An interventional study of ESDM intervention and MOOC in Early Intervention in Remote Autism, sponsored by University Hospital, Brest. Not yet recruiting at 4 sites in France. Open to participants aged 15 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 90 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(8) Impossibility for family to have access to the MOOC
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
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 · Other: MOOC
Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations
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
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
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest