- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302295
Analysis of Suicidal Behavior Among Children and Adolescents in the Auvergne-Rhone-Alpes Region During the Covid 19 Pandemic Period (TSPedCovid)
Clinical and Socioeconomic Characteristics of Suicidal Behaviour in Children and Adolescents During the Covid19 Pandemic Period in Auvergne-Rhône-Alpes. Prospective Quantitative and Qualitative Study
In 2020, the world is hit by a global health crisis due to a pandemic following the appearance of Sars-cov-2 or "covid-19". This pandemic was accompanied by a constant fear of contamination and death, relayed by the media. In France, the government proposed in response to the arrival of this virus on French territory. This policy was implemented in different ways over 3 distinct periods: strict containment at the start of the epidemic, then a "lighter" one, and finally a period of social restrictions without between these periods. This policy had a direct and rapid impact on the population's daily routines. Children and adolescents, are more susceptible to psychological trauma, as stress has a direct and psychic development. Studies have shown deleterious impact of the French health situation on the paediatric population. They point to an increase of psychological disorders such as depression and anxiety in the under -20s population, and an increase in suicidal gestures over the 2020-2021 period, with rates remaining higher than in previous years. Suicide is the 2nd leading cause of death in the population aged 15-24.
Studies continue to focus on the incidence of suicidal gestures of suicidal gestures and psychological disorders, and few of them examine the factors linked to the increase in these incidences, the traumatic impact or the story of the trajectory. Similarly, the few studies focus only on the population aged 12 and over, and in some cases, do not distinguish between age groups (15-24 or under 20).
Investigators believe that the various periods of social restrictions and eco-anxiety caused by the pandemic may have influenced suicidal behaviour in this population.
The main objective of this study is to investigate the clinical and socio-economic characteristics of the pediatric population who experienced suicidal behaviors in the Auvergne Rhone Alpes region during the covid 19 pandemic.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elise MAMIMOUE, Dr
- Phone Number: +33 472129567
- Email: elise.mamimoue@chu-lyon.fr
Study Contact Backup
- Name: Sonia GALLETTI
- Phone Number: +33 427857739
- Email: Sonia.galletti@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant- Service de pédopsychiatrie de l'enfant et de l'adolescent
-
Contact:
- Elise MAMIMOUE, Dr
- Phone Number: +33 472129567
- Email: elise.mamimoue@chu-lyon.fr
-
Principal Investigator:
- Elise MAMIMOUE, Dr
-
Clermont-Ferrand, France, 63000
- Not yet recruiting
- CHU de Clermont-Ferrand - Service de psychiatrie de l'enfant et de l'adolescent
-
Contact:
- Jonathan Lachal, Pr
- Phone Number: +33 473750750
- Email: jonathan.lachal@chu-clermontferrand.fr
-
Principal Investigator:
- Jonathan LACHAL, Pr
-
Grenoble, France, 38043
- Not yet recruiting
- CHU de Grenoble - Service de psychiatrie de l'enfant et de l'adolescent
-
Principal Investigator:
- Stéphanie BIOULAC, Dr
-
Contact:
- Stéphanie Bioulac, Dr
- Phone Number: +33 +330476767575
- Email: SBioulacrogier@chu-grenoble.fr
-
Saint-Etienne, France, 42100
- Not yet recruiting
- CHU de Saint-Etienne - Urgences psychiatriques
-
Contact:
- Catherine Massoubre, Pr
- Phone Number: +33 +33477828000
- Email: catherine.massoubre@chu-st-etienne.fr
-
Principal Investigator:
- Catherine Massoubre, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The population (subjects and controls) will be divided into age categories:
- Pre-adolescents (≥ 8 years and < 11 years)
- Adolescents (≥ 11 years and < 15 years)
- Older adolescents (≥ 15 years and < 18 years)
Subjects with suicidal behavior during the health crisis (Group 1):
- Age > 8 years and < 18 years during the period 2020 to 2022.
- Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and/or 2022 for suicidal behavior (defined as suicidal ideation and/or suicide attempt and/or self-harm/self-poisoning with suicidal intent).
Subjects with suicidal behavior during the health crisis with qualitative interviews (Group 1b):
- Age > 8 years and < 18 years during the period 2020 to 2022.
- Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and/or 2022 for suicidal behavior (defined as suicidal ideation and/or suicide attempt and/or self-harm/self-poisoning with suicidal intent).
- Randomly selected from the population of Group 1.
- For whom the parent(s) and/or the subject have signed informed consent.
Controls with suicidal behavior before the health crisis (Group 2):
- Age > 8 years and < 18 years during the period 2018 to 2019.
- Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2018 and/or 2019 for suicidal behavior (defined as suicidal ideation and/or suicide attempt and/or self-harm/self-poisoning with suicidal intent).
Exclusion Criteria:
- Subjects with Suicidal Behavior during the Health Crisis with and without Qualitative Interviews (Group 1 and 1b):
• Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2020 to 2022.
Controls with Suicidal Behavior before the Health Crisis (Group 2):
- Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2018 to 2019.
- Intercurrent illness with a life expectancy of less than 24 hours.
