Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2023-12-31
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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ESDM 15h
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 intervention
Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
ESDM 8h + MOOC
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion 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
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
15 Months
36 Months
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Nathalie LAVENNE
Role: PRINCIPAL_INVESTIGATOR
CHRU BREST
Locations
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CH Réné-Dubos
Cergy-Pontoise, , France
CHU Le Havre
Le Havre, , France
CH Limoges
Limoges, , France
CHU Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IPAAD (29BRC19.0279)
Identifier Type: -
Identifier Source: org_study_id
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