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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03811041
Other study ID # 29BRC18.0221
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 28, 2019
Est. completion date March 11, 2021

Study information

Verified date April 2022
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 80
Est. completion date March 11, 2021
Est. primary completion date March 11, 2021
Accepts healthy volunteers No
Gender All
Age group 11 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
MDA
Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.
Routine Cares
Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.
Parental depression
Parents of depressed adolescents will be met for a screening test of depression.

Locations

Country Name City State
France Dr Phan Brest
France Dr Volant-Le-Berre Brest
France Dr Wauters Brest
France Dr AUGUSTIN Guilers
France Dr Le Grignou Guissény
France Dr Ac'h Landerneau
France Dr PITMAN Landivisiau
France Dr CHIRON Le Relecq-Kerhuon
France Dr CONNAN Le Relecq-Kerhuon
France Dr Cazuguel Locmaria-Plouzané
France Dr Coat-Gourio Plougastel-Daoulas
France Dr NABBE Plounéour-Trez

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Day 0 and Month12
Secondary Diagnosis of depression rate With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0 Day 0
Secondary 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. Day 0, Month6 and Month12
Secondary 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. Day 0
Secondary 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. Day 0
Secondary 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. Day 0
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