Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency of Early Intervention for Autism Spectrum Disorder (IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608333
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
University Hospital, Strasbourg, France
Versailles Hospital
Centre hospitalier Saint Jean de Dieu - ARHM
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: ESDM-12 Behavioral: control group Not Applicable

Detailed Description:

This is a multicenter (4 centers in France, 1 center in Switzerland and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 18 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. After diagnostic, Children will be included in a longitudinal cohort with the consent of the parents. Sixty children will be drawn lots among 180 children of the cohort and will be included in a ESDM intervention with the consent of the parents. Two groups will be compared: an experimental group of 60 children receiving 12 hours a week of ESDM intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. Global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the Mullen Scale of Early Learning (MSEL), the ADOS-2 and the Vineland Adaptive Behavior Scale. Cost of each intervention will be calculated.

The primary outcome is global development of the child, measured by the developmental quotient with the Mullen after 24 months of intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Intervention on the Global Development of Children With Autism Spectrum Disorder in a European French-speaking Population Dr Marie-Maude GEOFFRAY Le Vinatier Hospital
Actual Study Start Date : September 9, 2015
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ESDM-12
ESDM -12 : 60 children will receive 12 hours a week of ESDM ( Early Start Denver Model)intervention delivered by trained therapists during 2 years.ESDM is a comprehensive relational, developmental and behavioral intervention.It's described in a manual for Professional and parents.
Behavioral: ESDM-12

ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010).

Children receive ESDM 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

Other Name: Early Start Denver Model 12 hours per week

Active Comparator: Control group
control group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period
Behavioral: control group
heteregenous "as usual "community intervention




Primary Outcome Measures :
  1. Developmental quotient at the Mullen Scale of Early Learning [ Time Frame: Change from baseline in developmental quotient at 24 months follow-up ]
    This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:


Secondary Outcome Measures :
  1. Severity of autism symptoms is measured with ADOS 2 [ Time Frame: Change from baseline in severity score of autism symptoms at 24 months follow-up ]
    severity of autism symptoms is measured with ADOS 2 ( Autism Diagnostic observation Schedule 2)

  2. Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2 [ Time Frame: Change from baseline in adaptative behavior at 24 months follow-up ]
    Adaptative behavior score is measured by the composite score of Vineland adaptative behavior scale 2

  3. Productive language level assessed with a standardized French productive language developmental scale [ Time Frame: change from baseline in number of words at 24 months follow-up (T2) ]
    This criterion will be assessed with a standardized French productive language developmental scale (DLPF "Development du language de production" in French language) filled by parents

  4. Costs associated with interventions [ Time Frame: at 24 months follow-up (T2) ]
    Healthcare, social and personal resources devoted to child care throughout the study will be measured to evaluate the direct and indirect costs associated with intervention. Assessment will take place

  5. Developement of communication and symbolic behavior [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up ]
    Total score of Communication and Symbolic Behaviour Scale Developmental Profil CSBS-DP questionnaire for caregivers (Wetherby et al, 2002)

  6. Parent child naturalistic interaction during play [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2) ]
    Dyadic Communication Measure for Autism (DCMA)(Green et al, 2010; Pickles, 2015) will be used and score of parent's communication synchrony, child initiation, and shared attention will be assessed

  7. Sensorial profil [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2) ]
    Sensorial profil of Dunn

  8. Change at the Brief Observation of Social Communication Change (BOSCC) [ Time Frame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up ]
    The total score of Brief Observation of Social Communication Change



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 15 months to 36 months
  • Children with autism spectrum disorder (according to international criteria and standardized tests)
  • Children at a DQ of 30 at least at the MSEL
  • Family domiciled within 40 minutes of a early intervention unit (investigator center for the study)

Exclusion Criteria:

  • Severe neurological or physical disorder identified not allowing intensive care
  • Unavailability of the family for regular monitoring of the child by the investigator center
  • Rett Syndrom

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608333


Locations
Layout table for location information
France
Hopital Vinatier
Bron, Aura, France, 69678 cedex
Sponsors and Collaborators
Hôpital le Vinatier
University Hospital, Strasbourg, France
Versailles Hospital
Centre hospitalier Saint Jean de Dieu - ARHM
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: GEOFFRAY MARIE-MAUDE, DR CH LE VINATIER

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02608333    
Other Study ID Numbers: 2015-A00124-45
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hôpital le Vinatier:
Early intervention
ESDM
behavioral and developmental intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders