Early Intervention in Remote Autism (IPAAD)

Not Applicable

Not yet recruiting

• Conditions: Early Intervention in Remote Autism
• Interventions: Other: ESDM intervention; Other: MOOC

• Registration Number: NCT04660669
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESDM 15h	ESDM intervention	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.
ESDM 8h + MOOC	ESDM intervention	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.
ESDM 8h + MOOC	MOOC	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.

Primary Outcome Measures

Name	Time	Method
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)	From day 0 to months 12	Minimum = 49 (worse outcome) and maximum = 155 (better outcome)

Secondary Outcome Measures

Name	Time	Method
Assessment of child autism symptoms and change in autism symptoms using ADOS-2	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)
Assessment of child behavioral adaptation using The Vineland Adaptive Behavior Scales second version (VABS-2)	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)
Assessment of sensory reactivity using The Dunn's Sensory Profile for toddlers	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)
Assessment of the parent burden and quality of life using the CareQuol-7D	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)

Trial Locations

Locations (4)

CHU Le Havre; 🇫🇷 Le Havre, France

CH Limoges; 🇫🇷 Limoges, France

CHU Nantes; 🇫🇷 Nantes, France

CH Réné-Dubos; 🇫🇷 Cergy-Pontoise, France