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NCT Number: NCT04660669

Early Intervention in Remote Autism (IPAAD)

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.

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Key information

Conditions

Early Intervention in Remote Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

15 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

(8) Impossibility for family to have access to the MOOC

Treatment and study plan

ESDM intervention

Other

Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.

MOOC

Other

Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    Minimum = 0 (better outcome) and maximum = 28 (worse outcome)

  2. 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

    Minimum = 20 (worse outcome) and maximum = 160 (better outcome)

  3. 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

    Minimum = 38 (worse outcome) and maximum = 190 (better outcome)

  4. 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

    Minimum = 0 (worse outcome) and maximum = 100 (better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien CLARYSSE

CONTACT

[email protected]

02 29 02 00 88

Nathalie LAVENNE, Doctor

CONTACT

[email protected]

02 98 01 50 47

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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.

Acronym: IPAAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2020
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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