xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006871</url>
    </required_header>
    <id_info>
      <org_study_id>PI 106/22</org_study_id>
      <secondary_id>IND2020/BMD-17544</secondary_id>
      <secondary_id>Expte. 1061/22/EC-R.</secondary_id>
      <nct_id>NCT06006871</nct_id>
    </id_info>
    <brief_title>Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD</brief_title>
    <acronym>MOON</acronym>
    <official_title>The Secret Trail of Moon (MOON): a Personalized Treatment Video Game for Children and Adolescents With ADHD Based on Cognitive Training and Self-regulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Puerta de Hierro University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Puerta de Hierro University Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is the most common&#xD;
        neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties&#xD;
        and worse prognosis if undetected. Multimodal treatment is the treatment of choice, however,&#xD;
        sometimes it can be insufficient or have some drawbacks.&#xD;
  &#xD;
        Objective: To demonstrate the effectiveness of cognitive training through the video game 'The&#xD;
        Secret Trail of Moon' (MOON) in improving emotional regulation of ADHD in people aged 7 to 18&#xD;
        years.&#xD;
  &#xD;
        Hypotheses: H1: ADHD patients using MOON improve their emotional regulation more than the&#xD;
        control group; H2: ADHD patients using MOON improve in symptomatology with respect to the&#xD;
        control group; H3: ADHD patients using MOON improve their cognitive abilities than the&#xD;
        control group; H4: ADHD patients using MOON improve in academic performance with respect to&#xD;
        the control group; H5: The change of platform (face-to-face, online) does not entail&#xD;
        differences in emotional regulation; H6: There are no side effects associated with the video&#xD;
        game.&#xD;
  &#xD;
        Methods: Design: prospective, unicenter, randomized, unblinded, PRE-POST intervention study.&#xD;
        Randomization of the groups (MOON vs. Control) will be performed by electronic CRD. The MOON&#xD;
        intervention will be performed 2 times/week for 10 weeks (30 minutes/session). The first five&#xD;
        weeks (10 sessions) will be conducted face-to-face; the remaining weeks will be conducted&#xD;
        online at the participants' home.&#xD;
  &#xD;
        Sample: 152 patients with a clinical diagnosis of ADHD (CGI between 3 and 6) with&#xD;
        pharmacological treatment.&#xD;
  &#xD;
        Evaluation: a data collection notebook will be used to obtain demographic and clinical data.&#xD;
        The data will be recorded with electronic CRD (REDCap). Measures to answer the hypotheses&#xD;
        will be made through clinical scales for parents and objective tests of cognitive abilities&#xD;
        in patients. Additional information on academic performance will be collected.&#xD;
  &#xD;
        Statistical power analysis: The study has a power greater than 80% to detect differences.&#xD;
  &#xD;
        Statistical analysis: Classical statistics: T student, 2-factor ANOVA and Mann Whitney&#xD;
        analyses will be performed according to the characteristics of each variable.&#xD;
  &#xD;
        Ethics: The study was approved by the Research Ethics Committee of the Hospital Universitario&#xD;
        Puerta de Hierro on December 14th, 2022. The authorization of the Spanish Agency of Medicines&#xD;
        and Health Products was February 14th, 2023. Informed consent will be requested from legal&#xD;
        guardians and minors protecting their personal data to the provisions of the Organic Law&#xD;
        3/2018 of 5 December, on Personal Data Protection and guarantee of digital rights.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">January 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective, single-center, randomized, unblinded, PRE-POST intervention study with concealment of the randomization sequence.&#xD;
  A randomization of 2 groups by blocks will be performed: Group 1: &quot;The Secret Trail of Moon&quot; (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).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Strenghts and difficulties questionnaire (SDQ) for parents</measure>
      <time_frame>3 months</time_frame>
      <description>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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents</measure>
      <time_frame>3 months</time_frame>
      <description>The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The SNAP IV is a scale for the assessment of ADHD symptoms. It's an 18-item questionnaire with a Likert scale of 0-4 (approximately 5 minutes long) of which 9 assess attention deficit and another 9 assess hyperactive-impulsive component. The cut-off points for attention deficit are 1.78 for parents. For hyperactivity-impulsivity they are 1.44 for parents.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents</measure>
      <time_frame>3 months</time_frame>
