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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026785
Receipt No. R000030582
Scientific Title Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter
Date of disclosure of the study information 2017/03/31
Last modified on 2017/03/30

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Basic information
Public title Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter
Acronym CBT intervention for adolescents and adults who stutter
Scientific Title Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter
Scientific Title:Acronym CBT intervention for adolescents and adults who stutter
Region
Japan

Condition
Condition Stuttering
Classification by specialty
Psychiatry Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the treatment efficacy on stuttering of group training based on cognitive behavior therapy (CBT) for adolescents and adults who stutter
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes "The Stuttering Test" before the intervention, at the end of the intervention, and one month after the end of the intervention.
Key secondary outcomes Questionnaires filled before the intervention, at the end of the intervention, and one month after the end of the intervention (Overall Assessment of the Speaker's Experience of Stuttering (OASES), Japanese edition, Liebowitz Social Anxiety Scale in Japanese (LSAS-J), Stuttering Distress Questionnaire, Erickson Scale of Communication Attitudes, modified (S-24), Self-Assessment Scale of Speech, Preparatory behavior checklist for those who tend to stutter just before speech, Thought Chain Chart for those who stutter, UTBAS-6, General Self-Efficasy Scale(GSES), PHQ9)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Five weekly training sessions of two hours for adults and five daily sessions of two hours for the students of junior high and high schools.
Interventions/Control_2
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
12 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Persons who stutter older than 11 years old (junior high school students and above). Those who volunteer for participating in this group training program among stuttering patients of our hospital and those who apply to the program through public recruitment.
Key exclusion criteria Persons who can not speak at all because of severe stuttering. Persons with severe depression, or mental retardation. Persons who will not follow instructions. Persons who do not want improvement of stuttering.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohito Houjou
Organization National Rehabilitation Center for Persons with Disabilities
Division name Hospital
Zip code
Address 4-1 Namiki, Tokorozawa, Saitama, 359-8555
TEL 04-2995-3100
Email houjou-tomohito@rehab.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohito Houjou
Organization National Rehabilitation Center for Persons with Disabilities
Division name Hospital
Zip code
Address 4-1 Namiki, Tokorozawa, Saitama, 359-8555
TEL 04-2995-3100
Homepage URL http://www.kitsuon-kenkyu.org/
Email houjou-tomohito@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 Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

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
Date of protocol fixation
2017 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 18 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=R000030582

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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