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Completed

NCT Number: NCT04406558

Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents

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 .

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Key information

Conditions

Psychological Adaptation Psychology, Social

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Camille JUNG

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Other names: Interview

Primary outcomes

  1. Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire

    Time frame: At inclusion

    Scale 0-21

Secondary outcomes

  1. Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire

    Time frame: At inclusion

    Scale 0-60

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. Mean duration time in front of screen (hours per day)

    Time frame: At inclusion

  8. 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

  9. Presence or absence of difficulties with familial interactions

    Time frame: At inclusion

    Presence or absence of difficulties with familial interactions

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: COVADO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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