UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059427 |
|---|---|
| Receipt number | R000067967 |
| Scientific Title | The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/16 12:20:04 |
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Basic information
Public title
The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities
Acronym
The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities
Scientific Title
The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities
Scientific Title:Acronym
The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder and Intellectual Disabilities
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of sensory integration therapy for children with autism spectrum disorder accompanied by intellectual disability and contribute to the development of appropriate support programs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
1) Evaluation of Achievement of Individual Goals
i. Canadian Task Performance Measure: Determines and measures tasks meaningful to the individual.
ii. Goal Attainment Scaling: An evaluation method that creates individualized rating scales.
(2) Evaluation of Behavior
i. Vineland Adaptive Behavior Scale, Second Edition: Measures an individual's level of adaptive behavior.
Key secondary outcomes
(1) Sensory Evaluation
i. Japanese Version Sensory Profile: A questionnaire assessing sensory processing abilities. Since this study's subjects are aged 2 to 6 years, the Japanese Infant Sensory Profile is used for 2-year-olds, and the Sensory Profile is used for 3- to 6-year-olds.
(2) Parenting Stress Evaluation
i. Parenting Stress Index Short Form: A questionnaire assessing parental stress related to childcare, parent-child
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will undergo sensory integration therapy. The program consists of 16 sessions, held twice weekly for 60 minutes each, over an 8-week period.
Interventions/Control_2
The control group will receive usual care(occupational therapy at a child development support center). Sessions will be held 2 to 4 times over a period of 8 weeks, with a frequency of 1 to 2 times per month and a duration of 40 minutes per session.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children diagnosed with autism spectrum disorder (including autistic disorder).
2. Children rated as severe on the Childhood Autism Rating Scale Second Edition (CARS2).
3. Children with a developmental index of 70 or below on the New K-type Developmental Test 2001 administered at child guidance centers or similar facilities.
Key exclusion criteria
1. Children with obvious physical disabilities due to conditions such as cerebral palsy.
2. Children with medical restrictions on physical exertion due to conditions such as epilepsy or heart disease.
3. Children who have received sensory integration therapy from an occupational therapist, either currently or in the past.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Kiyomi |
| Middle name | |
| Last name | Tateyama |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science Department of Rehabilitation Science
Zip code
536-0025
Address
132, 2-chome, Morinomiya, Joto Ward, Osaka City, Osaka Prefecture
TEL
06-6167-1282
tateyama@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Nakamura |
Organization
Nishinomiya City Children's Future Center Clinic
Division name
Medical Services Division
Zip code
663-8202
Address
Nishinomiya City Children's Future Center, 2-77 Takahata-cho, Nishinomiya City
TEL
0798-65-1927
Homepage URL
df701004@st.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nishinomiya City Children's Future Center Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefecture University Graduate School Department of Comprehensive Rehabilitation Studies Research Ethics Committee
Address
536-0025 132, 2-chome, Morinomiya, Joto Ward, Osaka City, Osaka Prefecture
Tel
0661671261
gr-mrny-reha-rinri@omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067967
