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• A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)

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ClinicalTrials.gov ID

NCT04660669

Lead Sponsor

University Hospital, BrestOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

90Estimated

Last Update Posted

Jun 8, 2026Actual

Start Date

Dec 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

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.

Brief 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.

• Early Intervention in Remote Autism

• ESDM intervention
• MOOC

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, BrestOTHER

erwan.vion@ght-novo.fr01 30 75 48 30

karine.leydier@ch-havre.fr02 32 73 38 37