Childhood Autism Pervasive Developmental Disorders
Conditions
Interventions
This is a three-arm randomized controlled clinical trial with double blinding. Randomization of the 72 participants will be performed using electronic software, in blocks of 18, with stratified random
Sponsors
Universidade Federal de Ciências da Saúde de Porto Alegre
Universidade Federal de Ciências da Saúde de Porto Alegre
Eligibility
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: Be between 8 and 12 years of age; have prior experience with computer games; have a diagnosis of Autism Spectrum Disorder confirmed by presentation of the Identification Card for Persons with Autism Spectrum Disorder; demonstrate verbal communication skills or communication through Augmentative and Alternative Communication; present sensory difficulties as indicated by the Sensory Processing Measure; demonstrate the ability to complete at least 9 items of the Evaluation in Ayres Sensory Integration
Exclusion criteria
Exclusion criteria: Have a diagnosis of other neurological disorders such as cerebral palsy or Down syndrome; present comorbidities that preclude participation in Immersive Virtual Reality as reported by caregivers; present sensory deficits that prevent the use of Immersive Virtual Reality equipment; report malaise, nausea, or recurrent episodes of vomiting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement in child sensory processing abilities is expected as measured by the Evaluation in Ayres Sensory Integration based on standardized scores across 20 tasks comparing baseline and 10 weeks post intervention with scores closer to the typical range (-1 to +1) indicating better sensory integration skills | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in child functional skills is expected as measured by the Pediatric Evaluation of Disability Inventory based on domain scores of self care mobility and social function comparing baseline and 10 weeks post intervention with higher scores indicating better functional performance;An improvement in caregivers quality of life is expected as measured by the World Health Organization Quality of Life instrument abbreviated version comparing baseline and 10 weeks post intervention with higher scores indicating better quality of life;A reduction in child autistic behaviors is expected as measured by the Autistic Behavior Inventory comparing baseline and 10 weeks post intervention with lower scores indicating fewer challenging behavior;An increase in level of immersion in virtual reality is expected as measured by a Likert scale ranging from zero to five comparing baseline and 10 weeks post intervention with higher scores indicating greater immersion in the virtual environment;A reduction in simulator related sickness symptoms is expected as measured by the Simulator Sickness Questionnaire comparing baseline and 10 weeks post intervention with lower scores indicating less discomfort and better tolerance of the virtual reality environment | — |
Countries
BR
Contacts
Public ContactBibiana Steckel
Universidade Federal de Ciências da Saúde de Porto Alegre
Outcome results
None listed