TC-HPaS: The Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05746637
Collaborator
(none)
60
1
23.9
2.5

Study Details

Study Description

Brief Summary

The goal of this qualitative and quantitative cross-sectional observational study is to describe the complexity of the diagnostic pathway for Functional Neurological Symptomatology Disorder (TSNF) in children and adolescents based on the experience of the different protagonists of care (parents, adolescents, caregivers).

The main question[s] it aims to answer are:
  • How do the various stakeholders experiences the care pathway for children and adolescents with a diagnosis of TSNF

  • What are their expectations regarding the diagnosis and management of TSNF Participants will be enrolled in interviews in which they will describe their experience. Parents will also answer a lifestyle questionnaire.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Conversion Disorder (CD) or Functional Neurological Symptomatology Disorder (FNSD) is a pathology characterized by the occurrence of non-simulated physical symptoms of neurological appearance in the absence of underlying organic pathology.

    The hyperspecialization of medicine makes the therapeutic approach to FNSD very complex for several reasons:

    • Pediatric health professionals are trained to diagnose and treat physical disorders and are at a loss when it comes to psychological disorders

    • Physicians often increase the number of complementary tests before making a diagnosis of FNSD, for fear of missing a serious or urgent pathology

    • Psychiatric diagnosis is a diagnosis of exclusion, and TSNF is therefore often evoked at the end of the treatment, which leads to wandering in the patient's care This delay in diagnosis does not allow patients to receive appropriate care and the consequences can be serious.

    The objective of this mixed qualitative and quantitative study is to study the complexity of the care pathway of patients aged 6 to 18 years with a diagnosis of TSNF, as well as their parents and the health professionals who have taken care of them. The collection of their experience will be done by means of semi-structured interviews which will then be analyzed according to the Interpretative Phenomenological Analysis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Qualitative and Quantitative Study of the Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder
    Actual Study Start Date :
    Dec 6, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Study population

    The entire study population

    Outcome Measures

    Primary Outcome Measures

    1. Participants' experience of the diagnostic circumstances and care pathway [1 day]

      Obtaining a thematic grid describing the participants' experience of the diagnostic circumstances and care pathway of TSNF in children and adolescents.

    Secondary Outcome Measures

    1. Description the diversity of experiences according to each type of participant [1 day]

      Obtaining a thematic grid describing the diversity of experiences according to each type of participant

    2. Participants' expectations regarding the diagnosis and management of TSNF [1 day]

      Obtained a thematic grid describing the participants' expectations regarding the diagnosis and management of TSNF

    3. Total duration of the diagnosis pathway [1 day]

      Total duration (days) between the 1st medical consultation related to TSNF and the 1st psychological consultation (psychiatrist, child psychiatrist, psychologist or multidisciplinary evaluation with psychologist or psychiatrist on the team). This period corresponds to the pre-diagnostic period for the study.

    4. Total number of outpatient consultations related to TSNF [1 day]

      Total number of outpatient consultations related to TSNF during the pre-diagnosis period, including: consultations with general practitioners and specialists other than psychiatrists, consultations in pediatric or adult emergency rooms.

    5. Total number of part-time inpatient stays [1 day]

      Total number of part-time inpatient stays related to TSNF during the pre-diagnosis period

    6. Total number of full-time inpatient stays in the OOH setting [1 day]

      Total number of full-time inpatient stays in the OOH setting during the pre-diagnosis period

    7. Total length of stay in full-time OCM hospitalization [1 day]

      Total length of stay in full-time OCM hospitalization related to TSNF in the pre-diagnosis period.

    8. Presence of one or more biological or radiological additional examination from the list [1 day]

      Presence of at least one biological or radiological additional examination from the following list during the care pathway : biological blood sample, biological cerebrospinal fluid sample, any radiological examination, electroencephalogram or electromyogram related to TSNF or to the search for a differential diagnosis in the pre-diagnostic period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients

    • Child or adolescent, boy or girl, aged 6 to 17 years inclusive, treated at the Clermont-Ferrand University Hospital for a conversion disorder diagnosed by a psychiatrist during the past year

    • Presence or not of a follow-up in child psychiatry after the diagnosis

    • Agreement of the legal representatives for participation in the study.

    • Affiliation to a Social Security system.

    • Parents / legal representatives

    o Adult subject, parent or legal representative of a child or adolescent meeting the above-mentioned inclusion criteria and participating in the study

    • Health professionals

    o Person affiliated with the Clermont-Ferrand University Hospital, with experience in caring for children or adolescents with a conversion disorder (pediatrician, psychiatrist, nurse, psychologist,

    • For all participants

    • Able to give informed consent to participate in the research.

    • Proficiency in the French language [NB the written language must be mastered by the parents to answer the questionnaires].

    Exclusion Criteria:
    • For all participants: Present a decompensated somatic or psychiatric pathology or a disorder of vigilance compromising the realization of the research, refusal to participate in the research.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Clermont-Ferrand Clermont-Ferrand France

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    • Principal Investigator: Aurore Legrand-Viskoc, University Hospital, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT05746637
    Other Study ID Numbers:
    • RNI 2021 LEGRAND-VYSKOC
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2023