| CTRI Number |
CTRI/2025/08/093571 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Palliative Care Social Work Intervention for Families of Children with Chronic Neurological Conditions |
|
Scientific Title of Study
|
Palliative Care Social Work Intervention for Families of Children with Chronic Neurological Conditions: A feasibility 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 |
Najiya P |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Department of Psychiatric Social Work, Dr. M.V. Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, India Pin-560029
Bangalore KARNATAKA 560029 India |
| Phone |
07356057855 |
| Fax |
|
| Email |
najiya17p@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. E. Sinu |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Department of Psychiatric Social Work, Dr. M.V. Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, India Pin-560029
Bangalore KARNATAKA 560029 India |
| Phone |
9980654565 |
| Fax |
|
| Email |
esinu@nimhans.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Najiya P |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Department of Psychiatric Social Work, Dr. M.V. Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, India Pin-560029
Bangalore KARNATAKA 560029 India |
| Phone |
07356057855 |
| Fax |
|
| Email |
najiya17p@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission and National Institute of Mental Health and Neuro Sciences |
|
|
Primary Sponsor
|
| Name |
Najiya P |
| Address |
Ph.D. Scholar, Department of Psychiatric Social Work, National Institute of Mental Health and Neuro Sciences, Hosur Road, Bengaluru, Karnataka-560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 E Sinu |
National Institute of Mental Health and Neuroscience (NIMHANS) |
Department of Neurology,National Institute of Mental Health and Neuro Sciences (NIMHANS),Hosur Road, Bengaluru, Karnataka, India-560029
Bangalore
KARNATAKA Bangalore KARNATAKA |
9980654565
esinu@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, India-560029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
family caregivers of children with chronic neurological conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
palliative care social work intervention |
The intervention is a structured, need-based, family-centred palliative care social work program developed through literature review, expert consultation, and caregiver needs assessment. It aims to address psychosocial, emotional, and practical needs of families caring for children with developmental regression due to chronic neurological conditions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Parents or caregivers of children diagnosed with developmental regression
Parents or caregivers of children receiving inpatient care in pediatric neurology ward at NIMHANS.
Parents or caregivers of children who can speak Tamil, Kannada, Malayalam, English and Hindi
|
|
| ExclusionCriteria |
| Details |
• Parents or caregivers of children with acute or treatable neurological condition
• Participants who refused to be part of the study
• Participants for whom follow up is not possible.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Improved psychological and social functioning of parents/caregivers
Improved understanding and acceptance of the condition.
Reduced caregiver burden
Enhanced caregiver’s coping skills.
|
baseline, 3 months , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes:
Improved social support & empowerment among caregivers of children with Chronic Neurological Condition
Improved quality of life of the families of children with Chronic Neurological Conditions
Improve the awareness regarding welfare benefits & respite care support.
|
baseline, 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
01/01/2026 |
| 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="3" Months="6" Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 adopts a repeated-measures design to assess the feasibility of a family-centred palliative care social work intervention for parents/caregivers of children with developmental regression due to chronic neurological conditions (CNC). Conducted in the Inpatient Pediatric Neurology Unit at NIMHANS, Bangalore, the study will recruit 40 participants through consecutive sampling. Inclusion criteria are caregivers of children with developmental regression admitted to the ward and able to communicate in Tamil, Kannada, Malayalam, English, or Hindi. Exclusion criteria include acute/treatable neurological conditions, refusal, or inability to follow-up. The study has three phases. Phase 1 involves developing a culturally adapted intervention module through literature review, in-depth interviews with caregivers and subject experts, thematic analysis, Delphi validation, and pilot testing. Phase 2 delivers the intervention and assesses outcomes at baseline, 3 months, and 6 months. Phase 3 involves data analysis and reporting. Intervention components include psychosocial assessment, communication of prognosis, supportive psychotherapy, advocacy, anticipatory care planning, networking with support services, and grief counselling. Primary outcomes are improvements in caregiver psychological and social functioning, burden, and coping. Secondary outcomes include social support, empowerment, and family quality of life. Data will be collected using PedsQL 4.0, PedsQL Family Impact Module 2.0, Children’s Palliative Outcome Scale, Symptom Profile for Neurodegenerative Diseases in Children, and a core outcome checklist. Qualitative data will undergo thematic analysis, and quantitative data will be analysed using RMANOVA or Friedman test. Feasibility will be evaluated using the SAFE framework. Ethical clearance, CTRI registration, and written informed consent will be obtained. |