NCT05780242

Brief Summary

This qualitative study, combining psychiatric and anthropological perspectives, focused on the development and/or worsening of patients' eating disorders since Covid-19, as well as the experiences and perceptions of those around them - such as their family, teachers or staff. 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 Eating Disorders (EDs) will be addressed through semi-structured interviews offered to study participants.

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 20, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 29, 2024

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

March 20, 2023

Last Update Submit

January 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-questionnaire Eating Attitudes Test-40

    It is a self-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa. The total score varies from 0 to 120. The threshold score is 30 to define an eating disorder

    at inclusion

Secondary Outcomes (3)

  • Situational Anxiety and Trait Anxiety Inventory (STAI-Y)

    at inclusion

  • Beck Depression Inventory (BDI) scale

    at inclusion

  • Post-traumatic Check List Scale (PCL-5)

    at inclusion

Study Arms (1)

TCA

interviews based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant

Behavioral: Self-questionnaire Eating AttitudesBehavioral: Situational Anxiety and Trait AnxietyBehavioral: Beck Depression Inventory (BDI) scaleBehavioral: • Post-traumatic Check List Scale

Interventions

self-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa

TCA

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

TCA

a diagnostic self-questionnaire allowing a quantitative estimation of the intensity of depressive symptoms in adults and adolescents

TCA

questionnaire includes 20 items, each question is to be rated between 1 and 5 depending on the intensity and frequency of symptoms during the previous month.

TCA

Eligibility Criteria

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

* The patient presenting or having presented a TCA * The parents * One or more health professionals taking care of the patient * The school attended by the patient who will be questioned about the TCA and Covid-19 problem in general or not about the patient in particular.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lenval

Nice, France

Location

MeSH Terms

Conditions

Mental DisordersCOVID-19

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Louise-Emilie DUMAS, MD

    Fondation Lenval

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 22, 2023

Study Start

July 12, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

January 29, 2024

Record last verified: 2023-03

Locations