Clinical trial NCT04498416: CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19
Official title: Methodology of " CoCo 20 ": a Longitudinal Follow-up Study of the Paediatric Population and Their Families During and After the Coronavirus Pandemic and the Confinement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Disorder
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 70
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1 (PTSD): children with an identified traumatic history; Group 2 (Pathology): children with psychological follow-up treatment for a psychiatric disorder, without traumatic history; Group 3 (Control): children without traumatic experience and without psychiatric or psychological follow-up treatment.

Brief summary: In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.

After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.

The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term

Detailed description: In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.

After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.

The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term.

The major inclusion criteria are children and adolescents under 18 years of age who have been affected by the Covid 19 pandemic. Three groups were defined: children in group one had a previous history of traumatic events, those in group two had a record of previous psychiatric or psychological disorder with a follow-up treatment and Group three included children without traumatic history nor psychiatric or psychological follow-up treatment. Participants will be assessed at baseline (V0), 1 week after (V1), one month after baseline (V2), one week after the end of the containment (V3) and one month after the end of the containment (V4).

Main analyses comprise analyses of variance and regression analyses of predictors of clinical evolution over time

Eligibility criteria: Inclusion Criteria:

* Children affected by the Coronavirus disease 2019 (Covid-19) pandemic;
* Age between 0 and under 18 at the time of inclusion;
* Affiliated with a social security scheme;
* Having a good command of the French language (French);
* Children whose parents have accepted participation in the study (collection of informed consents).

Exclusion Criteria:

* Children and/or young adults with a psychotic disorder or autism spectrum disorder;
* Children and/or young adults with an average intellectual disability (\< to 50);
* Person deprived of liberty by judicial or administrative decision1;
* Person subject to a period of exclusion for another search.

Primary outcomes:
measure: diagnosis of possible psychological and psychiatric difficulties at baseline
timeFrame: at baseline Day 0
Secondary outcomes:
measure: follow up of psychological and psychiatric difficulties at V2
timeFrame: at one month after baseline
measure: follow up of psychological and psychiatric difficulties at V3
timeFrame: at one week after the end of the containment
measure: follow up of psychological and psychiatric difficulties at V4
timeFrame: at one month after the end of the containment
measure: impact of traumatic history prior to confinement
timeFrame: at one week after baseline and at one month after the end of the containment
measure: impact of other previous psychiatric disorders
timeFrame: at one month after baseline and at one month after the end of the containment
measure: parental reaction
timeFrame: at one week after baseline and at one week after the end of the containment
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Florence Gittard-Askenazy, Pr
role: STUDY_DIRECTOR
References:
citation: Gindt M, Fernandez A, Richez A, Nachon O, Battista M, Askenazy F. CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19). BMJ Open. 2021 Apr 8;11(4):e044667. doi: 10.1136/bmjopen-2020-044667.