      <description>The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The Conners scales are a set of scales for the assessment of patients with ADHD. CPRS-HI is a 10-item questionnaire with a Likert scale of 0-3 (approximately 2 minutes long). This revised and abbreviated version of the Conners scale is designed to be answered by parents of children ages 6-18. It consists of 10 items with a Likert type response: 0= not true at all/never; 1= just a little true/occasionally; 2= Pretty much true/often; 3=very much true/very often.&#xD;
  The cut-off points are divided by gender. For children, a score above 16 is suspected ADHD. While for girls, a suspected diagnosis of ADHD is from 12 points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impression Scale (CGI) for parents</measure>
      <time_frame>3 months</time_frame>
      <description>Symptom severity will be measured with the Clinical Global Impression Scale (CGI) adaptation for parents of approximately 1 minute duration, consisting of a &quot;thermometer&quot; with a Likert scale of 1-10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Sleep Disturbance Scale for Children (SDSC) for parents</measure>
      <time_frame>3 months</time_frame>
      <description>Sleep difficulties will be measured with the Sleep Disturbance Scale for Children (SDSC). It is a 26-item questionnaire with a Likert scale of 1-5 (1: never; 5: always) with an approximate duration of 5 minutes (Bruni et al., 1996)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents</measure>
      <time_frame>3 months</time_frame>
      <description>Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. The subjective test for parents will be performed with the Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire.The BRIEF-2 is a questionnaire designed for the evaluation of executive functions in children and adolescents. It is made up of 63 items with three answer options (never, sometimes and frequently). Its correction provides four general indexes: emotional regulation, cognitive regulation, behavioral regulation and global index of executive function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conners Continuous Performance Test 3rd Edition (CPT-3) for patients with ADHD</measure>
      <time_frame>3 months</time_frame>
      <description>Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Conners Continuous Performance Test-3 (CPT-3) is a task that is usually used to screen for ADHD in addition to measuring sustained attention, impulse control and processing speed. The Conners CPT-3 is a computerized, standardized, and validated application test for different age and gender groups. The test consists of pressing a button each time a letter (target) appears on the screen, except for the letter X (non-target), which should not be pressed. The duration is approximately 14 minutes and the presentation interval between letters is variable (1, 2 and 4 seconds). The test provides results on hits, error of omission (undetected target) and errors of commission (reacted non-target), which are considered a measure of impulsivity. In addition, CPT3-3 provides information on mean reaction time and reaction time variability of hits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Corsi Cubes for patients with ADHD</measure>
      <time_frame>3 months</time_frame>
      <description>Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Corsi Cubes to measure visuospatial working memory (Corsi, 1972; Kessels et al., 2000)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comprehensive Trail-Making Test Second Edition (CTMT-2) for patients with ADHD</measure>
      <time_frame>3 months</time_frame>
      <description>Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Comprehensive Trail-Making Test Second Edition (CTMT-2) to measure cognitive flexibility, with three indexes: inhibitory control, task switching and total index.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Game Addiction Scale for Adolescents (GASA) for patients with ADHD</measure>
      <time_frame>3 months</time_frame>
      <description>Game Addiction Scale for Adolescents (GASA) is a 7-item questionnaire to assess video game addiction (Lemmens et al., 2009)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Academic notes</measure>
      <time_frame>3 months</time_frame>
      <description>Information about academic performance will be obtained with grades.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&quot;Clinical Examinations Questionnaire&quot;(UKU) for patients with ADHD</measure>
      <time_frame>3 months</time_frame>
      <description>UKU is a tool designed to evaluate possible secondary symptoms that happen during the week. This scale is not included in the assessment phases. Only the MOON with VR group should complete the scale after each cognitive training session.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Clinical Global Impression Scale (CGI) for clinicians</measure>
      <time_frame>3 months</time_frame>
      <description>Symptom severity will be measured with the Clinical Global Impression Scale (CGI) approximately 1 minute duration. ADHD symptomatology severity based on clinician-assessed CGI score (between 3-6) for inclusion criteria</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Attention Deficit Hyperactivity Disorder</condition>
