NCT03924973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

April 19, 2019

Last Update Submit

March 4, 2025

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Wechsler (Wechsler Intelligence Scale for Children)

    3 YEARS

  • VABS (Vineland Adaptive Behavior Scales)

    3 YEARS

  • PPVT ( Peabody Picture Vocabulary Test )

    3 YEARS

  • Parental self-assentiment

    3 YEARS

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

ESDM followed by treatment as usualBEHAVIORAL

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).

Also known as: Treatment as usual delivered in the community
Control groupExperimental group

Eligibility Criteria

Age39 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Requiring less than 40 minutes travel to the assessment center

You may not qualify if:

  • Impossibility of coming in for assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • GEOFFRAY MARIE-MAUDE, PH

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
randomization will follow that of the IDEA study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 23, 2019

Study Start

April 17, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

FR(1)