| CTRI Number |
CTRI/2022/05/042455 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the Effect of life skill training on caregivers who have children with behavioural disorders.
|
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Scientific Title of Study
|
Effect of life skill training on quality of life, perceived stress and self efficacy among caregivers of children with behavioural disorders.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANITA PAUL SAMANTA |
| Designation |
PHD NURSING SCHOLAR |
| Affiliation |
SUM Nursing College , SIKSHA O ANUSANDHAN Deemed to be University |
| Address |
Department of Nursing
Sum Nursing College
Kalinga Nagar
Bhubaneswar
Department of Nursing
Sum Nursing College
Kalinga Nagar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8617218809 |
| Fax |
|
| Email |
anitasamantap1973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sasmita Das |
| Designation |
Associate Dean |
| Affiliation |
Sum Nursing College, SIKHA O ANUSANDHAN Deemed to be University |
| Address |
Faculty of Nursing
Sum Nursing College
ITER Campus II
Siksha O Anusandhan Deemed to be University
Kalinga Nagar
Bhubaneswar
Faculty of Nursing
Sum Nursing College
ITER Campus II
Siksha o Anusandhan Deemed to be University
Kalinga Nagar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9776645936 |
| Fax |
0674-2386295 |
| Email |
das.sasmita2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANITA PAUL SAMANTA |
| Designation |
Clinical Instructor |
| Affiliation |
Govt. College of Nursing, R.G.Kar Medical College and Hospital |
| Address |
Department of Nursing
Govt. College of Nursing,
Academic Building, 6th and 7th Floor
R.G.Kar Medical College and Hospital
1, Khudiram Bose Sarani
Kolkata-4
West Bengal
Department of Nursing
Govt. College of Nursing,
Academic Building, 6th and 7th Floor
R.G.Kar Medical College and Hospital
1, Khudiram Bose Sarani
Kolkata-4, West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
8617218809 |
| Fax |
|
| Email |
anitasamantap1973@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.G.Kar Medical College and Hospital, Kolkata |
|
|
Primary Sponsor
|
| Name |
Anita Paul Samanta |
| Address |
Govt College of Nursing
6th and 7th Floor
Academic Building R G Kar Medical College and Hospital Campus, R G Kar Medical College and Hospital, 1, Khudiram Bose Sarani Kolkata 700004
West Bengal |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anita Paul Samanta |
R.G.Kar. Medical College and Hospital |
Department of Psychiatry
Child Guidance Clinic
4th Floor, Emergency Building
R G Kar MCH Campus, Kolkata
700004
Kolkata
WEST BENGAL |
8617218809
anitasamantap1973@gmail.com |
| Anita Paul Samanta |
Calcutta Medical College and Hospital |
Department of Psychiatry, OPD Block, Special Clinic Room, Ground Floor, Ezra Building, Calcutta Medical College and Hospital Campus, 88, College Street, Kolkata 700073
Kolkata
WEST BENGAL |
8617218809
anitasamantap1973@gmail.com |
| Anita Paul Samanta |
NRS Medical College & Hospital |
Department of Psychiatry Child Guidance Clinic 4th Floor
OPD Building, NRS Medical College and Hospital Campus, 138 A.J.C Bose Road, Kolkata 700014
Kolkata
WEST BENGAL |
8617218809
anitasamantap1973@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics COMMITTEE RGKARMCH KOLKATA |
Approved |
| Institutional Ethics Committee, Medical College Kolkata, West Bengal |
Approved |
| Institutional Ethics Committee, Nilratan Sircar Medical College & Hospital Kolkata |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants are Caregivers of children with behavioual disorders are healthy adults
Problems studied are Quality Of Life and stress perception of these healthy adults |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Life skill training |
The intervention will be in sessions. In a session a subjects will receive each domain of life skill training which consisted of introduction to disease management communication skill problem solving skill and stress management skill along with standard mental health care services each session will be introduce in a 2 weeks interval a subject will receive a maximum of 6 sessions which includes 2 follow up sessions on over all life skill training at one months interval after completion of 4 sessions. this will take a maximum of 4 months Here standard of care is as per protocol of mental health services First session will be on introduction of behavioural disorder Second session will be on communication skill and problem solving skill and Third session will be on stress management skill training Fourth session will be on overall all domains of life skill training Each participant will involve in psychoeducation role play and group activities a group will be developed with maximum of 10 participants |
| Comparator Agent |
Standard of care as per mental health service protocol |
the participant in the control group will receive psychoeducation and other services as per the standard care protocol of behavioural disorders maintained in govt hospital
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant are those who are the parent of children with behavioural disorder consist of ADHD CD ODD and may or may not having mild mental retardation aged upto15 years
2. Both or single parent provided care to the children at least for 3 months after the confirmed diagnosis of ADHD CD ODD with or without mild mental retardation 3. Subjects willing to give informed consents and able to comply with schedule visits, intervention plan and other study procedures 4. caregiver Did not attend life skill training programme earlier
|
|
| ExclusionCriteria |
| Details |
1.Care givers diagnosed with severe depression acute psychosis and schizophrenia and mental illnesses
2. Caregivers of children with psychological disorders
3.Parent missed two sessions of interventions
4. Caregivers having responsibility of taking care of Seriously ill family members 5. Seriously ill parent of the children 6. Subjects not willing to give their informed consent to participate in the study 7. Participating in other interventional study or clinical trial in the prior one month |
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
quality of life is to be measured by using WHOQOLBREF stress is to be measured by using PSS Scale of Cohen et al and self efficacy will be measured by standardised General self efficacy scale
the quality of life and perceived stress and self efficacy of the caregivers may change after life skill training of the participant in the interventional group |
After final session immediate assessment followed by assessment at four weeks and eight weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| caregivers quality of life will be improved and stress will be reduced |
after the intervention of the life skill training with 3 repeated measurement that is immediately after one month and 2 months of intervention |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/05/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
title : Effect of life skill training on quality of life perceived stress and self efficacy among care givers of children with behavioural disorders
This is a prospective clinical study. Parents of behavioural disorder children namely ADHD, CD And ODD is to be considered as caregivers. A randomised control trial with Pre test post test control group design is to be used. The purpose of the the study is to find out the effect of life skill training on quality of life , perceived stress and self efficacy of the caregivers of behavioural disorders children and find out the correlation between the stress, quality of life and self efficacy if any. the intervention consist of four areas namely awareness to behavioural disorder , communication skill problem solving skill and stress management skill. duration of each session is 120 minutes. The hypothesis is to be tested at 0.05 level of significance. The quality of life perceived stress and self efficacy may changed after life skill training intervention and there is a significant difference in between experimental group and control group in terms of stress quality of life and self efficacy after the intervention |