| CTRI Number |
CTRI/2025/10/095653 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Adapting and testing a Kannada version of the Parental Playfulness Questionnaire on parents to measure how playful they are with their children |
|
Scientific Title of Study
|
Cross-cultural adaptation and validation of the Kannada version of the parental playfulness questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmitha shetty |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy,
Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9606311459 |
| Fax |
|
| Email |
sushmitha.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy,
Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy,
Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy,
Manipal College of Health Professions, MAHE, Manipal, Karnataka, 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajivi |
Balvadi halladi |
Halladi harkadi, Kundapura taluk, udupi district
Udupi
KARNATAKA |
9964189181
rajivijayarama@gmail.com |
| Dr Sumita Rege |
Department of Occupational therapy |
Department of Occupational Therapy,
Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA |
9739131050
sumita.rege@manipal.edu |
| Sathish shettigar |
GHPS bidkalkatte |
HRH7 bidkalkatte kundapura
Udupi
KARNATAKA |
9945196864
ghpsbidkalkatte@gmail.com |
| Shaila |
GLPS Gavali |
GLPS gavali, halladi, harkadi, kunapura taluk
Udupi
KARNATAKA |
9449469847
glpsgavali@gmail.com |
| Shobhavathi |
GLPS halladi harkadi |
Halladi harkadi kundapura taluk udupi district
Udupi
KARNATAKA |
8105075475
shobavathirao970@gmail.com |
| Sujatha |
Government lower primary school harkadi |
Halladi harkadi kundapura taluk udupi district
Udupi
KARNATAKA |
8722715471
sujathakarkala531@gmail.com |
| Shilpa shetty |
Ishna Play school |
13-1-35B 4th Cross Lalbhadur Shastri Road Ajjarkad Karnataka 576101
Udupi
KARNATAKA |
9741209805
ishnaplayschool@gmail.com |
| Divya Shetty |
Little millenium preschool manipal |
5-297/A2 nearby shoolin resorts manipal udupi
Udupi
KARNATAKA |
9820507693
shettydivya646@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Balvadi |
No Objection Certificate |
| G H P S bidkalkatte |
No Objection Certificate |
| G L P S gavali |
No Objection Certificate |
| G L P S halladi |
No Objection Certificate |
| G L P S harkadi |
No Objection Certificate |
| Ishna Playschool |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 Student Research |
Approved |
| Little Millenium Preschool |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents (mother and/or father) who have at least one typically developing child between the ages of 2- 8 years
2. Parents who know how to read and write in Kannada
3. Parents should be living with their children
|
|
| ExclusionCriteria |
| Details |
Parents who have children with disability. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Translation of Parental Playfulness Questionnaire into Kannada version
2. Evaluate its psychometric properties among Kannada-speaking parents.
|
1 day
15 days (intra-rater reliability 30 parents) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
17/10/2025 |
| 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="1"
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
|
This study involves translating and checking the accuracy of a questionnaire that measures how playful parents are with their children. Once the translation of the Parental Playfulness Questionnaire is complete, 210 parents who have at least one child aged 2-8, who can read and write in Kannada, live with their children, and spend time with them, will be eligible to participate in the study. The study will be conducted in three parts, each with a different number of parents participating. First, 10 parents of children aged 2-8 years will be selected to test the clarity and ease of understanding of the translated questionnaire, and they will also be interviewed to gather more detailed information. Then, the questionnaire will be administered to 200 parents to verify its effectiveness and yield accurate results. After two weeks, 30 of these parents will be asked to complete the questionnaire again to verify if it yields the same results. |