Early Intervention in Remote Autism (IPAAD)

Study Overview
=================
Brief 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.

Official Title
-----------------
Early Remote Intervention in Autism: a Randomized Noninferiority Clinical Trial Comparing Semi-intensive Early Start Denver Model (ESDM) Intervention With Remote Parental Training/ Supervision Versus Intensive ESDM Intervention.

Conditions
-----------------
Early Intervention in Remote Autism

Intervention / Treatment
-----------------
* Other: ESDM intervention
* Other: MOOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ASD based on the Diagnosis and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria; 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); Aged between 15 and 36 months; DQ of 30 or above at the MSEL Sign informed consent form by both parents Exclusion Criteria: A neurodevelopmental disorder with known etiology (e.g. fragile X syndrome, Rett syndrom) Significant sensory or motor impairment Major physical problems such as a chronic serious health condition History of a serious head injury and/or neurologic disease Seizures at time of entry 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 receives 15 hours per week of ESDM intervention from ESDM therapists. The parents benefit from a 20 hour parent training program delivered in the participating center. Group 2 receives 8 hours per week of ESDM intervention from ESDM therapists in addition to whatever community service the parents choose. The parents benefit from a training program remotely delivered via a MOOC platform as well as parental supervision of sessions delivered at home 1 hour per week for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ESDM 15h<br>This arm receives 15 hours per week of ESDM intervention from ESDM therapists. The parents benefit from a 20 hour parent training program delivered in the participating center. | Other: ESDM intervention<br>* Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.<br>|
| Other: ESDM 8h + MOOC<br>This arm receives 8 hours per week of ESDM intervention from ESDM therapists in addition to whatever community service the parents choose. The parents benefit from a training program remotely delivered via a MOOC platform as well as parental supervision of sessions delivered at home 1 hour per week for the duration of the study. | Other: ESDM intervention<br>* Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.<br>Other: MOOC<br>* Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL) | Minimum = 49 (worse outcome) and maximum = 155 (better outcome) | From day 0 to months 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of child autism symptoms and change in autism symptoms using ADOS-2 | Minimum = 0 (better outcome) and maximum = 28 (worse outcome) | 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) | 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) | 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) | At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, ASD, ESDM, MOOC