Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Participant recruitment
研究概览
简要总结
Suicide is a major public health issue. Repeated self-harm may lead to potential future suicide deaths. In addition, it may lead to substantial loss in medical costs. Recently, smartphones have been widely used. Researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. However, the research evidence remains sparse. Furthermore, self-harm behaviors might be influenced by different cultural contexts. There is a need to conduct local studies in Taiwan. The aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (BCI) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.
详细描述
Study objectives:
- To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention.
- To evaluate the feasibility of BCI, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the BCI.
Methods:
- In study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the BCI. We will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team.
- In study 2, we will recruit 30 participants who have self-harm experiences to participate in the BCI. The BCI will be delivered through texts and web pages and will last around 5 months. The content of BCI will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. We will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (BSRS), and mental well-being scale) before and after receiving the BCI. We will collect the participants' feedback regarding the BCI and evaluate the required resources to further revise the BCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years or over
- •Mentally and physically stable and able to participate in individual interviews and interventions
- •Able to communicate in Mandarin and provide written informed consent
- •Willing to be recorded during the interviews
- •Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts.
- •Able to use the smartphone to access the internet
排除标准
- •Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.
研究组 & 干预措施
BCI group
Participants will be asked to participate in a brief contact intervention and to evaluate its feasibility, including the feasibility of recruitment, intervention resources, the appropriateness of data collection, and the acceptance of the intervention.
干预措施: Brief contact intervention (Behavioral)
结局指标
主要结局
Participant recruitment
时间窗: through study completion, an average of 1 year
Recruitment: the proportion of participants who are eligible and invited actually consent to participate.
Participant retention rate
时间窗: 6 month
The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.
Number of repeated self-harm episodes (self-report)
时间窗: 6 month
Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.
Number of repeated self-harm episodes (nationwide self-harm registry)
时间窗: 6 month
Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry
The acceptability of the intervention to participants
时间窗: within 3 months of study completion
The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst participants.
The feasibility of intervention to participants
时间窗: within 3 months of study completion
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.
Participant recruitment
时间窗: through study completion, an average of 1 year
Recruitment: the proportion of participants who are eligible and invited actually consent to participate.
Participant retention rate
时间窗: 6 month
The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.
Number of repeated self-harm episodes (self-report)
时间窗: 6 month
Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.
Number of repeated self-harm episodes (nationwide self-harm registry)
时间窗: 6 month
Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry
Participant retention rate
时间窗: 3 month
The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.
Number of repeated self-harm episodes (self-report)
时间窗: 3 month
Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.
Number of repeated self-harm episodes (nationwide self-harm registry)
时间窗: 3 month
Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry
次要结局
- Self-Efficacy to Avoid Suicidal Action (SEASA)(From enrollment to 3 months and 6 months)
- Help-seeking behavior questionnaire(From enrollment to 3 months and 6 months)
- Brief Symptom Rating Scale (BSRS)(From enrollment to 3 months and 6 months)
- The World Health Organisation- Five Well-Being Index (WHO-5)(From enrollment to 3 months and 6 months)