NCT03924973

3 Year Follow up Study of the IDEA Population

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 39 Months – 60 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Autism

Interventions

Type	Name	Description
BEHAVIORAL	ESDM followed by treatment as usual	The intervention was ESDM, delivered by professionals, one therapist per child, 12 hours per week during 2 years. Then, they will receive the treatment as usual during 3 years in this current follow-up study. Precise description of the 2 years ESDM treatment can be found in the published protocol of IDEA. 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. All the interventions received by the children will be monitored in IDEA-2. All different treatment approaches will be quantified (type, frequency, intensity and duration).

Timeline

• Start date: 2019-04-17
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-04-23
• Last updated: 2025-03-06

Locations

1 site across 1 country: France