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Early Intervention in Remote Autism (IPAAD) (IPAAD)

Primary Purpose

Early Intervention in Remote Autism

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESDM intervention
MOOC
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Early Intervention in Remote Autism focused on measuring Autism, ASD, ESDM, MOOC

Eligibility Criteria

15 Months - 36 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • CH Réné-Dubos
  • CHU Le Havre
  • CH Limoges
  • CHU Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ESDM 15h

ESDM 8h + MOOC

Arm 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.

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.

Outcomes

Primary Outcome Measures

The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
Minimum = 49 (worse outcome) and maximum = 155 (better outcome)

Secondary Outcome Measures

Assessment of child autism symptoms and change in autism symptoms using ADOS-2
Minimum = 0 (better outcome) and maximum = 28 (worse outcome)
Assessment of child behavioral adaptation using The Vineland Adaptive Behavior Scales second version (VABS-2)
Minimum = 20 (worse outcome) and maximum = 160 (better outcome)
Assessment of sensory reactivity using The Dunn's Sensory Profile for toddlers
Minimum = 38 (worse outcome) and maximum = 190 (better outcome)
Assessment of the parent burden and quality of life using the CareQuol-7D
Minimum = 0 (worse outcome) and maximum = 100 (better outcome)

Full Information

First Posted
November 9, 2020
Last Updated
February 7, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04660669
Brief Title
Early Intervention in Remote Autism (IPAAD)
Acronym
IPAAD
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Intervention in Remote Autism
Keywords
Autism, ASD, ESDM, MOOC

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESDM 15h
Arm Type
Other
Arm 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.
Arm Title
ESDM 8h + MOOC
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
ESDM intervention
Intervention Description
Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
Intervention Type
Other
Intervention Name(s)
MOOC
Intervention Description
Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations
Primary Outcome Measure Information:
Title
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
Description
Minimum = 49 (worse outcome) and maximum = 155 (better outcome)
Time Frame
From day 0 to months 12
Secondary Outcome Measure Information:
Title
Assessment of child autism symptoms and change in autism symptoms using ADOS-2
Description
Minimum = 0 (better outcome) and maximum = 28 (worse outcome)
Time Frame
At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention
Title
Assessment of child behavioral adaptation using The Vineland Adaptive Behavior Scales second version (VABS-2)
Description
Minimum = 20 (worse outcome) and maximum = 160 (better outcome)
Time Frame
At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention
Title
Assessment of sensory reactivity using The Dunn's Sensory Profile for toddlers
Description
Minimum = 38 (worse outcome) and maximum = 190 (better outcome)
Time Frame
At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention
Title
Assessment of the parent burden and quality of life using the CareQuol-7D
Description
Minimum = 0 (worse outcome) and maximum = 100 (better outcome)
Time Frame
At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie LAVENNE, Doctor
Phone
02 98 01 50 47
Email
nathalie.lavenne-collot@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Adrien CLARYSSE
Phone
02 29 02 00 88
Email
adrien.clarysse@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie LAVENNE
Organizational Affiliation
CHRU BREST
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Réné-Dubos
City
Cergy-Pontoise
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwan VION
Phone
01 30 75 48 30
Email
erwan.vion@ght-novo.fr
Facility Name
CHU Le Havre
City
Le Havre
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine LEYDIER
Phone
02 32 73 38 37
Email
karine.leydier@ch-havre.fr
Facility Name
CH Limoges
City
Limoges
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise DUPONT
Phone
02 28 08 84 90
Email
francoise.dupont@chu-nantes.fr

12. IPD Sharing Statement

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Early Intervention in Remote Autism (IPAAD)

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