Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality) (SEVIRE)

Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.

Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.

The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: virtual reality training; Behavioral: usual care

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Remi CLAIRE; Phone Number: +33 02 47 47 88 47; Email: r.claire@chu-tours.fr

Study Locations

• France
  • Tours, France, 37000
    • Recruiting
    • Le Centre universitaire de pédopsychiatrie
  • Tours, France, 37044
    • Not yet recruiting
    • Pedopsychiatry, University Hospital, Tours
    • Contact: Remi CLAIRE; Phone Number: +33 02 47 47 88 47; Email: r.claire@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child / adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).
• Without intellectual delay (QNV> 70, WISC-IV or V, WAIS-III or IV).
• Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).
• Schooled in the ordinary school context (primary school, middle school, high school, ULIS).

• Having expressed their agreement to participate in the study.

  • Whose parents or legal representatives have signed written consent.
  • Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.

Exclusion Criteria:

• Neuromotor disorders.
• Uncorrected visual disorders.
• Hearing impairment.
• Known epilepsy.
• Anxiety syndromes identified.
• Hyper ADD / H type activity.
• Treatment with methylphenidate. - Rare genetic syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Behavioral: virtual reality training; training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care; Behavioral: usual care; usual program of interventions in usual care
Sham Comparator: Control group	Behavioral: usual care; usual program of interventions in usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland Adaptive Behavior Scales II (VABS II) score	Behavioral scale VABS II is a test for assessing autonomy of child/adolescent in everyday life. From 0 to 108, higher is the score, more independent the person is in the rated field.	Baseline, week 15 (after training), 6 months after training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)	ECA2 provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)	Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)	ECA2P provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)	baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Dunn sensory profile	Dunn sensory profile is completed by the parents. From 0 to 110, higher is the score more important is the comportement	Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)	VABS-II provides an assessment of problematic behaviour. From 0 to 108, higher is the score, more independent the person is in the rated field.	Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure	Neuropsycological tests	Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)	Evaluation of intensity scores for signs of stereotyped and repetitive activity on the EC2R.Factor sensory-motor stereotypies is evaluated by a score from 0 to 44. Factor reaction to change and modulating insufficiency factor are evaluated by a score from 0 to 28. Factor restricted behaviors is evaluated by a score from 0 to 32. Higher is the score more important is the severity.	Baseline, week 15 (after training), 6 months after training

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: DR200078

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No