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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05260866
Other study ID # ANR-21-COVR-0010-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date June 30, 2022

Study information

Verified date February 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.


Description:

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.


Recruitment information / eligibility

Status Completed
Enrollment 500000
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Children and adolescents aged from 6 to 18 years - One dispensation of psychotropic medication or - One mental-health related hospitalization or - One reimbursement for an outpatient mental-health related consultation or - One eligibility to long-term diseases corresponding to long term psychiatric diseases or - One mental-health related cause of death using ICD-10 codes Exclusion Criteria: - none

Study Design


Intervention

Other:
national population-based study
No intervention

Locations

Country Name City State
France Robert Debre Hospital - Assistance Publique Hopitaux de Paris Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Nationale de Recherche (ANR) National Research Agency

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the impact of COVID-19 pandemic on use of mental health resources prescriptions of psychotropic medications; mental health-related outpatient visits; mental health-related hospitalizations and emergency department visits 1 year
Secondary To evaluate the impact of COVID-19 pandemic on episodes of fatal and non-fatal self-harm episodes in children and adolescents in France monthly counts and rates of fatal and non-fatal self-harm episodes will be assessed throughout the study period 1 year
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