CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19
- Conditions
- Mental Health Disorder
- Interventions
- Diagnostic Test: Quantitative and qualitative assessments of mental health
- Registration Number
- NCT04498416
- Lead Sponsor
- Fondation Lenval
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 3 Control Quantitative and qualitative assessments of mental health children without traumatic experience and without psychiatric or psychological follow-up treatment. Group 1 Post-Traumatic Stress Disorder (PTSD) Quantitative and qualitative assessments of mental health children with an identified traumatic history Group 2 Pathology Quantitative and qualitative assessments of mental health children with psychological follow-up treatment for a psychiatric disorder, without traumatic history;
- Primary Outcome Measures
Name Time Method diagnosis of possible psychological and psychiatric difficulties at baseline at baseline Day 0 measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :
- Secondary Outcome Measures
Name Time Method follow up of psychological and psychiatric difficulties at V2 at one month after baseline measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
follow up of psychological and psychiatric difficulties at V3 at one week after the end of the containment measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
follow up of psychological and psychiatric difficulties at V4 at one month after the end of the containment measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
impact of traumatic history prior to confinement at one week after baseline and at one month after the end of the containment measure by Post-Traumatic Stress Disorder (PTSD) scale: The frequency and intensity of PTSD symptoms will be assessed using the Young Child PTSD Checklist (YCP) for children aged 3 months to 6 years and 11 months; or the Child PTSD checklist (CPC) for children aged 7 years to 17 years and 11 months ; or with the Post-Traumatic Stress Disorder ( PTSD) checklist 5 (PCL 5 ) for adults
impact of other previous psychiatric disorders at one month after baseline and at one month after the end of the containment measure by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS): This is a semi-directed interview for children over the age of 7. It is done by interviewing the parent and the child. The interview covers both current issues.
parental reaction at one week after baseline and at one week after the end of the containment measure by Parenting stress index-short form (PSI-SF) that measures the extent of parental stress, as well as stress in the relationship between parent and child, and parents' difficulties in the day-to-day management of children.
Trial Locations
- Locations (1)
Hôpitaux Pédiatriques de Nice CHU-Lenval
🇫🇷Nice, France