Clinical trial NCT05752994: Multisensory Environment Room in Children With Autism Spectrum Disorder
Official title: Effect of Multisensory Environment Room on Behavior in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of multisensory environment room on behavior in children with autism spectrum disorder age 3-5 years old. The children will be randomized into 2 groups: the experimental and the control group. The control group will be educated about the autistic and hoe program training. The intervention group will got the same educational program as the control group plus training in multisensory room environment once a week for 10 weeks. The outcome measurement was done as the before intervention, at the 5th and 10th week.

Detailed description: This project is a pilot study.

Eligibility criteria: Inclusion Criteria:

* the children who was diagnosed with autism according to DSM-5
* age 3-5 years old
* has the severity mild-to-moderate and severe according to childhood autism rating scale, 2nd edition

Exclusion Criteria:

* The guardians deny to enroll into the study.
* blindness, deafness
* got the treatment of r-TMS less than 1 year

Primary outcomes:
measure: Vineland Adaptive Behavior Scales-Third Edition (VABS-III)
timeFrame: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks
Secondary outcomes:
measure: Parent Stress Index 4th Edition: Short Form [PSI-4-SF]
timeFrame: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chakri Naruebodindra Medical Institute
state: Samut Prakarn
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital Mahidol University
Study officials:
affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University
name: Sivaporn Vongpipatana, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Unwin KL, Powell G, Jones CR. The use of Multi-Sensory Environments with autistic children: Exploring the effect of having control of sensory changes. Autism. 2022 Aug;26(6):1379-1394. doi: 10.1177/13623613211050176. Epub 2021 Oct 24.
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citation: Srikosai Soontaree, Moanchai Patcharee, Kamfou Chadaporn, Taweewattanaprecha Siriwan, Saipanish Ratana. ความ ตรง และ ความ เชื่อถือ ได้ ของ ดัชนี ชี้ วัด ความเครียด ผู้ ปกครอง ของ เด็ก อายุ 1เดือน ถึง 12 ปี. Journal of Mental Health of Thailand. 2020;28(1):56-71.
citation: Pajareya K, Sutchritpongsa S, Kongkasuwan R. DIR/Floortime® Parent Training Intervention for Children with Developmental Disabilities: a Randomized Controlled Trial. Siriraj Medical Journal. 2019;71(5):331- 38.
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citation: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.2014.