Clinical trial NCT03254264: Impact of Early Interventions on Neurocognitive Profile of Children With Autism Spectrum Disorder
Official title: Impact of Early Intervention on Neurocognitive Profile of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010).

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

Brief summary: The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral model that aim to enhance socio-comunicative abilities and also global development of children with Autism spectrum disorder (ASD). The purpose of this study is to identify changes in neurocognitive profile of children population with ASD receiving Early Start Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other interventions. That is a study proposed to children with ASD and their families that participate already to a randomized control study called IDEA registered on clinicaltrials.gov NCT02608333.

the investigators hypothesized that ESDM would increase social cognition, reduce shifting attention time and increase preference for unpredictable stimuli.

Detailed description: IDEA is a multicenter (4 centers in France and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 15 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 an 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. In IDEA development of communication and social interactions and global developmental of all the children will be measured at different time points (at baseline (t0), after 1 year (t1), after 2 years( t2)) over the two years through standardized tests such as Autism diagnostic observation Schedule (ADOS-2), Mullen Scales of Early Learning (MSEL) and the Vineland Adaptive Behavior Scale (VABS-2).

Children will be included in this second study called IDEA-EYE with parents' consent. Then, preference for biological motion and social scene, shifting attention time and preference for sameness will be measure in both groups with an Eye-tracker Tobii TX 300 at t0,t1 and t2. These measures will also be collected in a group of children without ASD at t0,t1 and t2.

the investigators expect, as primary criteria, a significant superior time spend on biological motion in ESDM group versus control group after 2 years of treatment. the investigators also expect a significant superior orientation toward eyes in complex social scenes, an inferior shifting attention time and a superior preference for unpredictable stimuli in ESDM group versus ASD control group after 2 years. the investigators also expect that ESDM group would have time spend on biological motion, orientation toward eyes in complex scenes, shifting attention time and preference for unpredictable stimuli comparable to children without ASD after 2 years.

This study would allow better understanding of ESDM active principles.

Eligibility criteria: Inclusion Criteria:

* Children 15 months to 36 months
* Children with autism spectrum disorder (according to international criteria, ADI and ADOS)
* DQ at 30 at least at the Early Learning Mullen Scale
* Family domiciled within 40 minutes of an early intervention unit

Exclusion Criteria:

* Severe neurological or physical disorder identified in the child or family that would interfere with intervention
* Unavailability of the family for regular monitoring of the child by the investigator center
* Child with a Rett Sd or Childhood disintegrative disorders
* Visual problems or with eyes in general

Primary outcomes:
measure: The primary outcome will be the time spent on biological motion in the task of visual preference stimuli.
timeFrame: 2 years
Secondary outcomes:
measure: Average proximity from pattern eyes norm in complex social scene task
timeFrame: 2 years
measure: Difference of saccadic latencies between overlap and gap condition
timeFrame: 2 years
measure: Time spent on unpredictable stimuli
timeFrame: 2 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: GEOFFRAY Marie-Maude, PHD
role: PRINCIPAL_INVESTIGATOR
References: