<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/NCT04418921</url>
  </required_header>
  <id_info>
    <org_study_id>SR-MRehab</org_study_id>
    <nct_id>NCT04418921</nct_id>
  </id_info>
  <brief_title>Improving Self-regulation in Children With Neurodevelopmental Disorders:</brief_title>
  <official_title>Self-Regulation in Children With Neurodevelopmental Disorders &quot;SR-MRehab: Un Colegio Emocionante&quot;: a Protocol Study With Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with neurodevelopmental disorders may show difficulties in self-regulation. The main&#xD;
      objective of this study is to improve self-regulation skills in children between 6 and 11&#xD;
      years old with neurodevelopmental disorders. Methodology: A randomized controlled trial will&#xD;
      be conducted with the use of &quot;SF-MRehab: Un colegio emocionante&quot;, a non-inmersive virtual&#xD;
      reality system where virtual objects can be managed by children in a natural way by using&#xD;
      their hands. Children will be recruited from several schools from Granada (Spain) and they&#xD;
      will be randomly allocated to two groups. Assessment will be conducted before and after the&#xD;
      intervention as well as 24 weeks after the end of the intervention process. Experimental&#xD;
      group will receive the intervention using virtual reality. Control group will receive the&#xD;
      intervention through a standard self-regulation program. Both interventions will be performed&#xD;
      once a week for a total of 10 sessions. Changes in self-regulation, as well as acceptability&#xD;
      of technology with the use of SR-MRehab will be evaluated. The results will be published and&#xD;
      will contribute with evidence regarding the use of this type of intervention on children with&#xD;
      neurodevelopmental disorders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The &quot;SR-MRehab: un colegio Emocionante&quot; is a randomized controlled trial, a non-inmersive&#xD;
      virtual reality system will be conducted through Mrehab tool (39, 40). Children will be&#xD;
      recruited from several schools from Granada (Spain) and they will be randomly allocated to&#xD;
      two groups: experimental or control group. Assessment will be conducted before and after the&#xD;
      intervention as well as 24 weeks after the end of the intervention process. Experimental&#xD;
      group will receive the intervention using virtual reality. Control group will receive the&#xD;
      intervention through a standard self-regulation program. Both interventions will be performed&#xD;
      once a week for a total of 10 sessions (50 min sessions per day). The inclusion criteria are:&#xD;
      1) have special educational needs; 2) possible oral comprehension, with the possibility of&#xD;
      fixing the gaze; 3) be able to attend to verbal and visual instructions; 4) maintain&#xD;
      sustained attention for at least four minutes. Exclusion criteria are: 1) severe motor&#xD;
      disability; 2) children with major behavioural problems, such as self-harm; 3) children with&#xD;
      high abilities. Initially, all students of this center with special educational needs will be&#xD;
      invited.&#xD;
&#xD;
      2.2. Procedure and Enrollment The implementation of the program covers the period from&#xD;
      September 2019 to May 2020, divided into six stages: recruitment, pre-evaluation,&#xD;
      assignation, intervention, post-evaluation and follow-up at 6 months. The initial stage&#xD;
      corresponds to the acceptance by the management of the centers, and the subsequent invitation&#xD;
      to the participants by sending a letter to the parents/legal guardians, which contains an&#xD;
      informative document of the characteristics of the project and the corresponding informed&#xD;
      consent for participate in it. Children are randomly assigned through the online&#xD;
      randomization program. The type of allocation to each group will be by simple randomization.&#xD;
      Recruitment and study procedure is shown in Figure 1 2.2.1. Study Variables The main&#xD;
      variables of the study can be divided into two main dimensions: 1) executive functions:&#xD;
      inhibitory control, flexibility, planning, reasoning, and problem solving; 2) socio-emotional&#xD;
      competences: recognition of emotions, emotional regulation and social competence. These&#xD;
      variables were and will be evaluated through several questionnaires provided to parents,&#xD;
      teachers and students and test performed by children, as shown in Table 1.&#xD;
&#xD;
      Additionally, other sociodemographic data and information on the child's development and&#xD;
      learning history were collected. Through the &quot;SR-MRehab: un colegio emocionante&quot;, in each&#xD;
      session, the following information will be collected for each task: number of hits, cognitive&#xD;
      errors, time each participant to complete the task.&#xD;
&#xD;
      The assessment will be made in the first weeks of December 2020, dividing the assessment into&#xD;
