Multisensory Room in Autism Spectrum Disorder

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: TAU; Behavioral: TAU+Multisensory room

Study type: Interventional

Funder types: Other

Identifiers

NCT06184802

SENSROOM01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

The group consists of 50 patients diagnosed with autism spectrum disorder, randomly assigned. The patients underwent treatment as usual (TAU) integrated with the use of multisensory room, in a 1:1 ratio. All the exercises have been customized by the therapists according to the individual treatment needs, adapting the level of difficulty to the patient's abilities. Overall, each patient was treated over a period of 6 months, up to a total of n. 48 sessions, twice a week, lasting 45 minutes each.

Treatment:

Behavioral: TAU+Multisensory room

Control Group (CG)

Active Comparator group

Description:

The group consists of 50 patients diagnosed with autism spectrum disorder randomly assigned. The patients underwent TAU, consisting in standard neuro-psychomotor training. The treatment was tailored according to each child's goals need and preferences. Overall, each patient was treated over a period of 6 months, up to a total of n. 48 sessions, twice a week, lasting 45 minutes each.

Treatment:

Behavioral: TAU