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3 Year Follow up Study of the IDEA Population

NCT03924973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Hôpital le Vinatier

    lead OTHER

Principal Investigators

  • GEOFFRAY MARIE-MAUDE, PH · CH LE VINATIER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
39 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924973 on ClinicalTrials.gov