      three blocks. First, the EQ-i:YV questionnaire (41) and Clocks and Affect Recognition&#xD;
      subtests from NEPSY-II (42) will be provided to students, and on the other hand, teachers and&#xD;
      parents will asked to complete the EPYFEI-Escolar (44) and EPYFEI (45) questionnaires&#xD;
      respectively, they'll have to fill in and come back within the next week. Second, the&#xD;
      students will complete the assessment corresponding to the subtests of Design Fluency and&#xD;
      Theory of Mind of the NEPSY-II. Finally, in a third session, they will carry out a final&#xD;
      block to assess executive functions through Trail Making Test A and B (TMT A-B) and Stroop&#xD;
      test.&#xD;
&#xD;
      The same evaluation will be carried out immediately after finishing the program. In addition,&#xD;
      the acceptability of the technology will be evaluated with the children at the end of each&#xD;
      session and at the end of the whole program. A combination of methods will be used to assess&#xD;
      acceptability (46). Firsts, in each session, a visual analog scale will be used to evaluate&#xD;
      each activity, type Smileyometer, which consists of a visual analog scale with coding based&#xD;
      on a 5 point Likert scale (Horrible=1; Great=5). In addition, at the end of the program the&#xD;
      method &quot;This or That&quot; will be used, though five questions, for example: what has been the&#xD;
      most fun of the program? Or what game would you like to have at home?. To check the&#xD;
      maintenance of the results of the program, a follow-up will be carried out at 3 months, in&#xD;
      which the emotional regulation and executive functioning in the children will be re-assessed.&#xD;
&#xD;
      2.2.3. Intervention 2.2.3.1. Experimental Group Intervention on self-regulation will be&#xD;
      carried out through a non-immersive virtual reality platform, &quot;SR-Mrehab: Un colegio&#xD;
      emocionante&quot; in which students must conduct a series of activities designed specifically for&#xD;
      this purpose. These activities will be performed by the children using mainly their hands to&#xD;
      manage the virtual objects showed in the screen. To do this, our system make use of a Kinect&#xD;
      motion sensor connected to the computer to control the body movements of the children.&#xD;
      Moreover, our system records some relevant data of the execution of these activities for&#xD;
      further analysis of the children's performance.&#xD;
&#xD;
      The exercises will be divided into two blocks, emotional regulation (ER) and cognitive&#xD;
      regulation (CR), in a total of 10 sessions, once a week, performing an exercise of each block&#xD;
      per session. Each session will consists of 60 minutes. In general, each session will take&#xD;
      into account the development of the various executive functions: working memory, inhibitory&#xD;
      control, flexibility, reasoning, planning and problem solving (15) and emotional competencies&#xD;
      divided into the following dimensions: perception and emotional awareness, emotional&#xD;
      regulation, emotional autonomy and social competence (47). Table 2 lists the organization,&#xD;
      description and aims of each session. These sessions will take place from January to April&#xD;
      2021.&#xD;
&#xD;
      The MRehab tool allows establishing five levels of difficulty. Before starting the&#xD;
      intervention program, a database will be created with each participant, assigning each of the&#xD;
      tasks designed for each child according to the results of the previous assessment.&#xD;
&#xD;
      The intervention will begin with the explanation of the group session of 3 to 4 children.&#xD;
      Subsequently, individually in order to record the responses and perform the activities, it&#xD;
      will be asked to perform different tasks with the support and supervision of the occupational&#xD;
      therapist and psychologist. The session would end with a small assembly in which each child&#xD;
      discusses their experience and how and where the skills learned could be generalized in their&#xD;
      activities of daily living. Each session will be one hour long.&#xD;
&#xD;
      2.2.3.2. Control Group&#xD;
&#xD;
      The children from control group will follow a program of emotional education of Primary&#xD;
      Schools, though group activities in the classroom (5, 49). Each session will last 50 minutes,&#xD;
      just like in the experimental group. The content of the sessions will include 5 sessions of&#xD;
      emotional awareness and 5 sessions of emotional and cognitive regulation. The activities are&#xD;
      similar as those listed in Table 2 for the experimental group, but the virtual reality system&#xD;
      will not be used. It will be held in parallel in another room of the school, on the same day&#xD;
      and time, carried out by occupational therapists and students from the students in the last&#xD;
