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"
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Behavior rating inventory executive function (BRIEF-2)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adolescents and young adults (male and female) between the ages of 12 and
- •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.
Arms & Interventions
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.
Intervention: Cognitive Traning with The Secret Trail of Moon (Behavioral)
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.
Intervention: Cognitive Traning with Therapeutic Chess (Behavioral)
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.
Intervention: Control Group (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Teacher and Parent Rating Scale( SNAP-IV)(3 months)
- Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-5)(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)
- Udvalg für Kliniske Undersolgelser (UKU)(3 months)
- Conners Continuous Performance Test 3rd Edition (CPT-3)(3 months)
Investigators
Dr. Hilario Manuel Blasco Fontecilla
Psychiatrist
Puerta de Hierro University Hospital