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

3 Year Follow up Study of the IDEA Population

Sponsors

Lead sponsor: Hôpital le Vinatier

Source Hôpital le Vinatier
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.

Overall Status Recruiting
Start Date April 17, 2019
Completion Date December 31, 2025
Primary Completion Date December 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
ADOS (Autism Diagnostic Observation Schedule ) 3 YEARS
Secondary Outcome
Measure Time Frame
Wechsler (Wechsler Intelligence Scale for Children) 3 YEARS
VABS (Vineland Adaptive Behavior Scales) 3 YEARS
PPVT ( Peabody Picture Vocabulary Test ) 3 YEARS
Parental self-assentiment 3 YEARS
Enrollment 174
Condition
Intervention

Intervention type: Behavioral

Intervention name: ESDM followed by treatment as usual

Description: 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).

Other name: 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

Gender: All

Minimum age: 39 Months

Maximum age: 60 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GEOFFRAY MARIE-MAUDE, PH Principal Investigator CH LE VINATIER
Overall Contact

Last name: GEOFFRAY MARIE-MAUDE, PH

Phone: 0033437915256

Email: [email protected]

Location
facility status contact contact_backup Hopital Vinatier GEOFFRAY Marie-Maude, PhD +33 (0)4 72 75 53 24 [email protected]
Location Countries

France

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Experimental group

Arm group type: Experimental

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.

Arm group label: Control group

Arm group type: Other

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.

Acronym IDEA2SCOLA
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: single blind

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: randomization will follow that of the IDEA study

Source: ClinicalTrials.gov