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Completed

NCT Number: NCT02608333

Efficiency of Early Intervention for Autism Spectrum Disorder

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.

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Key information

Conditions

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

Age range

15 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Vinatier

Bron, AURA, 69678 cedex, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESDM-12

Behavioral

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 names: Early Start Denver Model 12 hours per week

Control Group

Behavioral

heteregenous "as usual "community intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Collaborators

  • Centre hospitalier Saint Jean de Dieu - ARHM
  • Hospices Civils de Lyon
  • University Hospital, Strasbourg, France
  • Versailles Hospital

Registry information

Official study 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

Acronym: IDEA

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2015
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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