| CTRI Number |
CTRI/2025/10/096349 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding parental stress, wellbeing and coping of children with special needs . |
|
Scientific Title of Study
|
Assessment of Stress, Quality of Life (QoL) and Coping Strategies Adopted by Parents of Children with Autism Spectrum 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 |
Lipika Debbarma |
| Designation |
Ph.D Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer College of Nursing. Ground floor Nursing Department-5, Teerthanker Mahaveer University, Delhi Road, NH-9, Moradabaad UttarPradesh-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9862693718 |
| Fax |
|
| Email |
lipika.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Ram Kumar Garg |
| Designation |
Professor, HOD, Community Health Nursing |
| Affiliation |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer College of Nursing. 3rd floor, Department of Community Health Nursing. Teerthanker Mahaveer University, Delhi Road, NH-9, Moradabaad UttarPradesh-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
919355641979 |
| Fax |
|
| Email |
ram.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Lipika Debbarma |
| Designation |
Ph.D scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer College of Nursing. Ground floor, Nursing Department-5, Teerthanker Mahaveer University, Delhi Road, NH-9, Moradabaad UttarPradesh-244001.
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9862693718 |
| Fax |
|
| Email |
lipika.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lipika Debbarma |
| Address |
Teerthanker Mahaveer College of Nursing. Teerthanker Mahaveer University, Delhi Road, NH-9, Moradabaad UttarPradesh-244001 |
| 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 |
| Lipika Debbarma |
Composite Regional Centre for Skill Development (CRC) |
SRE-CRC, Depatment of Rehabilitation Centre, ground floor, room no-3, Narsingarh, Agartala, Tripura (W)
West Tripura
TRIPURA |
9862693718
lipika.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Teerthanker Mahaveer Dental College & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress, coping strategies, and wellbeing among parents of children with Pervasive Developmental Disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Parents of children with clinically diagnosed ASD
Both old and new cases of autism spectrum disorder.
Residing in the State of Tripura
|
|
| ExclusionCriteria |
| Details |
Not willing to participate
Not available during the period of data collection
Physically & mentally ill parents.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stress, quality of life and coping strategies adopted by parents of children with ASD |
single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/10/2025 |
| 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="6"
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 cross-sectional study will evaluate stress, quality of life (QoL), and coping strategies among parents of children with Autism Spectrum Disorder (ASD). Using standardized questionnaires, the research will examine the levels of stress and QoL, as well as the types of coping mechanisms adopted by these parents. The primary hypothesis is that higher stress levels are associated with poorer QoL and that use of adaptive coping strategies correlates with lower stress and improved QoL in this population. Findings from this study are expected to inform the development of targeted psychological and social interventions for families affected by ASD. |