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Not yet recruiting NCT04660669

Early Intervention in Remote Autism (IPAAD)

No phase Interventional Early Intervention in Remote Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ESDM intervention, MOOC.
Who it may be relevant to
Registry conditions: Early Intervention in Remote Autism. Basic parameters: 15 months — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Interventions

  • Other ESDM intervention
    Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
  • Other MOOC
    Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations

Primary outcome measures

  • The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL) [Time frame: From day 0 to months 12]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • CHU Nantes — Nantes
  • CH Réné-Dubos — Cergy-Pontoise
  • CHU Le Havre — Le Havre
  • CH Limoges — Limoges

Identifiers

NCT: NCT04660669 · IPAAD (29BRC19.0279)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