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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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