Early Intervention in Remote Autism (IPAAD)

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Early Intervention in Remote Autism

Treatments: Other: ESDM intervention; Other: MOOC

Study type: Interventional

Funder types: Other

Identifiers

NCT04660669

IPAAD (29BRC19.0279)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 15 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

ESDM 15h

Other group

Description:

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.

Treatment:

Other: ESDM intervention

ESDM 8h + MOOC

Other group

Description:

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.

Treatment:

Other: ESDM intervention

Other: MOOC