For Group 1:
- Pregnant, postpartum, or breastfeeding women.
- Persons deprived of liberty by judicial or administrative decision.
- Adults subject to a legal protection measure (guardianship, curatorship).
- Persons not affiliated with a social security scheme or beneficiaries of a similar scheme.
- Persons who do not understand and do not speak French.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Subjects with suicidal behaviors during the health crisis of covid-19 between 2020 and 2022 (group1)
|
The demographic and diagnostic characteristics will be collected in aggregate form nafrom digital services departments or medical information departments of participating hospitals.
|
|
Experimental: Subjects with suicidal behaviors during covid-19 period with qualitative interviews (group 1b)
|
The psychopathological and socioeconomic characteristics will be collected.
For subjects who agreed, they will participate in interviews and/or focus groups.
Parent's subjects who agreed will be part of focus groups too.
|
|
Experimental: Subjects control with suicidal behaviors before the health crisis (Group 2).
|
The demographic and diagnostic characteristics will be collected in aggregate form nafrom digital services departments or medical information departments of participating hospitals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic and diagnostic characteristics
Time Frame: Baseline
|
The following demographic and diagnostic characteristics will be collected in aggregate form for the entire population of children and adolescents who engaged in suicidal behavior during the health crisis and in the two preceding years:
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients aged 8-17 and 11month admitted to pediatric emergency
Time Frame: Baseline
|
Number of patients aged 8-17 and 11month admitted to pediatric emergency rooms or hospitalized in a continuous care/intensive care unit of university hospitals (CHU) or general hospitals (CH) for suicidal behavior during the COVID-19 pandemic period of 2020, 2021, and 2022, and those in the two preceding years: 2018 and 2019.
|
Baseline
|
|
Psychopathological and socio-economic characteristics
Time Frame: Baseline
|
The following psychopathological and socio-economic characteristics will be collected:
|
Baseline
|
|
Scores to CRIES
Time Frame: Up to 3 months
|
Scores on the Children's Revised Impact of Events Scale (CRIES-13) (Horowitz et al., 1979; Brunet et al., 2003) among children from a representative sample of the cohort (group 1b, volunteer subjects).
|
Up to 3 months
|
|
CAS scale
Time Frame: Up to 3 months
|
Scores on the Climate Anxiety Scale (CAS) (Clayton and Karazsia, 2020; Mouguiama-Daouda et al., 2022) among children from a representative sample of the cohort (group 1b, volunteer subjects).
|
Up to 3 months
|
|
Qualitative interview
Time Frame: Up to 3 months
|
Semi-structured interviews with children and adolescents with suicidal behavior from a representative sample of the cohort. Subjects who agreed to interviews. We will try to have a sample of volunteers from Group 1 who can be representative of our population (care orientation, age, personal psychiatric history, and place of residence.) |
Up to 3 months
|
|
Results to focus groups (parent's subjects, group 1b)
Time Frame: Up to 3 months
|
Focus groups with the parents of children and adolescents with suicidal behavior from a representative sample of the cohort (randomly selected).
|
Up to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Self-Injurious Behavior
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Behavior
- COVID-19
- Suicide
- Suicidal Ideation
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Data Collection
Other Study ID Numbers
- 69HCL22_1175
- 2023-A02237-38 (Other Identifier: ID-RCB)
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.
Clinical Trials on Suicidality
-
Compass Behavioral HealthCompleted
-
Janssen Scientific Affairs, LLCCompletedSuicidalityUnited States
-
Sinead NugentUnknownAdolescent Suicidality
-
VA Eastern Colorado Health Care SystemUS Department of Veterans Affairs; The Catholic University of AmericaCompleted
-
University of California, Los AngelesActive, not recruiting
-
University of ZurichCompletedSuicide, Attempted | SuicidalitySwitzerland
-
San Diego State UniversityUniformed Services University of the Health Sciences; Palo Alto Veterans Institute...Recruiting
-
Rabin Medical CenterCompleted
-
Children's Hospital Medical Center, CincinnatiActive, not recruitingSuicidality | Depression DisordersUnited States
-
Prof. Yoram YovellUniversity of HaifaUnknown
Clinical Trials on Aggregated data collection
-
Care Management PlusCompletedHealth Information Technology | Nurse Based Care ManagementUnited States
-
University Hospital, Basel, SwitzerlandRecruitingInfections With CPBSwitzerland
-
M.D. Anderson Cancer CenterUnknownPediatric CancerUnited States
-
GlaxoSmithKlineCompletedInfections, StreptococcalRomania, Slovenia, Poland, Lithuania, Estonia
-
Xuanwu Hospital, BeijingRecruitingMultiple Sclerosis | Myasthenia Gravis | Autoimmune Encephalitis | Acute Disseminated Encephalomyelitis | NMO Spectrum Disorder | Myelin Oligodendrocyte Glycoprotein Antibody-associated DiseaseChina
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompleted
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompleted
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingCerebrospinal; DisorderFrance
-
Vanda PharmaceuticalsRecruitingSleep-wake Disorder in Blind IndividualsUnited States
-
Women and Infants Hospital of Rhode IslandTerminated