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)

NCT05171244 | Unknown

• 1 other identifier: DR200078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

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.

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

Secondary Outcomes (6)

• Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)

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

• Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)

  baseline, week 15 (after training), 6 months after training

• Measures of autistic behaviour by Dunn sensory profile

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

• Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)

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

• Cognitive rigidity measure

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

Study Arms (2)

Experimental group

EXPERIMENTAL

Behavioral: virtual reality training; Behavioral: usual care

Control group

SHAM COMPARATOR

Behavioral: usual care

Interventions

virtual reality training BEHAVIORAL

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

Experimental group

usual care BEHAVIORAL

usual program of interventions in usual care

Control group; Experimental group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

Le Centre universitaire de pédopsychiatrie

Tours, 37000, France

RECRUITING

Pedopsychiatry, University Hospital, Tours

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Remi CLAIRE

CONTACT

02 47 47 88 47; r.claire@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center Randomized Pilot Study in Parallel Groups

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 28, 2021
• Study Start: March 3, 2022
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

FR (2)