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

Active, not recruiting

• Conditions: Autism Spectrum Disorders

• Registration Number: NCT02625116
• Lead Sponsor: University Hospital, Montpellier

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.

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.

Study Timeline

• Study Start: 2014-09-27
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 919

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adaptive behavior scores obtained using the three sub-scales of the Vineland Adaptive Behavior Scale	18 months	Communication, Daily Living Skills and Socialization

Trial Locations

Locations (1)

CHU Montpellier-Hôpital La Colombière; 🇫🇷 Montpellier, France