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CTRI Number  CTRI/2024/02/062582 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 17/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Emotional Strength Building intervention on Emotional Regulation, Psychological Hardiness, and Self-Awareness among adolescents. 
Scientific Title of Study   Effectiveness of Emotional Strength Building intervention on Emotional Regulation, Psychological Hardiness, and Self-Awareness among adolescents attending selected schools in Udupi district, Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Preejana Sharma 
Designation  PhD Scholar 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal. 
Address  Department of fundamentals of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7679971835  
Fax  8202922572  
Email  sharmapreeju@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Linu Sara George 
Designation  Professor and Head 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal. 
Address  Department of fundamentals of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9845602400  
Fax  8202922572  
Email  linu.j@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Linu Sara George 
Designation  Professor and Head 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal. 
Address  Department of fundamentals of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal.


KARNATAKA
576104
India 
Phone  9845602400  
Fax  8202922572  
Email  linu.j@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, karnataka. 
 
Primary Sponsor  
Name  Preejana Sharma 
Address  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self] 
 
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 Linu Sara George  Manipal College of Nursing  Room Number 302, 3rd Floor, Department of Fundamentals of Nursing. Manipal College of Nursing, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA 		 9845602400

linu.j@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  Adolescents studying in 8th and 9th Grades 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Emotional Strength Building Intervention  The intervention will last for 5 weeks, comprising one weekly session lasting for a duration of 2 hours each, which will be conducted during regular school hours. It includes: Communication and Interpersonal relationship, Understanding Emotions, Build Resilience and support, Emotion management and Self-regulation strategies.  
Comparator Agent  NIL  Not Applicable 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Phase I (survey)
Adolescents-
1. Studying in 8th and 9th Grades.
2. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the
adolescent themselves.

Phase I (Focus Group Discussion)
Adolescents
1. Studying in 8th and 9th Grades.
2. Adolescents scoring >30 score for the emotional regulation scale.
3. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the adolescent themselves.

Parents-
1. Parents of adolescents attending selected English-medium schools who are currently in the 8th and 9th grades.
2. Parents of adolescents scoring >30 score for the Emotional Regulation scale.
3. Those who are willing to provide written informed consent.

Teachers-
1. Teachers who are teaching 8th and 9th grade adolescents.
2. Those who are willing to provide written informed consent.

Phase II (intervention)
Adolescents-
1. Studying in 8th and 9th Grades.
2. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the
adolescent themselves.


 
 
ExclusionCriteria 
Details  Phase I ( Focus Group Discussion)
Teachers-
1. Teachers whose children are studying in 8th and 9th grade in the same school.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Emotional Regulation, Psychological Hardiness, and Self-Awareness  baseline,
15 days after completion of intervention,
1 month after intervention,
3 month after intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="1335"
Sample Size from India="1335" 
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 1 
Date of First Enrollment (India)   19/02/2024 
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)
Modification(s)  		 Not Applicable 
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  
Introduction

Adolescence is the transitional phase between childhood and adulthood, spanning from ages 10 to 19. It is a time of significant physical, cognitive, and emotional growth, which can shape an individual’s feelings, thoughts, behaviors, and interactions with the world (WHO, 2023). During childhood and adolescence, important stages occur that lay the foundation for a person’s healthy development and mental well-being. These stages are crucial and need to be handled carefully (Barry et al., 2013). The World Health Organization (WHO) reports that mental health problems are a major concern for adolescents worldwide, affecting around 10-20% of this population (WHO, 2021). The period of adolescence, which is characterized by emotional difficulties and developing regulatory brain circuitry, is one in which emotional regulation abilities considerably advance (Kopp, 1989). Emotional regulation (ER) plays a vital role in developing and maintaining several mental health disorders, and it is a key target variable of preventive interventions (Malhi et al., 2017). Further, study has revealed that individuals with higher levels of psychological hardiness exhibited greater self-awareness. They were more attuned to their emotions, thoughts, and behaviours, and had a better understanding of their strengths, weaknesses, and personal values, suggesting that psychological hardiness may contribute to the development of self-awareness in individuals (Bartone et al, 2009). Self-awareness is being aware of one’s own self, having the reflection about self and recognizing oneself as a separate individual from one’s own environment and other individuals (Kalaiyarasan & Solomo, 2013). Being aware of what one is feeling is one of the fundamentals of having a healthy mental health. Feelings give rise to the thinking process which in turn determines how one will react to various situations (Kulkarni, 2022). Many mental health promotion programs have been implemented at the district and school levels to identify early mental health symptoms and their management (National Health Mission). Even so, there remains a substantial gap in understanding adolescent mental health requirements, and regrettably, things have gotten worse since the COVID- 19 outbreak (Mehra et al., 2022). There are only limited studies from India which have explored the factors contributing to emotional regulation, psychological hardiness, and self-awareness or have planned an intervention, according to those factors. By understanding the prevalence and factors associated with these variables, the study aims to develop and validate an Emotional Strength Building Intervention that can effectively support adolescents’ mental well-being. The findings from this study will inform mental health practitioners and researchers aboutthe potential benefits of incorporating such interventions into existing strategies to enhance emotional and psychological hardiness in adolescents. Furthermore, through this research, we aim to contribute to the field of adolescent mental health and provide valuable insights for researchers, practitioners, and policymakers in their efforts to promote positive well-being and adaptive functioning among adolescents.

 Objectives
PHASE I 
1. To assess the Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents.
2. To assess the relationship between Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents.
3. To explore the factors in the development of Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents. 
4. To develop and validate Emotional Strength Building intervention for adolescents.

PHASE II 
5. To determine the effectiveness of Emotional Strength Building intervention on enhancement of Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents.


Hypotheses

All the hypotheses will be tested at a 0.05 level of significance.

 

H1. There will be a significant difference between the mean pre- and post-intervention scores of Emotional Regulations between the intervention and control groups.

 

H2. There will be a significant difference between the mean pre- and post-intervention scores of Psychological Hardiness between the intervention and control groups.

 

H3. There will be a significant difference between the mean pre- and post-intervention scores of Self-Awareness between the intervention and control groups.

 

H4. There will be a significant relationship between Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents.


Research design-

 For Phase I

The research design of phase I is described in two parts.

Part I

The objective of part I is to assess Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents. A cross-sectional survey design is found to be most suitable for collecting the information.

Part II

A focus group discussion will be conducted with non-clinical adolescents, their parents and teachers to explore the factors associated with Emotional Regulation, Psychological Hardiness, and Self- Awareness among adolescents. Further, an awareness program will be planned for teacher and parents based on the findings from focus group discussion.

 

For Phase II

 To find the effectiveness of Emotional Strength Building intervention, the research design selected is pre-test post-test control group design

Research setting- English medium schools located in Udupi district, Karnataka.

Population- Adolescents attending English medium school who fulfil the inclusion criteria and are available during data collection.

Sample and Sample size

Sample- adolescents attending English medium schools studying in 8th and 9th Grades in selected schools in Udupi district, Karnataka.

Sample  Size

 

PHASE I

PHASE II

Part I

Part II

The sample size for Part I is calculated considering the following.

 

n=((Z_(1-α/2)^2 )(p)(1-p))/d^2

 

α : level of significance (5%)

d :  margin of error (3%)

p : prevalence (anticipated to be 50%)

 

Substituting the values, we have n=1068.

Incorporating a drop-out (20%), we have 1335 adolescents.

Sample size will be recomputed after the completion of a pilot study subsequent to the ethical approvals.

For Part II, the study makes use of a focus group discussion with the following stakeholders (students, parents and teachers)

Focus group research is commonly conducted with at least two focus groups for each demographic stratum in the study.

