NCT05260866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

February 17, 2022

Last Update Submit

February 22, 2023

Conditions

Keywords

pediatricsCOVID 19 pandemicmental healthpsychotropic drug

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the impact of COVID-19 pandemic on episodes of fatal and non-fatal self-harm episodes in children and adolescents in France

    1 year

Interventions

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents aged from 6 to 18 years

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital - Assistance Publique Hopitaux de Paris

Paris, 75019, France

Location

MeSH Terms

Conditions

Neurodevelopmental DisordersCOVID-19Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Florentia Kaguelidou, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 2, 2022

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 23, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations