<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/NCT04467229</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200623</org_study_id>
    <nct_id>NCT04467229</nct_id>
  </id_info>
  <brief_title>Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner</brief_title>
  <acronym>REPERADO</acronym>
  <official_title>Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 research aims to create a tool for detection of mental health disorders in adolescents&#xD;
      with chronic pain. The first part is testing a screening questionnaire and comparing in with&#xD;
      existing questionnaires. The second part involves two focus group with the adolescents aimed&#xD;
      at recording their perception of the questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First part : creation of a screening tool. After detailed interviews with chronic pain&#xD;
      experts and bibliographic research, a screening tool for mental disorders in chronically&#xD;
      painful adolescents has been designed for use by the general practitioner. This tool is&#xD;
      composed of 10 questions, making up a score of 10 points. The tool will be compared to two&#xD;
      screening tools used in different clinical contexts, the HAD scale and the RPPS scale, in&#xD;
      order to determine a positivity threshold. There is only one center participating in the&#xD;
      research, the Centre de la Douleur et de la migraine de l'hôpital Trousseau (Trousseau&#xD;
      Hospital Pain Center). Parents' consent is required for participation. For this assessment,&#xD;
      the adolescents (between 10 and 18 years old) that see a doctor at the Centre de la douleur,&#xD;
      will be asked to fill up the questionnaires in the waiting room. The filling of the&#xD;
      questionnaire takes a few minutes. At the end of the appointment, the doctor will read the&#xD;
      questionnaire to check that all elements have been addressed during the appointment.&#xD;
&#xD;
      Second part : focus group on the questionnaire: 5 to 10 adolescents will participate in a&#xD;
      discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de&#xD;
      Trousseau. Two groups will be organized, the length of the group discussion being one hour.&#xD;
      These focus groups will explore the adolescents' perception of the questionnaire and of&#xD;
      different elements of the screening. The group will undergo full transcription. The verbatim&#xD;
      will be anonymous and will be analysed through qualitative methods.&#xD;
&#xD;
      The data will help designing a guidebook for the clinician explaining the main points in&#xD;
      screening for mental disorders in chronic pain adolescent patients.&#xD;
&#xD;
      A validation study for the screening tool will be eventually carried out after the completion&#xD;
      of this preliminary study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 6, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screening questionnaire score</measure>
    <time_frame>Baseline visit</time_frame>
    <description>A new Screening questionnaire elaborated beforehand by the study will be answered by patients in order to detect psychological suffering in chronically painful adolescents The screening questionnaire consists in 10 items (yes/no response format)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression (HAD) score</measure>
    <time_frame>Baseline visit</time_frame>
    <description>Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Pain Screening Tool (PPST) score</measure>
    <time_frame>Baseline visit</time_frame>
    <description>Patients complete a Pediatric Pain Screening Tool questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants feedback</measure>
    <time_frame>up to 3 months upon recuitment</time_frame>
    <description>Focus group questions will provide descriptions of patients' experiences with the questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Focus group with chronically painful adolescents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents with chronic pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus group</intervention_name>
    <description>5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.</description>
    <arm_group_label>Focus group with chronically painful adolescents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient from 10 to 18 years old&#xD;
&#xD;
          -  chronic pain (existing for more than 3 months or longer than tissue repair time)&#xD;
&#xD;
          -  first consultation in the service&#xD;
&#xD;
          -  Collection of the written consent of the holders of parental authority and agreement&#xD;
             of the adolescent&#xD;
&#xD;
          -  Adolescents able to understand the questionnaire and the purpose of the study&#xD;
&#xD;
          -  Affiliation to a social security scheme or beneficiary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Decompensated physical or psychological pathology requiring urgent medical treatment&#xD;
&#xD;
          -  Heavy psychological pathology preventing the adolescent's understanding of the study&#xD;
&#xD;
          -  Patient benefiting from State Medical Aid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra LOISEL</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexandra LOISEL, PH</last_name>
    <phone>01 71 73 85 47</phone>
    <email>loisel.alexandra@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barbara TOURNIAIRE, ph</last_name>
    <phone>01 71 73 89 19</phone>
    <email>barbara.tourniaire@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de la douleur et de la migraine-Hôpital Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Alexandra LOISEL, PH</last_name>
      <phone>01 71 73 85 47</phone>
      <email>loisel.alexandra@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Barbara TOURNIAIRE, PH</last_name>
      <phone>01 71 73 89 19</phone>
      <email>barbara.tourniaire@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>Mental Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic 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/NCT04467229
org study id: APHP200623
nct id: NCT04467229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research aims to create a tool for detection of mental health disorders in adolescents
      with chronic pain. The first part is testing a screening questionnaire and comparing in with
      existing questionnaires. The second part involves two focus group with the adolescents aimed
      at recording their perception of the questionnaire.
First part : creation of a screening tool. After detailed interviews with chronic pain
      experts and bibliographic research, a screening tool for mental disorders in chronically
      painful adolescents has been designed for use by the general practitioner. This tool is
      composed of 10 questions, making up a score of 10 points. The tool will be compared to two
      screening tools used in different clinical contexts, the HAD scale and the RPPS scale, in
      order to determine a positivity threshold. There is only one center participating in the
      research, the Centre de la Douleur et de la migraine de l'hôpital Trousseau (Trousseau
      Hospital Pain Center). Parents' consent is required for participation. For this assessment,
      the adolescents (between 10 and 18 years old) that see a doctor at the Centre de la douleur,
      will be asked to fill up the questionnaires in the waiting room. The filling of the
      questionnaire takes a few minutes. At the end of the appointment, the doctor will read the
      questionnaire to check that all elements have been addressed during the appointment.

      Second part : focus group on the questionnaire: 5 to 10 adolescents will participate in a
      discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de
      Trousseau. Two groups will be organized, the length of the group discussion being one hour.
      These focus groups will explore the adolescents' perception of the questionnaire and of
      different elements of the screening. The group will undergo full transcription. The verbatim
      will be anonymous and will be analysed through qualitative methods.

      The data will help designing a guidebook for the clinician explaining the main points in
      screening for mental disorders in chronic pain adolescent patients.

      A validation study for the screening tool will be eventually carried out after the completion
      of this preliminary study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Screening questionnaire score
time frame: Baseline visit
description: A new Screening questionnaire elaborated beforehand by the study will be answered by patients in order to detect psychological suffering in chronically painful adolescents The screening questionnaire consists in 10 items (yes/no response format)
measure: Hospital Anxiety and Depression (HAD) score
time frame: Baseline visit
description: Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire
measure: Pediatric Pain Screening Tool (PPST) score
time frame: Baseline visit
description: Patients complete a Pediatric Pain Screening Tool questionnaire
measure: Participants feedback
time frame: up to 3 months upon recuitment
description: Focus group questions will provide descriptions of patients' experiences with the questionnaire
arm group label: Focus group with chronically painful adolescents
arm group type: Experimental
description: Adolescents with chronic pain
intervention type: Behavioral
intervention name: Focus group
description: 5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.
arm group label: Focus group with chronically painful adolescents
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Alexandra LOISEL
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Alexandra LOISEL, PH
phone: 01 71 73 85 47
email: loisel.alexandra@aphp.fr
last name: Barbara TOURNIAIRE, ph
phone: 01 71 73 89 19
email: barbara.tourniaire@aphp.fr
facility: 
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No