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

Primary Purpose

Autism

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESDM followed by treatment as usual
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

39 Months - 60 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Hopital VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

ADOS (Autism Diagnostic Observation Schedule )
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 Outcome Measures

Wechsler (Wechsler Intelligence Scale for Children)
The WISC-IV, the Wechsler Intelligence Scale for Children and Adolescents - 4th Edition - measures total IQ as well as 4 indices: verbal comprehension, perceptual reasoning, processing speed and working memory. It is for children aged 6 to 16 and lasts 60 to 90 minutes. The WPPSI-R or the Revised Wechsler Primary and Preschool Intelligence Scale is a psychometric test for very young children, for children from 2 to 6 years old The scores of standard items are between 7 and 13 for the average, if they are less than 4, the child is very deficient in this item. 3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
VABS (Vineland Adaptive Behavior Scales)
The items refer to the age of the person: the first items correspond to the simplest tasks that even a small child should know how to do, and at the end of the scale are grouped the most complex tasks. In the field of communication: items range from 1 to 67.Depending on the standard score obtained, five adaptive levels can be defined:top, moderately High, adequate, moderately low, low Daily adaptive skills measured by the composite score from the Vineland Adaptive Behavior Scales ( VABS) 3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
PPVT ( Peabody Picture Vocabulary Test )
Receptive language skills measured by Peabody Picture Vocabulary Test (PPVT)3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Parental self-assentiment
Scholastic skills and interventions measured by Parental self-assentiment

Full Information

First Posted
April 19, 2019
Last Updated
May 23, 2023
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT03924973
Brief Title
3 Year Follow up Study of the IDEA Population
Acronym
IDEA2SCOLA
Official Title
Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind
Masking
Outcomes Assessor
Masking Description
randomization will follow that of the IDEA study
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
ESDM followed by treatment as usual
Other Intervention Name(s)
Treatment as usual delivered in the community
Intervention 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).
Primary Outcome Measure Information:
Title
ADOS (Autism Diagnostic Observation Schedule )
Description
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.
Time Frame
3 YEARS
Secondary Outcome Measure Information:
Title
Wechsler (Wechsler Intelligence Scale for Children)
Description
The WISC-IV, the Wechsler Intelligence Scale for Children and Adolescents - 4th Edition - measures total IQ as well as 4 indices: verbal comprehension, perceptual reasoning, processing speed and working memory. It is for children aged 6 to 16 and lasts 60 to 90 minutes. The WPPSI-R or the Revised Wechsler Primary and Preschool Intelligence Scale is a psychometric test for very young children, for children from 2 to 6 years old The scores of standard items are between 7 and 13 for the average, if they are less than 4, the child is very deficient in this item. 3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Time Frame
3 YEARS
Title
VABS (Vineland Adaptive Behavior Scales)
Description
The items refer to the age of the person: the first items correspond to the simplest tasks that even a small child should know how to do, and at the end of the scale are grouped the most complex tasks. In the field of communication: items range from 1 to 67.Depending on the standard score obtained, five adaptive levels can be defined:top, moderately High, adequate, moderately low, low Daily adaptive skills measured by the composite score from the Vineland Adaptive Behavior Scales ( VABS) 3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Time Frame
3 YEARS
Title
PPVT ( Peabody Picture Vocabulary Test )
Description
Receptive language skills measured by Peabody Picture Vocabulary Test (PPVT)3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Time Frame
3 YEARS
Title
Parental self-assentiment
Description
Scholastic skills and interventions measured by Parental self-assentiment
Time Frame
3 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GEOFFRAY MARIE-MAUDE, PH
Phone
0033437915256
Email
Marie-Maude.GEOFFRAY@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GEOFFRAY MARIE-MAUDE, PH
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GEOFFRAY Marie-Maude, PhD
Phone
+33 (0)4 72 75 53 24
Email
marie-maude.geoffray@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
+33 (0)4 37 91 55 31
Email
veronique.vial@ch-le-vinatier.fr

12. IPD Sharing Statement

Learn more about this trial

3 Year Follow up Study of the IDEA Population

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