Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents (COVADO)

January 10, 2023 updated by: Centre Hospitalier Intercommunal Creteil

Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)

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 .

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Creteil, France, 94000
        • Camille JUNG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be proposed to all the adolescents followed in the Centre hospitalier Intercommunal de Creteil for a chronic disease or not.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire
Time Frame: At inclusion
Scale 0-21
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire
Time Frame: At inclusion
Scale 0-60
At inclusion
Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13
Time Frame: At inclusion
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
Presence or absence of difficulty in falling asleep, sleeping
Time Frame: At inclusion
a question on the quality and quantity of sleep will be asked to the teenager on a questionnaire
At inclusion
Presence or absence of feeding difficulty
Time Frame: At inclusion
a question on the presence or absence of feeding difficulty will be asked to the teenager on a questionnaire
At inclusion
Presence or absence of difficulty performing physical activity
Time Frame: At inclusion
a question on the presence or absence of difficulty performing physical activity will be asked to the teenager on a questionnaire
At inclusion
Presence or absence of toxic consomption (drug, acohol) during the lockdown
Time Frame: At inclusion
a question on the presence or absence of toxic consomption will be asked to the teenager on a questionnaire
At inclusion
Mean duration time in front of screen (hours per day)
Time Frame: At inclusion
At inclusion
Presence or absence of difficulties with social interactions
Time Frame: At inclusion
A question on the presence or absence of difficulties with social interactions will be asked to the teenager on a questionnaire
At inclusion
Presence or absence of difficulties with familial interactions
Time Frame: At inclusion
Presence or absence of difficulties with familial interactions
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

January 27, 2020

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • COVADO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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