Mental Disorder, ChildMENTALPEDNCT05260866
Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents
An observational study of Mental Disorder, Child, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Mental Disorder, Child
- What is being tested?
- national population-based study
- How many people
- 500,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged from 6 to 18 years
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Robert Debre Hospital - Assistance Publique Hopitaux de Paris
Paris, 75019
About this study
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.
Read the 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.
- Conditions
- Mental Disorder, Child
- Being tested
- national population-based study
- Keywords
- pediatrics, COVID 19 pandemic, mental health, psychotropic drug
- Medical subject headings
- Neurodevelopmental Disorders, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
national population-based studyOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
monthly counts and rates of fatal and non-fatal self-harm episodes will be assessed throughout the study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Disorder, ChildStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Nationale de Recherche (ANR) National Research Agency
- Responsible party
- Sponsor
- Investigators
- Florentia Kaguelidou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260866
- Sponsor's protocol ID
- ANR-21-COVR-0010-01
- Acronym
- MENTALPED
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valtuille Z, Acquaviva E, Trebossen V, Ouldali N, Bourmaud A, Sclison S, Gomez A, Revet A, Peyre H, Delorme R, Kaguelidou F. Prescription Trends of Medications Used to Treat Sleep Disturbances in School-Aged Children: An Interrupted Time-Series Analysis in France, 2016-2023. J Pediatr. 2025 May;280:114502. doi: 10.1016/j.jpeds.2025.114502. Epub 2025 Feb 5.
PubMed 39921118
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05260866
- Acronym / sponsor ID
- MENTALPED / ANR-21-COVR-0010-01
- Conditions
- Mental Disorder, Child
- Keywords
- pediatrics, COVID 19 pandemic, mental health, psychotropic drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Nationale de Recherche (ANR) National Research Agency
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Mar 2022 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged from 6 to 18 years
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| national population-based studyNo intervention | Other | – |
Primary outcome
To evaluate the impact of COVID-19 pandemic on use of mental health resources
Time frame: 1 year
prescriptions of psychotropic medications; mental health-related outpatient visits; mental health-related hospitalizations and emergency department visits
1 secondary outcome
To evaluate the impact of COVID-19 pandemic on episodes of fatal and non-fatal self-harm episodes in children and adolescents in France
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 39921118Valtuille Z, Acquaviva E, Trebossen V, Ouldali N, Bourmaud A, Sclison S, Gomez A, Revet A, Peyre H, Delorme R, Kaguelidou F. Prescription Trends of Medications Used to Treat Sleep Disturbances in School-Aged Children: An Interrupted Time-Series Analysis in France, 2016-2023. J Pediatr. 2025 May;280:114502. doi: 10.1016/j.jpeds.2025.114502. Epub 2025 Feb 5.
- Individual participant dataSharing planned: No
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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.
Florentia Kaguelidou, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, Child, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the impact of COVID-19 pandemic on use of mental health resources (time frame: 1 year). 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 NCT05260866, which also lists 1 linked publication.
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 23 Feb 2023.