UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021940 |
|---|---|
| Receipt number | R000025306 |
| Scientific Title | Effectiveness research of training using voice volume application for autism spectrum disorder |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2021/10/20 14:21:38 |
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Basic information
Public title
Effectiveness research of training using voice volume application for autism spectrum disorder
Acronym
Effectiveness of voice volume app in ASD
Scientific Title
Effectiveness research of training using voice volume application for autism spectrum disorder
Scientific Title:Acronym
Effectiveness of voice volume app in ASD
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine efficacy of application that children with autism spectrum disorder can practice voice volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of Voice volume and changes in daily life(Social skills,Problem behavior, Self-efficacy, Social anxiety)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Children practice the voice volume at home by using application everyday of the month.
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
| 4 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with Autism Spectrum Disorder at the outpatient clinic of Osaka University Hospital
Key exclusion criteria
Children with intellectual disability (Preschooler DQ/IQ<70, School children DQ/IQ<50)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoka |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka University United Graduate School of Child Development Medicine
Division name
Molecular Research Center for Children's Mental Development
Zip code
5650871
Address
2-2 Yamadaoka Suita-city, Osaka
TEL
06-6879-3863
t-yamamoto@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka University United Graduate School of Child Development Medicine
Division name
Molecular Research Center for Children's Mental Development
Zip code
5650871
Address
2-2 Yamadaoka Suita city, Osaka
TEL
06-6879-3863
Homepage URL
t-yamamoto@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University United Graduate School of Child Development Medicine
Institute
Department
Personal name
Funding Source
Organization
Hakuho Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
0662108289
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025306
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
