Mental Health DisorderCoCo-20NCT04498416
CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19
An observational study of Mental Health Disorder, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- Quantitative and qualitative assessments of mental health
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 31 Jul 2021
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Mental Health Disorder
- Being tested
- Quantitative and qualitative assessments of mental health
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative and qualitative assessments of mental healthDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Post-Traumatic Stress Disorder (PTSD) | children with an identified traumatic history Receives: Diagnostic Test: Quantitative and qualitative assessments of mental health | |
| Group 2 Pathology | children with psychological follow-up treatment for a psychiatric disorder, without traumatic history; Receives: Diagnostic Test: Quantitative and qualitative assessments of mental health | |
| Group 3 Control | children without traumatic experience and without psychiatric or psychological follow-up treatment. Receives: Diagnostic Test: Quantitative and qualitative assessments of mental health |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of possible psychological and psychiatric difficulties at 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 :
Measured: at baseline Day 0
Secondary outcomes (6)
follow up of psychological and psychiatric difficulties at V2
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
Measured: at one month after baseline
follow up of psychological and psychiatric difficulties at V3
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
Measured: at one week after the end of the containment
follow up of psychological and psychiatric difficulties at V4
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
Measured: at one month after the end of the containment
impact of traumatic history prior to confinement
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
Measured: at one week after baseline and at one month after the end of the containment
impact of other previous psychiatric disorders
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.
Measured: at one month after baseline and at one month after the end of the containment
parental reaction
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.
Measured: at one week after baseline and at one week after the end of the containment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start27 Apr 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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 Health DisorderStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Gittard-Askenazy, Pr, Study director, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498416
- Sponsor's protocol ID
- 20-HPNCL-05
- Acronym
- CoCo-20
- Status last verified
- Jan 2022
- First submitted
- 31 Jul 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34270445
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498416
- Acronym / sponsor ID
- CoCo-20 / 20-HPNCL-05
- Conditions
- Mental Health Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 4 Aug 2020 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Post-Traumatic Stress Disorder (PTSD) | – | Diagnostic Test: Quantitative and qualitative assessments of mental healthchildren with an identified traumatic history |
| Group 2 Pathology | – | Diagnostic Test: Quantitative and qualitative assessments of mental healthchildren with psychological follow-up treatment for a psychiatric disorder, without traumatic history; |
| Group 3 Control | – | Diagnostic Test: Quantitative and qualitative assessments of mental healthchildren without traumatic experience and without psychiatric or psychological follow-up treatment. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Quantitative and qualitative assessments of mental healthEmergency 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 | Diagnostic test | Group 1 Post-Traumatic Stress Disorder (PTSD), Group 2 Pathology, Group 3 Control |
Primary outcome
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 :
6 secondary outcomes
follow up of psychological and psychiatric difficulties at V2
Time frame: at one month after baseline
follow up of psychological and psychiatric difficulties at V3
Time frame: at one week after the end of the containment
follow up of psychological and psychiatric difficulties at V4
Time frame: at one month after the end of the containment
impact of traumatic history prior to confinement
Time frame: at one week after baseline and at one month after the end of the containment
impact of other previous psychiatric disorders
Time frame: at one month after baseline and at one month after the end of the containment
parental reaction
Time frame: at one week after baseline and at one week after the end of the containment
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 27 Apr 2022.
- Derived from this study: PubMed 34270445Gindt 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.
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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.
Florence Gittard-Askenazy, Pr study director
Hôpitaux Pédiatriques de Nice CHU-LENVAL
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 Health Disorder, run by Fondation Lenval 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 5 inclusion and 4 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 27 Apr 2022. 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?
diagnosis of possible psychological and psychiatric difficulties at baseline (time frame: at baseline Day 0). 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 NCT04498416, 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 27 Apr 2022.