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/NCT06031701</url>
    </required_header>
    <id_info>
      <org_study_id>Neuro-e-Motion NMD</org_study_id>
      <nct_id>NCT06031701</nct_id>
    </id_info>
    <brief_title>Neuro-psychosocial Teleassistance for Neuromuscular Diseases</brief_title>
    <official_title>Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Deusto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Deusto</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>
        This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of&#xD;
        telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The&#xD;
        intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1&#xD;
        session per week of 1h duration. The intervention is aimed at strengthening aspects of social&#xD;
        cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general&#xD;
        improvement of psychological well-being.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Development of a neuro-psychosocial tele-assistance programme for groups of children and&#xD;
        adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular&#xD;
        dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and&#xD;
        intervention include social cognition, quality of life, psychological symptomatology and&#xD;
        coping strategies. The aim of this study is to test whether this programme improves the&#xD;
        indicators in the mentioned variables.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 2, 2021</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Quasi-experimental pretest-posttest design with a non-equivalent wait list control group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Social cognition - Emotion Recognition</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Social cognition - Theory of mind - NEPSY-II</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Social cognition - Theory of mind - Happé's Strange Stories</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Social cognition - Theory of mind - RMETC</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>How an individual's health status impacts their overall well-being and ability to lead a satisfying life&#xD;
  The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory (PedsQLTM 4.0) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Physical functioning, emotional functioning, social functioning, and academic functioning are the four dimensions covered by the 23-item assessment. The PedsQL 4.0 provides a physical and a psychosocial summary score in addition to a total score. It is answered through a likert scale with 5 response options that are then converted into quantitative scores ranging from 0-100 points, with a higher score being a better HRQoL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychopathology</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>Behavioral and emotional symptoms&#xD;
  The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) (Achenbach &amp; Rescorla, 2001) is a multiaxial assessment tool for identifying behavioral and emotional issues in children and adolescents that is aligned with the ASEBA (Achenbach System of Empirically Based Assessment). It has 113 items total, broken down into eight scales for the following syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thinking problems, attention problems, rule-breaking behavior and aggressive behavior. Scores for internalizing, externalizing, and overall difficulties are also provided by the items.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping strategies - EAN</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>Different styles to deal with stressful situations&#xD;
  Coping Scale for Children (EAN) (Morales-Rodríguez et al., 2012) is a self-report scale assesses coping strategies and is intended for children aged nine to 12 years. In the instrument, four problems related to the family context, health, schoolwork and social relationships are posed. The nine coping strategies assessed are distinguished between problem-focused coping and unproductive coping.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping strategies - ACS</measure>
      <time_frame>3 months after the intervention</time_frame>
      <description>Different styles to deal with stressful situations&#xD;
  Adolescent Coping Scales (ACS) (3rd edition) (Frydenberg and Lewis, 2000): assesses different coping strategies in adolescents aged 12-18 years to cope with their problems. The inventory assesses 18 different coping strategies and consists of 80 items, 79 closed-ended and one open-ended. Furthermore, the 18 strategies are classified into three basic coping styles: problem-directed coping, coping in relation to others, and unproductive coping.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Social Competence</condition>
    <condition>Self Esteem</condition>
    <condition>Quality of Life</condition>
    <condition>Social Skills</condition>
    <condition>Neuromuscular Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neuro-psychosocial intervention with 12 grupal sessions is offered</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Waiting list control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Neuro-psychosocial teleassistance program</intervention_name>
      <description>The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be diagnosed with a neuromuscular disease by a specialist&#xD;
  &#xD;
            -  Being between 7 and 16 years old&#xD;
  &#xD;
            -  Having signed an informed consent form through their legal guardians prior to&#xD;
               participation in the study&#xD;
  &#xD;
            -  Having Spanish as one of their main languages&#xD;
  &#xD;
            -  Having access to a computer (with a camera, microphone and speakers integrated) and&#xD;
               Internet connection to take part in the videoconferences&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of any other diagnosis or sensory deficit that would prevent the application&#xD;
               of the tests or hinder the correct performance of the intervention´s activities&#xD;
  &#xD;
            -  Being illiterate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Oscar Martínez, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Deusto</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Deusto</name>
        <address>
          <city>Bilbao</city>
          <state>Bizkaia</state>
          <zip>48007</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuromuscular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The plan is open for other researchers to contact the principal investigator of the study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>The data is available from now until 2025.</ipd_time_frame>
      <ipd_access_criteria>The plan is open for other researchers to contact the principal investigator of the study.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06031701
  org study id: Neuro-e-Motion NMD
  nct id: NCT06031701
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of
        telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The
        intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1
        session per week of 1h duration. The intervention is aimed at strengthening aspects of social
        cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general
        improvement of psychological well-being.
