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

This study is currently recruiting participants.
Verified April 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02625116
First Posted: December 9, 2015
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Caisse Nationale de Solidarité pour l'Autonomie
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

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
Autism Spectrum Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 900
Study Start Date: September 2012
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Amaria BAGHDADLI, Profesor 0467336383 a-baghdadli@chu-montpellier.fr
Contact: Julie Loubersac, CRA 04 67 33 98 64 rech-clinique-autisme@chu-montpellier.fr

Locations
France
CHU Montpellier-Hôpital La Colombière Recruiting
Montpellier, France
Contact: Amaria Baghdadli, Profesor    04.67.33.63.83    a-baghdadli@chu-montpellier.fr   
Contact: Cécile Michelon, CRA    04.67.33.09.86    rech-clinique-autisme@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Caisse Nationale de Solidarité pour l'Autonomie
Investigators
Principal Investigator: Amaria BAGHDADLI, Profesor Autism Ressource Center
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02625116     History of Changes
Other Study ID Numbers: 8852-2
First Submitted: December 4, 2015
First Posted: December 9, 2015
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Cohort

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders