Multisensory Room in Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184802
• Other study ID #: SENSROOM01
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Francesca Cucinotta, MD, PhD
• Phone: 09060128256
• Email: francesca.cucinotta[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• TAU+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
• TAU
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.

Locations

Country	Name	City	State
Italy	IRCCS Neurolesi Bonino Pulejo	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

References & Publications (4)

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (DSM-5®). Biobehavioral Reviews, 33, 1204-1214

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychoeducational Profile, Third Edition (PEP-3)	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	T0 (Baseline) - T1 (6 Months)
Primary	Childhood Autism Rating Scale (CARS-2)	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.	T0 (Baseline) - T1 (6 Months)