3 Year Follow up Study of the IDEA Population (IDEA2SCOLA)

Hôpital le Vinatier

Status: Completed

Conditions: Autism

Treatments: Behavioral: ESDM followed by treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03924973

2017-A02446-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 39 to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Experimental group

Experimental group

Description:

Children below the age of 3 in this group received 2 years of ESDM intervention for 12 hours per week, and then treatment as usual for the 3 following years. What is called "treatment as usual" is what the community can usually offer. That is what the control group in IDEA received. In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years. Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community.

Treatment:

Behavioral: ESDM followed by treatment as usual

Control group

Other group

Description:

Children in this group received treatment as usual delivered in the community for the 2 years of IDEA. Participants will still receive treatment as usual delivered in the community during IDEA-2, in the 3 years following IDEA.

Treatment:

Behavioral: ESDM followed by treatment as usual