Adolescent Depression Associated With Parental Depression (AdoDesP)
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| ClinicalTrials.gov Identifier: NCT03811041 |
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Recruitment Status :
Recruiting
First Posted : January 22, 2019
Last Update Posted : January 29, 2021
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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 |
| 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, 2022 |
| Estimated Study Completion Date : | March 28, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: MDA
Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares. |
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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.
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Other: Routine Cares
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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Other: Parental depression
Parents of depressed adolescents will be met for a screening test of depression. |
- 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.
- 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
- 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.
- 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.
- 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.
- 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 |
Inclusion Criteria:
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Parents of groups 1 and 2 :
- Major patient consulting his GP
- Depressed patient
- Parent of adolescent aged between 11 and 18 years old
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Adolescents of groups 1 and 2 :
- Aged more than 11 and less than 18 years old
- Parent included in the study
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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
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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:
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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
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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
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Adolescent of group 3 :
- Aged < 11 or ≥18
- Non depressed adolescent
- Non consenting patient
- Pregnant or nursing mother
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
| Contact: Guillaume BRONSARD, Pr | 0298015010 | guillaume.bronsard@chu-brest.fr |
Show 22 study locations
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT03811041 |
| Other Study ID Numbers: |
29BRC18.0221 |
| First Posted: | January 22, 2019 Key Record Dates |
| Last Update Posted: | January 29, 2021 |
| Last Verified: | January 2021 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |