Back to resultsMultisensory Environment Room in Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder, Autism
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Training in the multisensory room environment
Home program
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
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
Sites / Locations
- Chakri Naruebodindra Medical InstituteRecruiting
- Faculty of Medicine Ramathibodi Hospital Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Home program group
Multisensory room group
Arm Description
The guardians will receive the education about autistic spectrum disorder and home program training.
The guardians in this group will receiver the educational program the same as the home program group plus the training in multisensory room.
Outcomes
Primary Outcome Measures
Vineland Adaptive Behavior Scales-Third Edition (VABS-III)
To measure communication, interpersonal skill and relationship of the children with autistm spectrum and other people in scales; 2 = often, 1= sometimes and 0= never. The minimum score is o. The max score in receptive domain is 78. The max score of expressive domain is 98. The max score of written domain is 76. The max score of personal domain is 110. The max score of domestic domain is 60. The max score of community domain is 116. The interpersonal relationships domain max score is 86. The max score of play and leisure domain is 72. The max score of copling skill domain is 66. The max score of gross motor domain is 86. The max score of fine motor domain is 68. The max score of maladaptive behavior domain is 88.
Secondary Outcome Measures
Parent Stress Index 4th Edition: Short Form [PSI-4-SF]
To measure stress in guardians with children with autism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05752994
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home program group
Arm Type
Active Comparator
Arm Description
The guardians will receive the education about autistic spectrum disorder and home program training.
Arm Title
Multisensory room group
Arm Type
Experimental
Arm Description
The guardians in this group will receiver the educational program the same as the home program group plus the training in multisensory room.
Intervention Type
Other
Intervention Name(s)
Training in the multisensory room environment
Intervention Description
The children will start with the swing follow with the scheduled activities and tabletop activity. The session will end in the relaxation room such as bubble tube, fiberoptic cascade, fiberoptic carpet and aurora projector bundle while the therapist has the interactive communication with children
Intervention Type
Other
Intervention Name(s)
Home program
Intervention Description
Home program
Primary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales-Third Edition (VABS-III)
Description
To measure communication, interpersonal skill and relationship of the children with autistm spectrum and other people in scales; 2 = often, 1= sometimes and 0= never. The minimum score is o. The max score in receptive domain is 78. The max score of expressive domain is 98. The max score of written domain is 76. The max score of personal domain is 110. The max score of domestic domain is 60. The max score of community domain is 116. The interpersonal relationships domain max score is 86. The max score of play and leisure domain is 72. The max score of copling skill domain is 66. The max score of gross motor domain is 86. The max score of fine motor domain is 68. The max score of maladaptive behavior domain is 88.
Time Frame
baseline, change from baseline at 5 weeks, change from baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Parent Stress Index 4th Edition: Short Form [PSI-4-SF]
Description
To measure stress in guardians with children with autism
Time Frame
baseline, change from baseline at 5 weeks, change from baseline at 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chayakorn Harnpramukkul, MD.
Phone
083-705-8991
Email
nook.badbadz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sivaporn Vongpipatana, MD.
Phone
022011154
Email
sivaporn.vop@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivaporn Vongpipatana, MD.
Organizational Affiliation
Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chakri Naruebodindra Medical Institute
City
Bangkok
State/Province
Samut Prakarn
ZIP/Postal Code
10540
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sivaporn Vongpipatana
Phone
022011154
Email
sivaporn.vop@mahidol.ac.th
Facility Name
Faculty of Medicine Ramathibodi Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sivaporn Vongpipatana
Phone
022011154
Email
sivaporn.vop@mahidol.ac.th
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual information of the subject will be concealed. The collected information will be shared for analysis.
IPD Sharing Time Frame
The study protocol will be share among the researcher team to make a plan for data gathering and run the project. The statistical analytic plan and analytic code will be share among the data collector, statistician and primary investigator. The clinical study report will be share among the researcher team. The informed consent will be saved with the primary investigator.
IPD Sharing Access Criteria
only among the researcher team
Citations:
PubMed Identifier
21289533
Citation
Marco EJ, Hinkley LB, Hill SS, Nagarajan SS. Sensory processing in autism: a review of neurophysiologic findings. Pediatr Res. 2011 May;69(5 Pt 2):48R-54R. doi: 10.1203/PDR.0b013e3182130c54.
Results Reference
background
PubMed Identifier
29423607
Citation
Shea N, Payne E, Russo N. Brief Report: Social Functioning Predicts Externalizing Problem Behaviors in Autism Spectrum Disorder. J Autism Dev Disord. 2018 Jun;48(6):2237-2242. doi: 10.1007/s10803-017-3459-8.
Results Reference
background
PubMed Identifier
23221029
Citation
Sanchez A, Millan-Calenti JC, Lorenzo-Lopez L, Maseda A. Multisensory stimulation for people with dementia: a review of the literature. Am J Alzheimers Dis Other Demen. 2013 Feb;28(1):7-14. doi: 10.1177/1533317512466693. Epub 2012 Dec 7.
Results Reference
background
PubMed Identifier
34693744
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.
Results Reference
background
PubMed Identifier
34827458
Citation
Basadonne I, Cristofolini M, Mucchi I, Recla F, Bentenuto A, Zanella N. Working on Cognitive Functions in a Fully Digitalized Multisensory Interactive Room: A New Approach for Intervention in Autism Spectrum Disorders. Brain Sci. 2021 Nov 3;11(11):1459. doi: 10.3390/brainsci11111459.
Results Reference
background
PubMed Identifier
30933867
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.
Results Reference
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Citation
Staples KL, MacDonald M, Zimmer C. Assessment of motor behavior among children and adolescents with autism spectrum disorder. International Review of Research in Developmental Disabilities. 42: Elsevier; 2012. p. 179-214.
Results Reference
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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.
Results Reference
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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.
Results Reference
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Citation
American Psychiatric Association. The American Psychiatric Association's 2013 Annual Meeting. 2013. Contract No.: Abstract NR12-5
Results Reference
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Citation
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.2014.
Results Reference
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Links:
URL
https://www.psychiatry.org/psychiatrists/practice/dsm
Description
about the diagnosis of autism
Learn more about this trial
Multisensory Environment Room in Children With Autism Spectrum Disorder
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