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CTRI Number  CTRI/2023/09/057508 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 02/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Looking at Post Trauma conditions and its connection to Adverse Childhood Experiences and Parent child relations 
Scientific Title of Study   The Influence of Parental Bonding, Adverse Childhood Experiences and Emotional Regulation on Post Traumatic Growth 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namya Sinha 
Designation  Postgraduate student 
Affiliation  Manipal College of Health Professionals 
Address  Department of Clinical Psychology, Manipal College of Health Professionals, Manipal University, Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  09902335321  
Fax    
Email  namya.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Samyukta Vaidyanathan 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professionals 
Address  Department of Clinical Psychology, Manipal College of Health Professionals, Manipal University, Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  8939372782  
Fax    
Email  samyukta.v@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shwetha TS 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professionals 
Address  Department of Clinical Psychology, Manipal College of Health Professionals, Manipal University, Manipal - 576104

Udupi
KARNATAKA
576104
India 
Phone  9880993080  
Fax    
Email  shwetha.ts@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professionals, MAHE, Manipal- 576104 
 
Primary Sponsor  
Name  Namya Sinha 
Address  Department of Clinical Psychology, Manipal College of Health Professionals, Manipal University, Manipal - 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 Shwetha TS  Manipal College of Health Professionals  Department of Clinical Psychology, Manipal College of Health Professionals, Manipal University, Manipal - 576104
Udupi
KARNATAKA 		 9880993080

shwetha.ts@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  No health conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  • The participants must be between the ages 18 to 30 years of age.
• Participants must have a score of at least 1 on the Adverse Childhood Experiences Questionnaire.
• The participants must be of Indian origin.
• The participants must have a good English reading ability.
 
 
ExclusionCriteria 
Details  • The participants who have been brought up by a single parent.
• Participants with a prior and severe past psychiatric history should be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Moderating effect of Parental bonding & emotional regulation on the relationship between Adverse Childhood Experiences & Post traumatic growth   8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. The effect of Adverse childhood experiences on Post traumatic growth
2. Moderating effect of Parental bonding on adverse childhood experiences & post traumatic growth
3. Moderating effect of emotional regulation on adverse childhood experiences & post traumatic growth 		 8 weeks 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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)   01/10/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Aim:
To explore Post traumatic growth in relation to differences in Parent adult-child relationships, Adverse Childhood relationships and emotional regulation.

Objectives:

  1. To understand the relationship between Post traumatic growth with Adverse Childhood experiences and Parental bonding.

  2. To find out the relationship between Post traumatic growth and Emotional regulation

 
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