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/NCT05991791</url>
    </required_header>
    <id_info>
      <org_study_id>RECHMPL23_0056</org_study_id>
      <nct_id>NCT05991791</nct_id>
    </id_info>
    <brief_title>Intelligent Robotic Interactions for Children With Autism Spectrum Disorders</brief_title>
    <acronym>I-ROBI</acronym>
    <official_title>Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Montpellier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre National de la Recherche Scientifique, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Montpellier</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        For several years, studies have been developed on the contribution of social robots as a tool&#xD;
        for interventions for children with autism spectrum disorders (ASD). One of the recommended&#xD;
        intervention models is the ESDM (Early Start Denver Model). It consists of setting up an&#xD;
        individualized, intensive program (at least 20 hours per week) through the pleasure of play.&#xD;
        The teacher follows the motivation and interests of the child, and it is the child who&#xD;
        chooses the activities. Studies published in recent years tend to show that robots bring&#xD;
        benefits to ASD children, particularly in the treatment of social interactions and in&#xD;
        clinical settings. However, there is no scientific consensus on the generalized contribution&#xD;
        and effect over time of these interventions. Moreover, a robotic solution controlled by a&#xD;
        practitioner through a telepresence system allows for a better adaptability to the responses&#xD;
        and desires of the children during the interventions. The investigators believe that such a&#xD;
        solution would allow for better assessment of progress in the core skills of expressive&#xD;
        communication and imitation and greater engagement during interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 15, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Score of success on the selected task in the ESDM program</measure>
      <time_frame>From phase A (baseline) to phase C (post-intervention) = 19 weeks</time_frame>
      <description>Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of the child's viewing and movement of the head and body towards the robot (task 1: saying &quot;hello&quot;)</measure>
      <time_frame>During Phase B = 11 weeks</time_frame>
      <description>Measurement of the viewing and movement times toward the robot, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot.&#xD;
  Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying &quot;hello&quot;)</measure>
      <time_frame>From phase A (baseline) to phase C (post-intervention) = 19 weeks</time_frame>
      <description>Measurement of the viewing and movement times toward the therapist, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot.&#xD;
  Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child.</description>
    </other_outcome>
    <other_outcome>
      <measure>Response time of the child after the presentation of the imitation exercise (task 2: action imitation)</measure>
      <time_frame>From phase A (baseline) to phase C (post-intervention) = 19 weeks</time_frame>
      <description>Measurement of the child's response time during the imitation exercise</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of objects given to the robot (task 3 : give an object on verbal request)</measure>
      <time_frame>From phase A (baseline) to phase C (post-intervention) = 19 weeks</time_frame>
      <description>Measurement of the number of objects given out of the 5 requested (best score 5/5) in task 3.</description>
    </other_outcome>
    <other_outcome>
      <measure>Teleoperation success score for therapist (throught UX score)</measure>
      <time_frame>Phase C (from week 5 to 15)</time_frame>
      <description>Measurement of the success score (UX) of the teleoperation using the videos of the Pepper robot and according to the successful tasks to be performed during the session (the child and the second practitioner in the room can clearly hear the robot's instructions, the robot's gestures are fluid and is able to point to objects with the hand…). If the therapist was able to initiate each task, the score is 3/3.</description>
    </other_outcome>
    <other_outcome>
      <measure>Parent satisfaction score on current care</measure>
      <time_frame>During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).</time_frame>
      <description>Measurement of satisfaction score using a numerical satisfaction scale (EN). Parents will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 &quot;I am not at all satisfied with the effectiveness of the proposed care&quot; and 10 &quot;I am totally satisfied with the care&quot;).</description>
    </other_outcome>
    <other_outcome>
      <measure>Professional satisfaction score on current care.</measure>
      <time_frame>During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)</time_frame>
      <description>Measurement of satisfaction score using a numerical satisfaction scale (EN). Professionals will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 &quot;I am not at all satisfied with the effectiveness of the proposed care&quot; and 10 &quot;I am totally satisfied with the care&quot;).</description>
    </other_outcome>
    <other_outcome>
      <measure>Score of success in the ESDM tasks without teleoperation</measure>
      <time_frame>During phase A (to 4 weeks), Phase C (from week 16 to 19</time_frame>
      <description>This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score = 7)). This scoring will be done by therapist at the end of each intervention, after the current care.</description>
    </other_outcome>
    <other_outcome>
      <measure>Score of success in the ESDM tasks with teleoperation</measure>
      <time_frame>During phase B (from week 5 to 15)</time_frame>
      <description>This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)).The robotics analyses will be performed by a robotic engineer of the LIRMM independent to the project.</description>
    </other_outcome>
    <other_outcome>
      <measure>Teleoperation usability score for therapist (throught UMUX score)</measure>
      <time_frame>During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)</time_frame>
      <description>A User Experience Questionnaire (UMUX) was administered at weeks 5, 10 and 15 to assess the quality and ease of use of the teleoperation system over time. The questionnaires are evaluated on a scale from 0 (minimum score) to 10 (maximum score). 0=Not at all satisfied 10= Totally satisfied</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Children with autism spectrum disorders</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Early Start Denver Model (ESDM)</intervention_name>
      <description>Phase A&#xD;
  4 individual sessions (1 per week)&#xD;
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM&#xD;
  Satisfaction Evaluation - Parent&#xD;
  Satisfaction Evaluation - Therapist&#xD;
  Phase B :&#xD;
  11 sessions (1 per week)&#xD;
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper&#xD;
  Satisfaction Evaluation - Parent&#xD;
  Satisfaction Evaluation - Therapist&#xD;
  Phase C :&#xD;
  4 sessions (1 per week)&#xD;
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper&#xD;
  Satisfaction Evaluation - Parent&#xD;
  Satisfaction Evaluation - Therapist&#xD;
  All sessions will also be filmed and recorded</description>
