Clinical trial NCT06184802: Multisensory Room in Autism Spectrum Disorder
Official title: Effects of Integrated Therapy Using the Multisensory Room in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with diagnosis of ASD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
* age between 3 and 6 years;
* signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

Exclusion Criteria:

* children not aged between 3 and 6 years;
* significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders.
* Informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.

Primary outcomes:
measure: Psychoeducational Profile, Third Edition (PEP-3)
timeFrame: T0 (Baseline) - T1 (6 Months)
measure: Childhood Autism Rating Scale (CARS-2)
timeFrame: T0 (Baseline) - T1 (6 Months)
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Neurolesi Bonino Pulejo
Study officials:
References:
citation: Novakovic N, Milovancevic MP, Dejanovic SD, Aleksic B. Effects of Snoezelen-Multisensory environment on CARS scale in adolescents and adults with autism spectrum disorder. Res Dev Disabil. 2019 Jun;89:51-58. doi: 10.1016/j.ridd.2019.03.007. Epub 2019 Mar 29.
citation: Kaplan H, Clopton M, Kaplan M, Messbauer L, McPherson K. Snoezelen multi-sensory environments: task engagement and generalization. Res Dev Disabil. 2006 Jul-Aug;27(4):443-55. doi: 10.1016/j.ridd.2005.05.007. Epub 2005 Aug 24.
citation: McKee SA, Harris GT, Rice ME, Silk L. Effects of a Snoezelen room on the behavior of three autistic clients. Res Dev Disabil. 2007 May-Jun;28(3):304-16. doi: 10.1016/j.ridd.2006.04.001. Epub 2006 Jun 27.
citation: American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (DSM-5®). Biobehavioral Reviews, 33, 1204-1214