| CTRI Number |
CTRI/2025/02/080407 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Phenomenon of Self Injurious Behavior in Teenagers. |
|
Scientific Title of Study
|
Phenomenon of Self Harm in Teenagers with and without Attention Deficit Hyperactivity Disorder(ADHD) : A Cross Sectional Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Neslin Merin Ealias |
| Designation |
PG student |
| Affiliation |
ST.JOHNS MEDICAL COLLEGE HOSPITAL |
| Address |
Department of Psychiatry
St. Johns Medical College Hospital, Bangalore,560034
NIL
Bangalore
KARNATAKA
560034
India |
| Phone |
7559952578 |
| Fax |
- |
| Email |
neslinme@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Priya Sreedaran |
| Designation |
Professor |
| Affiliation |
Karnataka medical council |
| Address |
Dr. Priya Sreedaran
C/o Department of Psychiatry,
St. John’s Medical College and Hospital
Bangalore
Dr. Priya Sreedaran
C/o Department of Psychiatry,
St. John’s Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9916043454 |
| Fax |
- |
| Email |
drpriyasreedaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NESLIN MERIN EALIAS |
| Designation |
POST GRADUATE |
| Affiliation |
ST.JOHNS MEDICAL COLLEGE HOSPITAL |
| Address |
C/O DEPARTMENT OF PSYCHIATRY
ST.JOHN,S MEDICAL COLLEGE HOSPITAL
BANGLORE -560034
NIL
Bangalore
KARNATAKA
560034
India |
| Phone |
7559952578 |
| Fax |
- |
| Email |
neslinme@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical College, Sarjapur, John Nagar, Kormangala, Bengaluru, Karnataka 560034 |
|
|
Primary Sponsor
|
| Name |
Department Of Psychiatry |
| Address |
St Johns Medical College and Hospital Sarjapur Road Koramangala, Bengaluru,560034 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Neslin Merin Ealias |
St. Johns Medical College Hospital. |
Department of Psychiatry, St Johns Medical College and Hospital Sarjapur Road Koramangala, Bengaluru,560034
Bangalore
KARNATAKA |
07009486397
-
neslinme@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,SJMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, (2) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Teenagers in the age group of 13-19 yr of age.
Teenagers with history of self harm from the age of 12 yrs
|
|
| ExclusionCriteria |
| Details |
Teenagers with life time clinically diagnosed neurodevelopment disorder(autism spectrum disorder, intellectual disability, cerebral palsy).
Teenagers with life time clinically diagnosis of psychotic disorders.
Teenagers with substance use disorders currently in dependence pattern of use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Attention Deficit Hyperactivity Disorder in Teenagers with Self Harm Behavior. |
End of data collection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing Phenomenology Of Self Harm Behavior in Teenagers with & without Attention Deficit Hyperactivity Disorder. |
End of Data Collection |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/02/2025 |
| 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="2"
Months="0"
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 is a Cross Sectional Study which is being planned to be done in Adolescent age group who present with Self Harm Behavior. The Objective of study is to know the Prevalence of Attention Deficit Hyperactivity Disorder in Teenagers with Self Harm Behavior and to compare the Phenomenology of Self harm in between those with and without Attention Deficit Hyperactivity Disorder. |