      year of occupational therapy degree.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional Perception</measure>
    <time_frame>6 months</time_frame>
    <description>Change in the number of errors in the recognition of recognized emotions on faces in the Affect Recognition subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores are &quot;0&quot; and the maximum number of errors for children older than 6 years: 79. The higher the score, the worse the recognition of emotions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Regulation</measure>
    <time_frame>6 months</time_frame>
    <description>Change in the ability to understand mental functions, such as belief, intention, deceit, to understand the relationship between emotions and the social context, according to the Theory of Mind subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores is &quot;0&quot; and the maximum score is 28. The higher the score, the better the ability to mentalize and recognize the mental states of other people.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive Flexibility</measure>
    <time_frame>6 monhs</time_frame>
    <description>Change in the skills of maintaining attention and for the ability to change and maintain a new pattern of responses, according to the Auditory attention and cognitive flexibility subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum score is &quot;0&quot; and the maximum score is 30. The higher the score, the number of correct answers, the better the ability to attend and to be flexible with changes. In addition, it allows knowing the number of errors, divided into three types: commission, omission and inhibition errors. The greater the number of errors, the worse the attention and cognitive flexibility. The minimum error score is &quot;0&quot; and the maximum number of commission errors is 189, the maximum number of omission errors are 39, and the maximum number of inhibition errors is 33.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Planning, Sequencing</measure>
    <time_frame>6 months</time_frame>
    <description>Change in planning and organization skills, as well as in self-supervision capacity, according to the Children's Neuropsychology Assessment Battery Clocks subtest (NEPSY-II), whose minimum scores are &quot;0&quot; and the maximum score is 78. A higher Score best ability to plan, sequence and monitor the action.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Child Behavior Disorders</condition>
  <condition>ASD</condition>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention on self-regulation will be carried out through a non-immersive virtual reality platform, &quot;SR-Mrehab: Un colegio emocionante&quot; in which students must conduct a series of activities designed specifically for this purpose. These activities will be performed by the children using mainly their hands to manage the virtual objects showed in the screen. To do this, our system make use of a Kinect motion sensor connected to the computer to control the body movements of the children. Moreover, our system records some relevant data of the execution of these activities for further analysis of the children's performance.The exercises will be divided into two blocks, emotional regulation (ER) and cognitive regulation (CR), in a total of 10 sessions, once a week, performing an exercise of each block per session. Each session will consists of 60 minutes. .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom (5, 49). Each session will last 50 minutes, just like in the experimental group. The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation. The activities are similar for the experimental group, but the virtual reality system will not be used. It will be held in parallel in another room of the school, on the same day and time, carried out by occupational therapists and students from the students in the last year of occupational therapy degree.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality</intervention_name>
    <description>The principles of the programme will be based on the following premises for children with ASD: 1) Strengthening communicative attempts; 2) Choose the most natural contexts possible; 3) Establish structured and predictable routines and environments; 4)Visually support information; 5) Adapting our language to the understanding level of the child. On the difficulty of interpreting and responding to social emotions and cues, games of perspectives are of great interest, where the child and therapist describe the same object from different perspectives, beliefs (guess that may be in this box), games with social stories, which are short stories that use pictograms, to help understand especially situations with social ambiguity: 1) describing what happens; 2) orienting the action, indicating to the child what to do in that situation; 3) anticipating and explaining what can happen and how you can feel; 4) developing a strategy that can be applied in similar situations.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Traditional self-regulation program</intervention_name>
