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Autism Spectrum DisordersELENANCT02625116

ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

An observational study of Autism Spectrum Disorders, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors. This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services… Read more about this study

Who is it for?
Ages 2 to 16 years
Conditions the study is for
Autism Spectrum Disorders
How many people
919 participants
Where
1 siteFrance
Study dates
27 Sep 2014to Oct 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 2 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: The study population is aged between 2 and 16 years, and has a diagnosis of ASD formally established during a multidisciplinary assessment and made according international criteria of the ICD10.

Who may be able to join

  • Age between 2 and 16 years
  • Diagnosis of ASD formally established during a multidisciplinary assessment, according ICD 10 criteria and ADI
  • Patient who benefited in the last 12 months: Vineland, ADOS, intellectual level
  • Parents consent

Who cannot join

  • Subject refusal to participate
  • Parental refusal to participate

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Montpellier-Hôpital La Colombière

    Montpellier

Other trials in France

About this study

The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders.

Read the detailed description

Multidisciplinary cohort studies of children with Autism Spectrum Disorders (ASD) followed from childhood to adulthood exist abroad but not in France. The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders. The patients will be monitored every 18 months for at least 36 months and during a maximum of 10 years. Clinical, social, environmental, and genetic data, as well as data relating to the parental quality of life will be collected. The primary endpoint will be the adaptive level in three domains of the Vineland II (Communication, Socialization and Daily living skills). The secondary endpoints will be parental quality of life, comorbidities, interventions and severity of ASD.

The inclusion of 900 patients over a 10-year period is expected. This cohort should contribute to a better knowledge of the child with ASD's development, taking into account his physical, social and familial environment, the type of interventions and some genetic components. It should also lay the foundations for a national network of professionals working in the field of autism research by offering them a common tool for promoting translational studies.

Keywords
Cohort
Medical subject headings
Autism Spectrum Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adaptive behavior scores obtained using the three sub-scales of the Vineland Adaptive Behavior Scale

    Communication, Daily Living Skills and Socialization

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study start27 Sep 2014
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Prospective
Enrolment
919 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625116
Sponsor's protocol ID
8852-2
Acronym
ELENA
Status last verified
May 2024
First submitted
4 Dec 2015
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Peyre H, Baghdadli A. Investigating the ADOS-2 calibrated severity score: insights from the ELENA cohort. Front Child Adolesc Psychiatry. 2026 Jan 12;4:1674226. doi: 10.3389/frcha.2025.1674226. eCollection 2025.

    PubMed 41601706

  • Rattaz C, Peries M, Pickles A, Baghdadli A. The Impact of Inclusive Education Practices on Students With ASD'S Outcomes: Report From the ELENA French Cohort Study. Autism Res. 2026 Feb;19(2):e70164. doi: 10.1002/aur.70164. Epub 2026 Jan 8.

    PubMed 41508375

  • Nemorin H, Michelon C, Peyre H, Monnier M, Peries M, Baghdadli A. Profiling clinical heterogeneity in Autism Spectrum Disorder at time of children's diagnosis: A cluster analysis from the ELENA cohort. Res Dev Disabil. 2025 Aug;163:105040. doi: 10.1016/j.ridd.2025.105040. Epub 2025 May 22.

    PubMed 40409244

  • Mortamais M, Ongono JS, Michelon C, Hough I, Seyve E, Kloog I, Zaros C, Charles MA, Lepeule J, Baghdadli A. Prenatal Exposure to Ambient Particulate Matter and Autism Spectrum Disorder in Children, a Case Control Study in France. J Autism Dev Disord. 2026 Sep;56(9):3713-3725. doi: 10.1007/s10803-025-06795-y. Epub 2025 Mar 22.

    PubMed 40120015

  • Peries M, Duhr F, Picot MC, Heude B, Bernard JY, Baghdadli A. Breastfeeding is not a risk factor for clinical severity in Autism spectrum disorder in children from the ELENA cohort. Sci Rep. 2023 Jan 16;13(1):816. doi: 10.1038/s41598-022-27040-x.

    PubMed 36646708

  • Berard M, Peries M, Loubersac J, Picot MC, Bernard JY, Munir K, Baghdadli A. Screen time and associated risks in children and adolescents with autism spectrum disorders during a discrete COVID-19 lockdown period. Front Psychiatry. 2022 Dec 1;13:1026191. doi: 10.3389/fpsyt.2022.1026191. eCollection 2022.

    PubMed 36532191

  • Dellapiazza F, Michelon C, Rattaz C, Picot MC, Baghdadli A. Sex-related differences in clinical characteristics of children with ASD without ID: Results from the ELENA cohort. Front Psychiatry. 2022 Nov 28;13:998195. doi: 10.3389/fpsyt.2022.998195. eCollection 2022.

    PubMed 36518364

  • Vernhet C, Michelon C, Dellapiazza F, Rattaz C, Geoffray MM, Roeyers H, Picot MC, Baghdadli A; ELENA study group. Perceptions of parents of the impact of autism spectrum disorder on their quality of life and correlates: comparison between mothers and fathers. Qual Life Res. 2022 May;31(5):1499-1508. doi: 10.1007/s11136-021-03045-3. Epub 2021 Nov 25.

    PubMed 34822048

  • Miniarikova E, Vernhet C, Peries M, Loubersac J, Picot MC, Munir K, Baghdadli A. Anxiety and depression in parents of children with autism spectrum disorder during the first COVID-19 lockdown: Report from the ELENA cohort. J Psychiatr Res. 2022 May;149:344-351. doi: 10.1016/j.jpsychires.2021.11.022. Epub 2021 Nov 8.

    PubMed 34776249

  • Berard M, Rattaz C, Peries M, Loubersac J, Munir K, Baghdadli A. Impact of containment and mitigation measures on children and youth with ASD during the COVID-19 pandemic: Report from the ELENA cohort. J Psychiatr Res. 2021 May;137:73-80. doi: 10.1016/j.jpsychires.2021.02.041. Epub 2021 Feb 22.

    PubMed 33662654

  • Baghdadli A, Miot S, Rattaz C, Akbaraly T, Geoffray MM, Michelon C, Loubersac J, Traver S, Mortamais M, Sonie S, Pottelette J, Robel L, Speranza M, Vesperini S, Maffre T, Falissard B, Picot MC; ELENA Study Group. Investigating the natural history and prognostic factors of ASD in children: the multicEntric Longitudinal study of childrEN with ASD - the ELENA study protocol. BMJ Open. 2019 Jun 19;9(6):e026286. doi: 10.1136/bmjopen-2018-026286.

    PubMed 31221874

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorders, 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 4 inclusion and 2 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 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adaptive behavior scores obtained using the three sub-scales of the Vineland Adaptive Behavior Scale (time frame: 18 months). 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 NCT02625116, which also lists 11 linked publications.

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 May 2024.

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