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

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ClinicalTrials.gov Identifier: NCT04355065
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Doctorates IIS-Company in health sciences and technologies (i-PFIS) Carlos III Institute
Centre for the Development of Industrial Technology (CDTI)
Gammera Nest Technology Company
Information provided by (Responsible Party):
Dr. Hilario Manuel Blasco Fontecilla, Puerta de Hierro University Hospital

Brief 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. 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.

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: Cognitive Traning with The Secret Trail of Moon Behavioral: Cognitive Traning with Therapeutic Chess Drug: Control Group Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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"
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Training with Virtual Reality Videogame

The 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.

Behavioral: Cognitive Traning with The Secret Trail of Moon
Patients are pharmacologically stable and receive a cognitive intervention with our videogame once a week in the hospital.

Experimental: Cognitive Training with Therapeutic chess

The 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.

Behavioral: Cognitive Traning with Therapeutic Chess
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.

Active Comparator: Control Group
This 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.
Drug: Control Group

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.





Primary Outcome Measures :
  1. Behavior rating inventory executive function (BRIEF-2) [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-5) [ Time Frame: 3 months ]
    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.

  2. Teacher and Parent Rating Scale( SNAP-IV) [ Time Frame: 3 months ]
    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.

  3. The Conners Comprehensive Behaviour Rating Scale (CBRS) [ Time Frame: 3 months ]

    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


  4. Emotional Quotient Inventory: Youth Version.(BarOn EQ-i:YV) [ Time Frame: 3 months ]
    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.

  5. TEA Questionnaire for the Evaluation of ADHD and Executive Functions (ATENTO) [ Time Frame: 3 months ]
    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.

  6. Conners Continuous Performance Test 3rd Edition (CPT-3) [ Time Frame: 3 months ]
    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.

  7. Udvalg für Kliniske Undersolgelser (UKU) [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355065


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

Locations
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Spain
Puerta de Hierro University Hospital Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Hilario M Blasco-Fontecilla, ID    +34 655214857    hmblasco@yahoo.es   
Sponsors and Collaborators
Puerta de Hierro University Hospital
Doctorates IIS-Company in health sciences and technologies (i-PFIS) Carlos III Institute
Centre for the Development of Industrial Technology (CDTI)
Gammera Nest Technology Company
Publications of Results:

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Responsible Party: Dr. Hilario Manuel Blasco Fontecilla, Psychiatrist, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT04355065    
Other Study ID Numbers: Hilario Blasco Fontecilla
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Hilario Manuel Blasco Fontecilla, Puerta de Hierro University Hospital:
Attention deficit hyperactivity disorder
Serious videogames
Cognitive training
Chess
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases