UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040945 |
|---|---|
| Receipt number | R000046750 |
| Scientific Title | The Efficacy of Safe and Sound Protocol on auditory hypersensitivity and communication deficits in children with autism spectrum disorder |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2022/07/04 14:09:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Efficacy of Listening therapy on auditory hypersensitivity and communication deficits in children with autism spectrum disorder
Acronym
The Efficacy of Listening therapy on auditory hypersensitivity and communication deficits in children with autism spectrum disorder
Scientific Title
The Efficacy of Safe and Sound Protocol on auditory hypersensitivity and communication deficits in children with autism spectrum disorder
Scientific Title:Acronym
The Efficacy of Safe and Sound Protocol on auditory hypersensitivity and communication deficits in children with autism spectrum disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the efficacy of Safe and Sound Protocol on children with Autism Spectrum Diorder
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
SRS-2:The second edition of the widely administered Social Responsiveness Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using Safe and Sound Protocol 1 hour/day for 5 days
Interventions/Control_2
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
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Diagnosed as Autism Spectrum Disorder using ADOS-2 and ADI-R by research team
2.Who haven't experienced Listening therapy
3.Patients whose Legal representative fully understood the explanations and give their consent of their own free will to receive treatment
Key exclusion criteria
1) Patients with a serious physical disease or motor disfunction
2) Patients with a hereditary disease
3) Patients with a history of epilepsty
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Kishimoto |
Organization
National Center for Child Health and Development
Division name
Department of Pyschosical Medicine Divison of Early Childhood Mental Health
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535
TEL
0334160181
kishimoto-m@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Kishimoto |
Organization
National Center for Child Health and Development
Division name
Department of Pyschosical Medicine Divison of Early Childhood Mental Health
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535
TEL
0334160181
Homepage URL
kishimoto-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535
Tel
0334160181
kishimoto-m@ncchd.go.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
| 2020 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046750
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
