Early Intervention in Remote AutismIPAADNCT04660669
Early Intervention in Remote Autism (IPAAD)
A study testing ESDM intervention and MOOC in people with Early Intervention in Remote Autism, run by University Hospital, Brest at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 36 months
- Conditions the study is for
- Early Intervention in Remote Autism
- What is being tested?
- ESDM intervention and MOOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
- Use of psychoactive medications (7 ) Families unavailable for the intervention and the followup over a period of 12 months
- Impossibility for family to have access to the MOOC
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CH Réné-Dubos
Cergy-Pontoise
Erwan VION, 01 30 75 48 30, erwan.vion@ght-novo.fr
CHU Le Havre
Le Havre
Karine LEYDIER, 02 32 73 38 37, karine.leydier@ch-havre.fr
CH Limoges
Limoges
CHU Nantes
Nantes, France
Françoise DUPONT, 02 28 08 84 90, francoise.dupont@chu-nantes.fr
About this study
Official title: 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.
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.
- Conditions
- Early Intervention in Remote Autism
- Being tested
- ESDM intervention, MOOC
- Keywords
- Autism, ASD, ESDM, MOOC
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDM interventionOther
Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
MOOCOther
Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations
| Study group | Role | What they receive |
|---|---|---|
| ESDM 15h | Other | 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. Receives: Other: ESDM intervention |
| ESDM 8h + MOOC | Other | 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. Receives: Other: ESDM intervention; Other: MOOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
Minimum = 49 (worse outcome) and maximum = 155 (better outcome)
Measured: From day 0 to months 12
Secondary outcomes (4)
Assessment of child autism symptoms and change in autism symptoms using ADOS-2
Minimum = 0 (better outcome) and maximum = 28 (worse outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Intervention in Remote AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 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. Group 2 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie LAVENNE, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660669
- Sponsor's protocol ID
- IPAAD (29BRC19.0279)
- Acronym
- IPAAD
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04660669
- Acronym / sponsor ID
- IPAAD / IPAAD (29BRC19.0279)
- Conditions
- Early Intervention in Remote Autism
- Keywords
- Autism, ASD, ESDM, MOOC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 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. Group 2 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.
| Arm | Type | Receives |
|---|---|---|
| ESDM 15h | Other | Other: ESDM interventionThis 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 8h + MOOC | Other | Other: ESDM intervention, Other: MOOCThis 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. |
Who may qualify
- Ages
- 15 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESDM interventionEarly Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention. | Other | ESDM 15h, ESDM 8h + MOOC |
| MOOCMassive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations | Other | ESDM 8h + MOOC |
Primary outcome
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
Time frame: From day 0 to months 12
Minimum = 49 (worse outcome) and maximum = 155 (better outcome)
4 secondary outcomes
Assessment of child autism symptoms and change in autism symptoms using ADOS-2
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)
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
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
Time frame: At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie LAVENNE principal investigator
CHRU BREST
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESDM intervention and MOOC in people with Early Intervention in Remote Autism, run by University Hospital, Brest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie LAVENNE, Doctor (02 98 01 50 47, nathalie.lavenne-collot@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL) (time frame: From day 0 to months 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.