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

• Status: Recruiting
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puerta de Hierro University Hospital
• Collaborators: 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; Ministerio de Economía y Competitividad, Spain

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.