Multisensory Environment Room in Children With Autism Spectrum Disorder

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05752994
Collaborator
(none)
30
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Training in the multisensory room environment
  • Other: Home program
N/A

Detailed Description

This project is a pilot study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Multisensory Environment Room on Behavior in Children With Autism Spectrum Disorder
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Home program group

The guardians will receive the education about autistic spectrum disorder and home program training.

Other: Home program
Home program

Experimental: Multisensory room group

The guardians in this group will receiver the educational program the same as the home program group plus the training in multisensory room.

Other: Training in the multisensory room environment
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

Outcome Measures

Primary Outcome Measures

  1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III) [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 Outcome Measures

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

    To measure stress in guardians with children with autism

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Sivaporn Vongpipatana, MD., Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sivaporn Vongpipatana, Assistant Professor, Mahidol University
ClinicalTrials.gov Identifier:
NCT05752994
Other Study ID Numbers:
  • MURA2023/12
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023