| CTRI Number |
CTRI/2025/03/083286 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [effectiveness of Mental Health Promotion program ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Mental Health Promotion program |
|
Scientific Title of Study
|
A Quasi Experimental study on Effectiveness of Mental Health Promotion Program on Knowledge on prevention of suicide, suicidality, psychological well-being and self-esteem among adolescent school students of Gangtok, district Sikkim |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Karki |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College of Nursing Sikkim Manipal Institute of Medical Sciences |
| Address |
Sikkim Manipal College of Nursing
Sikkim Manipal Institute of Medical Sciences 5TH MILE TADONG GANGTOK EAST SIKKIM
East
SIKKIM
737102
India |
| Phone |
8250035672 |
| Fax |
|
| Email |
prerna.k@smims.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tessy Treesa Jose |
| Designation |
Associate Dean |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Department of Psychiatric
Mental Health Nursing Manipal College of Nursing
Manipal Academy of Higher Education
Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844152459 |
| Fax |
|
| Email |
tessy.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tessy Treesa Jose |
| Designation |
Associate Dean |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Department of Psychiatric
Mental Health Nursing Manipal College of Nursing
Manipal Academy of Higher Education
Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844152459 |
| Fax |
|
| Email |
tessy.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing , 2nd Floor, Room No 207 5th Mile Tadong Gangtok Sikkim , India Pin code 737102 |
|
|
Primary Sponsor
|
| Name |
Prerna Karki |
| Address |
Sikkim Manipal College of Nursing Sikkim Manipal Institute of Medical Sciences
5th Mile Tadong Gangtok East Sikkim, Pin code 737102, 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 |
| Prerna Karki |
Sikkim Manipal College of Nursing ,SMU |
Sikkim Manipal College of Nursing , 2nd Floor, Room No 207 5th Mile Tadong Gangtok Sikkim , India Pin code 737102
East
SIKKIM |
08250035672
prerna.mconmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS/IEC/2024-111 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Information Booklet |
For the comparator group the information booklet will be provided and follow up will be done after 1 month , 3 month, and 6 months |
| Intervention |
Mental Health Promotion program |
The total duration of intervention program will be for 40 days that is for 7 weeks in 10 schools Intervention group). Total session in each school will be four for 4 days.
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Phase I
Inclusion Criteria
Adolescent school students between the age group of 14 to 16 years of age
Adolescent school students studying in class eight nine and ten of secondary and senior secondary school
Parents and students who give consent for the study
Phase II
Inclusion Criteria
Based on Phase I Knowledge score of the students’ participants for phase II will be recruited. Intervention group will be selected based on knowledge score less than 60%
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Adolescents school students who have moderate to high suicide risk. Those who have high suicide risk will be send for referral to a trained mental health professional.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to improve the knowledge on prevention of suicide |
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in suicidality |
1 month, 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="6"
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
|
Sikkim has the highest suicide rate than the national average with rising trend since 2004 , Most existing studies are retrospective , cross sectional or hospital based focusing on socio demographic factors without control populations for comparison . While this studies highlight risk factors they cannot establish cause effect relationship or generalize findings. Therefore it is essential to implement intervention that enhance knowledge on suicide prevention improve psychological well being , enhance self esteem and reduced suicide rate in the region |