3 Year Follow up Study of the IDEA Population

Autism Clinical Trial

— IDEA2SCOLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924973
• Other study ID #: 2017-A02446-47
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Hôpital le Vinatier
• Contact: GEOFFRAY MARIE-MAUDE, PH
• Phone: 0033437915256
• Email: Marie-Maude.GEOFFRAY[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 39 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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).

Locations

Country	Name	City	State
France	Hopital Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 YEARS
Secondary	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	3 YEARS
Secondary	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	3 YEARS
Secondary	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	3 YEARS
Secondary	Parental self-assentiment	Scholastic skills and interventions measured by Parental self-assentiment	3 YEARS