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CTRI Number  CTRI/2019/01/017348 [Registered on: 31/01/2019] Trial Registered Prospectively
Last Modified On: 25/01/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Investigating the effect of phonological awareness training on word reading skills in typical first standard children learning to read Kannada 
Scientific Title of Study   Effect of Phonological Awareness Training on Word Decoding Abilities in Typically Developing First Standard Children Learning to Read Kannada 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shwetha prabhu 
Designation  Junior Project Fellow 
Affiliation  kasturba Medical College, Manipal Academy of Higher Education, Mangalore 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9986411290  
Fax    
Email  shwethagprabhu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shwetha Pabhu 
Designation  Junior Project Fellow 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9986411290  
Fax    
Email  shwethagprabhu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  shwetha prabhu 
Designation  Junior Project Fellow 
Affiliation  kasturba Medical College, Manipal Academy of Higher Education, Mangalore 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9986411290  
Fax    
Email  shwethagprabhu@gmail.com  
 
Source of Monetary or Material Support  
Department of Audiology and Speech Language Pathology, Kasturba medical college, Manipal Academy of Higher Education, Mangalore - 575001  
 
Primary Sponsor  
Name  NCERT 
Address  division of eductional research, sri aurobindo marg, New Delhi - 110016 
Type of Sponsor  Government funding agency 
 
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 
Dr Jayashree S Bhat  Kasturba Medical College  Department of Audiology and Speech Language Pathology, Light House Hill Road, Mangalore
Dakshina Kannada
KARNATAKA 
9900514692

bhat.js@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  normal school going children, adquate hearing, speech and language 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioural study.  Phonological awareness training will be for 7 weeks, 2 sessions per week. Each session lasts for 30 minutes. It is a paper pen method of training, done one to one basis.  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  5.60 Year(s)
Age To  6.60 Year(s)
Gender  Both 
Details  1. The child should meet the age and Grade criteria
2. The child should belong to schools with Kannada Medium of instructions with the curriculum affiliated to Karnataka state board.
3. The child belonging to a family with lower middle to middle socioeconomic status according to Scale for measuring the socioeconomic status of a family (Venkatesan, 2009).
4. The child’s parents should bear minimum literacy level of 10th standard.
 
