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

NCT04355065 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-04-21

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV
  • Gammera Nest Technology Company

    collaborator UNKNOWN
  • Puerta de Hierro University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2020-11-30
Completion
2021-01-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355065 on ClinicalTrials.gov