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CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19 (CoCo-20)

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ClinicalTrials.gov Identifier: NCT04498416
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Mental Health Disorder Diagnostic Test: Quantitative and qualitative assessments of mental health

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

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Post-Traumatic Stress Disorder (PTSD)
children with an identified traumatic history
Diagnostic Test: 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;
Diagnostic Test: 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.
Diagnostic Test: 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




Primary Outcome Measures :
  1. diagnosis of possible psychological and psychiatric difficulties at baseline [ Time Frame: 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 :
  1. follow up of psychological and psychiatric difficulties at V2 [ Time Frame: 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

  2. follow up of psychological and psychiatric difficulties at V3 [ Time Frame: 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

  3. follow up of psychological and psychiatric difficulties at V4 [ Time Frame: 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

  4. impact of traumatic history prior to confinement [ Time Frame: 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

  5. impact of other previous psychiatric disorders [ Time Frame: 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.

  6. parental reaction [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498416


Contacts
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Contact: Arnaud FERNANDEZ, MD 0492030326 ext +33 fernandez.a@pediatrie-chulenval-nice.fr
Contact: Morgane GINDT gindt.m@pediatrie-chulenval-nice.fr

Locations
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France
Hôpitaux Pédiatriques de Nice CHU-Lenval Recruiting
Nice, France
Contact: Arnaud FERNANDEZ, MD       fernandez.a@pediatrie-chulenval-nice.fr   
Contact: Morgane GINDT       gindt.m@pediatrie-chulenval-nice.fr   
Sub-Investigator: Michèle Battista         
Sub-Investigator: Morgane Gindt         
Sub-Investigator: Ophélie Nachon         
Sub-Investigator: Aurélien Richez         
Principal Investigator: Arnaud Fernandez         
Sponsors and Collaborators
Fondation Lenval
Investigators
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Study Director: Florence Gittard-Askenazy, Pr Hôpitaux Pédiatriques de Nice CHU-LENVAL
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT04498416    
Other Study ID Numbers: 20-HPNCL-05
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders