CTRI

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CTRI Number

CTRI/2025/07/091941 [Registered on: 29/07/2025] Trial Registered Prospectively

Last Modified On:

28/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

Assessing suicide risk in hospital patients admitted after a suicide attempt using a new screening tool.

Scientific Title of Study

Development and pilot testing of a suicide risk assessment proforma for patients admitted in a hospital setting.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Abel Dani Johnson
Designation	M Phil Postgraduate Trainee
Affiliation	Kasturba Medical College, Manipal
Address	Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone	9048442600
Fax
Email	abel.kmcmpl2023@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Soyuz John
Designation	Associate Professor
Affiliation	Kasturba Medical College, Manipal
Address	Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone	8867604011
Fax
Email	Soyuz.john@manipal.edu

Details of Contact Person
Public Query

Name	Dr Soyuz John
Designation	Associate Professor
Affiliation	Kasturba Medical College, Manipal
Address	Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone	8867604011
Fax
Email	Soyuz.john@manipal.edu

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Abel Dani Johnson
Address	Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104
Type of Sponsor	Other [Self Sponsored]

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 Soyuz John	Kasturba Medical College, Manipal	Room no 33, Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 Udupi KARNATAKA	8867604011 Soyuz.john@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
Patients	(1) ICD-10 Condition: X838\|\|Intentional self-harm by other specified means,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients admitted following a suicide attempt. 2.Patients who are willing to provide informed consent to participate in the study.

ExclusionCriteria

Details

1.Participants who are unwilling or unable to provide informed consent for participation.
2.Participants with severe physical conditions that preclude their ability to participate in the study or complete the assessment procedures.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Identification of key suicide risk factors, protective factors, and facilitation of risk stratification among patients admitted following a suicide attempt.	3 months

Secondary Outcome

Outcome	TimePoints
Evaluation of the effectiveness and clinical utility of the suicide risk assessment proforma over time through follow-up reassessment to determine whether participants have reattempted suicide or engaged in intentional self-harm.	6 months follow up

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

09/08/2025

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 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

1.Objectives of Phase I

To develop a suicide risk assessment proforma for patients admitted in a hospital setting.

To pilot test the suicide risk assessment measurements among patients admitted with a suicide attempt.

Objectives of Phase II

To follow up patients with a suicide attempt to assess the status of any further suicide attempts and compare with the baseline risk level.

2. Phase I

Step 1 Domain Identification

Conduct a comprehensive review of existing literature on suicide risk assessments.

List common risk and protective factors of suicide at individual, family, and societal levels.

Develop conceptual definitions of the domains based on an a priori framework.

Step 2 Item Generation and Evaluation

Use a deductive method, also known as logical partitioning or classification from above.

Identify and describe relevant domains and items through literature review and assessment of existing scales and proformas.

References will include the Risk Assessment Form of the Department of Psychiatry, KMC Manipal and Columbia Suicide Severity Rating Scale Baseline Version

Items will be evaluated by a panel of 3 experts from Psychiatry, Psychiatric Social Work, and Psychology.

Each item will be assessed for appropriateness, accuracy, and interpretability.

Items will be accepted, rejected, or modified based on majority opinion.

Step 3 Pretesting the Proforma

Conduct 5 to 15 interviews with patients admitted after a suicide attempt, selected from Consultation Liaison Psychiatry services.

Include participants from diverse demographic backgrounds.

Pretesting ensures

Questions produce the intended data.

Confusing or problematic questions are identified and improved.

Response options are appropriate and adequate.

3. Study Population

Patients admitted to KMC Manipal following a suicide attempt.

4. Sample and Sampling

Sixty patients admitted over a period of three months.

Convenient sampling method will be used.

5. Sources of Sample

Psychiatry Department

Consultation Liaison Psychiatry referrals

Emergency Department register of KMC Hospital

6. Tools of Data Collection

Suicide Risk Assessment Proforma developed in the current study

Columbia Suicide Severity Rating Scale Baseline Version

7. Statistical Analysis

Descriptive statistics will be used.

Assessment findings of both tools will be compared.

8. Phase II: Telephonic Follow-up

All patients who participated in the final administration of the proforma will be contacted via phone.

Participants will be asked about the occurrence of any further suicide attempt after discharge.

Contact details of patients and family members will be collected during the initial assessment.

Consent for telephonic follow-up will be obtained at the time of initial assessment.

9.Ethical Considerations

Approval will be obtained from the Department Scientific Committee.

Ethical clearance will be taken from the Institutional Ethics Committee.

Participants will be informed about the aim of the study.

Written consent will be obtained from all participants.

Consent for telephonic follow-up will also be collected.