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Multisensory Room in Autism Spectrum Disorder

Effects of Integrated Therapy Using the Multisensory Room in Autism Spectrum Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06184802
Enrollment
100
Registered
2023-12-28
Start date
2019-11-04
Completion date
2025-01-31
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

BEHAVIORALTAU+Multisensory room

Multisensory room session included exercises in different interaction areas that allow to make up a multisensory experience where the patient can freely perform in different directions experimenting combinations of play

BEHAVIORALTAU

neuro-psychomotor training promotes a better organization of global motor skills, improve hand-eye coordination, promote the development of language as communication, enriching representation and symbolization skills.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Psychoeducational Profile, Third Edition (PEP-3)T0 (Baseline) - T1 (6 Months)a scale to assess developmental skills and behaviors of children with autism and communication disabilities, aged between 6 months and 7 years. It identifies learning strengths and emerging abilities concerning communication, motor skills and maladaptive behaviors
Childhood Autism Rating Scale (CARS-2)T0 (Baseline) - T1 (6 Months)The CARS 2 evaluates the child's behavior in several areas, including verbal and nonverbal communication, socialization, stereotyped and repetitive behavior, and adaptation to change. It is made up of 15 questions with a rating scale ranging from 1 to 4, where 1 indicates normal behavior and 4 indicates highly anomalous behavior. It is possible to obtain a score between 15 and 60, where a higher score indicates a greater severity of ASD symptoms.

Countries

Italy

Contacts

Primary ContactFrancesca Cucinotta, MD, PhD
francesca.cucinotta@irccsme.it09060128256
Backup ContactIRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità
info@irccsme.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026