Adolescent Depression Associated With Parental Depression

NCT03811041 | Terminated

• 1 other identifier: 29BRC18.0221
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diagnosis of depression rate

  Day 0

• Changes in adolescents' quality of live

  Day 0, Month6 and Month12

• Prevalence of adolescent depression with depressed parent

  Day 0

• Prevalence of parental depression with depressed adolescent

  Day 0

• Risk and protection factors

  Day 0

Study Arms (3)

PC articulated with MDA

EXPERIMENTAL

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

Routine cares

ACTIVE COMPARATOR

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

Parental depression

EXPERIMENTAL

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

Interventions

MDA OTHER

Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.

PC articulated with MDA

Routine Cares OTHER

Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.

Routine cares

Parental depression OTHER

Parents of depressed adolescents will be met for a screening test of depression.

Parental depression

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (12)

Dr Phan

Brest, 29200, France

Location

Dr Volant-Le-Berre

Brest, 29200, France

Location

Dr Wauters

Brest, 29200, France

Location

Dr AUGUSTIN

Guilers, 29802, France

Location

Dr Le Grignou

Guissény, 29880, France

Location

Dr Ac'h

Landerneau, 29800, France

Location

Dr PITMAN

Landivisiau, 29400, France

Location

Dr CHIRON

Le Relecq-Kerhuon, 29480, France

Location

Dr CONNAN

Le Relecq-Kerhuon, 29480, France

Location

Dr Cazuguel

Locmaria-Plouzané, 29280, France

Location

Dr Coat-Gourio

Plougastel-Daoulas, 29470, France

Location

Dr NABBE

Plounéour-Trez, 29890, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 22, 2019
• Study Start: March 28, 2019
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

FR (12)