| CTRI Number |
CTRI/2025/03/083592 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Programme] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
How Life Skills Education Helps to Improve Health and Well-being in Adolescents |
|
Scientific Title of Study
|
Effectiveness of Life Skill Education Programme on Health and Wellbeing among Middle Adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rinu David |
| Designation |
Associate Professor, PhD Scholar |
| Affiliation |
Amala College of Nursing |
| Address |
Community Health Nursing Department, Amala College of Nursing,
Amala Nagar, Thrissur-680555,Kerala
Thrissur
KERALA
680555
India |
| Phone |
08943905640 |
| Fax |
|
| Email |
rinu.david45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Molly John |
| Designation |
Professor cum Guide |
| Affiliation |
Amala College of Nursing |
| Address |
HOD-Community Health Nursing Department, Amala College of Nursing, Amala Nagar,Thrissur,Kerala
Thrissur
KERALA
680555
India |
| Phone |
9496382109 |
| Fax |
|
| Email |
srmerlyjohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Molly John |
| Designation |
Professor ,Guide |
| Affiliation |
Amala College of Nursing, |
| Address |
HOD-Community Health Nursing Department, Amala College of Nursing, Amala Nagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9496382109 |
| Fax |
|
| Email |
srmerlyjohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rinu David,
Amala College of Nursing,Thrissur-680555, Kerala-India |
|
|
Primary Sponsor
|
| Name |
Rinu David |
| Address |
Community Health Nursing Department,Amala College of Nursing, Thrissur-680555,Kerala-India. |
| 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 |
| Rinu David |
Rural Higher secondary schools |
Rural Higher secondary schools
Thrissur Taluk
Thrissur
KERALA |
08943905640
rinu.david@amalaims.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAMALAINSTITUTEOFMEDICALSCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy middle adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Life Skill Education Programme(LSE) |
It is the structured educational programme designed by the investigator for selected group of adolescents to acquire knowledge and skills to navigate through different aspects of life. This educational initiative is conducted regularly for 12 weeks, with weekly one-hour sessions using diverse teaching methods. It includes Self awareness, Communication skills, Problem solving, Building positive Relationships, Nutrition, Stress management, Emotional Intelligence, Goal Setting, Substance abuse prevention, Healthy Practices, Career guidance & Assertiveness. |
| Comparator Agent |
Regular Education programme |
No specific programme on lifeskill education ,they will be following only the regular education programme |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
enrolled in 11th and 12th class of higher secondary school.
willing to participate
|
|
| ExclusionCriteria |
| Details |
On regular treatment for chronic noncommunicable diseases
leave at the time of data collection
physically Challenged
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improve health and well-being of adolescents |
2 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health and well-being among middle adolescents |
2yrs |
|
|
Target Sample Size
|
Total Sample Size="1140"
Sample Size from India="1140"
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)
|
09/06/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - rinu.david45@gmail.com
- For how long will this data be available start date provided 02-06-2025 and end date provided 02-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is aimed to assess effectiveness of life skill education programme on Health and well-being in middle adolescents.· Objectives of the study is determine the effectiveness of Life Skill Education programme on Health and well-being among middle adolescents and to find out the association between Health and Well-being among middle adolescents with selected demographic variables. The hypothesis will be a significant difference between pre-test and post-test values regarding Health and wellbeing among middle adolescents and There will be significant association between Health and well-being among middle adolescents with their selected demographic variables. Lifeskill Education Programme is the structured educational programme designed by the investigator for selected group of adolescents to acquire knowledge and skills to navigate through different aspects of life. This educational initiative is conducted regularly for 12 weeks, with weekly one-hour sessions using diverse teaching methods. |