 
ExclusionCriteria 
Details  1. The child with history or complaint of significant speech, language, hearing, developmental, intellectual, and neurological disorders ascertained using WHO ten-question disability screening checklist (Singhi, Kumar, Malhi, & Kumar, 2007).
2. The child with language based reading difficulties based on ‘Early identification of language based reading disability checklist’ (Catts, 1997).
3. The child with irregular school attendance.
4. The child with a history of change in the medium of instruction.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcomes of this intervention study ascertain the effectiveness of phonological awareness training on word decoding abilities in first standard typical children learning to read Kannada. Additionally, the developed phonological awareness training module will enable the clinicians to employ phonological awareness training more explicitly and systematically for the children learning to read Kannada.  At the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Professionals will know whether to consider phonological awareness training along with the regular classroom teaching to improve reading skills in typically developing children. Based on the results, it can be ascertained that, whether phonological awareness training can be considered on children who are at-risk to develop reading disabilities, which is expected to reduce the reading difficulties in children learning to read Kannada, reducing the dropout rates in school.   At the end of the study 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/02/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The role of phonological awareness in learning to read alphabetical languages is unequivocal. The importance of phonological awareness over other cognitive-linguistic skills in learning to read has been explored and has been identified as language universal skill in predicting the reading abilities. Majority of the studies conducted in alphasyllabary languages concentrates mainly on development and association of phonological awareness skills with reading in school going population (D’souza & Somashekara, 2015; Nag, 2007; Nagaraja & Sampathkumar, 2016; Prakash & Rekha, 1992; Prakash et al., 1993; Prema, 1998; Waknis, Chintala, & Vanaja, 2017). However, the few studies conducted in alphasyllabaries have not evidenced the strong association of phonological awareness with reading abilities and remained equivocal (Akila, 2000; Dinesh, 2002; (Akhila, 2000; Dinesh, 2002; Patel & Soper, 1987; Prakash & Rekha, 1992). Some claim that the phonological awareness is not a good predictor of reading skills in alphasyllabaries (Prakash & Mohanty, 1995; Prema, 1998; Prema & Karanth, 2003; Prakash, Rekha, Nigam, & Karanth, 1993; Rekha, 1997), however, some report that syllable awareness contributes significantly to word reading abilities followed by Akshara knowledge (Cho & Mc Bride-Chang, 2005; Nag, 2007; Nag & Snowling, 2012; Simpson & Kang, 2004; Vaid & Gupta, 2002; Vasanta, 2004; Winskel & Iemwanthong, 2009). These studies which were conducted in alphasyllabaries so far evaluated the relationship between phonological awareness and reading during later grades of primary and upper primary years of schooling, where the children would have developed sufficient decoding skills and also the phonological awareness would be at the ceiling, thereby effecting the relationship between the two variables. Majority of the studies conducted so far in alphasyllabaries are cross-sectional, correlational, and notably a single longitudinal study (Nag, 2007). Amongst longitudinal and correlational studies, the causal relationship can be best explained by training studies, that shows the change in one variable as a result of training in another variable. During the initial period of schooling, child consciously tries to map the written symbols such as graphemes to the respective sound they make. Training phonological awareness during this period would enable them to fine-tune the current level of phonological awareness thereby helping them to effortlessly map grapheme to a phoneme that has a positive impact on word decoding abilities. Moreover, initiating early phonological awareness intervention may be more effective than later in childhood. Because, it may prepare children to get involved in reading instruction more effectively (Bus & van Ijzendoorn, 1999). In a longitudinal research Juel (1988) reported that poor readers of first grade continued to fail in reading even when they reached fourth grade. The difference between unsuccessful readers and their contemporaries with typical reading abilities continued to widen over the elementary years (Stanovich, 1986), because intervening reading problems beyond Grade three becomes increasingly challenging (Fletcher & Foorman, 1994; Kennedy, Birman, & Demaline, 1986; Lyon, 1985). Hence, earlier the training, better the outcome.

A clear understanding of the phonological awareness role  is well established in alphabetical languages through intervention studies. However, the studies establishing the causal relationship between phonological awareness and reading in alphasyllaries are scarce. Earlier some of the studies developed and evaluated the effectiveness of remedial metaphonological training program in Kannada (Shilpashree & Prema, 2004) and Malayalam (Ponnumani & Prema, 2003) alphasyllabaries. Post-training, they assessed only metaphonological skills and reported improved metaphonological skills among children with dyslexia. These studies did not report the causal role of metaphonological training on reading skills.

The evidence from the training studies in alphabetical language during early years of schooling in both typically developing and also persons with reading disability resulted in improved word decoding skills (Charles Hulme, Bowyer-Crane, Carroll, Duff, & Snowling, 2012; Ehri et al., 2001; Leafsted, Richards, & Gerber, 2004; Kjeldsen, Kärnä, Niemi, Olofsson, & Witting, 2014; National Reading Panel, 2000; Torgesen, 2000), thus suggesting to employ phonological awareness training for typically developing to foster metaphonological skills so that reading skills improve. The training programs are also employed on children who are at-risk to develop reading disabilities in order to prevent them from developing reading disabilities in later grades. However, such programs cannot be employed regularly in the classroom in the Indian scenario, without the evidence of its effectiveness in improving metaphonological and reading skills. Subsidiary to these issues in training, the majority of school going children in the rural part of Karnataka opts invariably Kannada as the medium of instructions. Hence, it is essential to establish theoretical and pedagogical evidence of phonological awareness training in general or specific to children with reading difficulties.

Within the present scenario of equivocal understanding of phonological awareness and its association with reading abilities in alphasyllabaries, it is essential to determine the role of phonological awareness in reading, specifically during initial years of schooling. It can be achieved mainly through intervention studies which are scanty in alphasyllabary languages. Hence the present study aims to investigate the effectiveness of phonological awareness training on word decoding skills in typically developing first grade children learning to read the Kannada language.

 
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