Networked-Based Recovery With User Involvement for Young People With Mental Illness: A Nonrandomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Mental health status.
研究概览
简要总结
Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety and depression. Overall, mental health problems represent the greatest health burden among adolescents. This means that many young people have difficulties in meeting demands, and challenges in education and employment. Thus, it is estimated that up to 60% dropout in education is due to mental health problems. Therefore, an educational, well-coordinated and early intervention is needed to support the young person's recovery process by activating the young person's social network.
Methods Study design The project is designed as a non-randomized intervention study with a control group. Comparative analyzes will be performed with pre- and post-assessments, as outlined in Figure 1. The study involves a regional hospital in mental health and five municipalities. The trial takes place from January 2020 to December 2022.
Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group that will form the basis of real user involvement.
Study population The participants are young adults aged 18 - 30 years with experiences as an inpatient.
Procedure for recruitment Questionnaires administered to the patients within the first 48 hours after admission, at discharge, 1 month after discharge and 3 months after discharge (Figure 1). Patients who did not consent to participation or failed to complete the questionnaire at the beginning of their stay were excluded from the study, as were those hospitalized for less than a week.
Ethics Information of participants and data management is in accordance with the Helsinki Declaration. The project is reported to the Danish Data Protection Agency and the Region Zealand Ethics Committee. Data are entered into the EasyTrial © Online Clinical Trial Management system. All personal identifiers will be removed or disguised during analysis to preclude personal identification.
详细描述
Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety and depression. Overall, mental health problems represent the greatest health burden among adolescents. This means that many young people have difficulties in meeting demands, and challenges in education and employment. Thus, it is estimated that up to 60% dropout in education is due to mental health problems. Therefore, an educational, well-coordinated and early intervention is needed to support the young person's recovery process by activating the young person's social network.
In 1996, a group of US researchers and practitioners initiated an educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties. The primary goal of RENEW is to enhance young people's well-being through social inclusion and education, focusing on building young people's own capacities by supporting them in utilizing their existing social networks and adding new contacts in their path towards education and work. This support model has shown positive results with young people, where in particular their educational attainment and self-reported level of function have been improved. In 2013, the Psychiatric Center in Ballerup (Denmark) and the University of New Hampshire (USA) established a collaboration to investigate whether RENEW could be implemented in a Danish psychiatric setting, and achieve positive results as well. Young people with mental health difficulties have expressed lack of coherence in their pathways, which may result that the young people's problems are not dealt with in a timely manner, so that their problems worsen. It also means, there is a high risk that they will abandon education and become increasingly ill. New research by Tew et al also suggests that the network may have a greater impact than conventional treatment for young people with mental disorders. Thus, the Psychiatric Center in Ballerup wanted to create a greater degree of cohesion for the young people in their pathways across services through stronger cross-sectoral and team-based collaboration.
The Psychiatric Center Ballerup model has primarily focused on young outpatients and in municipal context. However, since the young inpatients usually have a greater need for support both in terms of their mental state, but also in relation to educational support and to support the young person's social network. Consequently, an improved intervention is needed to target this group: In order to prevent the development and aggravation of mental illness, there is a need for early intervention, recovery and inclusion of people with mental illness in education, work and everyday life. This project is based on the RENEW model and rooted in Psychiatry in Slagelse: RENEW-S. There is also a great desire for a high degree of user involvement in the project, partly for the purpose of learning for all parties involved, and partly to strengthen implementation. Involving users in the research project will enhance our understanding of young adults' perspectives in relation to the young person's hospitalization, social network, own resources and network based recovery. However, there is a lack of stakeholder involvement in this type of research. Co-operative inquiry is a research method that involves stakeholders such as service users and health professionals, as co-researchers. In co-operative inquiry, the production of knowledge is a joint venture among stakeholders and researchers who work together to create relevant and practice-oriented knowledge by means of the three following research steps: preparation, intervention and study outcomes assessment. The purpose of the project is to develop a network-based approach to the young inpatients with mental illness aged 18-30 years in order to strengthen the young person's social network and own resources using the RENEW model so that the young person achieves a higher degree of recovery, as well as education and employment.
Methods and analysis The research steps The research are involving the three steps: preparation, intervention and study outcomes assessment (see Table 1 for the timetable and tasks in relation to the research steps): A systematic review and focus interviews of young adults with mental illness together with health professionals are planned to inform the intervention. The preparation step regarding the systematic review is further explained in the Prospero protocol (ID: 151202). Likewise, further details concerning the planning and preparing of the focus group interviews are planned to be published as a study protocol in a qualitative journal.
Study design The project is designed as a non-randomized intervention study with a control group. Comparative analyzes will be performed with pre- and post-assessments, as outlined in Figure 1. The study involves a regional hospital in mental health and five municipalities. The trial takes place from January 2020 to December 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults aged 18 - 30 years
- •Diagnosed with a mental disorder
- •Have experienced hospitalization
排除标准
- •Cognitive deficit
- •Patients who did not consent to participation
- •Hospitalized for less than a week
研究组 & 干预措施
Intervention: RENEW in a psychiatric ward
Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group that will form the basis of real user involvement.
干预措施: An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties. (Other)
Conventional clinical practice in a psychiatric standard ward
The comparison group patients were admitted to a standard psychiatric ward that offered conventional care.
结局指标
主要结局
Change in Mental health status.
时间窗: At baseline and after 4 months.
Mental health status is valid and reliable indicator of the patients self-reported mentale state and well-being. Mental status is assessed using the standardized Short Form Health Survey (SF-36). Scores range from 0 (zero) to 100, with higher scores indicating better health.
次要结局
- Change in Level of function.(At baseline and after 4 months.)
- Change in Patient satisfaction.(At baseline and after 4 months.)
- Change in Recovery.(At baseline and after 4 months.)
