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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406558
Other study ID # COVADO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2019
Est. completion date February 27, 2020

Study information

Verified date January 2023
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 27, 2020
Est. primary completion date January 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: - Adolescents aged 11 to 18 years old - Previous consultation in the Centre Hospitalier intercommunal de Creteil - Agree to participate Exclusion Criteria: - Lack of computer equipment or internet connection

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.

Locations

Country Name City State
France Camille JUNG Creteil

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire Scale 0-21 At inclusion
Secondary Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire Scale 0-60 At inclusion
Secondary Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13 8 items that are scored on a four-point scale and 3 sub scales: intrusion (4 items); avoidance (4 items) and arousal (5 items) At inclusion
Secondary Presence or absence of difficulty in falling asleep, sleeping a question on the quality and quantity of sleep will be asked to the teenager on a questionnaire At inclusion
Secondary Presence or absence of feeding difficulty a question on the presence or absence of feeding difficulty will be asked to the teenager on a questionnaire At inclusion
Secondary Presence or absence of difficulty performing physical activity a question on the presence or absence of difficulty performing physical activity will be asked to the teenager on a questionnaire At inclusion
Secondary Presence or absence of toxic consomption (drug, acohol) during the lockdown a question on the presence or absence of toxic consomption will be asked to the teenager on a questionnaire At inclusion
Secondary Mean duration time in front of screen (hours per day) At inclusion
Secondary Presence or absence of difficulties with social interactions A question on the presence or absence of difficulties with social interactions will be asked to the teenager on a questionnaire At inclusion
Secondary Presence or absence of difficulties with familial interactions Presence or absence of difficulties with familial interactions At inclusion
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