NCT05795894

Brief Summary

A qualitative study, combining psychiatric and anthropological perspectives, focused on the lived experiences of patients who had recourse to HPNCL emergencies during the period of November 2021, as well as the experiences and perceptions of those around them - such as their family, teachers or school and nursing staff. This multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data. The hypotheses to explain the increase in the rate of suicidal crisis will be addressed through semi-structured interviews proposed to the participants of the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

March 21, 2023

Last Update Submit

January 26, 2024

Conditions

Keywords

pediatric

Outcome Measures

Primary Outcomes (1)

  • Situational Anxiety and Trait Anxiety Inventory

    This inventory aims to assess anxiety as a "personality trait" (feelings of apprehension, tension, nervousness and worry that the subject usually feels), and anxiety as a ' "emotional state" linked to a particular situation (feelings of apprehension, tension or nervousness that the subject feels at a specific moment). This is a questionnaire comprising 20 items for the "state" form and 20 items for the "trait" form. The instruction is to answer "in general, in the usual way" for the "trait" scale and "at the moment" for the "state" scale. Each score can therefore vary from 20 to 80 with a "very high" anxiety norm when the threshold is \> 65, "high" between 56 and 65, "medium" between 46 and 55, "low" between 36 and 45 and "very low" for a score \< or = 35.

    at inclusion

Secondary Outcomes (3)

  • Beck Depression Inventory

    at inclusion

  • "Suicidal risk" module of the Mini-International Neuropsychiatric Interview child/adolescent

    at inclusion

  • Post-traumatic Check List Scale

    at inclusion

Study Arms (1)

patents

Questionnaires

Behavioral: STAI-YBehavioral: BDI scaleBehavioral: M.I.N.I.KidBehavioral: PCL-5

Interventions

STAI-YBEHAVIORAL

Situational Anxiety and Trait Anxiety Inventory

patents
BDI scaleBEHAVIORAL

• Beck Depression Inventory scale

patents
M.I.N.I.KidBEHAVIORAL

Suicidal risk" module of the Mini-International Neuropsychiatric Interview child/adolescent version

patents
PCL-5BEHAVIORAL

Post-traumatic Check List Scale

patents

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

* The patient who consulted the emergency room during the month of November 2021 * The parent(s) of the study participant * One or more health professionals taking care of the patient * The school attended by the patient who will be questioned about the suicidal problem and Covid-19 in general or not about the patient in particular. * Child welfare professionals (ASE) potentially involved in the care of the study participant

You may qualify if:

  • Any patient having consulted in the child psychiatric emergency room of the HPNCL between November 1, 2021 and November 30, 2021 for suicidal thoughts.
  • Age between 13 years and 17 years and 11 months
  • Good understanding of written and oral French
  • Collection of the informed consent of the patient and of one of the two parents or holder of parental authority

You may not qualify if:

  • Refusal of participation by the patient or one of the legal guardians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hôpital Lenval

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

SuicideCOVID-19

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Louise-Emilie DUMAS, MD

    Fondation Lenval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise-Emilie DUMAS, MD

CONTACT

Brigitte REMY, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

July 12, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations