Multisensory Environment Room in Children With Autism Spectrum Disorder

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder; Autism
• Interventions: Other: Home program; Other: Training in the multisensory room environment

• Registration Number: NCT05752994
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-03
• Study Start: 2023-03-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home program group	Home program	The guardians will receive the education about autistic spectrum disorder and home program training.
Multisensory room group	Training in the multisensory room environment	The guardians in this group will receiver the educational program the same as the home program group plus the training in multisensory room.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Faculty of Medicine Ramathibodi Hospital Mahidol University; 🇹🇭 Bangkok, Thailand

Chakri Naruebodindra Medical Institute; 🇹🇭 Bangkok, Samut Prakarn, Thailand