Multisensory Environment Room in Children With Autism Spectrum Disorder

NCT ID: NCT05752994

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2024-03-31

Brief Summary

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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

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This project is a pilot study.

Conditions

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Autism Spectrum Disorder Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Home program group

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

Group Type ACTIVE_COMPARATOR

Home program

Intervention Type OTHER

Home program

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.

Group Type EXPERIMENTAL

Training in the multisensory room environment

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Home program

Home program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sivaporn Vongpipatana

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sivaporn Vongpipatana, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

Locations

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Chakri Naruebodindra Medical Institute

Bangkok, Changwat Samut Prakan, Thailand

Site Status RECRUITING

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Chayakorn Harnpramukkul, MD.

Role: CONTACT

083-705-8991

Sivaporn Vongpipatana, MD.

Role: CONTACT

022011154

Facility Contacts

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Sivaporn Vongpipatana

Role: primary

022011154

Sivaporn Vongpipatana

Role: primary

022011154

References

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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.

Reference Type BACKGROUND
PMID: 21289533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29423607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23221029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34693744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34827458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30933867 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

American Psychiatric Association. The American Psychiatric Association's 2013 Annual Meeting. 2013. Contract No.: Abstract NR12-5

Reference Type BACKGROUND

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.2014.

Reference Type BACKGROUND

Related Links

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Other Identifiers

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MURA2023/12

Identifier Type: -

Identifier Source: org_study_id

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