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
|
|
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
|
|
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
|
|
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. |