Early Intervention in Remote Autism (IPAAD) (IPAAD)

February 7, 2023 updated by: University Hospital, Brest

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: ESDM 15h
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
Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
OTHER: ESDM 8h + 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.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Minimum = 0 (better outcome) and maximum = 28 (worse outcome)
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
Minimum = 20 (worse outcome) and maximum = 160 (better outcome)
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
Minimum = 38 (worse outcome) and maximum = 190 (better outcome)
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
Minimum = 0 (worse outcome) and maximum = 100 (better outcome)
At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2023

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (ACTUAL)

December 9, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPAAD (29BRC19.0279)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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