Impact of Early Interventions on Neurocognitive Profile of Children With Autism Spectrum Disorder

NCT ID: NCT03254264

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2022-03-25

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESDM-12

an experimental group of 60 children receiving 12 hours a week of Early Start Denver Model (ESDM) 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.

Group Type: EXPERIMENTAL

Early Start Denver Model

Intervention Type: 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 at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

Control group

a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.

Group Type: ACTIVE_COMPARATOR

'as-usual' intervention

Intervention Type: BEHAVIORAL

a control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.

Interventions

Early Start Denver Model

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.

Intervention Type: BEHAVIORAL

'as-usual' intervention

a control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GEOFFRAY Marie-Maude, PHD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

Hopital Vinatier

Bron, , France

Countries

France

Other Identifiers

2015-A00696-43

Identifier Type: -

Identifier Source: org_study_id