    <description>The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom .The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation.Each session will last 50 minutes</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Educative programa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of Autism Spectrum Disorders and / or Attention Deficit Disorder&#xD;
             with Hyperactivity&#xD;
&#xD;
          -  Have special educational needs;&#xD;
&#xD;
          -  Oral comprehension, with the possibility of fixing the gaze;&#xD;
&#xD;
          -  Be able to attend to verbal and visual instructions;&#xD;
&#xD;
          -  Be able to maintain sustained attention for at least four minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe motor disability;&#xD;
&#xD;
          -  Children with major behavioural problems, such as self-harm;&#xD;
&#xD;
          -  Children with high abilities.&#xD;
&#xD;
        Initially, all students of this center with special educational needs will be invited.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dulce Romero Ayuso</last_name>
    <phone>+34626822916</phone>
    <email>dulceromero@ugr.es</email>
  </overall_contact>
  <reference>
    <citation>Alcaniz ML, Olmos-Raya E, Abad L. [Use of virtual reality for neurodevelopmental disorders. A review of the state of the art and future agenda]. Medicina (B Aires). 2019;79(Suppl 1):77-81. Spanish.</citation>
    <PMID>30776285</PMID>
  </reference>
  <reference>
    <citation>Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.</citation>
    <PMID>29234356</PMID>
  </reference>
  <reference>
    <citation>Parsons TD, Riva G, Parsons S, Mantovani F, Newbutt N, Lin L, Venturini E, Hall T. Virtual Reality in Pediatric Psychology. Pediatrics. 2017 Nov;140(Suppl 2):S86-S91. doi: 10.1542/peds.2016-1758I.</citation>
    <PMID>29093039</PMID>
  </reference>
  <reference>
    <citation>Eom H, Kim KK, Lee S, Hong YJ, Heo J, Kim JJ, Kim E. Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Cyberpsychol Behav Soc Netw. 2019 Mar;22(3):198-204. doi: 10.1089/cyber.2018.0377. Epub 2019 Jan 23.</citation>
    <PMID>30672714</PMID>
  </reference>
  <results_reference>
    <citation>Bekele E, Zheng Z, Swanson A, Crittendon J, Warren Z, Sarkar N. Understanding how adolescents with autism respond to facial expressions in virtual reality environments. IEEE Trans Vis Comput Graph. 2013 Apr;19(4):711-20. doi: 10.1109/TVCG.2013.42.</citation>
    <PMID>23428456</PMID>
  </results_reference>
  <results_reference>
    <citation>Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.</citation>
    <PMID>30907929</PMID>
  </results_reference>
  <results_reference>
    <citation>Bekele E, Crittendon J, Zheng Z, Swanson A, Weitlauf A, Warren Z, Sarkar N. Assessing the utility of a virtual environment for enhancing facial affect recognition in adolescents with autism. J Autism Dev Disord. 2014 Jul;44(7):1641-50. doi: 10.1007/s10803-014-2035-8.</citation>
    <PMID>24419871</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuan SNV, Ip HHS. Using virtual reality to train emotional and social skills in children with autism spectrum disorder. London J Prim Care (Abingdon). 2018 Jun 7;10(4):110-112. doi: 10.1080/17571472.2018.1483000. eCollection 2018.</citation>
    <PMID>30083244</PMID>
  </results_reference>
  <results_reference>
    <citation>Shema-Shiratzky S, Brozgol M, Cornejo-Thumm P, Geva-Dayan K, Rotstein M, Leitner Y, Hausdorff JM, Mirelman A. Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. Dev Neurorehabil. 2019 Aug;22(6):431-436. doi: 10.1080/17518423.2018.1476602. Epub 2018 May 17.</citation>
    <PMID>29771624</PMID>
  </results_reference>
  <results_reference>
    <citation>Blume F, Hudak J, Dresler T, Ehlis AC, Kuhnhausen J, Renner TJ, Gawrilow C. NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2017 Jan 24;18(1):41. doi: 10.1186/s13063-016-1769-3.</citation>
    <PMID>28118856</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Dulce Romero Ayuso</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
    <mesh_term>Child Behavior Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04418921
org study id: SR-MRehab
nct id: NCT04418921
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Children with neurodevelopmental disorders may show difficulties in self-regulation. The main
      objective of this study is to improve self-regulation skills in children between 6 and 11
      years old with neurodevelopmental disorders. Methodology: A randomized controlled trial will
      be conducted with the use of "SF-MRehab: Un colegio emocionante", a non-inmersive virtual
      reality system where virtual objects can be managed by children in a natural way by using
      their hands. Children will be recruited from several schools from Granada (Spain) and they
      will be randomly allocated to two groups. Assessment will be conducted before and after the
      intervention as well as 24 weeks after the end of the intervention process. Experimental
      group will receive the intervention using virtual reality. Control group will receive the
