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CTRI Number  CTRI/2024/01/061353 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative Method 
Study Design  Other 
Public Title of Study   Parenting practices and adolescent mental health 
Scientific Title of Study   Parenting practices and adolescent mental health: a multi-stakeholders’ perspective 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lena Ashok 
Designation  Professor 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Room #45, Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448984732  
Fax    
Email  lena.ashok@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Lena Ashok 
Designation  Professor 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Room #45, Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448984732  
Fax    
Email  lena.ashok@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Lena Ashok 
Designation  Professor 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Room #45, Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448984732  
Fax    
Email  lena.ashok@manipal.edu  
 
Source of Monetary or Material Support  
Scheme for Promotion of Academic and Research Collaboration 
 
Primary Sponsor  
Name  Scheme for Promotion of Academic and Research Collaboration, A Government of India Initiative 
Address  IIT Kharagpur 
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 Lena Ashok  Prasanna School of Public Health  Room #45, First Floor, Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 		 9448984732

lena.ashok@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  Healthy adolescents, their parents and stakeholders will be our participants. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Either parent of adolescents aged 10 to 19 years
2) Adolescents aged 10 to 19 years, both male and female, who have been residing within the same household as their parents
3) Academicians from the field of mental health; Clinicians in the field of Psychology, Psychiatric Social Work, and Psychiatry, having an expertise in child psychology; NGO practitioners involved in mental health care.
 
 
ExclusionCriteria 
Details  Individuals, both parents and adolescents, who have been diagnosed with any mental health disorders and are seeking medical advice and/or treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcomes of interest will include parenting practices, adolescent perceptions on parenting,mental health disorders and coping methods.  One year 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes of interest will include coping methods by adolescents and parents  One year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/01/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Adolescent mental health is a complex issue influenced by various factors like family dynamics, school environments, peer relationships, cultural backgrounds, and societal expectations. While parents and adolescents can provide first-hand experiences related to parenting practices and adolescent mental health, other stakeholders such as mental health practitioners, academicians, and clinicians offer expertise and insights into the broader context that allows for a better understanding of a holistic approach to adolescent well-being. The purposive sampling will be employed. About six participants per stakeholder group will be recruited from Udupi Taluk, totaling about 30 participants, or until saturation. This study will address a critical public health concern and provide valuable insights from various stakeholders from the community towards improving adolescent mental health. Outcomes of the study will include parenting practices, adolescent perceptions on parenting, prevalence of mental health disorders and coping methods.  
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