| CTRI Number |
CTRI/2026/01/101337 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing parental stress scale in malayalam: Validation of a measurement scale |
|
Scientific Title of Study
|
Validation and Reliability of
Malayalam Translated Parental
Stress Scale (PSS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika Shine |
| Designation |
Post Graduate student |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
Medical trust institute of medical sciences HOC township backside road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
9497299005 |
| Fax |
|
| Email |
malavikashine2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushmitha T |
| Designation |
Assistant Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
Medical trust institute of medical sciences HOC township backside road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
9400670655 |
| Fax |
|
| Email |
sushmitha.sushmi66@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anila paul |
| Designation |
Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
Medical trust institute of medical sciences HOC township backside road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
04842843502 |
| Fax |
|
| Email |
mtimsbpt@medicaltrusthospital.in |
|
|
Source of Monetary or Material Support
|
| Medical Trust Institute of Medical Sciences ,kochi Ernakulam pin:682309 |
|
|
Primary Sponsor
|
| Name |
Medical Trust Institute of Medical Sciences |
| Address |
Medical Trust Institute of Medical Sciences HOC township backside road,Irumpanam
Pin .682309 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sushmitha |
Janey special school |
Janey center tripunithura eroor road tripunithura ,Ernakulam
Pin:682306
Thrissur
KERALA |
04842843502
mtimsbpt@medicaltrusthospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of Disabled children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Parents who are able to read and write Malayalam and English
2.Parents of Differently abled children
3.Parents who are willing to participate |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental stress index short form (PSI-SF) |
10 days after the initial form fill |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
15/02/2026 |
| 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
|
The study aims to translate and validate the Parental Stress Scale (PSS) into Malayalam, addressing the lack of a validated tool for assessing parental stress in Kerala’s Malayalam-speaking population. The PSS is a widely used self-reported questionnaire measuring parental stress, but its absence in Malayalam limits research and intervention. A validated Malayalam version will enable accurate assessment and data collection, promoting culturally relevant support for parents and children." |