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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESDM 15h | Other | 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. |
|
| ESDM 8h + MOOC | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESDM intervention | Other | Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
(8) Impossibility for family to have access to the MOOC
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie LAVENNE, Doctor | Contact | 02 98 01 50 47 | nathalie.lavenne-collot@chu-brest.fr | |
| Adrien CLARYSSE | Contact | 02 29 02 00 88 | adrien.clarysse@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie LAVENNE | CHRU BREST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Nantes | France | France |
|
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
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| MOOC | Other | Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations |
|
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 |
| CH Réné-Dubos | Cergy-Pontoise | France |
|
| CHU Le Havre | Le Havre | France |
|
| CH Limoges | Limoges | France |