      intervention through a standard self-regulation program. Both interventions will be performed
      once a week for a total of 10 sessions. Changes in self-regulation, as well as acceptability
      of technology with the use of SR-MRehab will be evaluated. The results will be published and
      will contribute with evidence regarding the use of this type of intervention on children with
      neurodevelopmental disorders
The "SR-MRehab: un colegio Emocionante" is a randomized controlled trial, a non-inmersive
      virtual reality system will be conducted through Mrehab tool (39, 40). Children will be
      recruited from several schools from Granada (Spain) and they will be randomly allocated to
      two groups: experimental or control group. Assessment will be conducted before and after the
      intervention as well as 24 weeks after the end of the intervention process. Experimental
      group will receive the intervention using virtual reality. Control group will receive the
      intervention through a standard self-regulation program. Both interventions will be performed
      once a week for a total of 10 sessions (50 min sessions per day). The inclusion criteria are:
      1) have special educational needs; 2) possible oral comprehension, with the possibility of
      fixing the gaze; 3) be able to attend to verbal and visual instructions; 4) maintain
      sustained attention for at least four minutes. Exclusion criteria are: 1) severe motor
      disability; 2) children with major behavioural problems, such as self-harm; 3) children with
      high abilities. Initially, all students of this center with special educational needs will be
      invited.

      2.2. Procedure and Enrollment The implementation of the program covers the period from
      September 2019 to May 2020, divided into six stages: recruitment, pre-evaluation,
      assignation, intervention, post-evaluation and follow-up at 6 months. The initial stage
      corresponds to the acceptance by the management of the centers, and the subsequent invitation
      to the participants by sending a letter to the parents/legal guardians, which contains an
      informative document of the characteristics of the project and the corresponding informed
      consent for participate in it. Children are randomly assigned through the online
      randomization program. The type of allocation to each group will be by simple randomization.
      Recruitment and study procedure is shown in Figure 1 2.2.1. Study Variables The main
      variables of the study can be divided into two main dimensions: 1) executive functions:
      inhibitory control, flexibility, planning, reasoning, and problem solving; 2) socio-emotional
      competences: recognition of emotions, emotional regulation and social competence. These
      variables were and will be evaluated through several questionnaires provided to parents,
      teachers and students and test performed by children, as shown in Table 1.

      Additionally, other sociodemographic data and information on the child's development and
      learning history were collected. Through the "SR-MRehab: un colegio emocionante", in each
      session, the following information will be collected for each task: number of hits, cognitive
      errors, time each participant to complete the task.

      The assessment will be made in the first weeks of December 2020, dividing the assessment into
      three blocks. First, the EQ-i:YV questionnaire (41) and Clocks and Affect Recognition
      subtests from NEPSY-II (42) will be provided to students, and on the other hand, teachers and
      parents will asked to complete the EPYFEI-Escolar (44) and EPYFEI (45) questionnaires
      respectively, they'll have to fill in and come back within the next week. Second, the
      students will complete the assessment corresponding to the subtests of Design Fluency and
      Theory of Mind of the NEPSY-II. Finally, in a third session, they will carry out a final
      block to assess executive functions through Trail Making Test A and B (TMT A-B) and Stroop
      test.

      The same evaluation will be carried out immediately after finishing the program. In addition,
      the acceptability of the technology will be evaluated with the children at the end of each
      session and at the end of the whole program. A combination of methods will be used to assess
      acceptability (46). Firsts, in each session, a visual analog scale will be used to evaluate
      each activity, type Smileyometer, which consists of a visual analog scale with coding based
      on a 5 point Likert scale (Horrible=1; Great=5). In addition, at the end of the program the
      method "This or That" will be used, though five questions, for example: what has been the
      most fun of the program? Or what game would you like to have at home?. To check the
      maintenance of the results of the program, a follow-up will be carried out at 3 months, in
      which the emotional regulation and executive functioning in the children will be re-assessed.

