FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/032162 [Registered on: 19/03/2021] Trial Registered Prospectively
Last Modified On: 03/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Life skill training, Music therapy and pranayama]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A wellness approach on mental wellbeing among adolescents 
Scientific Title of Study   A wellness approach on mental wellbeing among adolescents- A mixed method approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lavina Rodrigues 
Designation  Ph.D Scholar 
Affiliation  NITTE Usha Institute of Nursing Sciences 
Address  NITTE Usha Institute of Nursing Sciences Deralakatte, Paneer Mangalore
Department of Mental Health Nursing Father Muller college of Nursing Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9008884848  
Fax    
Email  lovesyril@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jacintha Veigas 
Designation  Professor & Clinical Coordinator 
Affiliation  NITTE Usha Institute of Nursing Sciences 
Address  Department of Community Health Nursing NITTE Usha Institute of Nursing Sciences Deralakatte Paneer Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845230445  
Fax    
Email  jacintha@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Safeekh AT 
Designation  Professor & HOD 
Affiliation  Father Muller Hospital 
Address  Department of Psychiatry Father Muller Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9448465741  
Fax    
Email  safeekh@gmail.com  
 
Source of Monetary or Material Support  
The study will be conducted at selected colleges at Mangalore 
 
Primary Sponsor  
Name  Lavina Rodrigues 
Address  Nitte Usha Institute of Nursing Sciences Paneer Deralakatte Mangalore 
Type of Sponsor  Other [self funded] 
 
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 
Lavina Rodrigues  St Aloysius College  Light House Hill road, Mangalore
Dakshina Kannada
KARNATAKA 		 9008884848

lovesyril@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NITTE Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescents who are studying in selected colleges at Mangaluru 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Observation  No intervention 
Intervention  parental awareness, adolescent awareness, Pranayama, Music therapy and Life skill training program.   Experimental group will be given training on wellness approach at regular intervals. The activities will be imparted to the adolescents in 20 sessions. Each session will be of 45 minutes duration, given twice in a week. The activities include parental counselling, adolescent counselling, Pranayama, Music therapy and Life skill training programme. Also initiation of a health club in the college where all the participants can freely communicate their concerns to the investigator through E-mail or in writing. Investigator will post various health related tips to promote mental wellbeing in the form of small articles and will ensure that the participants go through it. This will be an ongoing activity for 6 months. Followed by the intervention, 7th day, the post-test will be conducted to assessing the level of mental wellbeing in experimental & control group followed by 7th month, 8th month and 12th month and also the saliva sample is obtained from the participants to estimate the Salivary Alpha Amylase on 7th day followed by the intervention.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Qualitative strand
Adolescents who are willing to share their experiences

Quantitative strand
Adolescents (between the age group of 16- 17years) who are studying in I year P.U.C program in selected Pre-University colleges at Mangaluru
 
 
ExclusionCriteria 
Details  Adolescents who
are studying in evening college/ part time basis
are diagnosed with mental illness and on treatment
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Phase 1: Qualitative
1.To explore the mental disturbances among adolescents
Phase II: Quantitative
1.To determine the pre-intervention level of mental wellbeing among the adolescents
2.To find the effectiveness of wellness approach on mental wellbeing in the experimental group at repeated intervals
3.To compare the post test scores on mental wellbeing
4.To find the association between mental wellbeing among adolescents with selected baseline variables
 		 The outcome will be assessed followed by the intervention, 7th day, the post-test will be conducted to assessing the level of mental wellbeing in experimental & control group followed by 7th month, 8th month and 12th month and also the saliva sample is obtained from the participants to estimate the Salivary Alpha Amylase on 7th day followed by the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
To promote and maintain mental wellbeing among the adolescents  2 years 
 
Target Sample Size   Total Sample Size="720"
Sample Size from India="720" 
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)   01/07/2021 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   After the study completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  lovesyril@gmail.com

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 01-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Early detection and treatment involves addressing the needs of adolescents with defined mental health conditions. Avoiding institutionalization and over-medicalization, prioritizing non-pharmacological approaches, and respecting the rights of children in line with the United Nations Convention on the Rights of the Child and other human rights instruments are key for adolescents. WHO’s Mental Health Action Plan 2013–2020 is a commitment by all WHO Member States to take specific actions to promote mental well-being, prevent mental disorders, provide care, enhance recovery, promote human rights and reduce the mortality, morbidity and disability of persons with mental disorders, including adolescents. 
Close