<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/NCT03811041</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC18.0221</org_study_id>
    <nct_id>NCT03811041</nct_id>
  </id_info>
  <brief_title>Adolescent Depression Associated With Parental Depression</brief_title>
  <acronym>AdoDesP</acronym>
  <official_title>Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Depression is difficult to identify, prevent and treat in adolescents because of complex and&#xD;
      stigmatized multiform symptoms and pathways of care.&#xD;
&#xD;
      In children the existence of a parental depression is a significant and recognized risk&#xD;
      factor for the development of a depression. It is regularly reported that 30% of adolescents&#xD;
      of depressed parents have depression themselves. General Practitioners (GP) have significant&#xD;
      access to the depression of adults, potentially parents of teenagers. In fact, 20% of&#xD;
      patients in the regular active file of one GP have depression. The primary health care system&#xD;
      could provide indirect but voluminous and unprecedented access to the identification of&#xD;
      adolescent depression at an early stage from the encounter of depressed parents.&#xD;
&#xD;
      The difficulties of articulation between primary care (PC) and mental health devices are&#xD;
      demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and&#xD;
      may even disturb early detection of depression. An organized joint between the PC and a&#xD;
      specialized mental health service for adolescents (&quot;Maison Des Adolescents&quot; MDA) could&#xD;
      promote the process of screening and preventing depression of adolescents of depressed&#xD;
      parents encountered in PC.&#xD;
&#xD;
      In addition, if the effects of parental depression on adolescents are established, they&#xD;
      remain complex and interactive. They vary by age and sex of the child but also the sex of the&#xD;
      parent. A concomitant study of adolescent and parent depression will provide data to analyze&#xD;
      the prevalence of depressed parent adolescent depression and to define risk or protection&#xD;
      factors.&#xD;
&#xD;
      AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group&#xD;
      of adolescent with PC articulated with mental health service (MDA) and an other group without&#xD;
      articulation (routine cares).&#xD;
&#xD;
      A third group of depressed adolescents will be constituted to analyse parental depression of&#xD;
      depressed adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The decision was made not to extend the inclusions due to the low inclusion rate since the&#xD;
    beginning of the study. The last inclusion took place on 06/22/2020.&#xD;
  </why_stopped>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in adolescents' depression intensity</measure>
    <time_frame>Day 0 and Month12</time_frame>
    <description>The depression intensity will be evaluated by Adolescent Depression Rating Scale (ADRS) at Day 0 and Month 12. The investigators will compare its evolution between group 1 (PC articulated with MDA) and 2 (Routine cares).&#xD;
Adolescent depression rating scale (ADRS) assesses depression in adolescents in 10 items. The items measure insomnia, anxiety, sadness and fatigability. If ADRS score is less than 4 : low risk of depression, between 4 and 8 : moderate risk of depression and more than 8 : significant risk of depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of depression rate</measure>
    <time_frame>Day 0</time_frame>
    <description>With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in adolescents' quality of live</measure>
    <time_frame>Day 0, Month6 and Month12</time_frame>
    <description>The quality of live will be evaluated by Pediatric Quality of Life InventoryTM (PedsQL) scale at Day 0, Months 6 and 12 and the investigators will compare its evolution between group 1 and 2. 3 scores will be calculated : psychosocial health summary score (average score of 15 items), physical health summary score (average score of 8 items) and the total score (average score of all items). Scores are between 0 and 100% and the higher scores indicate better Health-Related Quality of Life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of adolescent depression with depressed parent</measure>
    <time_frame>Day 0</time_frame>
    <description>With group 1 and 2, the investigators will calculate de prevalence of adolescent depression when a parent is depressed. Adolescent depression will be assessed by Adolescent Depression Rating Scale (ADRS). This scale is composed of 8 true (1)/false(0) questions. The score is the sum of all item. An adolescent is consider depressed when his score is higher than 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of parental depression with depressed adolescent</measure>
    <time_frame>Day 0</time_frame>
    <description>With group 3, the investigators will calculate de prevalence of parental depression when a adolescent is depressed. Parental depression will be assessed by Hopkins Symptom Checklist (HSCL25). This scale is composed of 25 questions with 4 answers (1-4). The score is the average score of the 25 items. The parent is considered depressed when the score is higher or equal to 1.75.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk and protection factors</measure>
    <time_frame>Day 0</time_frame>
