Multisensory Room in Autism Spectrum Disorder

NCT06184802 | Unknown

• 1 other identifier: SENSROOM01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Behavioral: TAU+Multisensory room

Control Group (CG)

ACTIVE COMPARATOR

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.

Behavioral: TAU

Interventions

TAU+Multisensory room BEHAVIORAL

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

Experimental Group (EG)

TAU BEHAVIORAL

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.

Control Group (CG)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi Bonino Pulejo

Messina, 98124, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 30933867 BACKGROUND

• 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.

  PMID: 16122905 BACKGROUND

• 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.

  PMID: 16806812 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Francesca Cucinotta, MD, PhD

CONTACT

09060128256; francesca.cucinotta@irccsme.it

IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità

CONTACT

info@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 28, 2023
• Study Start: November 4, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

IT (1)