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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035599
Receipt No. 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

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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
Email 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
Email mkpoikanke.otu@unn.edu.ng

Sponsor
Institute Otusum Consult, Training & Services, Nigeria
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040359

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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