    <description>With the 3 groups, the investigators will isolate risk and protection factors for adolescent of depressed parents and for parents of depressed adolescents. Sociodemographics informations will be used and protective or risk factors may be highlighted from the study of some of the medico-psychological and social characteristics of families.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>PC articulated with MDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Depressed parent encountered in PC for confirmation of depression with Hopkins Symptom Checklist-25 (HSCL25) scale. If confirmed, the adolescent will also be encountered by the GP for a screening test of depression (Adolescent Depression Rating Scale - ADRS). If negative, the patient will go out of the study. If positive, 2 others tests will be performed to study the intensity of the depression (Child depressionInventory - CDI) and the quality of life (Pediatric Quality of Life InventoryTM).Finally, the patient will be oriented to the MDA of Brest and will meet again the GP at 6 and 12 month to answers the same tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine cares</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Depressed parent encountered in PC for confirmation of depression with Hopkins Symptom Checklist-25 (HSCL25) scale. If confirmed, the adolescent will also be encountered by the GP for a screening test of depression (Adolescent Depression Rating Scale - ADRS). If negative, the patient will go out of the study. If positive, 2 others tests will be performed to study the intensity of the depression (Child depressionInventory - CDI) and the quality of life (Pediatric Quality of Life InventoryTM). Finally, the patient will be oriented to the routine cares and will meet again the GP at 6 and 12 month to answers the same tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parental depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parental depression will be studied. Depressed adolescent encountered in MDA of Marseille for confirmation of depression with 3 tests : ADRS, CDI and PedsQL. If positive, the parent will come to the MDA for a screening test of depression (HSCL25). Parents and adolescent are seen only once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MDA</intervention_name>
    <description>Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.</description>
    <arm_group_label>PC articulated with MDA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Cares</intervention_name>
    <description>Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.</description>
    <arm_group_label>Routine cares</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parental depression</intervention_name>
    <description>Parents of depressed adolescents will be met for a screening test of depression.</description>
    <arm_group_label>Parental depression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of groups 1 and 2 :&#xD;
&#xD;
               -  Major patient consulting his GP&#xD;
&#xD;
               -  Depressed patient&#xD;
&#xD;
               -  Parent of adolescent aged between 11 and 18 years old&#xD;
&#xD;
          -  Adolescents of groups 1 and 2 :&#xD;
&#xD;
               -  Aged more than 11 and less than 18 years old&#xD;
&#xD;
               -  Parent included in the study&#xD;
&#xD;
          -  Parents of group 3 :&#xD;
&#xD;
               -  Parent of depressed adolescent under care at the MDA of Marseille, included in&#xD;
                  the study and whose depression is confirmed by HSCL25 scale&#xD;
&#xD;
          -  Adolescents of group 3 :&#xD;
&#xD;
               -  Aged more than 11 and less than 18 years old&#xD;
&#xD;
               -  Depressed patient&#xD;
&#xD;
               -  Under care at the MDA of Marseille since less than 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents of groups 1, 2 and 3 :&#xD;
&#xD;
               -  Minor patient&#xD;
&#xD;
               -  Enable to give his consent&#xD;
&#xD;
               -  Patient with guardianship or curatorship&#xD;
&#xD;
               -  Non consenting patient&#xD;
&#xD;
               -  Pregnant or nursing mother&#xD;
&#xD;
          -  Adolescents of groups 1 and 2 :&#xD;
&#xD;
               -  Aged &lt; 11 or ≥18&#xD;
&#xD;
               -  Parent whose depression isn't confirmed by HSCL25 scale&#xD;
&#xD;
               -  Non consenting adolescent&#xD;
&#xD;
               -  Pregnant or nursing mother&#xD;
&#xD;
          -  Adolescent of group 3 :&#xD;
&#xD;
               -  Aged &lt; 11 or ≥18&#xD;
&#xD;
               -  Non depressed adolescent&#xD;
&#xD;
               -  Non consenting patient&#xD;
&#xD;
               -  Pregnant or nursing mother&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr Phan</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Volant-Le-Berre</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Wauters</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr AUGUSTIN</name>
      <address>
        <city>Guilers</city>
        <zip>29802</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Le Grignou</name>
      <address>
        <city>Guissény</city>
        <zip>29880</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Ac'h</name>
      <address>
        <city>Landerneau</city>
        <zip>29800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr PITMAN</name>
      <address>
        <city>Landivisiau</city>
        <zip>29400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr CHIRON</name>
      <address>
        <city>Le Relecq-Kerhuon</city>
        <zip>29480</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr CONNAN</name>
      <address>
        <city>Le Relecq-Kerhuon</city>
        <zip>29480</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Cazuguel</name>
      <address>
        <city>Locmaria-Plouzané</city>
        <zip>29280</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Coat-Gourio</name>
      <address>
        <city>Plougastel-Daoulas</city>
        <zip>29470</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr NABBE</name>
      <address>
        <city>Plounéour-Trez</city>
        <zip>29890</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning 3 years and ending fifteen years following the final study report completion</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement</ipd_access_criteria>
  </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/NCT03811041
org study id: 29BRC18.0221
nct id: NCT03811041
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Depression is difficult to identify, prevent and treat in adolescents because of complex and
      stigmatized multiform symptoms and pathways of care.

      In children the existence of a parental depression is a significant and recognized risk
      factor for the development of a depression. It is regularly reported that 30% of adolescents
      of depressed parents have depression themselves. General Practitioners (GP) have significant
      access to the depression of adults, potentially parents of teenagers. In fact, 20% of
      patients in the regular active file of one GP have depression. The primary health care system
      could provide indirect but voluminous and unprecedented access to the identification of
      adolescent depression at an early stage from the encounter of depressed parents.

      The difficulties of articulation between primary care (PC) and mental health devices are
      demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and
      may even disturb early detection of depression. An organized joint between the PC and a
      specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could
      promote the process of screening and preventing depression of adolescents of depressed
      parents encountered in PC.

      In addition, if the effects of parental depression on adolescents are established, they
      remain complex and interactive. They vary by age and sex of the child but also the sex of the
      parent. A concomitant study of adolescent and parent depression will provide data to analyze
      the prevalence of depressed parent adolescent depression and to define risk or protection
      factors.

      AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group
      of adolescent with PC articulated with mental health service (MDA) and an other group without
      articulation (routine cares).

      A third group of depressed adolescents will be constituted to analyse parental depression of
      depressed adolescents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes in adolescents' depression intensity
time frame: Day 0 and Month12
description: The depression intensity will be evaluated by Adolescent Depression Rating Scale (ADRS) at Day 0 and Month 12. The investigators will compare its evolution between group 1 (PC articulated with MDA) and 2 (Routine cares).
Adolescent depression rating scale (ADRS) assesses depression in adolescents in 10 items. The items measure insomnia, anxiety, sadness and fatigability. If ADRS score is less than 4 : low risk of depression, between 4 and 8 : moderate risk of depression and more than 8 : significant risk of depression.
measure: Diagnosis of depression rate
time frame: Day 0
description: With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0
measure: Changes in adolescents' quality of live
time frame: Day 0, Month6 and Month12
description: The quality of live will be evaluated by Pediatric Quality of Life InventoryTM (PedsQL) scale at Day 0, Months 6 and 12 and the investigators will compare its evolution between group 1 and 2. 3 scores will be calculated : psychosocial health summary score (average score of 15 items), physical health summary score (average score of 8 items) and the total score (average score of all items). Scores are between 0 and 100% and the higher scores indicate better Health-Related Quality of Life.
measure: Prevalence of adolescent depression with depressed parent
time frame: Day 0
description: With group 1 and 2, the investigators will calculate de prevalence of adolescent depression when a parent is depressed. Adolescent depression will be assessed by Adolescent Depression Rating Scale (ADRS). This scale is composed of 8 true (1)/false(0) questions. The score is the sum of all item. An adolescent is consider depressed when his score is higher than 4.
measure: Prevalence of parental depression with depressed adolescent
time frame: Day 0
description: With group 3, the investigators will calculate de prevalence of parental depression when a adolescent is depressed. Parental depression will be assessed by Hopkins Symptom Checklist (HSCL25). This scale is composed of 25 questions with 4 answers (1-4). The score is the average score of the 25 items. The parent is considered depressed when the score is higher or equal to 1.75.
measure: Risk and protection factors
time frame: Day 0
description: With the 3 groups, the investigators will isolate risk and protection factors for adolescent of depressed parents and for parents of depressed adolescents. Sociodemographics informations will be used and protective or risk factors may be highlighted from the study of some of the medico-psychological and social characteristics of families.
arm group label: PC articulated with MDA
arm group type: Experimental
description: Depressed parent encountered in PC for confirmation of depression with Hopkins Symptom Checklist-25 (HSCL25) scale. If confirmed, the adolescent will also be encountered by the GP for a screening test of depression (Adolescent Depression Rating Scale - ADRS). If negative, the patient will go out of the study. If positive, 2 others tests will be performed to study the intensity of the depression (Child depressionInventory - CDI) and the quality of life (Pediatric Quality of Life InventoryTM).Finally, the patient will be oriented to the MDA of Brest and will meet again the GP at 6 and 12 month to answers the same tests.
arm group label: Routine cares
arm group type: Active Comparator
description: Depressed parent encountered in PC for confirmation of depression with Hopkins Symptom Checklist-25 (HSCL25) scale. If confirmed, the adolescent will also be encountered by the GP for a screening test of depression (Adolescent Depression Rating Scale - ADRS). If negative, the patient will go out of the study. If positive, 2 others tests will be performed to study the intensity of the depression (Child depressionInventory - CDI) and the quality of life (Pediatric Quality of Life InventoryTM). Finally, the patient will be oriented to the routine cares and will meet again the GP at 6 and 12 month to answers the same tests.
arm group label: Parental depression
arm group type: Experimental
description: Parental depression will be studied. Depressed adolescent encountered in MDA of Marseille for confirmation of depression with 3 tests : ADRS, CDI and PedsQL. If positive, the parent will come to the MDA for a screening test of depression (HSCL25). Parents and adolescent are seen only once.
intervention type: Other
intervention name: MDA
description: Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.
arm group label: PC articulated with MDA
intervention type: Other
intervention name: Routine Cares
description: Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.
arm group label: Routine cares
intervention type: Other
intervention name: Parental depression
description: Parents of depressed adolescents will be met for a screening test of depression.
arm group label: Parental depression
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available beginning 3 years and ending fifteen years following the final study report completion
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement