| CTRI Number |
CTRI/2025/11/097846 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shared Book Reading Intervention for Children with Language Delay |
|
Scientific Title of Study
|
Development of Shared Book Reading Intervention for Children with Language Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Vrinda R |
| Designation |
Lecturer/Speech Language Pathologist |
| Affiliation |
National Institute of Speech and Hearing |
| Address |
Department of Neurodevelopmental Sciences, National Institute of Speech and Hearing, NISH Road, Aakkulam, Trivandrum, Kerala
Thiruvananthapuram KERALA 695017 India |
| Phone |
9744684800 |
| Fax |
|
| Email |
vrinda@nish.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Subash S |
| Designation |
HoD/ Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur |
| Address |
Dept. of Paediatrics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
Kattankulathur, Chennai
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9500675124 |
| Fax |
|
| Email |
subashs@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mrs Vrinda R |
| Designation |
Lecturer/Speech Language Pathologist |
| Affiliation |
National Institute of Speech and Hearing |
| Address |
Department of Neurodevelopmental Sciences, National Institute of Speech and Hearing, NISH Road, Aakkulam, Trivandrum, Kerala
Thiruvananthapuram KERALA 695017 India |
| Phone |
9744684800 |
| Fax |
|
| Email |
vrinda@nish.ac.in |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
National Institute of Speech and Hearing NISH |
| Address |
NISH Road, Aakkulam, Thiruvananthapuram, Kerala, India Pincode: 695017 |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suja K Kunnath |
National Institute of Speech and Hearing |
Department of Neurodevelopmental Sciences, National Institute of Speech and Hearing, NISH Road, Aakkulam, Trivandrum, Kerala Thiruvananthapuram KERALA |
6282167437
sujamathews@nish.ac.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NISHIEC |
Approved |
| NISHIEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F802||Mixed receptive-expressive language disorder, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General instructions on the importance of shared book reading |
The control group will not receive the shared book intervention. The same reading materials given to the intervention group will be provided to the control group, and they will receive only general instructions regarding the importance of reading. |
| Intervention |
Shared Book Reading Intervention |
The Delphi survey will be adopted to develop a shared book reading intervention module to review and finalize the various aspects of the intervention module. In keeping with earlier research, a shared book reading intervention module will be created by combining dialogic reading (Whitehurst et al., 1988), print referencing (Ezell & Justice, 2000), and phonological awareness strategies. The shared book reading intervention using the module prepared will be delivered in Malayalam to the intervention group. The clients satisfying the inclusion-exclusion criteria will be assigned to either the control or the experimental group. The control group will not receive the shared book intervention. The same reading materials given to the intervention group will be provided to the control group, and they will receive only general instructions regarding the importance of reading. A log book will be provided to track their shared book-reading practice. Also, the details of the intervention the child attends, if any, will be collected.The experimental group will receive the shared book-reading intervention for 6 weeks at a frequency of 2 sessions per week. The shared book reading intervention will be conducted in groups of five parent-child dyads. The strategies will be illustrated to the parents, focusing on promoting child engagement and participation, language, and emergent literacy skills. Parents are expected to practice the SBR at home. To ensure the fidelity of implementation, a daily logbook will be prepared, and the parents will be asked to record in the logbook the date, book title, session duration, strategies used, and any difficulties encountered while practicing shared reading. |
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for children
Children who are diagnosed with language disorder by a qualified Speech Language Pathologist following DSM 5 criteria.
The children should be in the age range of 3-5 years
Language age should be between
Receptive language age: 2- 2.11 and 3-3.11 (according to ALD)
Expressive language age: 2-2.11 and 3-3.11 (according to ALD)
Minimum 6 months of expressive language delay compared to their chronological age
Max
Children should be native speakers of Malayalam settled in Kerala
Inclusion criteria for parents
Parent should have graduation as the minimum level of education.
Malayalam should be the primary language
There are no significant concerns related to sensory ability
Families belonging to middle (upper/lower) class families as per Kuppuswamy Socioeconomic scale (2024).
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for children
Children with any known motor delay or disorder, neurological impairments; sensory impairments (This will be confirmed through a detailed case history.)
Exclusion criteria for parents
Parents with psychiatric conditions, seizures, and other severe health conditions as per clinical records
Parents with education or work exposure related to behavioral sciences, psychology and rehabilitation
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Receptive & Expressive vocabulary
Parent child interaction during Shared Book Reading
Emergent literacy skills |
Baseline & 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Social validity of the Shared Book Reading (SBR) intervention |
After 6 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
22/12/2025 |
| 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="1" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response (Others) - Researchers in the field of child language disorders, emergent literacy, or related areas, upon reasonable request.
- For what types of analyses will this data be available?
Response (Others) - For secondary analyses and meta-analyses.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vrinda@nish.ac.in].
- For how long will this data be available start date provided 15-01-2027 and end date provided 14-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Shared book reading (SBR) has been shown to support a wide range of early language skills, including vocabulary, narrative and conversation abilities, print awareness, phonological awareness, and future reading development, with the affective quality of interactions playing a vital role in fostering children’s interest in literacy and language learning. Although SBR is emerging as a promising language stimulation technique in speech-language pathology, research in India remains limited, with most studies focusing on parental attitudes, beliefs, or maternal interactions among typically developing children. Evidence on SBR as an intervention strategy for children with language disorders is lacking, despite its potential to address language delays and reduce the risk of specific learning disorder by establishing strong foundations for language and emergent literacy skills. To the best of the researcher’s knowledge, no shared reading intervention has been reported for children with language disorders in India. The present study therefore aims to develop and test the efficacy and examine the social validity of a shared book reading intervention module. The study will be conducted in three phases. Phase 1 will involve developing and validating an intervention module using a Delphi survey with 20 experts in child language disorders, shared reading, or emergent literacy; Phase 2 will test the efficacy of the module with 30 parent–child dyads (3–5 years) divided into intervention and control groups, with pre- and post-assessments including ACIRI, ProBEL, book-specific vocabulary testing, and a parental perspectives questionnaire; and Phase 3 will adapt and administer the Social Validity Questionnaire (Justice et al., 2011) in Malayalam to evaluate parental perceptions. The hypothesis tested will be 1) there is no significant difference in the use of SBR strategies by the parents or the child’s participation in SBR between the intervention group and control group and 2) there is no significant difference in the children’s vocabulary or emergent literacy skills between the intervention group and control group. The intervention will be provided twice weekly for six weeks, and reassessments will follow. Young children with language disorder may be helped to catch up in their language and emergent literacy development by using shared book reading as an intervention technique. SBR intervention helps to reduce the risk of developing specific learning disorder as shared reading lays a strong foundation for emergent literacy skills
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