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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorUniversity Hospital, Tours

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Neuromotor disorders.

Uncorrected visual disorders.

Hearing impairment.

Known epilepsy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • virtual reality training

    Behavioral

    training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care

  • usual care

    Behavioral

    usual program of interventions in usual care

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, week 15 (after training), 6 months after training

Secondary outcomes

1

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)

Time frame
Baseline, week 15 (after training), 6 months after training
2

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)

Time frame
baseline, week 15 (after training), 6 months after training
3

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

Time frame
Baseline, week 15 (after training), 6 months after training
4

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.

Time frame
Baseline, week 15 (after training), 6 months after training

Other outcomes

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