Can less therapy at home match intensive autism treatment?
NCT ID NCT04660669
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a semi-intensive therapy program (8 hours per week at a center plus online parent training) to the standard intensive program (15 hours per week) for young children with autism. The goal is to see if the remote approach works just as well for improving development and reducing autism symptoms. The trial plans to enroll 90 children aged 15 to 36 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Early Start Denver Model (ESDM) behavioral therapy
- What this could lead to
- If successful, this could offer a more accessible and less intensive therapy option for families with young autistic children, reducing the need for frequent center visits.
- What could go wrong
- This is a noninferiority trial, meaning it aims to show the remote approach is not worse than intensive therapy, but it may still be less effective for some children. The study is not yet recruiting and has a small sample size of 90.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 36 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CH Limoges
Limoges, France
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CH Réné-Dubos
Cergy-Pontoise, France
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CHU Le Havre
Le Havre, France
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CHU Nantes
Nantes, France, France
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