CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19
NCT ID: NCT04498416
Last Updated: 2022-04-27
Study Results
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Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2020-04-27
2021-07-31
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 Post-Traumatic Stress Disorder (PTSD)
children with an identified traumatic history
Quantitative and qualitative assessments of mental health
Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
Group 2 Pathology
children with psychological follow-up treatment for a psychiatric disorder, without traumatic history;
Quantitative and qualitative assessments of mental health
Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
Group 3 Control
children without traumatic experience and without psychiatric or psychological follow-up treatment.
Quantitative and qualitative assessments of mental health
Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
Interventions
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Quantitative and qualitative assessments of mental health
Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
Eligibility Criteria
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Inclusion Criteria
* 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 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.
17 Years
ALL
No
Sponsors
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Fondation Lenval
OTHER
Responsible Party
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Principal Investigators
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Florence Gittard-Askenazy, Pr
Role: STUDY_DIRECTOR
Hôpitaux Pédiatriques de Nice CHU-LENVAL
Locations
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Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, , France
Countries
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References
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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.
Other Identifiers
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20-HPNCL-05
Identifier Type: -
Identifier Source: org_study_id
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