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Clinical Trials in France / NCT04660669
Starting soon Not applicable

Early Intervention in Remote Autism (IPAAD)

NCT04660669 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Brest
Phase
Not applicable
Started
2026-12
Last updated
2026-06-08

Condition(s) studied

Early Intervention in Remote Autism

Investigational drug(s) / intervention(s)

ESDM interventionMOOC

ESDM intervention: Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.

MOOC: Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations

Study summary

The Early Start Denver Model (ESDM) has shown its efficiency in the early management of ASD.

The study aims to evaluate the efficiency of a new type of management based on a semi-intensive center-based intervention (8h per week) coupled with a MOOC (Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations) for remote parental training/supervision. The goal is to determine if compared to the ESDM reference intervention (15h per week), this type of care can bring, a sufficient improvement in child development course and decreased symptoms of autism in young children, and if it could be, therefore, better suited to the needs of children and their family, bypassing the previously stated obstacles.

Eligibility

Sex
ALL
Min age
15 Months
Max age
36 Months
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of ASD based on the Diagnosis and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria; 2. Diagnosis of ASD on the Autism Diagnosis Observation Schedule (ADOS-2) and Autism Diagnosis Interview (ADIR) for toddlers (we will include children above or equal to 13, which is the research cut-off); 3. Aged between 15 and 36 months; 4. DQ of 30 or above at the MSEL 5. Sign informed consent form by both parents Exclusion Criteria: 1. A neurodevelopmental disorder with known etiology (e.g. fragile X syndrome, Rett syndrom) 2. Significant sensory or motor impairment 3. Major physical problems such as a chronic serious health condition 4. History of a serious head injury and/or neurologic disease 5. Seizures at time of entry 6. Use of psychoactive medications (7 ) Families unavailable for the intervention and the followup over a period of 12 months (8) Impossibility for family to have access to the MOOC

Primary outcome measure(s)

  • The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL) — From day 0 to months 12
    Minimum = 49 (worse outcome) and maximum = 155 (better outcome)

Trial sites (4)

FacilityCityRegionStatus
CHU Nantes Nantes France
CH Réné-Dubos Cergy-Pontoise France
CHU Le Havre Le Havre France
CH Limoges Limoges France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04660669 on ClinicalTrials.gov ↗ ← All trials in France