MENTALPED: Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05260866
• Collaborator: Agence Nationale de Recherche (ANR) National Research Agency (Other)
• Enrollment: 500,000
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 41809.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorder, Child	Other: national population-based study

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Outcome Measures

Primary Outcome Measures

1. To evaluate the impact of COVID-19 pandemic on use of mental health resources [1 year]

   prescriptions of psychotropic medications; mental health-related outpatient visits; mental health-related hospitalizations and emergency department visits

Secondary Outcome Measures

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]

   monthly counts and rates of fatal and non-fatal self-harm episodes will be assessed throughout the study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital - Assistance Publique Hopitaux de Paris	Paris		France	75019

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• Agence Nationale de Recherche (ANR) National Research Agency

Investigators

• Principal Investigator: Florentia Kaguelidou, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05260866
• Other Study ID Numbers: ANR-21-COVR-0010-01
• First Posted: Mar 2, 2022
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: pediatrics; COVID 19 pandemic; mental health; psychotropic drug
• Additional relevant MeSH terms: COVID-19; Mental Disorders; Neurodevelopmental Disorders

Study Results

No Results Posted as of Mar 2, 2022