| CTRI Number |
CTRI/2024/12/077698 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the Life Skill Intervention Program on Mental health in Adolescent School
going children in Rural Central India |
|
Scientific Title of Study
|
Effectiveness of the Life Skill Intervention Program in Reducing Psychological Distress in Adolescent School
going students in the Field Practice area of RHTC Bela |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandeesh Kuravatti |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NAGPUR |
| Address |
Department of Community Medicine
4th floor, Medical College Building
AIIMS Nagpur, Mihan, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7795943569 |
| Fax |
|
| Email |
nkuravatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjan Solanki |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NAGPUR |
| Address |
Department of Community Medicine
4th floor, Medical College Building
AIIMS Nagpur, Mihan, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7264821671 |
| Fax |
|
| Email |
drranjansolanki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandeesh Kuravatti |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NAGPUR |
| Address |
Department of Community Medicine
4th floor, Medical College Building
AIIMS Nagpur, Mihan, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7795943569 |
| Fax |
|
| Email |
nkuravatti@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Nagpur, Plot No. 2, Sector - 20, MIHAN, Nagpur, Maharashtra, Pin: 441108
info@aiimsnagpur.edu.in
aiimsnagpur1@gmail.com |
|
|
Primary Sponsor
|
| Name |
AIIMS Nagpur |
| Address |
MIHAN, Nagpur 441108 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunil Mulewar |
Lok Jeevan Vidyalaya and Junior College |
Lok Jeevan Vidyalaya & Junior College Bela Bela Nagpur Nagpur 441108
Nagpur
MAHARASHTRA |
7276892197
sunilmulewar@gmail.com |
| Rajendra Tidke |
Vimlabai Tidke Hs, Bela |
Vimalavai Tidke High school Bela Nagpur 441108
Nagpur
MAHARASHTRA |
9764914352
vthjr12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfullness based Life skill intervention |
Based on the WHO Programme on Mental Healths theoretical foundation and a mindfulness approach, Life skills like Decision-making, Problem-solving, Creative thinking, Critical thinking, Effective communication, Interpersonal relationship skills, Self-awareness, Empathy, coping with emotions, and coping with stress were taught.
There are 16 modules. One hour module per week over two months. |
| Comparator Agent |
No intervention |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
All school students studying in the class 8th to 10th standard
|
|
| ExclusionCriteria |
| Details |
Not available after approaching two times.
Not providing consent for the intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in psychological distress |
Reduction in psychological distress after 2months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in self esteem and body image esteem |
After 2months of intervention |
|
|
Target Sample Size
|
Total Sample Size="241"
Sample Size from India="241"
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)
|
03/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Rationale: Choosing the adolescent age group-this age group undergoes physical, mental, and emotional changes and is more vulnerable to going into distress. The Life skill training is one kind of the preventive measure in decreasing the emerging psychiatric illness in the adulthood. It is a pragmatic cluster trial, which is non-randomised and open-labeled done in the Field practice area of Rural Health Training Centre Bela, Nagpur. All the School-going students are children of class 8th, 9th and 10th in the schools in the rural area of Bela, Nagpur. We will be selecting 2 schools purposively, taking one school as an intervention and the other school as the control group. 3 sections (one section from each class to be randomly chosen from 8th, 9th and 10th standard) of one school will be taken as intervention group, and a similar number of students will be selected from 3 randomly chosen sections from 8th, 9th, 10th standard from other school and will be taken as controls. Pre-intervention Assessment of socio-demographics, psychological distress, self-esteem, and body image. Life Skills Training Intervention (The total time duration needed to impart the training is 16 hours and would be spanned across 2 months). Post- Post-intervention assessment (psychological distress, self-esteem, body image.)
|