UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017928 |
|---|---|
| Receipt number | R000020782 |
| Scientific Title | The effect of early intervention program for stuttering |
| Date of disclosure of the study information | 2015/06/16 |
| Last modified on | 2020/06/23 10:25:01 |
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Basic information
Public title
The effect of early intervention program for stuttering
Acronym
The early intervention for stuttering
Scientific Title
The effect of early intervention program for stuttering
Scientific Title:Acronym
The early intervention for stuttering
Region
| Japan |
Condition
Condition
Stuttering
Classification by specialty
| Pediatrics | Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect for early intervention for stuttering of preschool children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sympton of stuttering (frequency and severity rating)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Environmental Control for once a month over one year
No Lidcombe Program for Japan
Interventions/Control_2
Environmental Control for once a month over three months
Lidcombe Program for Japan for once a week over one year
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
| 2 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
parent and children who have concerned about stuttering in 3 and a half medical examination.
And they have intention of participant for this program.
Key exclusion criteria
If they cannot comeregularly, it is difficult to participate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
Kitasato University
Division name
Allied Health Sciences
Zip code
252-0373
Address
kanagawaken Sagamiharasi minami-ku kitasato 1-15-1
TEL
042-778-9661
bara@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
Kitasato University
Division name
Allied Health Sciences
Zip code
252-0373
Address
Kanagawaken Sagamiharasi Minamiku kitasato 1-15-1
TEL
042-778-9661
Homepage URL
bara@kitasato-u.ac.jp
Sponsor or person
Institute
Hara Yuki
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
Kanagawaken Sagamiharashi Minamiku Kitasato 1-15-1
Tel
042-778-9602
inouek@kitasato-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 16 | 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
15
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020782
| Research Plan | |
|---|---|
| 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 |
