Viewing Study NCT06184802



Ignite Creation Date: 2024-05-06 @ 7:55 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06184802
Status: RECRUITING
Last Update Posted: 2023-12-28
First Post: 2023-12-15

Brief Title: Multisensory Room in Autism Spectrum Disorder
Sponsor: IRCCS Centro Neurolesi Bonino-Pulejo
Organization: IRCCS Centro Neurolesi Bonino-Pulejo

Study Overview

Official Title: Effects of Integrated Therapy Using the Multisensory Room in Autism Spectrum Disorder
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Autism spectrum disorder ASD is a complex neurological development with onset in infancy or early childhood Atypical sensory processing has been widely reported in ASD and recent literature suggest that this abnormality extends across the life span with consequent important implications in every-day life of autistic individuals and their families Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits Therefore the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD
Detailed Description: Autism spectrum disorder ASD is a complex neurological development with onset in infancy or early childhood In the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders sensory features were finally take into account and atypical responses to sensory stimuli was included in the diagnostic criterion such as the presence of hyper- or hypo-responsiveness to sensory inputs or unusual interests towards sensory aspects of the environment and it must be considered APA 2013 Atypical sensory processing has been widely reported in ASD and recent literature suggest that this abnormality extends across the life span with consequent important implications in every-day life of autistic individuals and their families

Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits The multisensory rooms were designed to provide multiple stimulation opportunities that cover all sensory channels Among the present literature data interventions targeting sensory integration seems to be useful in reducing challenging behaviors in many individuals with developmental disabilities including ASD Novakovic N et al 2019 Kaplan H et al 2006 McKee et al 2007 The aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None