跳至主要内容
临床试验/CTRI/2025/07/091941
CTRI/2025/07/091941尚未招募不适用

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

Abel Dani Johnson1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Identification of key suicide risk factors, protective factors, and facilitation of risk stratification among patients admitted following a suicide attempt.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients admitted following a suicide attempt.
  • 2.Patients who are willing to provide informed consent to participate in the study.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 3 months

次要结局

  • 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)

研究者

发起方
Abel Dani Johnson
申办方类型
Other [Self Sponsored]
责任方
Principal Investigator
主要研究者

Abel Dani Johnson

Kasturba Medical College, Manipal

研究点 (1)

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