| CTRI Number |
CTRI/2025/07/092008 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Psychosocial interventions for prevention of self-harm and suicide among transpersons |
|
Scientific Title of Study
|
Self-harm and suicidal behaviour focused
psychosocial interventions among homeless transpersons- A feasibility 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 |
Sinu Jesin Timothy |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room no. 108, 1st floor, Department of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS CAMPUS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
08147085098 |
| Fax |
|
| Email |
sinujesintimothy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Janaki Raman |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room no. 110, 1st floor, Department of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS CAMPUS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
janakitrichy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sinu Jesin Timothy |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room no. 108, 1st floor, Department of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS CAMPUS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
08147085098 |
| Fax |
|
| Email |
sinujesintimothy@gmail.com |
|
|
Source of Monetary or Material Support
|
| UGC-JRF (University Grants Commission - Junior Research Fellowship) |
|
|
Primary Sponsor
|
| Name |
UGC-JRF |
| Address |
University Grants Commission (UGC)
Bahadur Shah Zafar Marg,
New Delhi - 110002.
011-23604127, 011-23604200 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| K Janaki Raman |
National Institute of Mental Health and Neurosciences |
Dr. MV Govindaswamy building
NIMHANS CAMPUS, Hosur road
Bangalore
KARNATAKA |
8903511045
janakitrichy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (NIMHANS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
General population of transgender individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioural interventions |
Psychosocial interventions focused on self-harm and suicide prevention.
The intervention will be administered in groups, utilising a manual developed by the researcher, with a specific focus on the outcome variables. The intervention will be for 20 hours for each group. |
| Comparator Agent |
Not applicable |
There is no control group in the study. Although the improvement in suicidal behaviour among the experimental group can be compared with genderal population |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male to female transpersons
Transpersons who belongs to the age group 20-45years
Transpersons receiving service from NGOs or community organisations working in Urban Bengaluru.
Transperson living without family support for a period not less than 6 months.
Transpersons who can speak Malayalam, Hindi, Tamil, Kannada, English.
|
|
| ExclusionCriteria |
| Details |
Female to male transpersons
Transperson individuals who are living with the support of the family
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced self-harm and suicidal behaviour |
pre and post intervention and after 1 month followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased stress management skills and coping skills |
pre and post intervention and after 1 month followup |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sinujesintimothy@gmail.com].
- For how long will this data be available start date provided 30-12-2025 and end date provided 31-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study adopts an exploratory sequential mixed method design to examine the psychosocial issues contributing to self-harm and suicidal behaviors among homeless transpersons. It also aims to understand their expectations regarding support services. The study will explore the mediating role of depression in self-harm and suicidal behaviors. A psychosocial intervention module will be developed, validated, and tested for use in clinical practice. The main aim is to develop and test the feasibility of focused psychosocial interventions to reduce self-harm and suicidal behaviors in this population. The research will be conducted in three phases. Phase I involves qualitative research using focus group discussions with experts and key informant interviews to assess the needs and guide the development of the intervention. Phase II focuses on developing a psychosocial intervention module based on findings from Phase I, which will then be validated by experts. Phase III involves a quasi-experimental pre-post design without a control group to evaluate the effectiveness of the intervention. Assessments will be conducted before the intervention, immediately after, and at a three-month follow-up. Hypotheses: -
H1: Focused psychosocial interventions will reduce self-harm, suicidal behavior, and stress levels. -
H2: Focused psychosocial interventions will enhance coping and resilience. |