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

NCT04355065 | Unknown Phase 2

• 1 other identifier: Hilario Blasco Fontecilla
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention deficit hyperactivity disorder; Serious videogames; Cognitive training; Chess

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (7)

• Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-5)

  3 months

• Teacher and Parent Rating Scale( SNAP-IV)

  3 months

• The Conners Comprehensive Behaviour Rating Scale (CBRS)

  3 months

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

  3 months

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

  3 months

Study Arms (3)

Cognitive Training with Virtual Reality Videogame

EXPERIMENTAL

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

Cognitive Training with Therapeutic chess

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Cognitive Traning with The Secret Trail of Moon BEHAVIORAL

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

Cognitive Training with Virtual Reality Videogame

Cognitive Traning with Therapeutic Chess BEHAVIORAL

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.

Cognitive Training with Therapeutic chess

Control Group DRUG

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.

Control Group

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Instituto de Salud Carlos III: collaborator
• Ministerio de Economía y Competitividad, Spain: collaborator
• Gammera Nest Technology Company: collaborator

Study Sites (1)

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 25911280 RESULT

• 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.

  PMID: 26325247 RESULT

• 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.

  PMID: 29234356 RESULT

• 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.

  PMID: 9000892 RESULT

• 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.

  PMID: 27558893 RESULT

• 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.

  PMID: 28149281 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Hilario M Blasco-Fontecilla, ID

CONTACT

+34 655214857; hmblasco@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Model Details: The study is prospective, unicentric, ramdominated, superiority with a control group and with a sample of 105 patients diagnosed with ADHD and pharmacologically stable.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: December 9, 2019
• Primary Completion: November 30, 2020
• Study Completion: January 22, 2021
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

ES (1)