ELENA-E0 - Study of outcome trajectories and risk factors in a cohort of children and adolescents with Autism Spectrum Disorders (ASD)
Head :
Baghdadli Amaria, CESP INSERM U 1178
Last update : 09/08/2017 | Version : 1 | ID : 5021
| General | |
| Identification | |
| Detailed name | Study of outcome trajectories and risk factors in a cohort of children and adolescents with Autism Spectrum Disorders (ASD) |
| Sign or acronym | ELENA-E0 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 1601742 v 0 |
| General Aspects | |
| Medical area |
Neurology Pediatrics Psychology and psychiatry |
| Health determinants |
Genetic Social and psychosocial factors |
| Keywords | trajectories of change, clinical epidemiology, childhood, adolescence, autism spectrum disorders, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Baghdadli |
| Surname | Amaria |
| Address | CHU de Montpellier, 291 avenue du Doyen Gaston Giraud 34295 Montpellier cedex 5 |
| Phone | + 33 (0)4 67 33 99 68 |
| a-baghdadli@chu-montpellier.fr | |
| Unit | CESP INSERM U 1178 |
| Organization | Centre de Ressources Autisme |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Appel d'offre interne cohorte 2011 - CNSA 2012 - PHRCN2013 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU MONTPELLIER |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | 1) To describe the characteristics of a large sample of individuals with a diagnosis of ASD aged between 2 and 16 years, in the clinical, biological, developmental and psychosocial domains 2) To identify outcome trajectories over years and their determinants. |
| Inclusion criteria | Children and adolescents under age 20, with a diagnosis of ASD formally established by a multidisciplinary team according to international criteria. Parents must have given their oral consent. |
| Population type | |
| Age |
Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population covered |
Sick population |
| Pathology | F84 - Pervasive developmental disorders |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 13 centers |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2012 |
| Date of last collection (YYYY or MM/YYYY) | in progress |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 550 patients recruted |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | ADI, ADOS, Vineland 2, IQ, motricity |
| Declarative data (detail) |
Paper self-questionnaire Internet self-questionnaire Face to face interview Phone interview |
| Details of collected declarative data | medical history, Quality of lie, aberrant behavior checklist, comorbidities, |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | The follow-up consists of multidisciplinary assessments spaced out of 30 months and a yearly collection of life and medical events, adaptive behaviors and intervention. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/25444837 |
| Description | Mise en place d’une cohorte française d’enfants et adolescents présentant des troubles du spectre autistique : cohorte ELENA. A. Baghdadli, J. Loubersac, M. Soussana, C. Rattaz, C. Michelon. RESP 2014 Oct;62(5):297-303. doi: 10.1016/j.respe.2014.07.002 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | access to the data base is subject to the approval of the scientific leader and the sponsor of the study |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
