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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2023-12-15

Brief Summary

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Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice, however, sometimes it can be insufficient or have some drawbacks.

Objective: To demonstrate the effectiveness of cognitive training through the video game 'The Secret Trail of Moon' (MOON) in improving emotional regulation of ADHD in people aged 7 to 18 years.

Hypotheses: H1: ADHD patients using MOON improve their emotional regulation more than the control group; H2: ADHD patients using MOON improve in symptomatology with respect to the control group; H3: ADHD patients using MOON improve their cognitive abilities than the control group; H4: ADHD patients using MOON improve in academic performance with respect to the control group; H5: The change of platform (face-to-face, online) does not entail differences in emotional regulation; H6: There are no side effects associated with the video game.

Methods: Design: prospective, unicenter, randomized, unblinded, PRE-POST intervention study. Randomization of the groups (MOON vs. Control) will be performed by electronic CRD. The MOON intervention will be performed 2 times/week for 10 weeks (30 minutes/session). The first five weeks (10 sessions) will be conducted face-to-face; the remaining weeks will be conducted online at the participants' home.

Sample: 152 patients with a clinical diagnosis of ADHD (CGI between 3 and 6) with pharmacological treatment.

Evaluation: a data collection notebook will be used to obtain demographic and clinical data. The data will be recorded with electronic CRD (REDCap). Measures to answer the hypotheses will be made through clinical scales for parents and objective tests of cognitive abilities in patients. Additional information on academic performance will be collected.

Statistical power analysis: The study has a power greater than 80% to detect differences.

Statistical analysis: Classical statistics: T student, 2-factor ANOVA and Mann Whitney analyses will be performed according to the characteristics of each variable.

Ethics: The study was approved by the Research Ethics Committee of the Hospital Universitario Puerta de Hierro on December 14th, 2022. The authorization of the Spanish Agency of Medicines and Health Products was February 14th, 2023. Informed consent will be requested from legal guardians and minors protecting their personal data to the provisions of the Organic Law 3/2018 of 5 December, on Personal Data Protection and guarantee of digital rights.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, single-center, randomized, unblinded, PRE-POST intervention study with concealment of the randomization sequence.

A randomization of 2 groups by blocks will be performed: Group 1: "The Secret Trail of Moon" (MOON): a personalized cognitive training with a face-to-face and online video game (n=76); Group 2: Passive control (TAU): usual treatment (pharmacological) without cognitive training intervention (n=76).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

The Secret Trail of Moon 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: sustained attention, working memory, reasoning, planning and visuospatial ability. Aspects of rewards and music therapy have been added to this enhanced version of the game.

In this second clinical trial, the impact has been extended to twice a week during 20 sessions. There are two platforms of the same version of the game: computer (7-11 years old) and virtual reality (12-18 years old). Patients have to come to the hospital twice a week for training sessions of about 20-30 minutes duration for 10 weeks. Subsequently, they are given the computer version of the video game on a USB so that they can play it at home for another 10 weeks (twice a week).

Participants are monitored for possible difficulties and/or side effects.

Group Type EXPERIMENTAL

The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

Intervention Type BEHAVIORAL

Patients are pharmacologically stable and receive a cognitive intervention with our videogame twice a week in the hospital (10 sessions) and twice a week in their home with a computer video game (other 10 sessions).

Usual treatment for ADHD

Intervention Type DRUG

All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Control Group

This group corresponds to the control group (n=76). 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.

Group Type ACTIVE_COMPARATOR

Usual treatment for ADHD

Intervention Type DRUG

All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Interventions

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The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game

Patients are pharmacologically stable and receive a cognitive intervention with our videogame twice a week in the hospital (10 sessions) and twice a week in their home with a computer video game (other 10 sessions).

Intervention Type BEHAVIORAL

Usual treatment for ADHD

All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No