UMIN-CTR Clinical Trial

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
Email	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
Email	liaison@kyotogakuen.ac.jp

Sponsor
Institute	kyoto university of advanced science
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025665