- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406558
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
Conditions
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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