| CTRI Number |
CTRI/2023/09/057823 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Negative experiences in childhood and attachments styles on decision to have children among married individuals |
|
Scientific Title of Study
|
The influence of adverse childhood experiences and attachment styles on decision to have children among married individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharshini G |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department of Clinical Psychology Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9585998717 |
| Fax |
|
| Email |
dharshini1.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Marina Rasquinha |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department of Clinical Psychology Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9980057079 |
| Fax |
|
| Email |
deepa.rasquinha@learnermanipal.onmicrosoft.com |
|
Details of Contact Person
Public Query
|
| Name |
DharshiniG |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department of Clinical Psychology Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9585998717 |
| Fax |
|
| Email |
dharshini1.mchpmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Dharshini G |
| Address |
Department of Clinical Psychology Manipal College of Health
Professions, Manipal Academy of Higher Education, Manipa |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dharshini G |
Kasturba Medical College, Manipal |
Department of Clinical
Psychology Manipal
College of Health
Professions, Manipal
Academy of Higher
Education, Manipal
Udupi
KARNATAKA
Udupi
KARNATAKA |
9585998717
dharshini1.mchpmpl2022@learner.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 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants between the ages 21 to 45 years who are married and are married for at
least 3 years and are currently residing in India are eligible to participate in the study |
|
| ExclusionCriteria |
| Details |
Individuals who have major psychiatric problems and same-sex couples are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adverse Childhood Experiences
Attachment styles |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will find out if adverse childhood experiences and attachment styles will have an effect on the decision to have children |
7 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
30/09/2023 |
| 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="7"
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
|
This study explores the role of adverse childhood experiences and adult attachments in the decision to have children. The scales used in this study are the Adverse Childhood Experiences short form scale and Experiences in Close Relationships scale. The sociodemographic details of the participants will be taken, and they will be screened according to the inclusion/exclusion criteria. StataSE 16 will be used for the statistical analysis of data. |