Clinical trial NCT02608333: Efficiency of Early Intervention for Autism Spectrum Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Early intervention
ESDM
behavioral and developmental intervention
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: University Hospital, Strasbourg, France
name: Versailles Hospital
name: Centre hospitalier Saint Jean de Dieu - ARHM
name: Hospices Civils de Lyon
First posted: 2015-11-18
Enrollment: 180
Sex: ALL
Minimum age (years): 15
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Developmental quotient at the Mullen Scale of Early Learning
timeFrame: Change from baseline in developmental quotient at 24 months follow-up
Secondary outcomes:
measure: Severity of autism symptoms is measured with ADOS 2
timeFrame: Change from baseline in severity score of autism symptoms at 24 months follow-up
measure: Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2
timeFrame: Change from baseline in adaptative behavior at 24 months follow-up
measure: Productive language level assessed with a standardized French productive language developmental scale
timeFrame: change from baseline in number of words at 24 months follow-up (T2)
measure: Costs associated with interventions
timeFrame: at 24 months follow-up (T2)
measure: Developement of communication and symbolic behavior
timeFrame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
measure: Parent child naturalistic interaction during play
timeFrame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
measure: Sensorial profil
timeFrame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)
measure: Change at the Brief Observation of Social Communication Change (BOSCC)
timeFrame: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
state: Aura
Study officials:
affiliation: CH LE VINATIER
name: GEOFFRAY MARIE-MAUDE, DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Touzet S, Occelli P, Schroder C, Manificat S, Gicquel L, Stanciu R, Schaer M, Oreve MJ, Speranza M, Denis A, Zelmar A, Falissard B, Georgieff N, Bahrami S, Geoffray MM; IDEA Study Group. Impact of the Early Start Denver Model on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design. BMJ Open. 2017 Mar 27;7(3):e014730. doi: 10.1136/bmjopen-2016-014730.