Status:

COMPLETED

Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD

Lead Sponsor:

Puerta de Hierro University Hospital

Conditions:

Attention Deficit Hyperactivity Disorder

Eligibility:

All Genders

7-18 years

Phase:

PHASE3

Brief Summary

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties and worse prognosis if undet...

Eligibility Criteria

Inclusion

  • Age 7-17 years (could turn 18 during the study)
  • Clinical diagnosis of ADHD in any presentation.
  • With pharmacological treatment for ADHD.
  • Ability to follow verbal instructions
  • Ability to play a video game (not necessary to play regularly).
  • Clinically stable. ADHD symptomatology severity based on clinician-assessed CGI score (between 3-6).

Exclusion

  • Severe patients (\> or equal to 5 CGI) or very mild patients (CGI \< or equal to 1)
  • Patient at risk of suicide (according to the clinical judgment of the professional in charge of the patient)
  • Motor difficulties that prevent playing the videogame
  • Participation in other similar studies
  • Intention to initiate any psychotherapeutic treatment (including cognitive-behavioral therapy) in the next 3 months of the course of participation in the clinical trial.

Key Trial Info

Start Date :

May 9 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 15 2023

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT06006871

Start Date

May 9 2023

End Date

December 15 2023

Last Update

February 13 2024

Active Locations (1)

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1

Puerta de Hierro University Hospital

Majadahonda, Madrid, Spain, 28222