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Adolescent Depression Associated With Parental Depression (AdoDesP)

Primary Purpose

Depression

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MDA
Routine Cares
Parental depression
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depression

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Dr Phan
  • Dr Volant-Le-Berre
  • Dr Wauters
  • Dr AUGUSTIN
  • Dr Le Grignou
  • Dr Ac'h
  • Dr PITMAN
  • Dr CHIRON
  • Dr CONNAN
  • Dr Cazuguel
  • Dr Coat-Gourio
  • Dr NABBE

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

PC articulated with MDA

Routine cares

Parental depression

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in adolescents' depression intensity
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.

Secondary Outcome Measures

Diagnosis of depression rate
With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0
Changes in adolescents' quality of live
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.
Prevalence of adolescent depression with depressed parent
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.
Prevalence of parental depression with depressed adolescent
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.
Risk and protection factors
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.

Full Information

First Posted
January 15, 2019
Last Updated
April 4, 2022
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03811041
Brief Title
Adolescent Depression Associated With Parental Depression
Acronym
AdoDesP
Official Title
Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
The decision was made not to extend the inclusions due to the low inclusion rate since the beginning of the study. The last inclusion took place on 06/22/2020.
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PC articulated with MDA
Arm Type
Experimental
Arm 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 Title
Routine cares
Arm Type
Active Comparator
Arm 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 Title
Parental depression
Arm Type
Experimental
Arm 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(s)
MDA
Intervention Description
Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.
Intervention Type
Other
Intervention Name(s)
Routine Cares
Intervention Description
Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.
Intervention Type
Other
Intervention Name(s)
Parental depression
Intervention Description
Parents of depressed adolescents will be met for a screening test of depression.
Primary Outcome Measure Information:
Title
Changes in adolescents' depression intensity
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.
Time Frame
Day 0 and Month12
Secondary Outcome Measure Information:
Title
Diagnosis of depression rate
Description
With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0
Time Frame
Day 0
Title
Changes in adolescents' quality of live
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.
Time Frame
Day 0, Month6 and Month12
Title
Prevalence of adolescent depression with depressed parent
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.
Time Frame
Day 0
Title
Prevalence of parental depression with depressed adolescent
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.
Time Frame
Day 0
Title
Risk and protection factors
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Dr Phan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Dr Volant-Le-Berre
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Dr Wauters
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Dr AUGUSTIN
City
Guilers
ZIP/Postal Code
29802
Country
France
Facility Name
Dr Le Grignou
City
Guissény
ZIP/Postal Code
29880
Country
France
Facility Name
Dr Ac'h
City
Landerneau
ZIP/Postal Code
29800
Country
France
Facility Name
Dr PITMAN
City
Landivisiau
ZIP/Postal Code
29400
Country
France
Facility Name
Dr CHIRON
City
Le Relecq-Kerhuon
ZIP/Postal Code
29480
Country
France
Facility Name
Dr CONNAN
City
Le Relecq-Kerhuon
ZIP/Postal Code
29480
Country
France
Facility Name
Dr Cazuguel
City
Locmaria-Plouzané
ZIP/Postal Code
29280
Country
France
Facility Name
Dr Coat-Gourio
City
Plougastel-Daoulas
ZIP/Postal Code
29470
Country
France
Facility Name
Dr NABBE
City
Plounéour-Trez
ZIP/Postal Code
29890
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning 3 years and ending fifteen years following the final study report completion
IPD Sharing 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

Learn more about this trial

Adolescent Depression Associated With Parental Depression

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