NCT02828332

Brief Summary

Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD, but little is known about their determinant in a long-term perspective. The EpiTED cohort was set-up in order to understand the heterogeneity of developmental trajectories among children with a diagnosis of PDD and the role of clinical, biological and environmental factors in their adaptive outcome. It is one of the rare cohorts involving a long term prospective follow-up based on a large set of variables, and precise phenotypes of the entire autism spectrum.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

October 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

July 5, 2016

Last Update Submit

July 6, 2016

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum DisordersCohort

Outcome Measures

Primary Outcomes (1)

  • Vineland II (VABS -II)

    semi-structured interview with a psychologist; Measure 4 areas: Communication, skills of daily living, socialization and skills Motrices

    1 day

Secondary Outcomes (2)

  • Quality of life

    1 day

  • comorbidities

    1 day

Study Arms (1)

Patient with autism disorder

OTHER

Interview with a psychologist who do Vineland II (VABS -II) and evaluate Quality of life and comorbidities

Other: Vineland II (VABS -II)Other: Quality of life

Interventions

Vineland II (VABS -II)OTHER

semi-structured interview with a psychologist; Measure 4 areas: Communication, skills of daily living, socialization and skills Motrices

Patient with autism disorder
Quality of lifeOTHER

Evaluation of the quality of life and comorbidities

Patient with autism disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients previously include in the troop constituted in 1997 /1999 as part of PHRC 96/97 and having been followed during 10 years.
  • Patients are 18

You may not qualify if:

  • Refusal of participation
  • Women pregnant breastfeeding
  • persons deprived of freedom by court order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Amaria Baghdadli, MCU-PH

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share