  Development of a neuro-psychosocial tele-assistance programme for groups of children and
        adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular
        dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and
        intervention include social cognition, quality of life, psychological symptomatology and
        coping strategies. The aim of this study is to test whether this programme improves the
        indicators in the mentioned variables.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Social cognition - Emotion Recognition
  time frame: 3 months after the intervention
  description: Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children
  measure: Social cognition - Theory of mind - NEPSY-II
  time frame: 3 months after the intervention
  description: Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.
  measure: Social cognition - Theory of mind - Happé's Strange Stories
  time frame: 3 months after the intervention
  description: The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.
  measure: Social cognition - Theory of mind - RMETC
  time frame: 3 months after the intervention
  description: The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.
  measure: Health-related quality of life
  time frame: 3 months after the intervention
  description: How an individual's health status impacts their overall well-being and ability to lead a satisfying life
  The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory (PedsQLTM 4.0) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Physical functioning, emotional functioning, social functioning, and academic functioning are the four dimensions covered by the 23-item assessment. The PedsQL 4.0 provides a physical and a psychosocial summary score in addition to a total score. It is answered through a likert scale with 5 response options that are then converted into quantitative scores ranging from 0-100 points, with a higher score being a better HRQoL.
  measure: Psychopathology
  time frame: 3 months after the intervention
  description: Behavioral and emotional symptoms
  The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) (Achenbach & Rescorla, 2001) is a multiaxial assessment tool for identifying behavioral and emotional issues in children and adolescents that is aligned with the ASEBA (Achenbach System of Empirically Based Assessment). It has 113 items total, broken down into eight scales for the following syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thinking problems, attention problems, rule-breaking behavior and aggressive behavior. Scores for internalizing, externalizing, and overall difficulties are also provided by the items.
  measure: Coping strategies - EAN
  time frame: 3 months after the intervention
  description: Different styles to deal with stressful situations
  Coping Scale for Children (EAN) (Morales-Rodríguez et al., 2012) is a self-report scale assesses coping strategies and is intended for children aged nine to 12 years. In the instrument, four problems related to the family context, health, schoolwork and social relationships are posed. The nine coping strategies assessed are distinguished between problem-focused coping and unproductive coping.
  measure: Coping strategies - ACS
  time frame: 3 months after the intervention
  description: Different styles to deal with stressful situations
  Adolescent Coping Scales (ACS) (3rd edition) (Frydenberg and Lewis, 2000): assesses different coping strategies in adolescents aged 12-18 years to cope with their problems. The inventory assesses 18 different coping strategies and consists of 80 items, 79 closed-ended and one open-ended. Furthermore, the 18 strategies are classified into three basic coping styles: problem-directed coping, coping in relation to others, and unproductive coping.
  arm group label: Intervention
  arm group type: Experimental
  description: Neuro-psychosocial intervention with 12 grupal sessions is offered
  arm group label: Control
  arm group type: Experimental
  description: Waiting list control group
  intervention type: Behavioral
  intervention name: Neuro-psychosocial teleassistance program
  description: The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
  arm group label: Control
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Oscar Martínez, PhD
  role: Principal Investigator
  affiliation: University of Deusto
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Neuromuscular Diseases
  sharing ipd: Yes
  ipd description: The plan is open for other researchers to contact the principal investigator of the study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: The data is available from now until 2025.
  ipd access criteria: The plan is open for other researchers to contact the principal investigator of the study.