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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

3 Year Follow up Study of the IDEA Population

Clinicaltrials.gov identifier NCT03924973

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted January 7, 2020

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.

  • Condition or Disease:Autism
  • Intervention/Treatment: Behavioral: ESDM followed by treatment as usual
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 174 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: single blind
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2025
Arms and interventions
Arm Intervention/treatment
Other: 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.
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).
Experimental: 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.
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).
Outcome Measures
  • Primary Outcome Measures: 1. ADOS (Autism Diagnostic Observation Schedule ) [ Time Frame: 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: 1. Wechsler (Wechsler Intelligence Scale for Children) [ Time Frame: 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 IDEA
  • 2. VABS (Vineland Adaptive Behavior Scales) [ Time Frame: 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 IDEA
  • 3. PPVT ( Peabody Picture Vocabulary Test ) [ Time Frame: 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
  • 4. Parental self-assentiment [ Time Frame: 3 YEARS ]
    Scholastic skills and interventions measured by Parental self-assentiment
Eligibility Criteria
  • Ages Eligible for Study: 39 to 60 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: GEOFFRAY MARIE-MAUDE, PH 0033437915256 Marie-Maude.GEOFFRAY@ch-le-vinatier.fr

Contact: VIAL VERONIQUE 0033437915531 veronique.vial@ch-le-vinatier.fr

Locations

France
Hopital Vinatier
Bron

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator: GEOFFRAY MARIE-MAUDE, PH CH LE VINATIER

More Information
  • Responsible Party: Hôpital le Vinatier
  • ClinicalTrials.gov Identifier: NCT03924973 History of Changes
  • Other Study ID Numbers: 2017-A02446-47
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: January 7, 2020
  • Last Verified: January 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Autistic Disorder