ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders (ELENA)
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|ClinicalTrials.gov Identifier: NCT02625116|
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : April 27, 2016
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.
|Condition or disease|
|Autism Spectrum Disorders|
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.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||October 2025|
- Adaptive behavior scores obtained using the three sub-scales of the Vineland Adaptive Behavior Scale [ Time Frame: 18 months ]Communication, Daily Living Skills and Socialization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625116
|Contact: Amaria BAGHDADLI, Profesoremail@example.com|
|Contact: Julie Loubersac, CRA||04 67 33 98 firstname.lastname@example.org|
|CHU Montpellier-Hôpital La Colombière||Recruiting|
|Contact: Amaria Baghdadli, Profesor 04.67.33.63.83 email@example.com|
|Contact: Cécile Michelon, CRA 04.67.33.09.86 firstname.lastname@example.org|
|Principal Investigator:||Amaria BAGHDADLI, Profesor||Autism Ressource Center|