      2.2.3. Intervention 2.2.3.1. Experimental Group Intervention on self-regulation will be
      carried out through a non-immersive virtual reality platform, "SR-Mrehab: Un colegio
      emocionante" in which students must conduct a series of activities designed specifically for
      this purpose. These activities will be performed by the children using mainly their hands to
      manage the virtual objects showed in the screen. To do this, our system make use of a Kinect
      motion sensor connected to the computer to control the body movements of the children.
      Moreover, our system records some relevant data of the execution of these activities for
      further analysis of the children's performance.

      The exercises will be divided into two blocks, emotional regulation (ER) and cognitive
      regulation (CR), in a total of 10 sessions, once a week, performing an exercise of each block
      per session. Each session will consists of 60 minutes. In general, each session will take
      into account the development of the various executive functions: working memory, inhibitory
      control, flexibility, reasoning, planning and problem solving (15) and emotional competencies
      divided into the following dimensions: perception and emotional awareness, emotional
      regulation, emotional autonomy and social competence (47). Table 2 lists the organization,
      description and aims of each session. These sessions will take place from January to April
      2021.

      The MRehab tool allows establishing five levels of difficulty. Before starting the
      intervention program, a database will be created with each participant, assigning each of the
      tasks designed for each child according to the results of the previous assessment.

      The intervention will begin with the explanation of the group session of 3 to 4 children.
      Subsequently, individually in order to record the responses and perform the activities, it
      will be asked to perform different tasks with the support and supervision of the occupational
      therapist and psychologist. The session would end with a small assembly in which each child
      discusses their experience and how and where the skills learned could be generalized in their
      activities of daily living. Each session will be one hour long.

      2.2.3.2. Control Group

      The children from control group will follow a program of emotional education of Primary
      Schools, though group activities in the classroom (5, 49). Each session will last 50 minutes,
      just like in the experimental group. The content of the sessions will include 5 sessions of
      emotional awareness and 5 sessions of emotional and cognitive regulation. The activities are
      similar as those listed in Table 2 for the experimental group, but the virtual reality system
      will not be used. It will be held in parallel in another room of the school, on the same day
      and time, carried out by occupational therapists and students from the students in the last
      year of occupational therapy degree.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Emotional Perception
time frame: 6 months
description: Change in the number of errors in the recognition of recognized emotions on faces in the Affect Recognition subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores are "0" and the maximum number of errors for children older than 6 years: 79. The higher the score, the worse the recognition of emotions.
measure: Emotional Regulation
time frame: 6 months
description: Change in the ability to understand mental functions, such as belief, intention, deceit, to understand the relationship between emotions and the social context, according to the Theory of Mind subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores is "0" and the maximum score is 28. The higher the score, the better the ability to mentalize and recognize the mental states of other people.
measure: Cognitive Flexibility
time frame: 6 monhs
description: Change in the skills of maintaining attention and for the ability to change and maintain a new pattern of responses, according to the Auditory attention and cognitive flexibility subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum score is "0" and the maximum score is 30. The higher the score, the number of correct answers, the better the ability to attend and to be flexible with changes. In addition, it allows knowing the number of errors, divided into three types: commission, omission and inhibition errors. The greater the number of errors, the worse the attention and cognitive flexibility. The minimum error score is "0" and the maximum number of commission errors is 189, the maximum number of omission errors are 39, and the maximum number of inhibition errors is 33.
measure: Planning, Sequencing
time frame: 6 months
description: Change in planning and organization skills, as well as in self-supervision capacity, according to the Children's Neuropsychology Assessment Battery Clocks subtest (NEPSY-II), whose minimum scores are "0" and the maximum score is 78. A higher Score best ability to plan, sequence and monitor the action.
arm group label: Experimental Group
arm group type: Experimental
description: Intervention on self-regulation will be carried out through a non-immersive virtual reality platform, "SR-Mrehab: Un colegio emocionante" in which students must conduct a series of activities designed specifically for this purpose. These activities will be performed by the children using mainly their hands to manage the virtual objects showed in the screen. To do this, our system make use of a Kinect motion sensor connected to the computer to control the body movements of the children. Moreover, our system records some relevant data of the execution of these activities for further analysis of the children's performance.The exercises will be divided into two blocks, emotional regulation (ER) and cognitive regulation (CR), in a total of 10 sessions, once a week, performing an exercise of each block per session. Each session will consists of 60 minutes. .
