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CTRI Number  CTRI/2024/02/062390 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   A study to assess the common behaviour related issues among children in primary school of Karnataka State. 
Scientific Title of Study   A SAMARPAN Program (Prevention of Suicide, Substance abuse, Abuse and Neglect, Eating problems, Peer pressure, Managing emotions and Behavioural problems) among children in primary school of Karnataka State. 
Trial Acronym  SAMARPAN  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanju Pant 
Designation  Lecturer 
Affiliation  Department of Psychiatric Mental Health Nursing Manipal college of Nursing, MAHE Manipal  
Address  Department of Psychiatric mental health Nursing Manipal college of Nursing, MAHE Manipal

Udupi
KARNATAKA
567104
India 
Phone  9991402789  
Fax    
Email  sanju.pant@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tessy Treesa Jose 
Designation  Associate Dean, HoD 
Affiliation  Department of Psychiatric Mental Health Nursing Manipal college of Nursing, MAHE Manipal  
Address  Department of Psychiatric mental health Nursing Manipal college of Nursing, MAHE Manipal

Udupi
KARNATAKA
567104
India 
Phone  9844152459  
Fax    
Email  tessy.j@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Judith A Noronha 
Designation  Dean 
Affiliation  Department of Obstetrics and genecology Manipal college of Nursing, MAHE Manipal  
Address  Department of Obstetrics and genecology Manipal college of Nursing, MAHE Manipal

Udupi
KARNATAKA
567104
India 
Phone  9448506594  
Fax    
Email  judith.n@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research New Delhi 
Type of Sponsor  Government funding agency 
 
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 
Dr Sanju Pant  Department of Psychiatric mental health Nursing MCON  Room no: 601 Department of Psychiatric mental health Nursing Manipal college of Nursing, MAHE Manipal
Udupi
KARNATAKA 
9991402789

sanju.pant@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A SAMARPAN Program (Prevention of Suicide, Substance abuse, Abuse and Neglect, Eating problems, Peer pressure, Managing emotions and Behavioural problems) among children in primary school of Karnataka State  A three-day workshop will be conducted in randomly selected schools from 31 districts of Karnataka state by an expert panel. It will cover a total population of 15,000 schoolchildren and primary teachers. The study is funded by the Indian Council of Medical Research from 20 January 2023 for a 3-year duration.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  11.00 Day(s)
Age To  13.00 Day(s)
Gender  Both 
Details  Children
children who are willing to give consent and got consent from parents
children who are studying in 7th standards.

Teacher
Teachers who are willing to give consent.
Teachers who are teaching the primary school children.
 
 
ExclusionCriteria 
Details  children
children who have missed a Single session of workshop
children t who is absent in school that day because of any medical or personal issues.

Teacher
Teacher who is absent in school that day because of any medical or personal issue
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Behavioural Problem, knowledge   1 month  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="15000"
Sample Size from India="15000" 
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)   15/02/2024 
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  

Issues related to mental health account for 13% - 20% of the global burden of disease and injury in primary scholars. Half of all mental health issues start at a young age, but remain undetected and untreated. Lack of self-control, emotional instability, and negative thinking are the root causes of mental health disorders. The consequences of not addressing adolescent mental health issues extend into adulthood, impairing both physical & mental health and limiting opportunities to lead fulfilling lives as adults. Promoting mental hygiene and protecting this vulnerable group of children from risk factors are important for a healthy adulthood.

Therefore, this SAMARPAN program is designed for the need-based assessment of the current generation. The issues addressed in this program are related to suicide, substance abuse, eating disorders, abuse & neglect, Peer pressure, Managing emotions, and Behavioural problems. A three-day workshop will be conducted in randomly selected schools from 31 districts of Karnataka state by an expert panel. This ambitious project aims to cover a total population of 15,000 schoolchildren and primary teachers from 31 districts of Karnataka. The project firmly believes that early awareness for the children in the primary school age group

will help in influencing the decision-making ability of the participants, development of assertive communication, coping with the school and family stress and behaviour to overcome the peer pressure often faced by the preschooler’s and to lead a healthy society for this beloved nation, India. 

 
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