Early Intervention in Remote Autism (IPAAD)

NCT04660669 | Unknown DMC

• 1 other identifier: IPAAD (29BRC19.0279)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

Early Intervention in Remote Autism

Keywords

Autism; ASD; ESDM; MOOC

Outcome Measures

Primary Outcomes (1)

• The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)

  Minimum = 49 (worse outcome) and maximum = 155 (better outcome)

  From day 0 to months 12

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

ESDM 15h

OTHER

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.

Other: ESDM intervention

ESDM 8h + MOOC

OTHER

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.

Other: ESDM intervention; Other: MOOC

Interventions

ESDM intervention OTHER

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

ESDM 15h; ESDM 8h + MOOC

MOOC OTHER

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

ESDM 8h + MOOC

Eligibility Criteria

• Age: 15 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (4)

CH Réné-Dubos

Cergy-Pontoise, France

Location

CHU Le Havre

Le Havre, France

Location

CH Limoges

Limoges, France

Location

CHU Nantes

Nantes, France

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nathalie LAVENNE

  CHRU BREST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie LAVENNE, Doctor

CONTACT

02 98 01 50 47; nathalie.lavenne-collot@chu-brest.fr

Adrien CLARYSSE

CONTACT

02 29 02 00 88; adrien.clarysse@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 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. Group 2 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.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

FR (4)