For the majority of non-commercial themes, a focus group should have five to eight people (Krueger and Casey (2015), Hennick et al., (2019)).

Sample size is computed as two sets of 8 students (8+8=16), parents (8+8=16) and teachers (8+8=16) i.e., 48 and data collection will continue until reaching sample size requirements or saturation, whichever is lesser.

The sample size for Phase II is calculated using the formula:

 n=2/δ^2  [σ_b^2+σ^2/k (1+(k-1)ρ)] [Z_((1-α/2))+ Z_((1-β)) ]^2

To determine the efficacy of a school-based intervention among the adolescent population in Udupi, the minimum sample size (per group) needed to perform a two-group (intervention and control group) repeated measures study design involving one primary outcome measured across four time points (correlation among repeated measures is 0.5) is 82 at 5% level of significance, 80% power, and an effect size of 0.25. With the drop-out rate (20%) and the design effect (1.5), we get a sample size requirement of 154, or 77 per group. Following the conclusion of a pilot study and the receipt of ethical permissions, the sample size will be recalculated.


      



























Sampling criteria

 

 

 

 

Adolescents

Parents

Teachers

 

 

 

 

 

 

 

 

 

 

Inclusion Criteria

 

 

Survey

1. Studying in 8th and 9th Grades.

2. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the

adolescent themselves.

 

 

-

 

 

-

 

 

Focus Group Discussion

1. Studying in 8th and 9th Grades.

2. Adolescents scoring >30 score for the emotional regulation scale.

3. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the adolescent themselves.

1.  Parents of adolescents attending selected English-medium schools who are currently in the 8th and 9th grades.

2. Parents of adolescents scoring >30 score for the Emotional Regulation scale.

3. Those who are willing to provide written informed consent.

1. Teachers who are teaching 8th and 9th  grade adolescents                  

2. Those who are willing to provide written informed consent.

Intervention

1. Studying in 8th and 9th Grades.

2. Those who are willing to provide written informed consent from either parent of the adolescent participant, as well as assent from the adolescent themselves.

 

 

 

 

 

-

 

 

 

 

 

-

Exclusion Criteria

Focus Group Discussion

 

 

-

 

 

-

1. Teachers whose children are studying in 8th and 9th grade in same school.
Sampling Technique
Phase 1

For part I proportionate sampling technique will be used to select the participants from each selected school from Udipi district Karnataka.

In Part II, the participants for the focus group discussion will be selected using purposive sampling techniques. Specifically, individuals with a score of >30 on the emotional regulation scale from the survey conducted in Part I will be chosen. Additionally, only those who have provided their consent to take part in the study and meet the inclusion criteria will be included in the selection process.


Phase II

 

For Phase II simple random sampling technique will be used for selecting the schools.


Development of an Emotional Strength Building Intervention

The researcher will develop an Emotional Strength Building Intervention for adolescents based on the existing literature, evidence, consultation with the experts and after analyzing the modifiable factors collected through focus group discussions separately with teachers, parents and adolescents.


Delivery of Intervention

 

The intervention will last for 5 weeks, comprising one weekly session lasting for a duration of 2 hours each, which will be conducted during regular school hours.

A post-test will be conducted 15 days after the completion of the intervention, and then 1 month and 3 months using a standard tool to measure Emotional Regulation, Psychological Hardiness, and Self-Awareness.

During the study, if any adolescents display signs of psychological distress, immediate steps will be taken to address the situation. 

The following areas will be addressed in the Emotional Strength Building intervention:

1. Communication and Interpersonal relationship

2. Understanding Emotion

3. Build Resilience and support.

4. Emotion management

5. Self-regulation strategies

Expected outcome

1. Development and implementation of the Emotional Strength Building intervention to adolescents. 

2. Emotional Strength Building intervention will improve Emotional Regulation, Psychological Hardiness, and Self-Awareness among adolescents.



 
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