| CTRI Number |
CTRI/2024/08/072027 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
An implementation research to reduce suicide risk behavior and improving wellbeing among students |
|
Scientific Title of Study
|
ICMRs Multistate Implementation Research Study on Suicide Risk Reduction and Improving Mental Well Being Among School and College Students |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Dahiya |
| Designation |
Program Officer |
| Affiliation |
Indian Council Of Medical Research |
| Address |
Division of Delivery Research, Indian Council Of Medical Research Headquarters, Government of India, New Delhi
South
DELHI
110029
India |
| Phone |
9968910438 |
| Fax |
|
| Email |
neha.dahiya@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Dahiya |
| Designation |
Program Officer |
| Affiliation |
Indian Council Of Medical Research |
| Address |
Division of Delivery Research, Indian Council Of Medical Research Headquarters, Government of India, New Delhi
South
DELHI
110029
India |
| Phone |
9968910438 |
| Fax |
|
| Email |
neha.dahiya@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Dahiya |
| Designation |
Program Officer |
| Affiliation |
Indian Council Of Medical Research |
| Address |
Division of Delivery Research, Indian Council Of Medical Research Headquarters, Government of India, New Delhi
South
DELHI
110029
India |
| Phone |
9968910438 |
| Fax |
|
| Email |
neha.dahiya@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medial Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramdas Ransing |
All India Institute of Medical Sciences Guwahati |
Room No 1022 Department of Psychiatry Silbharal Changsari Guwahati 781101
Kamrup
ASSAM |
9503145475
ramdas_ransing123@yahoo.co.in |
| Dr Neeti Rustagi |
All India Institute of Medical Sciences Jodhpur |
Department of Community Medicine and Family Medicine Room No 205 2nd Floor Academic building Marudhar Industrial Area 2nd Phase MIA 1st Phase Basni 342005
Jodhpur
RAJASTHAN |
8003996931
drneetigoswami@gmail.com |
| Dr Pragya Sharma |
Andaman & Nicobar Islands Institute of Medical Sciences |
DHS Annexe Building, Atlanta Point, Port Blair -744104
Andamans
ANDAMAN & NICOBAR ISLANDS |
9968604252
drpragyas@gmail.com |
| Dr Indu P S |
Government Medical College Kollam |
Department of Community Medicine Room No 4 Academic Block Govt Medical College Parippally PO Kollam Kerala PIN-691574
Kollam
KERALA |
9495980886
indupsaniltv@gmail.com |
| Dr Satabdi Chakraborty |
Institute of Health Behaviour and Allied Sciences (IHBAS) |
Room no 220 Academic Block GTB Enclave Dilshad Garden New Delhi 110095
East
DELHI |
9416026739
satapril27@yahoo.co.in |
| Dr Seema Mehrotra |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
Department of Clinical Psychology NIMHANS 3rd Floor MV Govindswamy Centre Bengaluru 560029
Bangalore
KARNATAKA |
9448503853
drmehrotra_seema@yahoo.com |
| Dr Tarun Mene |
Rajiv Gandhi University |
Arunachal Institute of Tribal Studies, Rono Hills, Doimukh, Dist- Papumpare, - 791112
Papum Pare
ARUNACHAL PRADESH |
8119859343
tarun.mene@rgu.ac.in |
| Dr Chetna Duggal |
Tata Institute of Social Sciences (TISS) |
School of Human Ecology 503 MS Gore Block Naoroji Campus
Deonar farm road Mumbai 400088
Mumbai
MAHARASHTRA |
9833059886
chetnaduggal02@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur- Institutional Ethics Committee (Human) |
Approved |
| Human Ethics Committee Government Medical College Kollam |
Approved |
| IEC AIIMS Guwahati |
Approved |
| IEC- IHBAS |
Approved |
| Institutional Ethics Committe Rajiv Gandhi University |
Approved |
| Institutional Ethics Committee ANIIMS |
Approved |
| Institutional Review Board TISS |
Approved |
| NIMHANS Ethics Committee - Behavioral Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gatekeeper Training for Suicide Prevention
|
This intervention aims at equipping individuals, often those who interact regularly with the target population, with the knowledge and skills to identify early signs of distress, offer initial help, and connect at-risk individuals with appropriate professional support.
|
| Intervention |
Leader Engagement for Mental Health First Response in Schools and Colleges. |
This initiative aims to establish standardized procedures that facilitate efficient mental health, suicide prevention, and crisis intervention care for students within educational institutions. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Promotive and Preventive Self-help Interventions for Youth
|
These interventions encompass modules that youth can utilize to enhance their knowledge about mental health and well-being, broaden their repertoires of psychosocial competencies for maintaining well being and facilitating personal growth |
| Intervention |
Youth engagement for mental health advocacy and peer support
|
Youth engagement initiatives operate from the framework of building necessary knowledge and skills in youth supporters, and thereafter leverage their support to advocate for mental health, reduce stigma about mental health, and improve help seeking behavior for mental health in the student community. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
1. School/ pre-university students (grades 9-12)
2. College students (graduate and postgraduate levels, including professional courses) |
|
| ExclusionCriteria |
| Details |
1. Educational institutes exclusively catering to adolescents with special needs
2. Doctoral students and students pursuing education through distance or online or certificate courses lasting less than a year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Achieving reduction of suicide risk behaviors and increase in help-seeking behavior among school and college students in selected districts.
2. The key barriers and facilitating factors will be identified and implementation outcomes including implementation costs will be documented for suggesting recommendations regarding potential nation-wide scaling. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establish, orient and engage district level health care service providers for referral support of high risk/ distressed students |
3 years |
|
|
Target Sample Size
|
Total Sample Size="472"
Sample Size from India="472"
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)
|
16/08/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [neha.dahiya@icmr.gov.in].
- For how long will this data be available start date provided 12-08-2024 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - As it is a multicenter trial, additional information plan/policy for sharing IPD will be taken care by ICMR office bearers
|
|
Brief Summary
|
This implementation study aims to evaluate a scalable, multicomponent intervention in schools and colleges across eight Indian states and union territories. The package spans care from promotion and prevention to enhancing help-seeking, early identification, crisis intervention, and postvention. Objectives include developing and assessing an implementation model for achieving reduction of suicide risk behavior (perceived stress, depressive symptoms , low help seeking) in selected educational institutes. The study will use a mixed methods design and the Updated Consolidated Framework for Implementation Research (CFIR). Based on the findings derived from the formative research work, the implementation model will undergo iterative cycles for optimization. The final phase focuses on monitoring, evaluating the optimized model’s implementation, and assessing its sustainability. The primary outcome aims at reduction of suicide risk behaviors among school and college students in selected districts. Identification of the key barriers and facilitating factors and assessing implementation outcomes including implementation costs will be documented for suggesting recommendations regarding potential nation-wide scaling. |