Conversion Disorder in ChildrenTC-HPaSNCT05746637
The Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder
An observational study of Conversion Disorder in Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Conversion Disorder in Children
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Our population will be a clinical population, made up of children and adolescents aged 6 to 18 years followed at the Clermont-Ferrand University Hospital for TSNF, their parents, and the health professionals who care for them. Before the age of 6, it is not easy to talk about oneself and the collection of information is generally done through the parents. After the age of 6, children are able to describe their experience, which allows us to collect their experiences and those of their parents separately. Adolescents between 16 and 18 years of age are often still followed by pediatric teams, and mostly followed by child psychiatry, which justifies the broad cut-off of 18 years.
Who may be able to join
- 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
Show all 12Show fewer
- 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].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Aurore Legrand-Vyskoc
About this study
Official title: Qualitative and Quantitative Study of the Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder
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.
Read the 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.
- Conditions
- Conversion Disorder in Children
- Keywords
- adolescents, functional neurological symptom disorder, children, qualitative study
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | The entire study population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' experience of the diagnostic circumstances and care pathway
Obtaining a thematic grid describing the participants' experience of the diagnostic circumstances and care pathway of TSNF in children and adolescents.
Measured: 1 day
Secondary outcomes (8)
Description the diversity of experiences according to each type of participant
Obtaining a thematic grid describing the diversity of experiences according to each type of participant
Measured: 1 day
Participants' expectations regarding the diagnosis and management of TSNF
Obtained a thematic grid describing the participants' expectations regarding the diagnosis and management of TSNF
Measured: 1 day
Total duration of the diagnosis pathway
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.
Measured: 1 day
Total number of outpatient consultations related to TSNF
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.
Measured: 1 day
Total number of part-time inpatient stays
Total number of part-time inpatient stays related to TSNF during the pre-diagnosis period
Measured: 1 day
Total number of full-time inpatient stays in the OOH setting
Total number of full-time inpatient stays in the OOH setting during the pre-diagnosis period
Measured: 1 day
Total length of stay in full-time OCM hospitalization
Total length of stay in full-time OCM hospitalization related to TSNF in the pre-diagnosis period.
Measured: 1 day
Presence of one or more biological or radiological additional examination from the list
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start6 Dec 2022
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conversion Disorder in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore Legrand-Viskoc, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746637
- Sponsor's protocol ID
- RNI 2021 LEGRAND-VYSKOC
- Acronym
- TC-HPaS
- Status last verified
- Dec 2022
- First submitted
- 18 Nov 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Study of the Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder
- ClinicalTrials.gov ID
- NCT05746637
- Acronym / sponsor ID
- TC-HPaS / RNI 2021 LEGRAND-VYSKOC
- Conditions
- Conversion Disorder in Children
- Keywords
- adolescents, functional neurological symptom disorder, children, qualitative study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –The entire study population |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Our population will be a clinical population, made up of children and adolescents aged 6 to 18 years followed at the Clermont-Ferrand University Hospital for TSNF, their parents, and the health professionals who care for them. Before the age of 6, it is not easy to talk about oneself and the collection of information is generally done through the parents. After the age of 6, children are able to describe their experience, which allows us to collect their experiences and those of their parents separately. Adolescents between 16 and 18 years of age are often still followed by pediatric teams, and mostly followed by child psychiatry, which justifies the broad cut-off of 18 years.
Key inclusion criteria (12 listed)
- Patients
- 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,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants' experience of the diagnostic circumstances and care pathway
Time frame: 1 day
Obtaining a thematic grid describing the participants' experience of the diagnostic circumstances and care pathway of TSNF in children and adolescents.
8 secondary outcomes
Description the diversity of experiences according to each type of participant
Time frame: 1 day
Participants' expectations regarding the diagnosis and management of TSNF
Time frame: 1 day
Total duration of the diagnosis pathway
Time frame: 1 day
Total number of outpatient consultations related to TSNF
Time frame: 1 day
Total number of part-time inpatient stays
Time frame: 1 day
Total number of full-time inpatient stays in the OOH setting
Time frame: 1 day
Total length of stay in full-time OCM hospitalization
Time frame: 1 day
Presence of one or more biological or radiological additional examination from the list
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore Legrand-Viskoc principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conversion Disorder in Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' experience of the diagnostic circumstances and care pathway (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.