| CTRI Number |
CTRI/2024/07/071328 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Phonological Awareness treatment on reading abilities in poor
readers of Kannada among primary school going children |
|
Scientific Title of Study
|
Effect Of Phonological Awareness Intervention on Reading Abilities in Poor Readers of Kannada Alphasyllabary among School going Children A single subject study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deekshitha |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education,
Madhav Nagar, Manipal (576104), Udupi, KARNATAKA, India.
Udupi KARNATAKA 576104 India |
| Phone |
6362759614 |
| Fax |
|
| Email |
deekshitha.mchp@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education,
Madhav Nagar, Manipal (576104), Udupi, KARNATAKA, India.
Udupi KARNATAKA 576104 India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education,
Madhav Nagar, Manipal (576104), Udupi, KARNATAKA, India.
Udupi KARNATAKA 576104 India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no. 416, 4th floor, Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal. |
|
|
Primary Sponsor
|
| Name |
Deekshitha |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr T M A Pai PhD Scholarship |
Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Tiwari |
Manipal College of Health Professions (MCHP), MAHE, Manipal |
Room no. 416, 4th floor, Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Udupi, KARNATAKA. Udupi KARNATAKA |
9986448718
shivani.tiwari@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 |
Poor readers are identified as children scoring below 1.5 standard deviations (SD) on standardized word reading accuracy measures. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Remedial Manual on Metaphonological Skills in Kannada (ReM-Kan) |
The ReM-K manual given by Shilpashri (2004), is a 30-day intensive training program useful in enhancing metaphonological skills of children with reading disability over 3 months. The core items of the manual include rhyme recognition, syllable reversal, syllable deletion, syllable and phoneme oddity for words and non-words, and phoneme deletion. The manual also provides instructions to carry out each skill. The training is conducted with the help of spoken words, pictures, and /or written words either by using pictures of flashcards or pictures from the manual. Since it is a training manual varying cues are also employed to support learning, including oral presentation of stimulus words, oral presentation coupled with additional cues like finger counting and table tapping, pictorial representation of stimulus words, combined pictorial and graphemic representations of words, and graphemic cues specifically for presenting non-words using flash cards. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1) Native Kannada-speaking school-going children or who use Kannada predominantly for communication as per the adapted Child KLEAP-Q questionnaire (Narasimhan et al., 2023) from grades 3 to 7
2) Children studying in Kannada medium schools since the commencement of schooling.
3) Children of either gender are in all grades.
4) No significant pre-existing history of middle ear disorders.
5) Children with intellectually average or above average as per Raven’s Progressive Matrices
6) Children who score below 1.5 S.D on word reading accuracy measures appropriate to his or her chronological age and intellectual abilities.
7) Having deficits in at least one of the four domains Akshara Knowledge, Syllable awareness, Phonological awareness and RAN
8) Children with normal or corrected-to normal vision.
9) Children with hearing sensitivity within normal limits (hearing thresholds ≤25 dBHL at audiometric
octave frequencies, i.e., 250 to 8000 Hz). |
|
| ExclusionCriteria |
| Details |
1) Children with a history of neurological, speech, language, hearing, cognitive, or motor difficulties or any such deficits reported or observed by the class teachers as on the WHO ten-question disability screening checklist.
2) Children with significant social and/or emotional problems affecting school
activities (on Strengths and Difficulties questionnaire, Goodman, 2010)
3) Children with a history of otologic, neurological, and auditory processing
deficits.
4) Children who cannot follow the instructions even after the three repetitions and/or rephrasing, owing to apparent attention deficits and hyperactivity.
