3 Year Follow up Study of the IDEA Population
- Conditions
- Autism
- Interventions
- Behavioral: ESDM followed by treatment as usual
- Registration Number
- NCT03924973
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Inclusion in the initial IDEA trail
- Requiring less than 40 minutes travel to the assessment center
- Impossibility of coming in for assessment
- Exclusion from IDEA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group ESDM followed by treatment as usual 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. Experimental group ESDM followed by treatment as usual 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.
- Primary Outcome Measures
Name Time Method ADOS (Autism Diagnostic Observation Schedule ) 3 YEARS 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
Name Time Method VABS (Vineland Adaptive Behavior Scales) 3 YEARS 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 IDEAParental self-assentiment 3 YEARS Scholastic skills and interventions measured by Parental self-assentiment
Wechsler (Wechsler Intelligence Scale for Children) 3 YEARS 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 IDEAPPVT ( Peabody Picture Vocabulary Test ) 3 YEARS 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
Trial Locations
- Locations (1)
Hopital Vinatier
🇫🇷Bron, France