Developmental Trajectories in ASD Until Adulthood: A 15 Years Follow-up Study (EpiTED)

Study of Developmental Trajectories From Childhood to Adulthood Patients of the Cohort EpiTED: Research for Prognostic Factors Clinical and Biological

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Other: Vineland II (VABS -II); Other: Quality of life

Detailed Description

Purpose: 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.

Participants: This longitudinal study for which recruitment began between 1997 and 1999, has initially involved 281 preschool aged children recruited from 5 French areas. They were seen at 8 (Time 2), 15 (Time 3) and 20 years of age (Time 4), with an average follow-up length of 15 years. At each follow-up, socio-demographical, clinical, developmental and interventional were collected. At Time 4 (fourth visit), DNA was collected to do a genetic study Findings to date: The main results show that there were two developmental trajectories from childhood to adolescence among the cohort leading to very distinct level of adaptive functioning. Prognosis factors in childhood were the intellectual level, the presence or absence of language, the autism degree and the absence or presence of epilepsy. During adolescence there was a negative impact on the quality of life of the parents of the presence of aberrant behavior and low level functioning, The children included in the cohort were followed during 15 years and were assessed four times (at 5, 8, 15 and 20 years on average, see flow chart in figure 1. From 2000 to 2002, 219 of the original group were reassessed (time 2, T2). At time 3 (T3), between 2007 and 2009, they were 152 to be re-assessed and 106 between 2012 and 2015 (time 4, T4).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Patients with diagnosis of infantile autism or atypical autism according to the criteria of the CIM 10 at the time of their initial inclusion.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient with autism disorder; Interview with a psychologist who do Vineland II (VABS -II) and evaluate Quality of life and comorbidities	Other: Vineland II (VABS -II); semi-structured interview with a psychologist; Measure 4 areas: Communication, skills of daily living, socialization and skills Motrices; Other: Quality of life; Evaluation of the quality of life and comorbidities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Evaluation of quality of life by questionnaire	1 day
comorbidities	Evaluation comorbidities by a clinician directed interview	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Amaria Baghdadli, MCU-PH, CHU de Montpellier

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Cohort; Autism Spectrum Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 8878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No