| CTRI Number |
CTRI/2025/04/085352 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study |
| Study Design |
Other |
|
Public Title of Study
|
Family conflicts and caregiving challenges for children with Autism in chengalpattu- A Qualitative study |
|
Scientific Title of Study
|
Exploring family conflicts and caregiving responsibilities for children with Autism spectrum disorder in Chengalpattu- A Qualitative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hasira Banu |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
PT 22, 4th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8925647744 |
| Fax |
|
| Email |
hb4142@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr K Vadivelan |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.15, 5th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, kattankulathur, chengalpattu district, Tamilnadu, India-603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841298555 |
| Fax |
|
| Email |
vadivelk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr K Vadivelan |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.15, 5th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, kattankulathur, chengalpattu district, Tamilnadu, India-603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841298555 |
| Fax |
|
| Email |
vadivelk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,SRM medical college hospital and research centre,kattankulathur,chengalpattu district,Tamilnadu,India-603203 |
|
|
Primary Sponsor
|
| Name |
Hasira Banu |
| Address |
PT 22, 4th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 S Hasira Banu |
SRM Medical College Hospital and Research Centre |
Autism Excellence Centre,Ground floor,SRM Medical College Hospital and Research Centre,Kattankulathur, Chengalpattu district, Tamilnadu, India-603203
Kancheepuram
TAMIL NADU |
8925647744
hb4142@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of Autism spectrum disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of children diagnosed with ASD who spend 4-6 hours daily on caregiving, fluent in English or Tamil. |
|
| ExclusionCriteria |
| Details |
1.Caregivers of children with significant medical or psychiatric conditions.
2.Those who are not agreed to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exploring caregiving responsibilities and family conflicts |
Outcome will be measured at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
30/04/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Eligible caregivers will be identified in collaboration with hospital staff to ensure the selection of appropriate participants for the study. Detailed explanations of the study procedures will be provided to the participants, along with consent forms made available in their preferred language to facilitate clear understanding and voluntary participation. Written consent will be obtained prior to proceeding to the study. Semi-structured interviews will be conducted using carefully designed open-ended questions to explore various aspects of family dynamics and caregiving conflicts in depth. These interviews will be audio-recorded and subsequently transcribed verbatim to maintain accuracy and authenticity. The collected data will undergo a thematic analysis process, utilizing systematic coding techniques to identify and interpret core themes and patterns that emerge from the participants’ responses. |