Skip to main content
Clinical Trials/NCT05752994
NCT05752994
Recruiting
Not Applicable

Effect of Multisensory Environment Room on Behavior in Children With Autism Spectrum Disorder

Mahidol University2 sites in 1 country30 target enrollmentMarch 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Mahidol University
Enrollment
30
Locations
2
Primary Endpoint
Vineland Adaptive Behavior Scales-Third Edition (VABS-III)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2023
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sivaporn Vongpipatana

Assistant Professor

Mahidol University

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

Outcomes

Primary Outcomes

Vineland Adaptive Behavior Scales-Third Edition (VABS-III)

Time Frame: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

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 Outcomes

  • Parent Stress Index 4th Edition: Short Form [PSI-4-SF](baseline, change from baseline at 5 weeks, change from baseline at 10 weeks)

Study Sites (2)

Loading locations...

Similar Trials