NCT02625116

Brief 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 specialized in the assessment of developmental disorders.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
919

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

9.9 years

First QC Date

December 4, 2015

Last Update Submit

May 24, 2024

Conditions

Autism Spectrum Disorders

Keywords

Cohort

Outcome Measures

Primary Outcomes (1)

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

    Communication, Daily Living Skills and Socialization

    18 months

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject refusal to participate
  • Parental refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier-Hôpital La Colombière

Montpellier, France

Location

Related Publications (11)

  • 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.

    PMID: 41601706DERIVED

  • 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 Jan 8. doi: 10.1002/aur.70164. Online ahead of print.

    PMID: 41508375DERIVED

  • 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.

    PMID: 40409244DERIVED

  • 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.

    PMID: 40120015DERIVED

  • 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.

    PMID: 36646708DERIVED

  • 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.

    PMID: 36532191DERIVED

  • 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.

    PMID: 36518364DERIVED

  • 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.

    PMID: 34822048DERIVED

  • 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.

    PMID: 34776249DERIVED

  • 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.

    PMID: 33662654DERIVED

  • 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.

    PMID: 31221874DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amaria BAGHDADLI, Profesor

    Autism Ressource Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 9, 2015

Study Start

September 27, 2014

Primary Completion

September 1, 2024

Study Completion

October 1, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)