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)

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: usual care; Behavioral: virtual reality training

• Registration Number: NCT05171244
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-28
• Study Start: 2022-03-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	usual care	-
Experimental group	virtual reality training	-
Experimental group	usual care	-

Primary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales II (VABS II) score	Baseline, week 15 (after training), 6 months after training	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive rigidity measure	Baseline, week 15 (after training), 6 months after training	Neuropsycological tests
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)	Baseline, week 15 (after training), 6 months after training	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.
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)	Baseline, week 15 (after training), 6 months after training	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)
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)	baseline, week 15 (after training), 6 months after training	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)
Measures of autistic behaviour by Dunn sensory profile	Baseline, week 15 (after training), 6 months after training	Dunn sensory profile is completed by the parents. From 0 to 110, higher is the score more important is the comportement
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)	Baseline, week 15 (after training), 6 months after training	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.

Trial Locations

Locations (2)

Pedopsychiatry, University Hospital, Tours; 🇫🇷 Tours, France

Le Centre universitaire de pédopsychiatrie; 🇫🇷 Tours, France