<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/NCT03288649</url>
  </required_header>
  <id_info>
    <org_study_id>20140600001072</org_study_id>
    <nct_id>NCT03288649</nct_id>
  </id_info>
  <brief_title>Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry</brief_title>
  <acronym>EVAADO</acronym>
  <official_title>Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry: Crossing Perspectives of Adolescents, Parents and Physicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Victor Dupouy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Victor Dupouy</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>
      Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal)&#xD;
      are a major public health concern in adolescence. Their treatment is a challenge for the&#xD;
      families, the health care system and society. The treatment is complex and non-standardized.&#xD;
      In clinical practice, the relational dimension between the stakeholders is recognized by all.&#xD;
      Nevertheless no study has ever crossed their perspectives about therapeutic alliance in&#xD;
      adolescent psychiatry.&#xD;
&#xD;
      Objective: to explore, within a qualitative approach, how a therapeutic alliance is&#xD;
      established in three different clinical situations according to the adolescents, their&#xD;
      parents and their physicians by crossing their perspectives.&#xD;
&#xD;
      Methods: This is a national (France) multi-center qualitative study based on 180&#xD;
      semi-structured interviews. Participants (purposively selected until data saturation) came&#xD;
      from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their&#xD;
      parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus&#xD;
      their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based&#xD;
      school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are&#xD;
      collected through open ended semi structured interviews and independently analyzed with NVivo&#xD;
      V.11 software by three researchers according to the principles of Interpretative&#xD;
      Phenomenological Analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">June 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach</measure>
    <time_frame>2 years</time_frame>
    <description>qualitative methodology using verbal data analysis of semi-structured interviex</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Anorexia Nervosa</condition>
  <condition>Depression</condition>
  <condition>School Phobia</condition>
  <arm_group>
    <arm_group_label>Anorexia nervosa</arm_group_label>
    <description>adolescents with anorexia nervosa (N=20 ?), their parents (N=20), their physicians (N=20)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anxiety based school refusal</arm_group_label>
    <description>adolescents with anxiety based school refusal (N=20 ?), their parents (N=20), their physicians (N=20)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Depression</arm_group_label>
    <description>adolescents with depression (N=20 ?), their parents (N=20), their physicians (N=20)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        adolescents with psychiatric disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adolescents, boys and girls, aged 12 to 18 years, speaking fluent French, with (i)&#xD;
             anorexia nervosa according to DSM 5 criteria (ii) depressive disorders (dysthymia,&#xD;
             depressive episode) according to DSM 5 criteria (iii) anxiety-based school refusal&#xD;
             according to four criteria:&#xD;
&#xD;
               1. refusal to attend school (to operationalize this first criterion, adolescents&#xD;
                  were included if they had not attended school at all for at least one month&#xD;
                  before starting treatment); (2) presence of a DSM-5 anxiety disorder (except&#xD;
                  obsessive-compulsive or post-traumatic stress disorders) with emotional upset at&#xD;
                  the prospect of attending school; (3) absence of a DSM-5 conduct disorder; and&#xD;
                  (4) parental knowledge of the adolescent's whereabouts during the period of&#xD;
                  non-attendance.&#xD;
&#xD;
                  that led to treatment that had begun at least six months earlier and clinically&#xD;
                  determined to be well enough to participate in a research interview.&#xD;
&#xD;
          -  receiving treatment for at least 6 months&#xD;
&#xD;
          -  one parent at least agrees to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute symptoms and serious somatic and/or psychiatric co-morbidities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Anne Revah-Levy, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paris diderot University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jordan Sibeoni, MD</last_name>
    <phone>+33 134232598</phone>
    <email>jordan.sibeoni@ch-argenteuil.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>CRC CRC</last_name>
    <email>crc@ch-argenteuil.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHVictorDupouy</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jordan Sibeoni, MD</last_name>
      <phone>+33 13423259</phone>
      <email>jordan.sibeoni@ch-argenteuil.fr</email>
    </contact>
    <contact_backup>
      <last_name>CRC CRC</last_name>
      <email>crc@ch-argenteuil.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHU Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc-Antoine Podlipski, MD</last_name>
      <email>M-A.podlipski@chu-rouen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Victor Dupouy</investigator_affiliation>
    <investigator_full_name>Anne Revah-Levy</investigator_full_name>
    <investigator_title>Pr Anne Revah-Levy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
    <mesh_term>Phobic 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/NCT03288649
org study id: 20140600001072
nct id: NCT03288649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal)
      are a major public health concern in adolescence. Their treatment is a challenge for the
      families, the health care system and society. The treatment is complex and non-standardized.
      In clinical practice, the relational dimension between the stakeholders is recognized by all.
      Nevertheless no study has ever crossed their perspectives about therapeutic alliance in
      adolescent psychiatry.

      Objective: to explore, within a qualitative approach, how a therapeutic alliance is
      established in three different clinical situations according to the adolescents, their
      parents and their physicians by crossing their perspectives.

      Methods: This is a national (France) multi-center qualitative study based on 180
      semi-structured interviews. Participants (purposively selected until data saturation) came
      from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their
      parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus
      their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based
      school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are
      collected through open ended semi structured interviews and independently analyzed with NVivo
      V.11 software by three researchers according to the principles of Interpretative
      Phenomenological Analysis.
observational model: Other
time perspective: Prospective
measure: to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach
time frame: 2 years
description: qualitative methodology using verbal data analysis of semi-structured interviex
arm group label: Anorexia nervosa
description: adolescents with anorexia nervosa (N=20 ?), their parents (N=20), their physicians (N=20)
arm group label: Anxiety based school refusal
description: adolescents with anxiety based school refusal (N=20 ?), their parents (N=20), their physicians (N=20)
arm group label: Depression
description: adolescents with depression (N=20 ?), their parents (N=20), their physicians (N=20)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
last name: Anne Revah-Levy, MD PhD
role: Principal Investigator
affiliation: Paris diderot University
last name: Jordan Sibeoni, MD
phone: +33 134232598
email: jordan.sibeoni@ch-argenteuil.fr
last name: CRC CRC
email: crc@ch-argenteuil.fr
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Victor Dupouy
investigator full name: Anne Revah-Levy
investigator title: Pr Anne Revah-Levy
mesh term: Anorexia
mesh term: Anorexia Nervosa
mesh term: Phobic Disorders
sharing ipd: No