    <arm_group>
      <arm_group_label>The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  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).&#xD;
  Participants are monitored for possible difficulties and/or side effects.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group corresponds to the control group (n=76). The control group continues with their prescribed pharmacological treatment without any cognitive intervention.&#xD;
  The participants of this group are contacted by telephone once a week to follow up on possible difficulties and/or side effects.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game</intervention_name>
      <description>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).</description>
      <arm_group_label>The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Usual treatment for ADHD</intervention_name>
      <description>All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 7-17 years (could turn 18 during the study)&#xD;
  &#xD;
            -  Clinical diagnosis of ADHD in any presentation.&#xD;
  &#xD;
            -  With pharmacological treatment for ADHD.&#xD;
  &#xD;
            -  Ability to follow verbal instructions&#xD;
  &#xD;
            -  Ability to play a video game (not necessary to play regularly).&#xD;
  &#xD;
            -  Clinically stable. ADHD symptomatology severity based on clinician-assessed CGI score&#xD;
               (between 3-6).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe patients (&gt; or equal to 5 CGI) or very mild patients (CGI &lt; or equal to 1)&#xD;
  &#xD;
            -  Patient at risk of suicide (according to the clinical judgment of the professional in&#xD;
               charge of the patient)&#xD;
  &#xD;
            -  Motor difficulties that prevent playing the videogame&#xD;
  &#xD;
            -  Participation in other similar studies&#xD;
  &#xD;
            -  Intention to initiate any psychotherapeutic treatment (including cognitive-behavioral&#xD;
               therapy) in the next 3 months of the course of participation in the clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hilario M Blasco-Fontecilla, Md, PhD</last_name>
      <phone>911911690</phone>
      <email>hmblasco@yahoo.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Puerta de Hierro University Hospital</name>
        <address>
          <city>Majadahonda</city>
          <state>Madrid</state>
          <zip>28222</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hilario M Blasco-Fontecilla, ID</last_name>
        <phone>+34 655214857</phone>
        <email>hmblasco@yahoo.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Blasco-Fontecilla H. A Virtual Reality Serious Videogame Versus Online Chess Augmentation in Patients with Attention Deficit Hyperactivity Disorder: A Randomized Clinical Trial. Games Health J. 2021 Aug;10(4):283-292. doi: 10.1089/g4h.2021.0073.</citation>
      <PMID>34370610</PMID>
    </reference>
    <results_reference>
      <citation>Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Royuela A, Blasco-Fontecilla H. A Virtual Reality Game (The Secret Trail of Moon) for Treating Attention-Deficit/Hyperactivity Disorder: Development and Usability Study. JMIR Serious Games. 2021 Sep 1;9(3):e26824. doi: 10.2196/26824.</citation>
      <PMID>34468332</PMID>
    </results_reference>
    <results_reference>
      <citation>Rodrigo-Yanguas M, Martin-Moratinos M, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Bella-Fernandez M, Blasco-Fontecilla H. Effectiveness of a Personalized, Chess-Based Training Serious Video Game in the Treatment of Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial. JMIR Serious Games. 2023 Apr 24;11:e39874. doi: 10.2196/39874.</citation>
      <PMID>37093628</PMID>
    </results_reference>
    <results_reference>
      <citation>Sujar A, Martin-Moratinos M, Rodrigo-Yanguas M, Bella-Fernandez M, Gonzalez-Tardon C, Delgado-Gomez D, Blasco-Fontecilla H. Developing Serious Video Games to Treat Attention Deficit Hyperactivity Disorder: Tutorial Guide. JMIR Serious Games. 2022 Aug 1;10(3):e33884. doi: 10.2196/33884.</citation>
      <PMID>35916694</PMID>
    </results_reference>
    <results_reference>
      <citation>Bella-Fernandez M, Martin-Moratinos M, Li C, Wang P, Blasco-Fontecilla H. Differences in Ex-Gaussian Parameters from Response Time Distributions Between Individuals with and Without Attention Deficit/Hyperactivity Disorder: A Meta-analysis. Neuropsychol Rev. 2023 Mar 6. doi: 10.1007/s11065-023-09587-2. Online ahead of print.</citation>
      <PMID>36877328</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Puerta de Hierro University Hospital</investigator_affiliation>
      <investigator_full_name>Dr. Hilario Manuel Blasco Fontecilla</investigator_full_name>
      <investigator_title>Child and adolescent psychiatrist</investigator_title>
    </responsible_party>
    <keyword>ADHD</keyword>
    <keyword>ADD</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006871
  org study id: PI 106/22
  secondary id: IND2020/BMD-17544
  secondary id: Expte. 1061/22/EC-R.
