<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/NCT04411797</url>
  </required_header>
  <id_info>
    <org_study_id>10477M-STIG</org_study_id>
    <nct_id>NCT04411797</nct_id>
  </id_info>
  <brief_title>Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders</brief_title>
  <acronym>STIG</acronym>
  <official_title>Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Januel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de Ville-Evrard, France</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>
      Impact of stigma on the empathy and quality of life of people with schizophrenic disorders&#xD;
      and their siblings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2020</start_date>
  <completion_date type="Anticipated">May 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Internalized Stigma of Mental Illness Scale</measure>
    <time_frame>1 hour and half</time_frame>
    <description>for people with schizophrenic disorders</description>
  </primary_outcome>
  <enrollment type="Anticipated">198</enrollment>
  <condition>The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings</condition>
  <eligibility>
    <study_pop>
      <textblock>
        people with schizophrenic disorders and the subjective sense of stigma and siblings of&#xD;
        people with schizophrenic disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for the Person with Schizophrenic Disorder&#xD;
&#xD;
          1. Aged between 18 and 35.&#xD;
&#xD;
          2. Medical follow-up in progress&#xD;
&#xD;
          3. DSM-5 diagnosis of Schizophrenia Spectrum Disorder&#xD;
&#xD;
          4. Reading and understanding the information and non-opposition form&#xD;
&#xD;
          5. Person affiliated to a social protection scheme or beneficiary of State Medical Aid&#xD;
&#xD;
          6. Volunteer mastering the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-inclusion criteria for the person with schizophrenic disorders:&#xD;
&#xD;
        1. Clinical condition incompatible with testing 2. Current or less than one month's&#xD;
        commitment to another research protocol 3. A person who is subject to a safeguard measure&#xD;
        of justice 4 A person of full age under guardianship 5. Minor patients with mental&#xD;
        disorders 6. Pregnant or breastfeeding women Version 1.2 date 19-05-2020 7. A person in&#xD;
        situations of social fragility (persons deprived of liberty by a judicial or administrative&#xD;
        decision, hospitalized persons) 8. Persons incapable or unable to give consent&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for a sibling member:&#xD;
&#xD;
          1. Age of 16 years or older&#xD;
&#xD;
          2. Volunteer with a sibling included in the study with a diagnosis of schizophrenia&#xD;
             according to DSM-5.&#xD;
&#xD;
          3. Reading and understanding the information and non-opposition form&#xD;
&#xD;
          4. Volunteer affiliated to a social protection scheme or beneficiary of State Medical Aid&#xD;
&#xD;
          5. Volunteer mastering the French language&#xD;
&#xD;
        Criteria for non-inclusion of siblings:&#xD;
&#xD;
          1. Clinical condition incompatible with testing&#xD;
&#xD;
          2. Current or less than one month's commitment to another research protocol&#xD;
&#xD;
          3. Brother or sister subject to a measure of safeguard of justice 4 Brother or sister&#xD;
             under curatorship&#xD;
&#xD;
        5. Brother or sister with mental health problems 6. Minor siblings under 16 years of age 7.&#xD;
        A pregnant or nursing sister 8. Brother or sister in situations of social fragility&#xD;
        (Persons deprived of liberty by a judicial or administrative decision, hospitalized&#xD;
        persons) 9.Brother or sister incapable or unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Davtian Hélène, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Les Funambules - Falret</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BENCHERIF Youcef, CRA</last_name>
    <phone>0143093030</phone>
    <email>y.bencherif@epsve.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rusheenthira THAVASEELAN, CRA</last_name>
    <phone>0143093030</phone>
    <email>r.thavaseelan@epsve.fr</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre hospitalier de Ville-Evrard, France</investigator_affiliation>
    <investigator_full_name>Januel</investigator_full_name>
    <investigator_title>Head of clinical research unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04411797
org study id: 10477M-STIG
nct id: NCT04411797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Impact of stigma on the empathy and quality of life of people with schizophrenic disorders
      and their siblings.
observational model: Cohort
time perspective: Cross-Sectional
measure: Internalized Stigma of Mental Illness Scale
time frame: 1 hour and half
description: for people with schizophrenic disorders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
last name: Davtian Hélène, Doctor
role: Principal Investigator
affiliation: Les Funambules - Falret
last name: BENCHERIF Youcef, CRA
phone: 0143093030
email: y.bencherif@epsve.fr
last name: Rusheenthira THAVASEELAN, CRA
phone: 0143093030
email: r.thavaseelan@epsve.fr
responsible party type: Sponsor-Investigator
investigator affiliation: Centre hospitalier de Ville-Evrard, France
investigator full name: Januel
investigator title: Head of clinical research unit
mesh term: Schizophrenia