Clinical trial NCT05171244: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center Randomized Pilot Study in Parallel Groups
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vineland Adaptive Behavior Scales II (VABS II) score
timeFrame: Baseline, week 15 (after training), 6 months after training
Secondary outcomes:
measure: Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)
timeFrame: Baseline, week 15 (after training), 6 months after training
measure: Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)
timeFrame: baseline, week 15 (after training), 6 months after training
measure: Measures of autistic behaviour by Dunn sensory profile
timeFrame: Baseline, week 15 (after training), 6 months after training
measure: Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)
timeFrame: Baseline, week 15 (after training), 6 months after training
measure: Cognitive rigidity measure
timeFrame: Baseline, week 15 (after training), 6 months after training
measure: Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)
timeFrame: Baseline, week 15 (after training), 6 months after training
Other outcomes:
Locations:
city: Tours
country: France
facility: Le Centre universitaire de pédopsychiatrie
city: Tours
country: France
facility: Pedopsychiatry, University Hospital, Tours
Study officials:
References: