3 Year Follow up Study of the IDEA Population

NCT ID: NCT03924973

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2023-12-31

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

ESDM followed by treatment as usual

Intervention Type: BEHAVIORAL

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).

Control group

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.

Group Type: OTHER

ESDM followed by treatment as usual

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Treatment as usual delivered in the community

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

• Minimum Eligible Age: 39 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GEOFFRAY MARIE-MAUDE, PH

Role: PRINCIPAL_INVESTIGATOR

CH LE VINATIER

Locations

Hopital Vinatier

Bron, , France

Countries

France

Other Identifiers

2017-A02446-47

Identifier Type: -

Identifier Source: org_study_id