      <arm_group_label>Children with autism spectrum disorders</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient living in the Hérault department (France),&#xD;
  &#xD;
            -  Patient with a diagnosis of ASD confirmed by a psychiatrist or a psychologist and&#xD;
               receiving current care according to the ESDM model in the MPEA Peyre Plantade child&#xD;
               psychiatry service.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients&#xD;
  &#xD;
                 -  Failure to obtain written informed consent after a cooling-off period&#xD;
  &#xD;
                 -  Participating in another type of program other than ESDM&#xD;
  &#xD;
                 -  Not being affiliated to a French social security system or being a beneficiary of&#xD;
                    such a system&#xD;
  &#xD;
            -  Therapist&#xD;
  &#xD;
                 -  History of epilepsy for health professionals (therapists)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Amaria BAGHDADLI, Pr</last_name>
      <phone>04 67 33 96 96</phone>
      <email>a-baghdadli@chu-montpellier.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital La Colombière - CHU de Montpellier</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Autism spectrum disorder</keyword>
    <keyword>children</keyword>
    <keyword>interventional care</keyword>
    <keyword>robotics</keyword>
    <keyword>telepresence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</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/NCT05991791
  org study id: RECHMPL23_0056
  nct id: NCT05991791
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For several years, studies have been developed on the contribution of social robots as a tool
        for interventions for children with autism spectrum disorders (ASD). One of the recommended
        intervention models is the ESDM (Early Start Denver Model). It consists of setting up an
        individualized, intensive program (at least 20 hours per week) through the pleasure of play.
        The teacher follows the motivation and interests of the child, and it is the child who
        chooses the activities. Studies published in recent years tend to show that robots bring
        benefits to ASD children, particularly in the treatment of social interactions and in
        clinical settings. However, there is no scientific consensus on the generalized contribution
        and effect over time of these interventions. Moreover, a robotic solution controlled by a
        practitioner through a telepresence system allows for a better adaptability to the responses
        and desires of the children during the interventions. The investigators believe that such a
        solution would allow for better assessment of progress in the core skills of expressive
        communication and imitation and greater engagement during interventions.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Score of success on the selected task in the ESDM program
  time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
  description: Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.
  measure: Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")
  time frame: During Phase B = 11 weeks
  description: Measurement of the viewing and movement times toward the robot, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot.
  Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child.
  measure: Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying "hello")
  time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
  description: Measurement of the viewing and movement times toward the therapist, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot.
  Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child.
  measure: Response time of the child after the presentation of the imitation exercise (task 2: action imitation)
  time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
  description: Measurement of the child's response time during the imitation exercise
  measure: Number of objects given to the robot (task 3 : give an object on verbal request)
  time frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
  description: Measurement of the number of objects given out of the 5 requested (best score 5/5) in task 3.
  measure: Teleoperation success score for therapist (throught UX score)
  time frame: Phase C (from week 5 to 15)
  description: Measurement of the success score (UX) of the teleoperation using the videos of the Pepper robot and according to the successful tasks to be performed during the session (the child and the second practitioner in the room can clearly hear the robot's instructions, the robot's gestures are fluid and is able to point to objects with the hand…). If the therapist was able to initiate each task, the score is 3/3.
  measure: Parent satisfaction score on current care
  time frame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).
  description: Measurement of satisfaction score using a numerical satisfaction scale (EN). Parents will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 "I am not at all satisfied with the effectiveness of the proposed care" and 10 "I am totally satisfied with the care").
  measure: Professional satisfaction score on current care.
  time frame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
  description: Measurement of satisfaction score using a numerical satisfaction scale (EN). Professionals will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 "I am not at all satisfied with the effectiveness of the proposed care" and 10 "I am totally satisfied with the care").
  measure: Score of success in the ESDM tasks without teleoperation
  time frame: During phase A (to 4 weeks), Phase C (from week 16 to 19
  description: This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score = 7)). This scoring will be done by therapist at the end of each intervention, after the current care.
  measure: Score of success in the ESDM tasks with teleoperation
  time frame: During phase B (from week 5 to 15)
  description: This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)).The robotics analyses will be performed by a robotic engineer of the LIRMM independent to the project.
  measure: Teleoperation usability score for therapist (throught UMUX score)
  time frame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
  description: A User Experience Questionnaire (UMUX) was administered at weeks 5, 10 and 15 to assess the quality and ease of use of the teleoperation system over time. The questionnaires are evaluated on a scale from 0 (minimum score) to 10 (maximum score). 0=Not at all satisfied 10= Totally satisfied
  arm group label: Children with autism spectrum disorders
  arm group type: Other
  intervention type: Other
  intervention name: Early Start Denver Model (ESDM)
  description: Phase A
  4 individual sessions (1 per week)
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM
  Satisfaction Evaluation - Parent
  Satisfaction Evaluation - Therapist
  Phase B :
  11 sessions (1 per week)
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper
  Satisfaction Evaluation - Parent
  Satisfaction Evaluation - Therapist
  Phase C :
  4 sessions (1 per week)
  Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper
  Satisfaction Evaluation - Parent
  Satisfaction Evaluation - Therapist
  All sessions will also be filmed and recorded
  arm group label: Children with autism spectrum disorders
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 5 Years
  healthy volunteers: No
  last name: Amaria BAGHDADLI, Pr
  phone: 04 67 33 96 96
  email: a-baghdadli@chu-montpellier.fr
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive