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Adolescent Depression Associated With Parental Depression (AdoDesP)

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ClinicalTrials.gov Identifier: NCT03811041
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Depression Other: MDA Other: Routine Cares Other: Parental depression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1068 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : March 28, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PC articulated with MDA
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.
Other: MDA
Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.

Active Comparator: Routine cares
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.
Other: Routine Cares
Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.

Experimental: Parental depression
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.
Other: Parental depression
Parents of depressed adolescents will be met for a screening test of depression.




Primary Outcome Measures :
  1. Changes in adolescents' depression intensity [ Time Frame: Day 0, Month6 and Month12 ]
    The depression intensity will be evaluated by Child DepressionInventory (CDI)scale at Day 0, Months 6 and 12 and the investigators will compare its evolution between group 1 and 2. Each of the 27 items is scored 0, 1 or 2 and the total score is the sum of all items. Score between 0 and 9 mean minor depression, 10 to 18 is mild depression, 19 to 29 is moderate depression and 30 to 63 is for the severe depressions.

  2. Changes in adolescents' quality of live [ Time Frame: Day 0, Month6 and Month12 ]
    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.


Secondary Outcome Measures :
  1. Prevalence of adolescent depression with depressed parent [ Time Frame: Day 0 ]
    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.

  2. Prevalence of parental depression with depressed adolescent [ Time Frame: Day 0 ]
    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.

  3. Risk and protection factors [ Time Frame: Day 0 ]
    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.



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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents of groups 1 and 2 :

    • Major patient consulting his GP
    • Depressed patient
    • Parent of adolescent aged between 11 and 18 years old
  • Adolescents of groups 1 and 2 :

    • Aged more than 11 and less than 18 years old
    • Parent included in the study and whose depression is confirmed by HSCL25 scale
  • Parents of group 3 :

    • Parent of depressed adolescent under care at the MDA of Marseille, included in the study and whose depression is confirmed by HSCL25 scale
  • Adolescents of group 3 :

    • Aged more than 11 and less than 18 years old
    • Depressed patient
    • Under care at the MDA of Marseille since less than 1 month

Exclusion Criteria:

  • Parents of groups 1, 2 and 3 :

    • Minor patient
    • Enable to give his consent
    • Patient with guardianship or curatorship
    • Non consenting patient
    • Pregnant or nursing mother
  • Adolescents of groups 1 and 2 :

    • Aged < 11 or ≥18
    • Parent whose depression isn't confirmed by HSCL25 scale
    • Non consenting adolescent
    • Pregnant or nursing mother
  • Adolescent of group 3 :

    • Aged < 11 or ≥18
    • Non depressed adolescent
    • Non consenting patient
    • Pregnant or nursing mother

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811041


Contacts
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Contact: Guillaume BRONSARD, Pr 0298015010 guillaume.bronsard@chu-brest.fr

Locations
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France
Dr Andro-De-Schotten Recruiting
Brest, France, 29200
Contact: Anne-Cécile ANDRO-DE-SCHOTTEN, Dr         
Dr GLOANEC Recruiting
Brest, France, 29200
Contact: Isabelle GLOANEC, Dr         
Dr MOUDEN Recruiting
Brest, France, 29200
Contact: Jean-Hervé MOUDEN, Dr         
Dr Phan Recruiting
Brest, France, 29200
Contact: Thi Xuân-Mai PHAN, Dr         
Dr Volant-Le-Berre Recruiting
Brest, France, 29200
Contact: Charlotte VOLANT-LE-BERRE, Dr         
Dr Wauters Recruiting
Brest, France, 29200
Contact: Thomas WAUTERS, Dr         
Dr CAMILLERI Recruiting
Gouesnou, France, 29850
Contact: Claire CAMILLERI, Dr         
Dr Magueres Recruiting
Gouesnou, France, 29850
Contact: Catherine MAGUERES, Dr         
Dr Ben Yahmed Recruiting
Guipavas, France, 29490
Contact: Khalil BEN YAHMED, Dr         
Dr Le Grignou Recruiting
Guissény, France, 29880
Contact: Caroline LE GRIGNOU, Dr         
Dr Ac'h Recruiting
Landerneau, France, 29800
Contact: Sylvie AC'H, Dr         
Dr Le Goff Recruiting
Landerneau, France, 29800
Contact: Delphine LE GOFF, Dr         
Dr Monnier Recruiting
Landerneau, France, 29800
Contact: Brigitte MONNIER, Dr         
Dr PITMAN Recruiting
Landivisiau, France, 29400
Contact: Roberto PITMAN, Dr         
Dr Beck-Robert Recruiting
Lanmeur, France, 29260
Contact: Emilie BECK-ROBERT, Dr         
Dr Crenn-Corvez Recruiting
Lanmeur, France, 29260
Contact: Hélène CRENN-CORVEZ, Dr         
Dr CHIRON Recruiting
Le Relecq-Kerhuon, France, 29480
Contact: Benoit CHIRON, Dr         
Dr CONNAN Recruiting
Le Relecq-Kerhuon, France, 29480
Contact: Elodie CONNAN, Dr         
Dr Cazuguel Recruiting
Locmaria-Plouzané, France, 29280
Contact: Yann CAZUGUEL, Dr         
Dr Gasnier Recruiting
Ploudalmezeau, France, 29830
Contact: Anne-laure GASNIER, Dr         
Dr Coat-Gourio Recruiting
Plougastel-Daoulas, France, 29470
Contact: Christine COAT-GOURIO, Dr         
Dr MAZE Recruiting
Saint-Renan, France, 29290
Contact: Maryline MAZE, Dr         
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03811041     History of Changes
Other Study ID Numbers: 29BRC18.0221
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning 3 years and ending fifteen years following the final study report completion
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders