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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026792
Receipt No. 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

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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
Email 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/
Email sakata-yoshimasa@rehab.go.jp

Sponsor
Institute National Rehabilitation Center for Persons with Disabilities
Institute
Department

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
Email

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
URL(English) https://upload.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


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