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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: virtual reality training, usual care.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Vineland Adaptive Behavior Scales II (VABS II) score [Time frame: Baseline, week 15 (after training), 6 months after training]
Secondary outcome measures (6)
- Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2) [Time frame: Baseline, week 15 (after training), 6 months after training]
- Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P) [Time frame: baseline, week 15 (after training), 6 months after training]
- Measures of autistic behaviour by Dunn sensory profile [Time frame: Baseline, week 15 (after training), 6 months after training]
- Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II) [Time frame: Baseline, week 15 (after training), 6 months after training]
- Cognitive rigidity measure [Time frame: Baseline, week 15 (after training), 6 months after training]
- Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R) [Time frame: Baseline, week 15 (after training), 6 months after training]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Le Centre universitaire de pédopsychiatrie — Tours
- Pedopsychiatry, University Hospital, Tours — Tours
Identifiers
NCT: NCT05171244 · DR200078