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