UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cognitive-Behavior Language Therapy for Speech Anxiety among Stuttering School Adolescents
Title of the study (Brief title)	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	Josephine Akabogu
Organization	University of Nigeria, Nsukka
Division name	Department of Arts Education, University of Nigeria
Address	Department of Arts Education, University of Nigeria, Nsukka
TEL	08035458263
Email	josephine.akabogu@unn.edu.ng

Public contact
Name of contact person	Mkpoikanke Sunday Otu
Organization	University of Nigeria, Nsukka
Division name	Department of Educational Foundations, University of Nigeria, Nsukka
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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