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CTRI Number  CTRI/2026/01/102002 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Family-Centred Educational Program ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of a Family-Centred Educational Program on Knowledge, Practices, and Caregiver Burden among Families of Children with Epilepsy. 
Scientific Title of Study   A Randomized Controlled Trial to Determine the Impact of a Family-Centred Educational Program on Caregivers Knowledge, Practice, and Burden among Families of Children with Epilepsy Attending Pediatric Out-Patient Department of a selected Tertiary Care Hospital in Eastern India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Singh 
Designation  M.Sc. Nursing student 
Affiliation  AIIMS, Kalyani 
Address  Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Nadia
WEST BENGAL
741245
India 
Phone  7007451029  
Fax    
Email  sneha.mscnursing-2025@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jamuna Rani R 
Designation  Associate Professor 
Affiliation  AIIMS, Kalyani 
Address  Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Nadia
WEST BENGAL
741245
India 
Phone  9894833696  
Fax    
Email  jamuna.nursing@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Jamuna Rani R 
Designation  Associate Professor 
Affiliation  AIIMS, Kalyani 
Address  Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Room No. 404, Department of Child Heath Nursing, College of Nursing, All India Institute of Medical Sciences, Kalyani, West Bengal, India
Nadia
WEST BENGAL
741245
India 
Phone  9894833696  
Fax    
Email  jamuna.nursing@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sneha Singh 
Address  All India Institute of Medical Sciences, Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, Nadia Dist., West Bengal-741245 
Type of Sponsor  Other [self] 
 
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 Niladri Sekhar Bhunia  All India Institute of Medical Sciences, Kalyani  Department of Paediatrics, Paediatric Outpatient Department Room No. 322
Nadia
WEST BENGAL 		 9123508732

niladri.peds@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IInstitutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary caregivers of paediatric epilepsy patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Family-Centred Educational Program   The Family-Centred Educational Program is a structured educational intervention designed to improve caregivers’ knowledge, caregiving practices, and to reduce caregiver burden while caring for children with epilepsy. The intervention focuses on active involvement of family members and emphasizes understanding epilepsy, Medication adherence, Home safety & Seizure first aid practice, its management, and psychosocial support. 
Comparator Agent  routine outpatient department care  Routine OPD care for children with epilepsy includes regular clinical follow-up by the paediatrician, assessment of seizure control, prescription and adjustment of antiepileptic medications, and brief verbal advice to caregivers regarding medication adherence and follow-up visits. No structured, family-centred educational program, planned teaching sessions, or standardized training on seizure first aid and caregiver burden management is provided as part of routine care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Primary caregivers of paediatric epilepsy patients age less than 18 years as diagnosed by clinician.
Primary caregivers aged 18 to 65 years who are primarily responsible for the care of paediatric epilepsy patient as diagnosed by clinician.
Willing to participate and provide informed consent.
Able to understand Bengali, Hindi, or English.
 
 
ExclusionCriteria 
Details  Caregivers with comorbid neurological disorders.
Those previously exposed to formal epilepsy education programs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Caregivers knowledge  Baseline assessment (0 week) and after completion of intervention (at 3 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Caregivers Practice  Baseline assessment (0 week) and after completion of intervention (at 3 weeks) 
Caregivers Burden  Baseline assessment (0 week) and after completion of intervention (at 3 weeks) 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   01/04/2026 
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="0"
Months="9"
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  

Epilepsy is a common neurological condition in children that requires long term care and supervision by family members. Caregivers often face challenges due to limited knowledge improper care practices and increased physical emotional and social burden. Family centred education may help caregivers manage childhood epilepsy more effectively and reduce caregiver burden. This randomized controlled trial aims to evaluate the effectiveness of a family centred educational program on caregivers knowledge practice and burden among families of children with epilepsy attending the paediatric outpatient department of a tertiary care hospital in Eastern India. Caregivers will be selected using purposive sampling and randomly allocated into experimental and control groups with equal numbers. The experimental group will receive a structured family centred educational program focusing on epilepsy awareness seizure first aid medication adherence home care and coping strategies. The control group will receive routine outpatient department care. Caregiver knowledge practice and burden will be assessed before and three weeks after the intervention using structured tools. The study findings are expected to provide evidence on the usefulness of family centred educational programs in improving caregiving outcomes and reducing caregiver burden in childhood epilepsy.

 
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