UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035599 |
|---|---|
| Receipt number | R000040359 |
| Scientific Title | Cognitive-Behavior Language Therapy for Speech Anxiety among Stuttering School Adolescents |
| Date of disclosure of the study information | 2019/01/20 |
| Last modified on | 2019/01/20 05:55:32 |
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Basic information
Public title
Cognitive-Behavior Language Therapy for Speech Anxiety among Stuttering School Adolescents
Acronym
Cognitive-Behavior Language Therapy
Scientific Title
Cognitive-Behavior Language Therapy for Speech Anxiety among Stuttering School Adolescents
Scientific Title:Acronym
Cognitive-Behavior Language Therapy
Region
| Africa |
Condition
Condition
Speech anxiety
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the current study was to determine the effectiveness of cognitive behavior language therapy (CBLT) for reduction in speech anxiety among stuttering school adolescents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Speech Anxiety Thoughts Inventory (SATI), Time 1, Time 2, Time 3.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Treatment group = Cognitive-Behavior Language Therapy for Speech Anxiety.
24 sessions (Two hours each) group intervention program structured to last for 12 weeks
Interventions/Control_2
Control group = waitlist
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were being 12 to 20 years of age; having stuttering rate greater than 2% syllables stuttered (%SS) when measured by the assessing clinician; and being able to keep regular attendance at the treatment; being willing to sign informed consent form and to participate in the study.
Key exclusion criteria
The exclusion criteria for the study were: being involved in any CBLT treatment and speech-related treatment during the previous 12 months; having limited functional English, intellectual disability, being currently suicidal; being unwilling inability to participate in the treatme
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Josephine Akabogu |
Organization
University of Nigeria, Nsukka
Division name
Department of Arts Education, University of Nigeria
Zip code
Address
Department of Arts Education, University of Nigeria, Nsukka
TEL
08035458263
josephine.akabogu@unn.edu.ng
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mkpoikanke Sunday Otu |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations, University of Nigeria, Nsukka
Zip code
Address
Department of Educational Foundations, University of Nigeria, Nsukka
TEL
+2348035599525
Homepage URL
mkpoikanke.otu@unn.edu.ng
Sponsor or person
Institute
Otusum Consult, Training & Services, Nigeria
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Nigeria
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 20 | 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 show that CBLT intervention was statistically and significantly effective in reducing speech anxiety among stuttering school adolescents exposed to the treatment intervention when compared to waitlist control group.
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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