UMIN-CTR Clinical Trial

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
Email	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
Email	kishimoto-m@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046750