AzTrials
AzTrials

Autism Spectrum DisorderNCT05752994

Multisensory Environment Room in Children With Autism Spectrum Disorder

A study testing Training in the multisensory room environment and Home program in people with Autism Spectrum Disorder and Autism, run by Mahidol University at 2 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 5 years
Conditions the study is for
Autism Spectrum Disorder, Autism
What is being tested?
Training in the multisensory room environment and Home program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesThailand
Study dates
9 Mar 2023to Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • The guardians deny to enroll into the study.
  • blindness, deafness
  • got the treatment of r-TMS less than 1 year

Trial locations and contacts

2 sites in 1 country.

Chayakorn Harnpramukkul, MD. contact

083-705-8991

nook.badbadz@gmail.com

Sivaporn Vongpipatana, MD. contact

022011154

sivaporn.vop@mahidol.ac.th

Thailand2 sites, 2 recruiting

  • Chakri Naruebodindra Medical Institute

    Bangkok, Changwat Samut Prakan, 10540

    Sivaporn Vongpipatana, 022011154, sivaporn.vop@mahidol.ac.th

    Recruiting

  • Faculty of Medicine Ramathibodi Hospital Mahidol University

    Bangkok, 10400

    Sivaporn Vongpipatana, 022011154, sivaporn.vop@mahidol.ac.th

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

Read the detailed description

This project is a pilot study.

Being tested
Training in the multisensory room environment, Home program
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in the multisensory room environmentOther

    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

  • Home programOther

    Home program

Study groups in NCT05752994
Study groupRoleWhat they receive
Home program groupActive comparatorThe guardians will receive the education about autistic spectrum disorder and home program training.
Receives: Other: Home program
Multisensory room groupExperimentalThe guardians in this group will receiver the educational program the same as the home program group plus the training in multisensory room.
Receives: Other: Training in the multisensory room environment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

Secondary outcomes (1)

  1. Parent Stress Index 4th Edition: Short Form [PSI-4-SF]

    To measure stress in guardians with children with autism

    Measured: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start9 Mar 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752994
Sponsor's protocol ID
MURA2023/12
Status last verified
Aug 2023
First submitted
10 Feb 2023
Last updated
16 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual information of the subject will be concealed. The collected information will be shared for analysis.

Publications

  • 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.

    PubMed 21289533

  • 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.

    PubMed 29423607

  • 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.

    PubMed 23221029

  • 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.

    PubMed 34693744

  • 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.

    PubMed 34827458

  • 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.

    PubMed 30933867

  • 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.

  • 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.

  • 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.

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Training in the multisensory room environment and Home program in people with Autism Spectrum Disorder and Autism, run by Mahidol University at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chayakorn Harnpramukkul, MD. (083-705-8991, nook.badbadz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vineland Adaptive Behavior Scales-Third Edition (VABS-III) (time frame: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05752994, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in