NCT04406558

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

May 24, 2020

Last Update Submit

January 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Scale 0-21

    At inclusion

Secondary Outcomes (9)

  • Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire

    At inclusion

  • Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13

    At inclusion

  • Presence or absence of difficulty in falling asleep, sleeping

    At inclusion

  • Presence or absence of feeding difficulty

    At inclusion

  • Presence or absence of difficulty performing physical activity

    At inclusion

  • +4 more secondary outcomes

Interventions

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.

Also known as: Interview

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Adolescents aged 11 to 18 years old
  • Previous consultation in the Centre Hospitalier intercommunal de Creteil
  • Agree to participate

You may not qualify if:

  • Lack of computer equipment or internet connection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camille JUNG

Créteil, 94000, France

Location

MeSH Terms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 28, 2020

Study Start

January 10, 2019

Primary Completion

January 27, 2020

Study Completion

February 27, 2020

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations