Autism Spectrum DisorderELENA-SNDSNCT04292522
Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort
An observational study of Autism Spectrum Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 903 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2020to 31 Dec 2021
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with ASD included in the ELENA Cohort
Who may be able to join
- Included in ELENA Cohort
Who cannot join
- Opposable to reuse data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Amaria Baghdadli, Professor, 04 67 33 98 64 ext. 33, rech-clinique-autisme@chu-montpellier.fr
About this study
Official title: Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System
Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).
The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Care pathway, Health administrative database
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Care pathway
Care pathway will be built from administrative database from birth to 2019
Measured: 1 day
Clinical characteristics
Clinical, social and environmental data of children from ELENA cohort
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 posted3 Mar 2020
- Study start27 Feb 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 903 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaria Baghdadli, Professor, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292522
- Sponsor's protocol ID
- RECHMPL19_0443-UF7969
- Acronym
- ELENA-SNDS
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Loubersac J, Picot MC, Belloc F, Boussac M, Baghdadli A. Linking the national health database to the cohort of children with autism spectrum disorders: a mixed approach to optimising the linkage. J Epidemiol Popul Health. 2026 Aug;74(4):203349. doi: 10.1016/j.jeph.2026.203349. Epub 2026 Jul 23.
PubMed 42492413
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System
- ClinicalTrials.gov ID
- NCT04292522
- Acronym / sponsor ID
- ELENA-SNDS / RECHMPL19_0443-UF7969
- Conditions
- Autism Spectrum Disorder
- Keywords
- Care pathway, Health administrative database
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 903 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Mar 2020 (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 lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).
The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with ASD included in the ELENA Cohort
Key inclusion criteria (1 listed)
- Included in ELENA Cohort
Key exclusion criteria (1 listed)
- Opposable to reuse data
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
Care pathway
Time frame: 1 day
Care pathway will be built from administrative database from birth to 2019
Clinical characteristics
Time frame: 1 day
Clinical, social and environmental data of children from ELENA cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 42492413Loubersac J, Picot MC, Belloc F, Boussac M, Baghdadli A. Linking the national health database to the cohort of children with autism spectrum disorders: a mixed approach to optimising the linkage. J Epidemiol Popul Health. 2026 Aug;74(4):203349. doi: 10.1016/j.jeph.2026.203349. Epub 2026 Jul 23.
- Individual participant dataSharing planned: Undecided. NC
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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.
Amaria Baghdadli, Professor principal investigator
University Hospitals of Montpellier
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 Autism Spectrum Disorder, run by University Hospital, Montpellier 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 1 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 5 Mar 2020. 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 Amaria Baghdadli, Professor (04 67 33 98 64 ext. 33, rech-clinique-autisme@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care pathway (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292522, which also lists 1 linked publication.
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 5 Mar 2020.