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Completed

NCT Number: NCT03924973

3 Year Follow up Study of the IDEA Population

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

39 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Vinatier

Bron, 69678, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESDM followed by treatment as usual

Behavioral

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 names: Treatment as usual delivered in the community

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: IDEA2SCOLA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2019
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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