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NCT04660669
Early Intervention in Remote Autism (IPAAD)
Conditions: Early Intervention in Remote Autism
Sex: All
Ages: 15 Months – 36 Months
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: University Hospital, Brest
Location: CHU Nantes Nantes France
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 Criteria
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
Source: ClinicalTrials.gov (NCT04660669). StuddyBuddy aggregates publicly available trial information.