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

Attention Deficit Disorder With Hyperactivity Clinical 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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355065
• Other study ID #: Hilario Blasco Fontecilla
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2019
• Est. completion date: January 22, 2021

Study information

• Verified date: April 2020
• Source: Puerta de Hierro University Hospital
• Contact: Hilario M Blasco-Fontecilla, ID
• Phone: +34 655214857
• Email: hmblasco[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: January 22, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Spain	Puerta de Hierro University Hospital	Majadahonda	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital	Centre for the Development of Industrial Technology (CDTI), Doctorates IIS-Company in health sciences and technologies (i-PFIS) Carlos III Institute, Gammera Nest Technology Company

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

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):13-2 — View Citation

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. Review. — View Citation

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 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months
Secondary	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.	3 months
Secondary	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	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months