| CTRI Number |
CTRI/2019/01/016884 [Registered on: 03/01/2019] Trial Registered Prospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing tool for speech sound production in children |
|
Scientific Title of Study
|
Development of Phonological Assessment Tool in Kannada |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena K D |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences MAHE |
| Address |
Department of Speech and Hearing
SOAHS MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena K D |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences MAHE |
| Address |
Department of Speech and Hearing
SOAHS MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena K D |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences MAHE |
| Address |
Department of Speech and Hearing
SOAHS MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NCERT |
| Address |
National Council of Educational Research and Training
Sri Aurobindo Marg
New Delhi 110016i |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veena K D |
School of Allied Health Sciences |
Room no. 405, 4th floor
Department of Speech and Hearing, School of Allied Health Sciences
Udupi
KARNATAKA |
9448824346
r.veena@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normally developing children from 2 years to 7 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Common Kannada being the primary language and mother tongue
2.Children developing normally in the areas of physical, intellectual, social, sensory and language development
3.Language age between 2 – 7years of age
4.The children will be screened using a checklist for normal hearing, speech, language, social and cognitive development. Only those children who pass the screening will be considered for the study
|
|
| ExclusionCriteria |
| Details |
1. Known sensory/physical/neurological/psychological deficits/ Shyness
2. Anxiety problem (if reported by parents or teachers)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Phonological measures such as Percentage of phonological processes, Percentage of consonant correct, Percentage of consonant cluster correct to obtain the percentile ranks for the phonological process followed by a pattern analysis based on distinctive features , syllable structure and consonant category deficiency and the phonological process. Finally, reflecting the phonetic inventory, frequency of occurrence of process, percentile ranks, total phonological deviancy and severity level. |
The data will be analyzed by December, 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of Speech Sound Disorder and intervention based on assessment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/01/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Phonological analysis in children can be performed using different types of pattern analysis such as place-manner-voice analysis, distinctive features and phonological process analysis among which, the phonological process analysis is the most common and widely used method. The phonological process analyses systematic patterns in a child’s pronunciation by comparison with the target adult pronunciation. There are many phonological tests available for western population. Due to the sociocultural variation the utility of these test to Indian context is inappropriate.
Literature reports suggest a very few phonological assessment tools in Indian context which generally follows routine procedures with no detailed pattern analysis of phonological processes. Hence the current study is planned.
|