NCT04660669Not yet recruiting
Early Intervention in Remote Autism (IPAAD)
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.
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 9 Nov 2020
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University Hospital, Brest
- Diseases
- Autism
- NCT number
- NCT04660669
What you commit to
- Study type: Interventional
- Planned participants: 90
- From Dec 2026 to the primary completion date, Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 15 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH René Dubos Coordinator of this site? Confirm its status | Cergy-Pontoise | France | Unknown status |
| CHU Le Havre Coordinator of this site? Confirm its status | Le Havre | France | Unknown status |
| CH Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.