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CTRI Number  CTRI/2023/01/048836 [Registered on: 09/01/2023] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mental Health First Aid training]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An experimental study to assesss the effectiveness of Mental Health First Aid among the adolescents in the Udupi district of Karnataka 
Scientific Title of Study   A Randomized Controlled Trial to assess the effectiveness of Mental Health First Aid (MHFA) training on mental health literacy, mental health stigma, confidence and skills among the late adolescents in the Udupi district of Karnataka 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
388/2020-13/12/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyothi Chakrabarty 
Designation  Professor 
Affiliation  Manipal College of Nursing,Manipal Academy of Higher Education 
Address  Manipal College of Nursing Manipal academy of Higher Education(MAHE)

Udupi
KARNATAKA
Manipal-576104
India 
Phone  9880078542  
Fax    
Email  jyothi.r@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Sooraj K 
Designation  Senior Research Fellow 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medical-Surgical Nursing Room No.602 Manipal College of Nursing Manipal Academy of Higher Education(MAHE)

Udupi
KARNATAKA
Manipal 576104
India 
Phone  9567172301  
Fax    
Email  sooraj.k@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sooraj K 
Designation  Senior Research Fellow 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medical-Surgical Nursing Room No:602 Manipal College of Nursing Manipal Academy of Higher Education(MAHE)

Udupi
KARNATAKA
Manipal 576104
India 
Phone  9567172301  
Fax    
Email  sooraj.k@learner.manipal.edu  
 
Source of Monetary or Material Support  
Indian Council Of Medical Research(ICMR) 
 
Primary Sponsor  
Name  Manipal College of Higher Education 
Address  Manipal Academy of Higher Education (MAHE) Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
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 
Sooraj K  Manipal College of Nursing  Department of Medical-Surgical Nursing Room No:602 Manipal Academy of Higher Education(MAHE) Manipal 576104 Udupi District
Udupi
KARNATAKA 
9567172301

sooraj.k@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adolescents -college students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mental Health First Aid  Randomly selected wait list control also will be assessed at the same time frame with the same variables. The wait-listed control will be providing MHFA training after the follow-up period. 
Intervention  Mental Health First Aid training  Randomly recruited experimental group will be undergoing 2 days of MHFA off-line training. They will be assessed on mental health literacy, Mental health stigma, Mental health first aid skill and Confidence at baseline (Pre-test), immediately after the intervention (Posttest) 45 days after intervention (Second post-test) and 6 months following the intervention(follow-up) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  1. Adolescents of undergraduate educational programs
2. Adolescents, who can read and understand English
3. Adolescents who are available and willing to take part in the study
 
 
ExclusionCriteria 
Details  1. Adolescents who are pursuing health science courses
2. Adolescents studying psychology/psychiatry as the main subject
3. Adolescents who attended MHFA training/mental health training program previously.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measure of this study is whether MHFA trained individuals will improve readiness to offer help to people with mental disorders compared to waiting list controls.   Baseline ,pre-test, post-test, after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures of this study are mental health literacy, mental health stigma, MHFA skill and confidence  Baseline ,pre-test, post-test, after 6 months 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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   Phase 2 
Date of First Enrollment (India)   01/02/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet done 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background of the study

 The WHO “defines health as a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity” (WHO, n.d). Unfortunately, mental aspects of health have not been got adequate attention contrary to physical ailments in our country. In India, people suffering from mental illnesses account for nearly 13.7 per cent of the country’s population and it is projected to be at 20 per cent by the end of 2020 (NIMHANS, 2016). At the same time, the WHO says that India has only 1 mental health professional for every 3,00,000 Indians (WHO, n.d). Subsequently, India envisages a severe shortage of mental health workforce including psychiatrists (0.3/100,000), psychiatric nurses (0.12/100,000) etc. in the mental health care delivery system (Prateek, 2017) led to a massive treatment gap, which is the difference between a total number of mentally ill people and those who receive treatment. And It is  83 per cent as per the national mental health survey conducted by NIMHANS which is alarming because this huge treatment gap itself is an indicator of quality, accessibility, and utilization of mental health care facilities (NIMHANS 2016). As a result, the President of India, Ram Nath Kovind avowed that “India is facing a possible mental health epidemic” (Prateek, 2017)

     Late adolescence, aged 18 to 21 years (Jaworska, & MacQueen (2015) is the intermediary phase of the transition from late adolescents to adults and 75% of mental disorder`s onset is usually seen in this period (Kessler, 2005) of which 70% of mentally ill late adolescents are not getting adequate interventions at the early stage (Jurewicz, 2015). Therefore, 16 per cent of the total burden of diseases in youngsters is due to psychiatric illnesses, which means 1 in 6  mentally people are adolescents (WHO, 2019). Besides, Substance use disorder is also alarmingly high (30.17%) among young people based on a recent study in India (Jasani et al., 2019) which also found that there is a close association between mental illness and substance use disorders. Furthermore, suicide, one of the major causes of mortality among late adolescents, is closely linked to mental disorders and 90 % of people who die by suicide had shown symptoms of mental illness (Conway, Swendsen, Husky, He, & Merikangas, 2016). Hence, early identification and management of mental illness can prevent secondary substance use disorders and suicide as well among young adults.

    Unfortunately, In India, conventional healers and unlicensed practitioners still assume a significant role in handling mental illness by exploiting the public`s poor mental health knowledge and stigma, therefore mentally ill people are being subjected to inhumane practices and human rights violations.(Ghanashyam & Nagarathinam, 2010). Hence, public training program like  Mental Health First Aid(MHFA) is need of the hour not only to reduce prevailing stigma related to mental illness but to improve mental health knowledge among the public.

    The MHFA course was devised to educate the public regarding mental illness and to identify early signs and symptoms of mental and behavioural disorders in 2000 by Betty Kitchener and Anthony Jorm. The former is a Registered Nurse and later is mental health literacy professor in Australia (www.mentalhealthfirstaid.org, 2013).MHFA can be “defined as the help provided to a person who is developing a mental health problem, experiencing a worsening of an existing mental health problem or in a mental health crisis. First aid is given until appropriate professional help is received or the crisis resolves” (Bovopoulos et al., 2016). Essentially, MHFA will equip the participants to give initial help to mentally ill people until they get professional care.

Purpose of the Trial

India is home to 464 million young adults and they are the future of our country. As mental health problems have a negative impact on youth`s productivity and capability, early identification and treatment of such problems is the key to the welfare of our society and country as a whole. The investigator has conducted a meticulous review of this topic and found out following points

1.     Most psychiatric illnesses (75%) are established before the age of 24 and 10 to 20 % of youngsters are with clinically diagnosable mental problems, of which 70% of them are not getting adequate interventions at an early age. Early identification, interventions, diagnosis, and treatment would be the panacea for helping late adolescents to reach healthy adulthood and thus, preventing such a large burden of untreated mental disorders. The investigator intends to focus primarily on these aspects in this study.  

2.     The study expects to provide MHFA training to late adolescents because they are a promising group to teach and learn. They would serve as mental health first aiders in their institution as well as in our society and thus they can be the changing agents of the mental health delivery system in our country.

3.     This project will help to create a pool of MHFA providers in the educational institution as well as in their community so that psychiatric problems can be identified at the beginning and can initiate action plans to provide help to individuals with mental problems or crises.

4.     This study will appraise the present MHL of late adolescents in the Udupi district which can be utilized for better mental health services.

 
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