UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022750 |
|---|---|
| Receipt number | R000025665 |
| Scientific Title | Correlates of articulation and phonological awareness.-make a test of phonological awareness for young children and longitudinal research |
| Date of disclosure of the study information | 2016/06/17 |
| Last modified on | 2020/04/24 12:17:14 |
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Basic information
Public title
Correlates of articulation and phonological awareness.-make a test of phonological awareness for young children and longitudinal research
Acronym
Correlates of articulation and phonological awareness
Scientific Title
Correlates of articulation and phonological awareness.-make a test of phonological awareness for young children and longitudinal research
Scientific Title:Acronym
Correlates of articulation and phonological awareness
Region
| Japan |
Condition
Condition
Speech sound disorder
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I make a test of phonological awareness for young children.
I research a correlates of articulation and phonological awareness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To research of discrimination of mora and phonological awareness in word.
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
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
tests of phonological awareness and articulation
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
| 6 | months-old | < |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
normal develpoment
Key exclusion criteria
high risks of pregnancy and perinatal period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Yuge |
Organization
kyoto university of advanced science
Division name
Department of Speech-Language-Hearing Sciences and Diorders
Zip code
6158577
Address
Gotandacho18,Yamanouit,Ukyoku,Kyoto city,Japan
TEL
075-406-9157
yuge.akiko@kuas.ac.jp
Public contact
Name of contact person
| 1st name | Seisuke |
| Middle name | |
| Last name | Nonami |
Organization
kyoto university of advanced science
Division name
Research support center
Zip code
6218555
Address
Nanjoootani1-1,sogabecho,kameoka city,kyoto,Japan
TEL
0771-29-3593
Homepage URL
liaison@kyotogakuen.ac.jp
Sponsor or person
Institute
kyoto university of advanced science
Institute
Department
Personal name
Funding Source
Organization
Ministory of education,culture,sports,sciences and technology,Japan
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
kyoto university of advanced science
Address
Nanjoootani1-1,sogabecho,kameoka city,kyoto,Japan
Tel
0771-29-3593
liaison@kuas.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
京都先端科学大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 17 | 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
3
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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
