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

Autism Spectrum Disorders Clinical Trial

— ELENA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02625116
• Other study ID #: 8852-2
• Status: Active, not recruiting
• Start date: September 27, 2014
• Est. completion date: October 2025

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 specialized in the assessment of developmental disorders.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 919
• Est. completion date: October 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject refusal to participate
• Parental refusal to participate

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
France	CHU Montpellier-Hôpital La Colombière	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Caisse Nationale de Solidarité pour l'Autonomie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptive behavior scores obtained using the three sub-scales of the Vineland Adaptive Behavior Scale	Communication, Daily Living Skills and Socialization	18 months