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CTRI Number  CTRI/2017/11/010399 [Registered on: 07/11/2017] Trial Registered Prospectively
Last Modified On: 07/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Semi Structured Interview about childhood school experience]  
Study Design  Other 
Public Title of Study   A interview that deals with life of adults with stutterering based on their negative school experiences 
Scientific Title of Study   Influence of school experience in the life of adults with stutterering: A Qualitative Analysis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angela Alappat 
Designation  PG Student 
Affiliation  Department of Speech and Hearing, SOAHS, Manipal University, Manipal 
Address  Department of Speech and Hearing, SOAHS, CTC 3rd Floor, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916638586  
Fax    
Email  angelaalapat@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Kanaka 
Designation  Associate Professor 
Affiliation  Department of Speech and Hearing, SOAHS, Manipal University, Manipal 
Address  Department of Speech and Hearing, SOAHS, CTC 3rd Floor, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845384136  
Fax    
Email  kanakachristy@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr G Kanaka 
Designation  Associate Professor 
Affiliation  Department of Speech and Hearing, SOAHS, Manipal University, Manipal 
Address  Department of Speech and Hearing, SOAHS, CTC 3rd Floor, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845384136  
Fax    
Email  kanakachristy@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal University Madhav Nagar, Near Tiger Circle, Karnataka 576104  
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Speech and Hearing, CTC 3rd Floor, SOAHS, Manipal University, Manipal  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Angela Alappat  Kasturba Medical College   Kasturba Medical College, CTC Building, 3rd Floor, Department of Speech and Hearing, Madhav Nagar, Near Tiger Circle, Manipal, Karnataka
Udupi
KARNATAKA 
9916638586

angelaalapat@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adults with Stuttering,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Semi Sturctured Interview  Study interview will be carried out in different dates, with a maximum of one our for 6 participants. Once data saturation occurs (which is expected to be achieved by 6 participants), reseacher follows the next phase. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Adults who stutter (AWS) or have overcome their developmental stuttering
2) Education level: primary or secondary education
3) Participants across; age:18+ years, gender and severity would be selected for attaining a wider range of experiences.
4) Participants who did or did not underwent speech therapy.
5) Participants with an ability to communicate in English, as the interview will be carried out in English.

 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1) Participants are excluded if they do not have a school level education.
2) Participants encountered with any obvious communication, neurological disorders
3) Participants who does not consent for the study.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To bring up an awareness on school resources in stuttering as a communication disorder and how ignoring the difficulties of a CWS in school can affect their future.
To indicate the relationship of school environment with personality and self-image in a developing stutterer.
To show the coping strategies adopted by the CWS at the school level, in response to the bulling, teasing, shame, and fear.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To bring up an awareness on school resources in stuttering as a communication disorder and how ignoring the difficulties of a CWS in school can affect their future.
To indicate the relationship of school environment with personality and self-image in a developing stutterer.
To show the coping strategies adopted by the CWS at the school level, in response to the bulling, teasing, shame, and fear.
 
6 months 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Bennett, E.M. (2006). Working with people who stutter: A lifespan approach. Upper Saddle River, NJ: Pearson. 2. Blood, G. W., & Blood, I. M. (2004). Bullying in adolescents who stutter: Communicative competence and self-esteem. Contemporary Issues in Communication Science and Disorder, 31, 69–79. 3. Corcoran, J. A., & Stewart, M. (1998). Stories of stuttering: A qualitative analysis of interview narratives. Journal of Fluency Disorders, 23(4), 247-264. 4)Daniels, D. E., Gabel, R. M., & Hughes, S. (2012). Recounting the K-12 school experiences of adults who stutter: A qualitative analysis. Journal of Fluency Disorders, 37(2), 71-82.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The study discovers the lived experience on stuttering and related factors from their K-10/12, which would provide a marked insight into attitudes from their school environment and thereby its effect in their post school education. The aim of the current study is to highlight the influence of school experience in the life of adults with stuttering. To investigate the effects of school experience in AWS’s by gathering information on:

a)      The role played by teachers in the life of AWS in school environment

b)      The role played  by peers in the life of AWS in school environment

c)      The coping strategies employed by the AWS during school years

d)     The current status of these AWS.

 
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