  nct id: NCT06006871
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 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 purpose: Treatment
  masking: None (Open Label)
  measure: Strenghts and difficulties questionnaire (SDQ) for parents
  time frame: 3 months
  description: 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)
  measure: The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) for parents
  time frame: 3 months
  description: The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The SNAP IV is a scale for the assessment of ADHD symptoms. It's an 18-item questionnaire with a Likert scale of 0-4 (approximately 5 minutes long) of which 9 assess attention deficit and another 9 assess hyperactive-impulsive component. The cut-off points for attention deficit are 1.78 for parents. For hyperactivity-impulsivity they are 1.44 for parents.
  measure: The Conners Abbreviated Symptom Questionnaire (CPRS-HI) for parents
  time frame: 3 months
  description: The main ADHD symptomatology (inattention, hyperactivity, impulsivity) will be measured with subjective scales for parents. The Conners scales are a set of scales for the assessment of patients with ADHD. CPRS-HI is a 10-item questionnaire with a Likert scale of 0-3 (approximately 2 minutes long). This revised and abbreviated version of the Conners scale is designed to be answered by parents of children ages 6-18. It consists of 10 items with a Likert type response: 0= not true at all/never; 1= just a little true/occasionally; 2= Pretty much true/often; 3=very much true/very often.
  The cut-off points are divided by gender. For children, a score above 16 is suspected ADHD. While for girls, a suspected diagnosis of ADHD is from 12 points
  measure: Clinical Global Impression Scale (CGI) for parents
  time frame: 3 months
  description: Symptom severity will be measured with the Clinical Global Impression Scale (CGI) adaptation for parents of approximately 1 minute duration, consisting of a "thermometer" with a Likert scale of 1-10.
  measure: The Sleep Disturbance Scale for Children (SDSC) for parents
  time frame: 3 months
  description: Sleep difficulties will be measured with the Sleep Disturbance Scale for Children (SDSC). It is a 26-item questionnaire with a Likert scale of 1-5 (1: never; 5: always) with an approximate duration of 5 minutes (Bruni et al., 1996)
  measure: Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire for parents
  time frame: 3 months
  description: Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. The subjective test for parents will be performed with the Behavior Rating Inventory Executive Function 2 (BRIEF-2) questionnaire.The BRIEF-2 is a questionnaire designed for the evaluation of executive functions in children and adolescents. It is made up of 63 items with three answer options (never, sometimes and frequently). Its correction provides four general indexes: emotional regulation, cognitive regulation, behavioral regulation and global index of executive function.
  measure: Conners Continuous Performance Test 3rd Edition (CPT-3) for patients with ADHD
  time frame: 3 months
  description: Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Conners Continuous Performance Test-3 (CPT-3) is a task that is usually used to screen for ADHD in addition to measuring sustained attention, impulse control and processing speed. The Conners CPT-3 is a computerized, standardized, and validated application test for different age and gender groups. The test consists of pressing a button each time a letter (target) appears on the screen, except for the letter X (non-target), which should not be pressed. The duration is approximately 14 minutes and the presentation interval between letters is variable (1, 2 and 4 seconds). The test provides results on hits, error of omission (undetected target) and errors of commission (reacted non-target), which are considered a measure of impulsivity. In addition, CPT3-3 provides information on mean reaction time and reaction time variability of hits.
