ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders
NCT ID: NCT02625116
Last Updated: 2024-05-28
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
919 participants
OBSERVATIONAL
2014-09-27
2025-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Parental refusal to participate
2 Years
16 Years
ALL
No
Sponsors
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Caisse Nationale de Solidarité pour l'Autonomie
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Amaria BAGHDADLI, Profesor
Role: PRINCIPAL_INVESTIGATOR
Autism Ressource Center
Locations
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CHU Montpellier-Hôpital La Colombière
Montpellier, , France
Countries
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References
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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.
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. 2025 Mar 22. doi: 10.1007/s10803-025-06795-y. Online ahead of print.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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8852-2
Identifier Type: -
Identifier Source: org_study_id
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