NCT04370210

Brief Summary

The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 29, 2020

Last Update Submit

September 3, 2024

Conditions

Keywords

ChildrenSleep Disturbance scale for childrenContainmentCOVID-19AnxietyPsychological DistressSleep Wake DisordersChild PsychiatryMental Health

Outcome Measures

Primary Outcomes (1)

  • Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up

    Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.

    An average of 1 day

Secondary Outcomes (7)

  • Assessment of child depression in both groups

    An average of 1 day

  • Assessment of child anxiety in both groups

    An average of 1 day

  • Assessment of the influence of socio-demographic factors on sleep in both groups

    An average of 1 day

  • Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups

    An average of 1 day

  • Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry

    An average of 1 day

  • +2 more secondary outcomes

Study Arms (2)

Child without follow-up in child psychiatry

Child enrolled, and their parents, must complete online questionnaires

Behavioral: Questionnaires

Child with follow-up in child psychiatry

Child enrolled, and their parents, must complete online questionnaires

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Child of both groups enrolled, and their parents, must complete online questionnaires

Child with follow-up in child psychiatryChild without follow-up in child psychiatry

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child aged 7 to 11 years and 11 months included on the first day of containment in France on 17 March 2020 and their parents

You may qualify if:

  • Child aged 7 to 11 years and 11 months included on the first day of containment in France on 17 March 2020
  • Child receiving care at the CMP of Cergy-le-Haut (medico-psychological center) on the 2020 active patient population (at least one appointment with a child psychiatrist, a psychologist, a psychomotor therapist or a speech therapist or in a therapeutic group between January and March 2020)
  • Child not receiving any psychiatric care and having no siblings (half-brother, half-sister) followed in child psychiatry
  • No parental opposition

You may not qualify if:

  • Poor French reading comprehension by parents
  • Objection of the child
  • Child under guardianship, curatorship or foster care
  • Child not on containment : child cared for outside his home everyday (in school and hospital daycare for example).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier René Dubos

Pontoise, 95300, France

Location

MeSH Terms

Conditions

ParasomniasCOVID-19Anxiety DisordersSleep Wake DisordersPsychological Well-Being

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System DiseasesMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Erwan VION

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 29, 2020

First Posted

April 30, 2020

Study Start

May 4, 2020

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

September 19, 2024

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations