DepressionAdoDesPNCT03811041

Adolescent Depression Associated With Parental Depression

A study testing MDA, Routine Cares and Parental depression in people with Depression, run by University Hospital, Brest at 12 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 11 years and older
Conditions the study is for: Depression
What is being tested?: MDA, Routine Cares and Parental depression
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 12 sitesFrance
Study dates: 28 Mar 2019to 11 Mar 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

France12 sites

Dr Phan
Brest, 29200
Dr Volant-Le-Berre
Brest, 29200
Dr Wauters
Brest, 29200
Dr AUGUSTIN
Guilers, 29802
Dr Le Grignou
Guissény, 29880
Dr Ac'h
Landerneau, 29800
Dr PITMAN
Landivisiau, 29400
Dr CHIRON
Le Relecq-Kerhuon, 29480
Dr CONNAN
Le Relecq-Kerhuon, 29480
Dr Cazuguel
Locmaria-Plouzané, 29280
Dr Coat-Gourio
Plougastel-Daoulas, 29470
Dr NABBE
Plounéour-Trez, 29890

Other trials in France

About this study

Official title: 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.

Conditions: Depression
Being tested: MDA, Routine Cares, Parental depression
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03811041
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Parental depression

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 and Month12

Secondary outcomes (5)

Diagnosis of depression rate
With group 1 and 2, screening rates for depression in adolescents will be evaluated at Day 0
Measured: 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.
Measured: Day 0, Month6 and Month12
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201911 Mar 2021

First posted22 Jan 2019
Study start28 Mar 2019
Primary completion11 Mar 2021
Study completion11 Mar 2021

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03811041
Sponsor's protocol ID: 29BRC18.0221
Acronym: AdoDesP
Status last verified: Apr 2022
First submitted: 15 Jan 2019
Last updated: 11 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected data that underlie results in a publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care
ClinicalTrials.gov ID: NCT03811041
Acronym / sponsor ID: AdoDesP / 29BRC18.0221
Conditions: Depression
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 80 participants (actual)
Lead sponsor: University Hospital, BrestUniversity, hospital or other
Study start: 28 Mar 2019 (actual)
Primary completion: 11 Mar 2021 (actual)
Study completion: 11 Mar 2021 (actual)
First posted: 22 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care.

A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
PC articulated with MDA	Experimental	Other: MDADepressed 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.
Routine cares	Active comparator	Other: Routine CaresDepressed 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	Experimental	Other: Parental depressionParental 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.

Who may qualify

Ages: 11 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

Parents of groups 1 and 2 :
Adolescents of groups 1 and 2 :
Parents of group 3 :
Adolescents of group 3 :

Key exclusion criteria (16 listed)

Parents of groups 1, 2 and 3 :
Adolescents of groups 1 and 2 :
Adolescent of group 3 :

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MDADepressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.	Other	PC articulated with MDA
Routine CaresDepressed adolescents of depressed parents will be oriented to routine cares for depression cares.	Other	Routine cares
Parental depressionParents of depressed adolescents will be met for a screening test of depression.	Other	Parental depression

Primary outcome

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.

5 secondary outcomes

Diagnosis of depression rate
Time frame: Day 0
Changes in adolescents' quality of live
Time frame: Day 0, Month6 and Month12
Prevalence of adolescent depression with depressed parent
Time frame: Day 0
Prevalence of parental depression with depressed adolescent
Time frame: Day 0
Risk and protection factors
Time frame: Day 0

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MDA, Routine Cares and Parental depression in people with Depression, run by University Hospital, Brest at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in adolescents' depression intensity (time frame: Day 0 and Month12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.