UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026792 |
|---|---|
| Receipt number | R000030753 |
| Scientific Title | Japan evaluation study of Stuttering Treatment in preschool children: A Randomized Trial |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/03/30 21:35:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japan evaluation study of Stuttering Treatment in preschool children: A Randomized Trial
Acronym
Japan evaluation study of Stuttering Treatment in preschool children: A Randomized Trial
(JSTART-study)
Scientific Title
Japan evaluation study of Stuttering Treatment in preschool children: A Randomized Trial
Scientific Title:Acronym
Japan evaluation study of Stuttering Treatment in preschool children: A Randomized Trial
(JSTART-study)
Region
| Japan |
Condition
Condition
stuttering
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying efficacy of the Lidcombe Program and the demands and capacities model based approach(DCM) in Japan against early childhood stuttering
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
stuttering severity(assessed with the severity rating scale of the Lidcombe Program)(pre and post 12-week intervention)
SDQ score(pre and post 12-week intervention)
KiddyCAT score(pre and post 12-week intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Lidcombe Program(LP)(once a week session for 12w)
Interventions/Control_2
DCM(once a week session 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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) >=6 months post onset of stuttering, (2) >=3 years old and >=6 months before school attendance, (3) >=1 with severity rating scale of the Lidcombe Program (0-9) by clinician at initial assessment, (4) >=3 % word stuttered with the standardized test for stuttering or at daily conversation, (5)not being treated with fluency shaping approach
Key exclusion criteria
Having concomitant problems which makes implementing DCM and LP impossible
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Sakata |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
College
Zip code
Address
4-1 Mamiki, Tokorozawa, Saitama, 359-8555, Japan
TEL
04-2995-3100
sakata-yoshimasa@rehab.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Sakata |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
College
Zip code
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555, Japan
TEL
04-2995-3100
Homepage URL
http://www.kitsuon-kenkyu.org/
sakata-yoshimasa@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
Kitasato University, Kanazawa University, University of Tsukuba, Hiroshima University, International University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立障害者リハビリテーションセンター（埼玉県）、北里大学（神奈川県）、金沢大学（石川県）、筑波大学（茨城県）、広島大学（広島県）、国際医療福祉大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030753
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
