| CTRI Number |
CTRI/2026/02/104145 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study to Find Out How a Life Skills Training Program Conducted by Nurses Can Help Improve Wellbeing, Confidence, and Coping in Children Living in Orphanages in Mangalore |
|
Scientific Title of Study
|
Effect of Nurse-led Life Skill Training Program on Psycho-Social Wellbeing, Self-Esteem, Coping Strategy among Children Residing in the Selected Orphanages, Mangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUPAMA H V |
| Designation |
PhD Scholar |
| Affiliation |
Masood College Of Nuring |
| Address |
Child health nursing Department
First floor
Masood College of Nursing
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
Child Health Nursing Department
First floor
Masood College of Nursing
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
Dakshina Kannada
KARNATAKA
575029
India |
| Phone |
07411775306 |
| Fax |
|
| Email |
anupamamsc30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUPAMA H V |
| Designation |
PhD Scholar |
| Affiliation |
Masood College Of Nuring |
| Address |
Masood College of Nursing
Child health nursing Department
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
Masood College of Nursing
Child health nursing department
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
Dakshina Kannada
KARNATAKA
575029
India |
| Phone |
07411775306 |
| Fax |
|
| Email |
anupamamsc30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUPAMA H V |
| Designation |
PhD Scholar |
| Affiliation |
Masood College Of Nuring |
| Address |
Masood College of Nursing
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
KARNATAKA
575029
India |
| Phone |
07411775306 |
| Fax |
|
| Email |
anupamamsc30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetory support self
Infrastructure is
Masood College of nursing
Child health nursing department
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru |
| self |
|
|
Primary Sponsor
|
| Name |
Anupama H V |
| Address |
Phd Scholar, Masood College of Nursing
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru, Karnataka
pin- 575029 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Veena Gretta Tauro |
Masood college of nursing |
Child health nursing department
First floor
Sagar Hills
Pedamale Post
Neermarga Village
Saripalla
Managaluru
Dakshina Kannada
KARNATAKA |
7204014849
venatauro@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MECT IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Orphan Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led Lifeskill Training Programme. |
A structured nurse-led life skill training program will be administered to children residing in selected orphanages. The program focuses on enhancing psycho-social wellbeing, self-esteem, and coping strategies.
The training includes interactive sessions on communication skills, emotional regulation, decision-making, interpersonal relationships, stress management, and problem-solving. The total duration of the intervention is 5 weeks, and the post-test is done after 31st days |
| Comparator Agent |
Routine Activities |
Standard care – children in the control group will receive routine activities and support provided by the orphanage without any additional life skill training intervention. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Able to comprehend and respond in Kannada or English |
|
| ExclusionCriteria |
| Details |
Suffering from any kind of psychiatric ailment and on treatment for the same
Those who had frequent contact with their families through regular weekend visits
Those with any history of significant neurological or mental deficits
Those who were taking any antipsychotic or mood stabiliser drugs at the time of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in Psychosocial well-being, self-esteem, and
coping strategies |
changes in behaviour assessed after 31st day of administering intervention
Total time period 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Over all welbeing of the Orphan child |
The total duration of the intervention is 5 weeks outcome is assessed after 31st
day
Total time period is 8 week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/02/2027 |
| 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="2"
Months="0"
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
|
This non-randomized interventional study aims to evaluate the effectiveness of a nurse-led life skill training program on psychosocial well-being, self-esteem, and coping strategies among children residing in selected orphanages in Mangalore, Karnataka. A total of 120 participants will be selected through purposive sampling and allocated into intervention and active control groups. The life skill training will be delivered by trained nurses over a structured schedule. Outcomes will be assessed using the Strengths and Difficulties Questionnaire (SDQ), the Rosenberg Self-Esteem Scale, and the KIDCOPE coping inventory. Pre- and post-intervention assessments will be conducted to measure changes in psychosocial well-being, self-esteem, and coping strategies. The study is expected to provide evidence for the role of behavioural interventions in promoting mental health and resilience among vulnerable children. |