UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026785 |
|---|---|
| Receipt number | 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 | 2022/03/15 17:23:30 |
* 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
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 | Tomohito |
| Middle name | |
| Last name | Houjou |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital
Zip code
359-8555
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555
TEL
04-2995-3100
houjou-tomohito@rehab.go.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | Houjou |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital
Zip code
359-8555
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555
TEL
04-2995-3100
Homepage URL
http://www.kitsuon-kenkyu.org/
houjou-tomohito@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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, National Rehabilitation Center for Persons with Disabilities
Address
4-1 Namiki, Tokorozawa, Saitama, 359-8555
Tel
04-2995-3100
kikakurinri@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
| 2017 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.jssfd.org/dl/gakkaishi04.pdf
Publication of results
Published
Result
URL related to results and publications
http://www.jssfd.org/dl/gakkaishi04.pdf
Number of participants that the trial has enrolled
48
Results
Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf
Results date posted
| 2022 | Year | 03 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf
Participant flow
Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf
Adverse events
Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf
Outcome measures
Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 19 | Day |
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
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030582
