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

NCT03254264 | Terminated DMC

• 1 other identifier: 2015-A00696-43
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the time spent on biological motion in the task of visual preference stimuli.

  2 different types of stimuli (dynamic biological or geometrical movements) are presented in parallel on each part of the screen alternatively (left and/ or right). Child sit at 60 cm from the screen of the Eye-tracker can look towards the one or the other one stimuli.

  2 years

Secondary Outcomes (3)

• Average proximity from pattern eyes norm in complex social scene task

  2 years

• Difference of saccadic latencies between overlap and gap condition

  2 years

• Time spent on unpredictable stimuli

  2 years

Study Arms (2)

ESDM-12

EXPERIMENTAL

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.

Behavioral: Early Start Denver Model

Control group

ACTIVE COMPARATOR

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

Behavioral: 'as-usual' intervention

Interventions

Early Start Denver Model 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.

ESDM-12

'as-usual' intervention BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 15 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• GEOFFRAY Marie-Maude, PHD

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: May 29, 2017
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

FR (1)