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临床试验/CTRI/2024/08/072474
CTRI/2024/08/072474尚未招募不适用

Self-Harm in Transitional Age Youth (TAY): Development and Validation of an Assessment Tool and Randomised Feasibility Trial of a Trauma-Focused CBT Intervention Module

University Grants Commission1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Frequency and severity of self harm

研究概览

简要总结

AIM: The aim of the study is to develop and validate a self-harm assessment tool and test feasibility of a Trauma-Focused CBT intervention module for Transitional Age Youth (TAY).

 OBJECTIVES:

Objective 1: To develop and validate a new self-harm assessment tool for TAY.

Objective 2: To modify Trauma-Focused CBT intervention module for TAY.

Objective 3: To assess the feasibility of the modified Trauma-Focused CBT intervention module in TAY.

Objective 4: To compare the experimental and the control group on outcome variables immediately after intervention.

 RATIONALE FOR STUDY:

Self-harm is a transdiagnostic problem that is prevalent in late adolescents and young adults. Late adolescence to young adulthood or transitional age youth (TAY) is a period of transition from a child to an adult. This time period has a significant impact on the individual. Problems during this time period increases the risk of psychopathology later in life like depression, anxiety, relationship problems, and occupational difficulties. Self-harm has strong links to trauma as evidenced by theory. The lack of research in India as well as Asia pertaining to self-harm makes it crucial to address this global health crisis. Majority of the tools for assessment have limited evidence for psychometric properties and are not based on the DSM-5 criteria. No tool has been developed or validated in India or translated to Hindi.

 SAMPLING:

Purposive sampling will be used for samples for scale development and validation. A list of potential patients will be prepared and a systematic random sampling will be done to recruit patients for the intervention. The sample will be taken from Psychiatry OPD, AIIMS, New Delhi.

研究设计

研究类型
Interventional

入排标准

年龄范围
16.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed case of specific mental illness including EUPD, Depression, Anxiety, PTSD, Adjustment disorder
  • History of experience of at least one trauma incident
  • History of self-harm- 5 incidents within last one year
  • Psychotherapy naïve
  • On/Off medication.

排除标准

  • Known case of physical, neurological, or mental disability
  • Diagnosed case of severe mental illness including BPAD, OCD, Psychosis, MBD due to substance use in dependent pattern, neurodevelopmental disorders (ID, ASD, ADHD)
  • History of suicide attempt or para-suicide attempt in past one year
  • Unable to understand Hindi or English
  • Not consenting.

结局指标

主要结局

Frequency and severity of self harm

时间窗: Baseline and post intervention (6-8 weeks after baseline assessment)

次要结局

  • Impulsivity, emotional regulation, depression, anxiety, stress, childhood trauma, resilience, peer relationships, emotional intelligence, family functioning(baseline & post intervention (6-8 weeks after baseline assessment))

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Akanksha Yadav

All India Institute of Medical Sciences (AIIMS), New Delhi

研究点 (1)

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