Clinical trial NCT04355065: The Secret Trail of Moon (Serious Videogame) and Chess on ADHD: a Clinal Trial
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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention deficit hyperactivity disorder
Serious videogames
Cognitive training
Chess
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Ministerio de Economía y Competitividad, Spain
name: Gammera Nest Technology Company
First posted: 2020-04-21
Enrollment: 105
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Behavior rating inventory executive function (BRIEF-2)
timeFrame: 3 months
Secondary outcomes:
measure: Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-5)
timeFrame: 3 months
measure: Teacher and Parent Rating Scale( SNAP-IV)
timeFrame: 3 months
measure: The Conners Comprehensive Behaviour Rating Scale (CBRS)
timeFrame: 3 months
measure: Emotional Quotient Inventory: Youth Version.(BarOn EQ-i:YV)
timeFrame: 3 months
measure: TEA Questionnaire for the Evaluation of ADHD and Executive Functions (ATENTO)
timeFrame: 3 months
measure: Conners Continuous Performance Test 3rd Edition (CPT-3)
timeFrame: 3 months
measure: Udvalg für Kliniske Undersolgelser (UKU)
timeFrame: 3 months
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Puerta de Hierro University Hospital
state: Madrid
Study officials:
References:
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citation: 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.
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 Serious Games. 2021 Sep 1;9(3):e26824. doi: 10.2196/26824.
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.