CTRI Number |
CTRI/2023/10/059181 [Registered on: 27/10/2023] Trial Registered Prospectively |
Last Modified On: |
23/10/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Problems in adolescents in schools |
Scientific Title of Study
|
Psychosocial problems of 13-16 year-olds during the recovery phase of the COVID-19 pandemic |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Samir Kumar Praharaj |
Designation |
Professor |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
Phone |
8971026304 |
Fax |
|
Email |
samirpsyche@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Samir Kumar Praharaj |
Designation |
Professor |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
Phone |
8971026304 |
Fax |
|
Email |
samirpsyche@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Samir Kumar Praharaj |
Designation |
Professor |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
Phone |
8971026304 |
Fax |
|
Email |
samirpsyche@yahoo.co.in |
|
Source of Monetary or Material Support
|
Kasturba Medical College, Manipal, Karnataka, India |
|
Primary Sponsor
|
Name |
Kasturba Medical College Manipal |
Address |
Madhav Nagar, Manipal, Karnataka, India - 576104 |
Type of Sponsor |
Private medical college |
|
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 Samir Kumar Praharaj |
Kasturba Medical College Manipal |
Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal Udupi KARNATAKA |
8971026304
samirpsyche@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical College and Kasturba Hospital Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Adolescents |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
13-16 years old children and adolescents living in Udupi District will be invited to participate in this survey. |
|
ExclusionCriteria |
Details |
Those attending special schools for students with intellectual disabilities will be excluded. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Bullying behavior |
Baseline (single assessment) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
04/11/2023 |
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="0" 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
|
There is a global concern
about the negative impact of the COVID-19 pandemic on mental health of children
and adolescents. Some studies suggest that psychiatric symptoms of children and
adolescents have indeed increased during the pandemic. Disease containment
measures, such as lockdowns, school closures, remote school, cessation of
hobbies, quarantines and social isolation have changed people’s lives
dramatically, exposing children and adolescents to several stressors, including
fear of contracting the disease, frustration, boredom, information overload,
family financial loss and changes in daily activity patterns. Parallel with the
COVID-19 pandemic, other global crises threaten the mental health of children
and adolescents globally. There is evidence that climate change -related
psychological distress with affective, cognitive and behavioural dimensions
exists and children and adolescents are particularly prone to it. Repeated
cross-sectional studies employing the same instruments, protocol and study sites
in different time-points can help to understand the factors and reasons behind
the changes. We studied adolescent wellbeing in 2000 children in 2015, and will
repeat the same to study the changes over time. We will study 2000 adolescents in Udupi district
(sample similar to our previous study). 13-16
years old children and adolescents living in Udupi District will be invited to
participate in this survey. Those attending special schools for students with
intellectual disabilities will be excluded. A student and a teacher survey will
be conducted. The student survey will be in bilingual form. Written permission will be
obtained from block education officer. We will collect data from the same
schools which we had included in our previous 2016 study. The school
authorities will be approached and asked to participate, and the teachers will
receive a detailed information letter explaining the aims and the rationale
behind the study. All respondents will be given a letter of consent, which
needs to be returned to the researchers. The students will be asked to complete
the questionnaires during class. They will not be asked to provide their name
or address. The students will be informed that they give their consent to
participate in the research by filling in the questionnaire and that they can
decline their participation by leaving the questionnaire blank. Before
responding to the questionnaire, the students will be given detailed
explanations on how to proceed.
Department scientific
committee and approval from IEC will be obtained. Permission from BEO and
school principal will be taken. Participation in the study planned is
completely voluntary for the students. Parents, students, and teachers will be
informed about the study prior to conducting the survey. The survey will be
conducted during school hours and students will not be asked to provide their
names or addresses in the questionnaires. The data will only be used for this
scientific research. Data gathering, storing, and processing will be conducted
confidentially. There will not be any compensation for participating in this
study. |