Skip to main content
Clinical Trials/NCT03924973
NCT03924973
Completed
N/A

Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism

Hôpital le Vinatier1 site in 1 country93 target enrollmentApril 17, 2019
ConditionsAutism

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism
Sponsor
Hôpital le Vinatier
Enrollment
93
Locations
1
Primary Endpoint
ADOS (Autism Diagnostic Observation Schedule )
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.

The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.

Detailed Description

180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA. Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.

Registry
clinicaltrials.gov
Start Date
April 17, 2019
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion in the initial IDEA trail
  • Requiring less than 40 minutes travel to the assessment center

Exclusion Criteria

  • Impossibility of coming in for assessment
  • Exclusion from IDEA

Outcomes

Primary Outcomes

ADOS (Autism Diagnostic Observation Schedule )

Time Frame: 3 YEARS

Autism Diagnostic Observation Schedule is a semi-structured, standardized, observational tool, which measures core autism symptoms, that is to say reciprocal sociocommunicative interaction, and repetitive and restrictive behaviors. This assessment will be administered by an assessor blind to the allocation group.

Secondary Outcomes

  • VABS (Vineland Adaptive Behavior Scales)(3 YEARS)
  • Parental self-assentiment(3 YEARS)
  • Wechsler (Wechsler Intelligence Scale for Children)(3 YEARS)
  • PPVT ( Peabody Picture Vocabulary Test )(3 YEARS)

Study Sites (1)

Loading locations...

Similar Trials