UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043239 |
|---|---|
| Receipt number | R000049345 |
| Scientific Title | A randomized controlled trial comparing two stuttering reatments in school-age children |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2021/03/04 17:33:07 |
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Basic information
Public title
A randomized controlled trial comparing two stuttering reatments in school-age children
Acronym
A randomized controlled trial comparing two stuttering reatments in school-age children
Scientific Title
A randomized controlled trial comparing two stuttering reatments in school-age children
Scientific Title:Acronym
A randomized controlled trial comparing two stuttering reatments in school-age children
Region
| Japan |
Condition
Condition
Developmental stuttering
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determining efficacy of cognitive behavioral therapy (CBT) and fluency shaping (FS) in school-age children who stutter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stuttering frequency(pre and post 12-week intervention)
Key secondary outcomes
The following items pre and post 12-week intervention
OASES-S-J
CAT
SR
SDQ
CBCL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavioral therapy for stuttering once in two weeks for 12w
Interventions/Control_2
Fluency Shaping
once in two weeks for 12w
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
| 7 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
School-age children who stutter
Key exclusion criteria
Having concomitant problems which makes implementing CBT and FS impossible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Kakuta |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital
Zip code
359-8555
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555, Japan
TEL
04-2995-3100
kakuta-kouhei@rehab.go.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Kakuta |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital
Zip code
359-8555
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555, Japan
TEL
04-2995-3100
Homepage URL
kakuta-kouhei@rehab.go.jp
Sponsor or person
Institute
National Rehabilitation Center for Persons with Disabilities
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethical Review Board in National Rehabilitation Center for Persons with Disabilities
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555, Japan
Tel
04-2995-3100
kakuta-kouhei@rehab.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
| 2021 | Year | 02 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2021 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049345
