UMIN-CTR Clinical Trial

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
Email	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
Email	kakuta-kouhei@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
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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049345