- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811041
Adolescent Depression Associated With Parental Depression (AdoDesP)
Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Brest, France, 29200
- Dr Phan
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Brest, France, 29200
- Dr Volant-Le-Berre
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Brest, France, 29200
- Dr Wauters
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Guilers, France, 29802
- Dr AUGUSTIN
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Guissény, France, 29880
- Dr LE GRIGNOU
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Landerneau, France, 29800
- Dr Ac'h
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Landivisiau, France, 29400
- Dr PITMAN
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Le Relecq-Kerhuon, France, 29480
- Dr CHIRON
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Le Relecq-Kerhuon, France, 29480
- Dr CONNAN
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Locmaria-Plouzané, France, 29280
- Dr Cazuguel
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Plougastel-Daoulas, France, 29470
- Dr Coat-Gourio
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Plounéour-Trez, France, 29890
- Dr NABBE
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.
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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.
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Parents of depressed adolescents will be met for a screening test of depression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in adolescents' depression intensity
Time Frame: Day 0 and Month12
|
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. |
Day 0 and Month12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of depression rate
Time Frame: Day 0
|
With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0
|
Day 0
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Changes in adolescents' quality of live
Time Frame: Day 0, Month6 and Month12
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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.
|
Day 0, Month6 and Month12
|
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.
|
Day 0
|
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.
|
Day 0
|
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.
|
Day 0
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC18.0221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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