| CTRI Number |
CTRI/2024/05/067903 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How do parents select a storybook for their child? |
|
Scientific Title of Study
|
Parental Considerations For Selection Of Storybook For Shared Book Reading Among Pre-school Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simone Salins |
| Designation |
Student |
| 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, Udupi, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9819261067 |
| Fax |
|
| Email |
simone.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunila John |
| 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, Udupi, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
08202937409 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunila John |
| 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, Udupi, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
08202937409 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal |
|
|
Primary Sponsor
|
| Name |
Simone Salins |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sunila John |
Manipal College of Health Professions |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104 Udupi KARNATAKA |
08202937409
sunila.john@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 |
Parents of pre school children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Parents of children between 3 to 5 years of age with age appropriate language skills, parent that spends most time reading with the child, minimum ten years of schooling, Both employed and homemakers, belonging to middle socioeconomic class
|
|
| ExclusionCriteria |
| Details |
Parents diagnosed with mental health conditions or any chronic health conditions, parents of children diagnosed with language delay/ neurologic disorders/ cognitive delay/ any chronic health conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Language preference, Genre preference, Modality or book format preference, Complexity of text
|
53 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of storybook reading and story telling, age of onset of storybook reading and story telling |
53 weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
30/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Justification for the study: Parent-child interaction forms the microsystem of the child’s environment and provides the child with tools to explore other parts of his social environment. Not selecting the appropriate book for shared reading can impact the quality of the parent-child interaction. Currently, books are available focusing on a variety of socio-emotional themes, languages, modalities and linguistic complexities thus, selection of an appropriate book can enhance the comprehension skills, vocabulary and socio-emotional development of the child. Book selection is a major part of shared reading and therefore more importance should be given to understanding the factors that parents consider while selecting a book for shared reading. As India is a diverse country, where multiple languages are spoken, we need to examine if language preferences play a role in parents book selection for shared book reading. In today’s digital age, we need to understand the different modalities and book formats that young children are exposed to. We also need to determine if young children are exposed to different genres and what factors influence those decisions. As storytelling is a common practice in Indian households, we need to examine if the frequency of storytelling and extent of storybook reading influences parental preferences for the complexity of book.
Aim and objectives of the study:
Aim: To understand the parental considerations of book selection for shared book reading among pre-school children Objective(s) of the study: To examine the variables associated with parental preference of book selection for shared book reading; To examine if there is a relationship between frequency of storybook reading, frequency of storytelling, age of onset of reading, and parental considerations for the complexity of book
|