Early Intervention in Remote Autism (IPAAD)

University Hospital, Brest90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Early Intervention in Remote Autism

Interventions

Eligibility

Sex: ALLMin age: 15 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (4)

CH Réné-Dubos

Cergy-Pontoise, France

CHU Le Havre

Le Havre, France

CH Limoges

Limoges, France

CHU Nantes

Nantes, France

Outcomes

Primary Outcomes

The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)

Minimum = 49 (worse outcome) and maximum = 155 (better outcome)

Time frame: From day 0 to months 12

Secondary Outcomes

Assessment of child autism symptoms and change in autism symptoms using ADOS-2

Minimum = 0 (better outcome) and maximum = 28 (worse outcome)

Time frame: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

Assessment of child behavioral adaptation using The Vineland Adaptive Behavior Scales second version (VABS-2)

Minimum = 20 (worse outcome) and maximum = 160 (better outcome)

Time frame: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

Assessment of sensory reactivity using The Dunn's Sensory Profile for toddlers

Minimum = 38 (worse outcome) and maximum = 190 (better outcome)

Time frame: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

Assessment of the parent burden and quality of life using the CareQuol-7D

Minimum = 0 (worse outcome) and maximum = 100 (better outcome)

Time frame: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

Early Intervention in Remote Autism (IPAAD)

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts