Multisensory Environment Room in Children With Autism Spectrum Disorder

August 15, 2023 updated by: Sivaporn Vongpipatana, Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project is a pilot study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital Mahidol University
        • Contact:
    • Samut Prakarn
      • Bangkok, Samut Prakarn, Thailand, 10540
        • Recruiting
        • Chakri Naruebodindra Medical Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Stress Index 4th Edition: Short Form [PSI-4-SF]
Time Frame: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks
To measure stress in guardians with children with autism
baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2023/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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