| CTRI Number |
CTRI/2021/02/031172 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Kindness towards Self, Ability to manage Emotions and Growth following Trauma in Adolescents with difficult Childhood Experiences currently living under Institutional Care |
|
Scientific Title of Study
|
Self-Compassion, Emotional Intelligence and Post-Traumatic Growth in Adolescents with Adverse Childhood Experiences currently living under Institutional Care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anika Salomi |
| Designation |
MPhil Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9108488955 |
| Fax |
|
| Email |
anikasalomi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha TS |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anika Salomi |
| Designation |
MPhil Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal.
KARNATAKA
576104
India |
| Phone |
9108488955 |
| Fax |
|
| Email |
anikasalomi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anika Salomi C |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| 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 |
| Anika Salomi |
Namma Boomi |
The Concerned for Working Children Namma Bhoomi, Kanyana Post
Near Hattiangadi Cross
Kundapura, Udupi District 576230
Karnataka, India
Udupi
KARNATAKA |
9108488955
anikasalomi@gmail.com |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental and Behavioral disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents aged between 14 and 17
2. History of any form of childhood trauma (Physical abuse, sexual abuse, neglect, witnessing trauma)
3. Currently living under institutional care for at least 1 year
4. Participants who can read either Kannada or English |
|
| ExclusionCriteria |
| Details |
1. Participants with any affective disorder
2. Participants with any psychotic disorder
3. Participants with any developmental disorder
4. Participants with any physical disability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self-Compassion, Emotional Intelligence and Post-Traumatic Growth |
25th February 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
10/02/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a cross-sectional study using purposive sampling method. It is to assess if self-compassion and emotional intelligence leads to post-traumatic growth among adolescents with adverse childhood experiences. The estimated sample size is 77 and the site of sample collection will be Namma Bhoomi (An NGO in Kundapura), for a study period of 4 months. The results will be statistically analysed using multiple linear regression analysis. If self-compassion and emotional intelligence does play a role in post-traumatic growth, institutes that cater to this population can develop interventions that facilitate post traumatic growth through the variables self-compassion and emotional intelligence.
|