The Secret Trail of Moon (MOON): a Personalized Treatment Video Game for Children and Adolescents With ADHD Based on Cognitive Training and Self-regulation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Strenghts and difficulties questionnaire (SDQ) for parents
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Usual treatment for ADHD (Drug)
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.
干预措施: Usual treatment for ADHD (Drug)
结局指标
主要结局
Strenghts and difficulties questionnaire (SDQ) for parents
时间窗: 3 months
This questionnaire has 25 items (duration of approximately 5 minutes). It mainly measures the scales 1) Emotional symptoms, 2) Behavioral problems, 3) Hyperactivity, 4) Problems with peers and 5) Prosocial behavior. A decrease of 3 to 4 points in the post-assessment visit (D70) with respect to the pre-assessment visit (D0) will be considered an improvement in emotional regulation (Goodman, 1977)
次要结局
- The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents(3 months)
- The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents(3 months)
- Clinical Global Impression Scale (CGI) for parents(3 months)
- The Sleep Disturbance Scale for Children (SDSC) for parents(3 months)
- Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents(3 months)
- Conners Continuous Performance Test 3rd Edition (CPT-3) for patients with ADHD(3 months)
- Corsi Cubes for patients with ADHD(3 months)
- Comprehensive Trail-Making Test Second Edition (CTMT-2) for patients with ADHD(3 months)
- Academic notes(3 months)
- "Clinical Examinations Questionnaire"(UKU) for patients with ADHD(3 months)
- Game Addiction Scale for Adolescents (GASA) for patients with ADHD(3 months)
研究者
Dr. Hilario Manuel Blasco Fontecilla
Child and adolescent psychiatrist
Puerta de Hierro University Hospital