Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm - a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 7
- 主要终点
- Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month
研究概览
简要总结
The study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (psychiatric and psychosocial treatments) has an effect on suicidal ideation and treatment compliance among post-discharge self-harm young adults.
详细描述
The proposed study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (TAU; psychiatric and psychosocial treatments) is effective in reducing suicidal ideation, enhancing treatment compliance, reducing thwarted belongingness and perceived burdensomeness and hopelessness among post-discharge self-harm young adults, and if personalized contact by volunteers has additional effects reducing suicidal ideation among post-discharge self-harm individuals.
108 participants aged 18-45 with an index self-harm episode will be recruited from the Accident & Emergency Department (AED) of 4 local public hospitals, and randomized into the TAU, mobile app group with, and without volunteer support. Each participant will complete a questionnaire at the 4 measurement time points at baseline (T0), one-month (T1) and the end of the 2-month intervention period (T2), and post-intervention at the three-month point (T3) from the baseline. The primary outcomes include Suicidal ideation, hopelessness, thwarted belongingness & perceived burdensomeness, treatment (TAU) compliance, and suicidality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with an index episode of self-poisoning or self-injury with or without suicide intent, based on the ICD-10 codes for self-harm with and without suicide intent (i.e., X60 to X84 and R45.8)
- •Admission to the AEDs at the 4 collaborating public hospitals in Hong Kong (United Christian Hospital, North District Hospital, Queen Mary Hospital, and Pamela Youde Nethersole Eastern Hospital)
- •Mentally well assessed by a psychiatrist or Consultation Liaison Nurses (CLNs)
- •Capable of providing written Informed Consent Form
排除标准
- •Individuals with DSM-IV-TR Axis II disorder; or
- •Individuals with severe psychotic mental illness or bipolar disorder
结局指标
主要结局
Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month
时间窗: Baseline, 1 month, 2 months, 3 months
Change in scores on Hopelessness as measured by a self-report 4-item short-form of Beck Hopelessness Scale Chinese version (BHS-4) (Beck, Weissman, Lester, \& Trexler, 1974; Yip \& Cheung, 2006; Shek, 1993).
Change from baseline Service Utilization at 1-month, 2-month and 3-month
时间窗: Baseline, 1 month, 2 months, 3 months
Self-reported compliance with prescribed treatment (frequency) in relation to the index self-harm episode, including psychiatric follow-up care (e.g., medication, out-patient follow-up treatment, and community psychiatric nursing service) and psycho-social services (e.g., clinical psychology service, medical social work service, etc.) as measured by a self-developed service utilization checklist.
Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month
时间窗: Baseline, 1 month, 2 months, 3 months
Change in scores on Suicidal ideation as measured by the self-report the Adult Suicidal Ideation Questionnaire - the four-item short form in Chinese (ASIQ-4) (Fu, Liu, \& Yip, 2007)
Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month
时间窗: Baseline, 1 month, 2 months, 3 months
Change in scores on Thwarted Belongingness (TB) and Perceived Burdensomeness (PB) as measured by the Interpersonal Needs Questionnaire (INQ-15), a 15-item measure of beliefs about whether one's need to belong is met or unmet and self-perceptions of being a burden to others (Van Orden, 2012).
Change from baseline Suicidality at 1-month, 2-month and 3-month
时间窗: Baseline, 1 month, 2 months, 3 months
Suicidality as measured by a four-item scale for levels of suicidality in the past 12 months (Centre for Suicide Research and Prevention, The University of Hong Kong, 2005)
次要结局
- Change from baseline suicide deaths at 1-month, 2-month and 3-month(Baseline, 1 month, 2 months, 3 months)
- Final and Monthly Qualitative Description on participants' progress(up to 3 months)
- Demographic and socioeconomic information(Baseline)
- Change from baseline Depressive state at 1-month, 2-month and 3-month(Baseline, 1 month, 2 months, 3 months)
- Change of time spent on each programme activity of the app at 1-months, 2-months(From Baseline to 2 months)
- Change from baseline Self-harming repetition at 1-month, 2-month and 3-month(Baseline, 1 month, 2 months, 3 months)
- Change of baseline index self-harm episode(Baseline, 1 month, 2 months, 3 months)
- Change of time spent and type of contact made by volunteers with participants at 1-months, 2-months(1-month, 2-months)
研究者
Dr.Yik-Wa Law
Associate Professor
The University of Hong Kong