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CTRI Number  CTRI/2024/09/074473 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emotional experiences of First-time Fathers during the Initial period of Childbirth  
Scientific Title of Study   The First Steps: Exploring the Emotional Terrain of First-time Fathers during Infancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharanya Chatterjee 
Designation  M.Sc Clinical Psychology student 
Affiliation  Manipal College of Health Professions  
Address  Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Madhav Nagar, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  6289854403  
Fax    
Email  sharanya1.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Samyukta Vaidyanathan 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions  
Address  Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Madhav Nagar, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8939372782  
Fax    
Email  samyukta.v@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Priyesh C 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions  
Address  Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Madhav Nagar, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9538752702  
Fax    
Email  c.priyesh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Karnataka 576104, India. 
 
Primary Sponsor  
Name  Sharanya Chatterjee 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Karnataka 576104 
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 Meha Sharma  Manipal College of Health Professions, MAHE.   Room number 2 Clinical Psychology, Department of Clinical Psychology, Manipal Academy of Higher Education, Madhav Nagar, Karnataka 576104
Udupi
KARNATAKA 		 7976694670

meha.sharma@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-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals without any diagnosed mental health condition. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  i. First-time fathers between the age range of 25-45 years who are experiencing fatherhood for the first time.
ii. Husbands of women who have given birth for the first time (primiparous women).
iii. Fathers who are living with the baby and the baby’s mother during the time of the study.
iv. Have an apparently well infant, born full-term (37 weeks of gestation) and with birth weight of 2500g and above.
v. Have a child of 1 year and under.
vi. Who are open and willing to discuss their emotional experiences, perceptions, and challenges related to their mental health throughout pregnancy and childbirth.
vii. Who read, write and speak English.
viii. Have access to online platforms.
 
 
ExclusionCriteria 
Details  i. Stepfathers.
ii. Who have severe mental illnesses.
iii. Fathers who are divorced or separated.
iv. Fathers who have children with malignancy, autoimmune disabilities or severe chronic physical illness.
v. Fathers who have babies with congenital anomalies detected in the antenatal scan.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Since it a qualitative study, the sample size will be taken till data saturation.
2. ⁠The outcome of the study is to explore the diverse emotional experiences and perspectives of first time fathers during infancy.
3. ⁠Implications of the study would be inclusion of first- time fathers from diverse cultural experiences, assess the need for mental health evaluations, influence family-related policies, and promote holistic support for both parents.
 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   30/09/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   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   This qualitative study delves into the experiences of first-time fathers during infancy through in-depth semi-structured interviews.Over the course of a year, the research will be conducted, focusing on identifying barriers to support, preferred types of support, the influence of gender roles on mental health, and positive experiences during early fatherhood. Participants, first-time fathers who have a child of 1 year and above, and aged 25-45, living with their baby and partner, will be selected through purposive sampling from KMC, Manipal, and via social media. Data analysis will employ thematic analysis following Braun and Clarke’s method, allowing for the identification of key themes and sub-themes. Necessary approvals will be obtained, ensuring confidentiality, offering mental health referrals, and securely managing audio recordings. 
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