5) Poor attendance in the school records
6) Children whose reading abilities fall below the 15th percentile for their grade in word reading accuracy measures (Nag & Snowling, 2012)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reading measures:
Reading accuracy (total scores in %),
reading rate (wpm), and reaction time (msec)
Phonological Awareness (PA) skills (Total PA
scores) |
After every three therapy sessions or once a week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Auditory Processing measures:
% Correct at 0 dBSNR (monosyllables), Total scores for words repeated correctly at 0dBSNR, SNR loss in dB (sentences), Gap Detection Threshold in milliseconds and
Temporal Fine Structure 1 threshold in dB |
After every three therapy sessions or once a week |
|
|
Target Sample Size
|
Total Sample Size="11" Sample Size from India="11"
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)
|
08/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
While there is growing knowledge regarding the role of Phonological Awareness (PA) in reading non-alphabetic languages, there is only limited evidence detailing the role of phonology in reading alphasyllabic languages. Available literature supports early focused training in phonological abilities and letter knowledge among younger children in some Indian languages (Nag, 2007; Prema, 2012), which needs to be extended to other age groups to understand the need for PA treatment in higher-grade levels. This can provide better insights into understanding the effect of treatment across the grades on reading and to compare the effects from lower to higher grades. Furthermore, not many studies have investigated the influence of auditory processing abilities in bottom-up treatment approaches as phonological intervention in children with poor reading abilities in Kannada. Hence, the need to investigate the role of auditory processing abilities in PA intervention for Kannada poor readers. The current study aims to investigate the effectiveness of PA intervention on reading abilities in poor readers of Kannada among school-going children in grades 3 to 7. The study will be conducted in two phases (Phase 1 is to identify poor Kannada readers and Phase 2 will have an intervention) with following objectives. The first objective of phase one is to identify poor readers in Kannada from grades 3 to 7. The second objective is to evaluate the effect of PA intervention in poor readers on reading ability and auditory processing skills. Further, the changes in reading and auditory processing abilities will be correlated post intervention in poor readers of grades 3 to 7. Initially, a list of schools from an Udupi district will be stratified using the stratified cluster sampling method using the details of the schools on school strength, location, and school category (private aided/Government/private unaided) which will be tabulated, and suitable filters will be used to match the inclusion of the study as well as to justify the cost of resources involved to make multiple visits to schools. The proposed study consists of two phases. In Phase I, Initially, all the children will be screened for language proficiency, disability, overall academic performances, emotions, and behaviors. Based on the strict inclusion and exclusion criteria of the study participants are involved in further testing. A comprehensive test battery will be used to assess their socio-economic status, intellectual abilities (Non-verbal Intelligent Quotient), broader oral language component, reading and hearing abilities. These tests will be administered individually to each child in the quiet environment of the schools over 2-3 sessions of 30-40 minutes each within a week which will be audio recorded. All the obtained data will be grouped as good, poor and non-readers. For group comparison, participants who score below 1.5 S.D mainly on their word reading accuracy measures are grouped as poor readers. Also, within the group children whose reading abilities fall below the 15th percentile for their grade in word reading accuracy measures will be considered as non-readers group as their reading performance will be exceptionally low in the word reading accuracy measures. Poor readers from urban schools who score lower than 1.5 S.D. on word and non-word reading accuracy testing (from phase 1) will be randomly chosen for the intervention phase (Phase II) across grades three to seven, considering factors such as school distance (rural setting), resource costs, and study feasibility. Phase 2 will commence with baseline assessments of all measures including word and non-word reading measures (accuracy, rate, and reaction times). The primary researcher will use the revised remedial module (The intervention items will be revised considering the change in the current curriculum, words usage and other environmental factors. The set of words will be pooled and compiled from grade specific textbooks and from standardized age-appropriate test batteries to include for baseline, weekly probe, and an intervention. These items will be validated by the teachers who have minimum of 3 years of working experience, parents who have children in age band 8 to 15 years, and Speech-Language Pathologists (SLPs) who have experience working with dyslexics or children with specific learning disorder for more than 3 years. The experts will be asked to rate the items on relevancy, age appropriateness, iconicity of the pictures, and size of the pictures. A five-point rating scale ranging from 0 to 5 will be used to rate the stimulus and will be asked to provide feedback or comment specific to an item or domain) deliver interventions to the participants within their respective schools. In the PA intervention phase, all the items within each subsection will be randomized for each session. The criteria for moving to sub-tasks/stimuli within the intervention module will be 80% or 4 out of 5 trials on two consecutive week probes and each session would last for 30 to 45 minutes. All session data will be audio-recorded for scoring and analysis purposes. The primary researcher will also maintain a record book for noting responses from each participant across sessions. Intervention fidelity will be assessed by an independent observer (a trained SLP) by listening to the recordings using an appropriate rating scale. After completion of the intervention or meeting the criteria, the maintenance will be checked for all group participants after a week. The tests administered for maintenance will be similar to pre-intervention assessment. All participants will be reassessed in follow-up assessments, administered a month after the maintenance, and three months after the first follow-up assessment. Additionally, feedback on the child’s reading performance will be collected from the teachers/parents of the poor readers after the intervention phase. Additional reading exercises and strategies to continue to help children’s reading skills (for poor readers) will be provided after the completion of the follow-up phase of the study. The findings of our study are expected to provide evidence for the effectiveness of PA intervention on poor readers for an extended age range, i.e., 8 years to 14 years. The study is expected to provide insights into understanding reading in alphasyllabic orthography, which could help develop suitable interventional modules and inform educational policies for children struggling with reading. This knowledge holds significant value for teachers and parents of children who experience difficulties in reading, as they can integrate this intervention into their curriculum to offer essential support to those children in need of reading assistance. |