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CTRI Number  CTRI/2024/01/061950 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 23/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   School-based Teen Mental Health promotion Program through peer support. 
Scientific Title of Study   “Effectiveness of School-based Scaling up Teen Mental Health Program through peer synergy (SUTMP) on mental health promotion, mental health literacy, and resilience among senior secondary students of Sikkim - A cluster randomized trial.”  
Trial Acronym  SUTMP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reshma Tamang 
Designation  Professor 
Affiliation  Sikkim Manipal Institute of medical sciences 
Address  Sikkim Manipal College Of Nursing,2nd floor, Room no.207 Department of Child Health Nursing, 5th Mile Tadong Gangtok Sikkim

East
SIKKIM
737102
India 
Phone  9609860544  
Fax    
Email  reshma.t@smims.smu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Binil V 
Designation  Additional Professor 
Affiliation  Manipal college of Nursing 
Address  Additional Professor Department of Mental Health Nursing Manipal college of Nursing Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844387432  
Fax    
Email  vp.binil@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Samrat Singh Bhandari  
Designation  Professor 
Affiliation  Sikkim Manipal Institute of Medical Sciences 
Address  Professor Department of Psychiatry Sikkim Manipal Institute of Medical Sciences 5th Mile Tadong Gangtok Sikkim Sikkim

East
SIKKIM
737102
India 
Phone  8348767641  
Fax    
Email  samrat.b@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Sikkim Manipal Institute of Medical Sciences 5th Mile Tadong Gangtok Sikkim 
 
Primary Sponsor  
Name  Prof.Reshma Tamang 
Address  Sikkim Manipal College of Nursing Sikkim Manipal Institute of Medical Sciences 5th Mile Tadong Gangtok Sikkim 
Type of Sponsor  Other [ [self (grant will be applied)]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ProfReshma Tamang  Sikkim Manipal College of Nursing  2nd floor, Room no. 207 5th Mile Tadong Pin No 737102 Gangtok Sikkim
East
SIKKIM 		 9609860544

reshma.t@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sikkim Manipal Institute of Medical Sciences,5th Mile Tadong ,Sikkim  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Senior Secondary school Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Regular school classes without intervention.  Control group will have regular school classes without intervention and will receive an informational booklet and videos after the study trial.The video will be on mental health promotion, literacy and access to app will be given after the study trail. 
Intervention  Teen Mental Health Program through peer synergy (SUTMP)   Intervention is School-based Scaling up Teen Mental Health Program through peer synergy.It is a multicomponent module designed specifically for senior secondary school students. • The program aims to promote mental health, enhance mental health literacy, and foster resilience among the students. • The intervention includes direct contact sessions and accompanying app that incorporates various app-based activities to enhance student resilience  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Students studying in Grade XI of a Government senior secondary school.

Students who can access a Smart phone either own or parents with android or iOS operating system.

Students score less than 73 in the resilience Scale of Gail M. Wagnild & Heather M. Young.
 
 
ExclusionCriteria 
Details  1.Students who are not willing to provide informed assent and parental consent.
2.Students who have undergone a similar type of training within a 3-month period prior to the study.
3.Students who are absent during the data collection phase of the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is mental health promotion among senior secondary students.  Post test , 3-months and 6-months post-intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Teen Mental Health Literacy ability to recognize mental health problems, knowledge on help seeking  Data will be collected at baseline and post test, 3-months and 6-months post-intervention  
Building Resilience among the senior secondary students ,ability to cope with challenges.  Data will be collected at baseline and post test, 3-months and 6-months post-intervention 
The Peer Mental Health Stigmatization among senior secondary students.  Data will be collected at baseline and post test, 3-months and 6-months post-intervention 
Peer synergy, that is Recognizing warning signs, when and how to tell a responsible adult, how to respond in a crisis will be assess by structure tool.  Data will be collected at baseline and post test, 3-months and 6-months post-intervention  
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
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 1 
Date of First Enrollment (India)   01/05/2024 
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)   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  

Globally , 1 in 7 individuals aged 10 to 19 experiences  mental disorders, forming 13% of their disease burden. Notably, depression, anxiety, and behavioral disorders rank high among the causes of illness and disability in adolescents, but unfortunately, these mental health issues often go unnoticed and untreated among this age group (WHO, 2021).In 2019, Northeast India featured in the top 10 states with the highest suicide rates, with Sikkim ranking second according to the NCRB report .Despite the urgent need to address mental health issues among adolescents, particularly in regions with high suicide rates such as Sikkim and Northeast India, there is a significant dearth of research focusing on mental health promotion and literacy in these areas. Furthermore, limited attention has been given to studying resilience and the effectiveness of peer-led interventions in the context of mental health promotion. In this study, SUTMP refers to School-based Scaling up Teen Mental Health Program through peer synergy. It is a multicomponent module designed specifically for senior secondary school students.The program aims to promote mental health, enhance   mental health literacy, and foster resilience among the students.The intervention includes direct contact sessions and an  accompanying app that incorporates various app-basedactivities an app with activities to enhance student resilience. Intervention will be implemented through Face-to-Face Sessions and App-Based i.e We Care App Sessions  on building resilience. The control group will receive an informational booklet and an awareness video after the post-test. Study will be  quantitative approach and a cluster randomized trial methodology, targed sample are Class XI students,  government senior secondary schools  of Sikkim. The assessment plan for the study includes pre-tests administered to both the intervention and control groups before the intervention implementation. Subsequently, post-tests will be conducted immediately after the intervention. Additionally, follow-up assessments are scheduled at 3-month and 6-month intervals post-intervention to gauge the sustained impact over time.

 
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