and 12 email or phone communications during training.

Discussion: This study aims to demonstrate the added efficacy of cognitive training to drug treatment. It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training (TC) and a control group.

TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique: the feeling of immersion in the scenarios, the variety of mechanics, the personalization and the playful aspect.

Being tested
Cognitive Traning with The Secret Trail of Moon, Cognitive Traning with Therapeutic Chess, Control Group
Keywords
Attention deficit hyperactivity disorder, Serious videogames, Cognitive training, Chess
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.

  • Cognitive Traning with The Secret Trail of MoonBehavioural

    Patients are pharmacologically stable and receive a cognitive intervention with our videogame once a week in the hospital.

  • Cognitive Traning with Therapeutic ChessBehavioural

    This group is pharmacologically stable. This group performs cognitive training through a therapeutic chess protocol designed by a chess psychologist. The training is done from home and we contact them weekly to correct the exercises done and to follow up.

  • Control GroupDrug

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

    They are contacted weekly by phone to follow up on the group.

Study groups in NCT04355065
Study groupRoleWhat they receive
Cognitive Training with Virtual Reality VideogameExperimentalThe Secret trail of mon 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: attention, memory, reasoning, planning and visuospatial ability. Patients have to go to the hospital once a week for training sessions of approximately forty minutes duration during 12 weeks.
Receives: Behavioral: Cognitive Traning with The Secret Trail of Moon
Cognitive Training with Therapeutic chessExperimentalThe training in Therapeutic chess consists of four sections: Video tutorial: Weekly videos have been recorded in which a chess board and the image of the psychologist explaining the lesson appear. Each week a chess concept will be explained. Traditional chess exercises Therapeutic chess exercises: The exercises use the elements of chess but it is not necessary to know how to play chess to perform them. The purpose of the exercise is to work on a specific cognitive area each week. Playing online games: The patient must play a minimum of 2 online games on the chess platform chess24.es . The psychologist will follow the progress of each patient. At the end of the week, the patient should send an email to the psychologist with the completed exercises and then they will receive a personalised email. This group carries out all the treatment online from their home.
Receives: Behavioral: Cognitive Traning with Therapeutic Chess
Control GroupActive comparatorThis group corresponds to the control group. 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: Control Group

What is being measured

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

  1. Behavior rating inventory executive function (BRIEF-2)

    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

Secondary outcomes (7)

  1. Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-5)

    This scale is made up of the 18 symptoms. The symptoms are divided into 9 for inattention, 6 for hyperactivity and 3 for impulsivity. Parents and teachers must answer yes/no to each of them. For its diagnosis, 6 or more of the attention deficit symptoms and/or 6 more of hyperactivity-impulsivity symptoms must be fulfilled. Depending on the symptoms met, the inattentive, hyperactive-impulsive or combined profile is specified.

    Measured: 3 months

  2. Teacher and Parent Rating Scale( SNAP-IV)

    The SNAPIV is a scale for the assessment of ADHD symptoms. It consists of 18 scalar items from 0 to 3, of which 9 assess attention deficit and another 9 assess hyperactive-impulsive component. The cut-off points for attention deficit are 2.56 for teachers and 1.78 for parents. For hyperactivity-impulsivity they are 1.78 for teachers and 1.44 for parents. For both components, the points are 2 for teacher and 1.67 for parents.

    Measured: 3 months

  3. The Conners Comprehensive Behaviour Rating Scale (CBRS)

    The Conners scales are a set of scales for the assessment of patients with ADHD. 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

  4. Emotional Quotient Inventory: Youth Version.(BarOn EQ-i:YV)

    The BarOn is a questionnaire that it has 60-question, answered by children and young people from 7 to 18 years old. It provides information on total emotional intelligence, divided into four subscales: intrapersonal, interpersonal, stress management and adaptability. It also provides a general mood scale and other validation scales such as positive impression and inconsistency.

    Measured: 3 months

  5. TEA Questionnaire for the Evaluation of ADHD and Executive Functions (ATENTO)

    The ATENTO is a questionnaire in the process of validation that give a complete profile of the clinical symptoms of ADHD. This questionnaire has three parts: the first, with 125 items is common to all ages from 3 to 18 years. The second part, with 40 items had to be filled in if it was a patient from 3 to 6 years old and was not used in our study since the sample started from 7 years old. The third and last part, with 48 items, evaluated the population from 6 to 18 years old. All the items are of the likert type, and the parents can give scores of: 1= never or almost neves; 2= Rarely; 3= Sometimes; 4= Many times; 5= Always or almost always.

    Measured: 3 months

  6. Conners Continuous Performance Test 3rd Edition (CPT-3)

    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. Udvalg für Kliniske Undersolgelser (UKU)

    The 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 TSTM 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 posted21 Apr 2020
  2. Study start9 Dec 2019
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion22 Jan 2021 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is prospective, unicentric, ramdominated, superiority with a control group and with a sample of 105 patients diagnosed with ADHD and pharmacologically stable.
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04355065
Sponsor's protocol ID
Hilario Blasco Fontecilla
Status last verified
Apr 2020
First submitted
17 Apr 2020
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Blasco-Fontecilla H, Gonzalez-Perez M, Garcia-Lopez R, Poza-Cano B, Perez-Moreno MR, de Leon-Martinez V, Otero-Perez J. Efficacy of chess training for the treatment of ADHD: A prospective, open label study. Rev Psiquiatr Salud Ment. 2016 Jan-Mar;9(1):13-21. doi: 10.1016/j.rpsm.2015.02.003. Epub 2015 Apr 22. English, Spanish.

    PubMed 25911280

  • Bul KC, Franken IH, Van der Oord S, Kato PM, Danckaerts M, Vreeke LJ, Willems A, van Oers HJ, van den Heuvel R, van Slagmaat R, Maras A. Development and User Satisfaction of "Plan-It Commander," a Serious Game for Children with ADHD. Games Health J. 2015 Dec;4(6):502-12. doi: 10.1089/g4h.2015.0021. Epub 2015 Sep 1.

    PubMed 26325247

  • Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.

    PubMed 29234356

  • Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. doi: 10.1037/0033-2909.121.1.65.

    PubMed 9000892

  • Brown M, O'Neill N, van Woerden H, Eslambolchilar P, Jones M, John A. Gamification and Adherence to Web-Based Mental Health Interventions: A Systematic Review. JMIR Ment Health. 2016 Aug 24;3(3):e39. doi: 10.2196/mental.5710.

    PubMed 27558893

  • Lau HM, Smit JH, Fleming TM, Riper H. Serious Games for Mental Health: Are They Accessible, Feasible, and Effective? A Systematic Review and Meta-analysis. Front Psychiatry. 2017 Jan 18;7:209. doi: 10.3389/fpsyt.2016.00209. eCollection 2016.

    PubMed 28149281

  • 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

  • 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, 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive Traning with The Secret Trail of Moon and Cognitive Traning with Therapeutic Chess in people with Attention Deficit Disorder With Hyperactivity, 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 4 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Hilario M Blasco-Fontecilla, ID (+34 655214857, hmblasco@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavior rating inventory executive function (BRIEF-2) (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 NCT04355065, which also lists 9 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 21 Apr 2020.

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