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) (SEVIRE)
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality training
usual care
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorder
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.
Sites / Locations
- Le Centre universitaire de pédopsychiatrieRecruiting
- Pedopsychiatry, University Hospital, Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
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
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.
Cognitive rigidity measure
Neuropsycological tests
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)
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.
Full Information
NCT ID
NCT05171244
First Posted
November 18, 2021
Last Updated
October 3, 2023
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT05171244
Brief 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)
Acronym
SEVIRE
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center Randomized Pilot Study in Parallel Groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
virtual reality training
Intervention Description
training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
usual program of interventions in usual care
Primary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales II (VABS II) score
Description
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 Outcome Measure Information:
Title
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)
Description
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
Title
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)
Description
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
Title
Measures of autistic behaviour by Dunn sensory profile
Description
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
Title
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)
Description
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
Title
Cognitive rigidity measure
Description
Neuropsycological tests
Time Frame
Baseline, week 15 (after training), 6 months after training
Title
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)
Description
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.
Time Frame
Baseline, week 15 (after training), 6 months after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Remi CLAIRE
Phone
02 47 47 88 47
Ext
+33
Email
r.claire@chu-tours.fr
Facility Information:
Facility Name
Le Centre universitaire de pédopsychiatrie
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Name
Pedopsychiatry, University Hospital, Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi CLAIRE
Phone
02 47 47 88 47
Ext
+33
Email
r.claire@chu-tours.fr
12. IPD Sharing Statement
Learn more about this trial
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)
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