  measure: Corsi Cubes for patients with ADHD
  time frame: 3 months
  description: Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Corsi Cubes to measure visuospatial working memory (Corsi, 1972; Kessels et al., 2000)
  measure: Comprehensive Trail-Making Test Second Edition (CTMT-2) for patients with ADHD
  time frame: 3 months
  description: Executive dysfunction will be evaluated by means of subjective scales for parents and objective tests for patients. Comprehensive Trail-Making Test Second Edition (CTMT-2) to measure cognitive flexibility, with three indexes: inhibitory control, task switching and total index.
  measure: Game Addiction Scale for Adolescents (GASA) for patients with ADHD
  time frame: 3 months
  description: Game Addiction Scale for Adolescents (GASA) is a 7-item questionnaire to assess video game addiction (Lemmens et al., 2009)
  measure: Academic notes
  time frame: 3 months
  description: Information about academic performance will be obtained with grades.
  measure: "Clinical Examinations Questionnaire"(UKU) for patients with ADHD
  time frame: 3 months
  description: UKU is a tool designed to evaluate possible secondary symptoms that happen during the week. This scale is not included in the assessment phases. Only the MOON with VR group should complete the scale after each cognitive training session.
  measure: Clinical Global Impression Scale (CGI) for clinicians
  time frame: 3 months
  description: Symptom severity will be measured with the Clinical Global Impression Scale (CGI) approximately 1 minute duration. ADHD symptomatology severity based on clinician-assessed CGI score (between 3-6) for inclusion criteria
  arm group label: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game
  arm group type: Experimental
  description: 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.
  arm group label: Control Group
  arm group type: Active Comparator
  description: 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.
  intervention type: Behavioral
  intervention name: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game
  description: 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).
  arm group label: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game
  intervention type: Drug
  intervention name: Usual treatment for ADHD
  description: All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.
  arm group label: Control Group
  arm group label: The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Hilario M Blasco-Fontecilla, Md, PhD
  phone: 911911690
  email: hmblasco@yahoo.es
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  citation: Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Blasco-Fontecilla H. A Virtual Reality Serious Videogame Versus Online Chess Augmentation in Patients with Attention Deficit Hyperactivity Disorder: A Randomized Clinical Trial. Games Health J. 2021 Aug;10(4):283-292. doi: 10.1089/g4h.2021.0073.
  PMID: 34370610
  citation: Rodrigo-Yanguas M, Martin-Moratinos M, Menendez-Garcia A, Gonzalez-Tardon C, Royuela A, Blasco-Fontecilla H. A Virtual Reality Game (The Secret Trail of Moon) for Treating Attention-Deficit/Hyperactivity Disorder: Development and Usability Study. JMIR Serious Games. 2021 Sep 1;9(3):e26824. doi: 10.2196/26824.
  PMID: 34468332
  citation: Rodrigo-Yanguas M, Martin-Moratinos M, Gonzalez-Tardon C, Sanchez-Sanchez F, Royuela A, Bella-Fernandez M, Blasco-Fontecilla H. Effectiveness of a Personalized, Chess-Based Training Serious Video Game in the Treatment of Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial. JMIR Serious Games. 2023 Apr 24;11:e39874. doi: 10.2196/39874.
  PMID: 37093628
  citation: Sujar A, Martin-Moratinos M, Rodrigo-Yanguas M, Bella-Fernandez M, Gonzalez-Tardon C, Delgado-Gomez D, Blasco-Fontecilla H. Developing Serious Video Games to Treat Attention Deficit Hyperactivity Disorder: Tutorial Guide. JMIR Serious Games. 2022 Aug 1;10(3):e33884. doi: 10.2196/33884.
  PMID: 35916694
  citation: Bella-Fernandez M, Martin-Moratinos M, Li C, Wang P, Blasco-Fontecilla H. Differences in Ex-Gaussian Parameters from Response Time Distributions Between Individuals with and Without Attention Deficit/Hyperactivity Disorder: A Meta-analysis. Neuropsychol Rev. 2023 Mar 6. doi: 10.1007/s11065-023-09587-2. Online ahead of print.
  PMID: 36877328
  responsible party type: Principal Investigator
  investigator affiliation: Puerta de Hierro University Hospital
  investigator full name: Dr. Hilario Manuel Blasco Fontecilla
  investigator title: Child and adolescent psychiatrist
  mesh term: Attention Deficit Disorder with Hyperactivity