Autism Spectrum DisorderECO-TSANCT06409728
Prevalence and Healthcare Consumption of ASD Patients Using French Medico-administrative Data
An observational study of Autism Spectrum Disorder, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 600 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2024to 1 Jan 2025
- 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 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Population Study are children aged 16 or younger with ASD hospitalized in unversity hospital.
Who may be able to join
- Children aged 16 years or younger
- For case : with an ICD-10 code for ASD (F84*)
- For control : without an ICD-10 code for ASD (F84*)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
University Hospital Dijon
Dijon
Catherine Quantin, Prof.
- Recruiting
University Hospital Montpellier
Montpellier, 34295
Amaria Baghdadli, Prof, +33467339864, rech-clinique-autisme@chu-montpellier.fr
Julie Loubersac, PhD, +33467339864, j-loubersac@chu-montpellier.fr
About this study
Official title: Prevalence and Healthcare Consumption of ASD Patients Using French Medico-administrative Data (SNDS)
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. It is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. The prevalence of ASD has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in France to 31/1,000 in Iceland. In France, prevalence has been estimated by two child disability registers set up in the departments of Haute-Garonne (RHE31), Isère, Savoie, and Haute-Savoie (RHEOP), but there is no epidemiological surveillance system to estimate the national prevalence of ASD in the general population. However, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with ASD and for evaluating public policies.
The main objective of our project is to estimate the annual prevalence of ASD in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (SNDS), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. Our secondary objectives are to validate an algorithm for detecting ASD in the National Health Data System (SNDS) and to estimate the direct medical costs associated with ASD management.
Read more
The SNDS databases contain all medical care and treatments reimbursed for Health Insurance beneficiaries provided in the private or public sector. A case detection algorithm will be tested and validated on validation samples. Then, the prevalence of ASD will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in France and abroad. An estimate of direct medical costs will be made from the health insurance perspective.
Our project therefore proposes the development of reliable indicators on the management of ASD in France with the aim of providing useful indicators and tools for guiding health and disability policies in France, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with ASD as well as reducing inequalities in access to healthcare for these vulnerable populations.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Administrative claims, Population surveillance
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
ASD diagnostic code in healthcare database
≥ 1 hospitalization with ASD diagnostic code (F84*)
Measured: 1 year
Secondary outcomes (2)
Prevalence of ASD
Measured: 2010-2019
Cost of medical care reimbursed by health insurance for patient with ASD
Measured: 2010-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409728
- Sponsor's protocol ID
- RECHMPL21_0063
- Acronym
- ECO-TSA
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Healthcare Consumption of ASD Patients Using French Medico-administrative Data (SNDS)
- ClinicalTrials.gov ID
- NCT06409728
- Acronym / sponsor ID
- ECO-TSA / RECHMPL21_0063
- Conditions
- Autism Spectrum Disorder
- Keywords
- Administrative claims, Population surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 10 May 2024 (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.
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. It is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. The prevalence of ASD has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in France to 31/1,000 in Iceland. In France, prevalence has been estimated by two child disability registers set up in the departments of Haute-Garonne (RHE31), Isère, Savoie, and Haute-Savoie (RHEOP), but there is no epidemiological surveillance system to estimate the national prevalence of ASD in the general population. However, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with ASD and for evaluating public policies.
The main objective of our project is to estimate the annual prevalence of ASD in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (SNDS), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. Our secondary objectives are to validate an algorithm for detecting ASD in the National Health Data System (SNDS) and to estimate the direct medical costs associated with ASD management.
The SNDS databases contain all medical care and treatments reimbursed for Health Insurance beneficiaries provided in the private or public sector. A case detection algorithm will be tested and validated on validation samples. Then, the prevalence of ASD will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in France and abroad. An estimate of direct medical costs will be made from the health insurance perspective.
Our project therefore proposes the development of reliable indicators on the management of ASD in France with the aim of providing useful indicators and tools for guiding health and disability policies in France, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with ASD as well as reducing inequalities in access to healthcare for these vulnerable populations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Population Study are children aged 16 or younger with ASD hospitalized in unversity hospital.
Key inclusion criteria (3 listed)
- Children aged 16 years or younger
- For case : with an ICD-10 code for ASD (F84*)
- For control : without an ICD-10 code for ASD (F84*)
Key exclusion criteria (0 listed)
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
ASD diagnostic code in healthcare database
Time frame: 1 year
≥ 1 hospitalization with ASD diagnostic code (F84*)
2 secondary outcomes
Prevalence of ASD
Time frame: 2010-2019
Cost of medical care reimbursed by health insurance for patient with ASD
Time frame: 2010-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
University Hospital Montpellier
Montpellier, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by University Hospital, Montpellier at 2 sites 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 3 inclusion and 0 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASD diagnostic code in healthcare database (time frame: 1 year). 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 10 May 2024.