NCT04292522

Brief Summary

Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...). The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
903

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

February 27, 2020

Last Update Submit

March 3, 2020

Conditions

Autism Spectrum Disorder

Keywords

Care pathwayHealth administrative database

Outcome Measures

Primary Outcomes (2)

  • Care pathway

    Care pathway will be built from administrative database from birth to 2019

    1 day

  • Clinical characteristics

    Clinical, social and environmental data of children from ELENA cohort

    1 day

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children with ASD included in the ELENA Cohort

You may qualify if:

  • \- Included in ELENA Cohort

You may not qualify if:

  • \- Opposable to reuse data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amaria Baghdadli, Professor

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amaria Baghdadli, Professor

CONTACT

04 67 33 98 64rech-clinique-autisme@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 3, 2020

Study Start

February 27, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

March 5, 2020

Record last verified: 2020-02

Locations

FR(1)