Psychological AdaptationCOVADONCT04406558
Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents
An observational study of Psychological Adaptation and Psychology, Social, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Adaptation, Psychology, Social
- What is being tested?
- Questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to 27 Feb 2020
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Adolescents aged 11 to 18 years old
- Previous consultation in the Centre Hospitalier intercommunal de Creteil
- Agree to participate
Who cannot join
- Lack of computer equipment or internet connection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Conditions
- Psychological Adaptation, Psychology, Social
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Interview
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire
Scale 0-21
Measured: At inclusion
Secondary outcomes (9)
Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire
Scale 0-60
Measured: At inclusion
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)
Measured: At inclusion
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
Measured: At inclusion
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
Measured: At inclusion
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
Measured: At inclusion
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
Measured: At inclusion
Mean duration time in front of screen (hours per day)
Measured: At inclusion
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
Measured: At inclusion
Presence or absence of difficulties with familial interactions
Presence or absence of difficulties with familial interactions
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start10 Jan 2019
- Primary completion27 Jan 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological AdaptationStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406558
- Sponsor's protocol ID
- COVADO
- Acronym
- COVADO
- Status last verified
- Jan 2023
- First submitted
- 24 May 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)
- ClinicalTrials.gov ID
- NCT04406558
- Acronym / sponsor ID
- COVADO / COVADO
- Conditions
- Psychological Adaptation, Psychology, Social
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 28 May 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Adolescents aged 11 to 18 years old
- Previous consultation in the Centre Hospitalier intercommunal de Creteil
- Agree to participate
Key exclusion criteria (1 listed)
- Lack of computer equipment or internet connection
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 |
|---|---|---|
| QuestionnaireAlso: InterviewAn 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. | Other | – |
Primary outcome
Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire
Time frame: At inclusion
Scale 0-21
9 secondary outcomes
Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire
Time frame: At inclusion
Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13
Time frame: At inclusion
Presence or absence of difficulty in falling asleep, sleeping
Time frame: At inclusion
Presence or absence of feeding difficulty
Time frame: At inclusion
Presence or absence of difficulty performing physical activity
Time frame: At inclusion
Presence or absence of toxic consomption (drug, acohol) during the lockdown
Time frame: At inclusion
Mean duration time in front of screen (hours per day)
Time frame: At inclusion
Presence or absence of difficulties with social interactions
Time frame: At inclusion
Presence or absence of difficulties with familial interactions
Time frame: At inclusion
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 11 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psychological Adaptation and Psychology, Social, run by Centre Hospitalier Intercommunal Creteil 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 3 inclusion and 1 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 11 Jan 2023. 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?
Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.