arm group label: Control group
arm group type: Active Comparator
description: The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom (5, 49). Each session will last 50 minutes, just like in the experimental group. The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation. The activities are similar for the experimental group, but the virtual reality system will not be used. It will be held in parallel in another room of the school, on the same day and time, carried out by occupational therapists and students from the students in the last year of occupational therapy degree.
intervention type: Behavioral
intervention name: Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality
description: The principles of the programme will be based on the following premises for children with ASD: 1) Strengthening communicative attempts; 2) Choose the most natural contexts possible; 3) Establish structured and predictable routines and environments; 4)Visually support information; 5) Adapting our language to the understanding level of the child. On the difficulty of interpreting and responding to social emotions and cues, games of perspectives are of great interest, where the child and therapist describe the same object from different perspectives, beliefs (guess that may be in this box), games with social stories, which are short stories that use pictograms, to help understand especially situations with social ambiguity: 1) describing what happens; 2) orienting the action, indicating to the child what to do in that situation; 3) anticipating and explaining what can happen and how you can feel; 4) developing a strategy that can be applied in similar situations.
arm group label: Experimental Group
intervention type: Behavioral
intervention name: Traditional self-regulation program
description: The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom .The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation.Each session will last 50 minutes
arm group label: Control group
other name: Educative programa
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Dulce Romero Ayuso
phone: +34626822916
email: dulceromero@ugr.es
citation: Alcaniz ML, Olmos-Raya E, Abad L. [Use of virtual reality for neurodevelopmental disorders. A review of the state of the art and future agenda]. Medicina (B Aires). 2019;79(Suppl 1):77-81. Spanish.
PMID: 30776285
citation: Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.
PMID: 29234356
citation: Parsons TD, Riva G, Parsons S, Mantovani F, Newbutt N, Lin L, Venturini E, Hall T. Virtual Reality in Pediatric Psychology. Pediatrics. 2017 Nov;140(Suppl 2):S86-S91. doi: 10.1542/peds.2016-1758I.
PMID: 29093039
citation: Eom H, Kim KK, Lee S, Hong YJ, Heo J, Kim JJ, Kim E. Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Cyberpsychol Behav Soc Netw. 2019 Mar;22(3):198-204. doi: 10.1089/cyber.2018.0377. Epub 2019 Jan 23.
PMID: 30672714
citation: Bekele E, Zheng Z, Swanson A, Crittendon J, Warren Z, Sarkar N. Understanding how adolescents with autism respond to facial expressions in virtual reality environments. IEEE Trans Vis Comput Graph. 2013 Apr;19(4):711-20. doi: 10.1109/TVCG.2013.42.
PMID: 23428456
citation: Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.
PMID: 30907929
citation: Bekele E, Crittendon J, Zheng Z, Swanson A, Weitlauf A, Warren Z, Sarkar N. Assessing the utility of a virtual environment for enhancing facial affect recognition in adolescents with autism. J Autism Dev Disord. 2014 Jul;44(7):1641-50. doi: 10.1007/s10803-014-2035-8.
PMID: 24419871
citation: Yuan SNV, Ip HHS. Using virtual reality to train emotional and social skills in children with autism spectrum disorder. London J Prim Care (Abingdon). 2018 Jun 7;10(4):110-112. doi: 10.1080/17571472.2018.1483000. eCollection 2018.
PMID: 30083244
citation: Shema-Shiratzky S, Brozgol M, Cornejo-Thumm P, Geva-Dayan K, Rotstein M, Leitner Y, Hausdorff JM, Mirelman A. Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. Dev Neurorehabil. 2019 Aug;22(6):431-436. doi: 10.1080/17518423.2018.1476602. Epub 2018 May 17.
PMID: 29771624
citation: Blume F, Hudak J, Dresler T, Ehlis AC, Kuhnhausen J, Renner TJ, Gawrilow C. NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2017 Jan 24;18(1):41. doi: 10.1186/s13063-016-1769-3.
PMID: 28118856
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Dulce Romero Ayuso
investigator title: Principal Investigator
mesh term: Mental Disorders
mesh term: Neurodevelopmental Disorders
mesh term: Child Behavior Disorders
sharing ipd: No