Peer to Community (P2C) Model for Supporting Community Integration Following Homelessness: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Community Integration
研究概览
简要总结
This study has been designed to conduct a pilot evaluation of a novel model of support aimed at promoting community integration (CI) following homelessness. This model is called the Peer to Community Model (P2C). The P2C model is an outreach peer support model aimed at facilitating CI for individuals living with concurrent disorders following homelessness. This approach uses relationship-building and engagement in meaningful activity facilitated by peer support specialists (PSS) in concert with occupational therapy (OT) and social work (SW) consultation. This model includes four distinct components: 1) peer support delivered in a community space dedicated to the program or community locations at a maximum ratio of 10:1; 2) OT and SW offering consultation to PSSs and service users; 3) a weekly support meeting for PSSs, OT and SW aimed at providing a venue for problem-solving through complex cases and providing mutual emotional support in the context of service delivery with a complex population; and 4) opportunities for social enterprise (developing ideas for income generation) within the community space.
***NOTE: This is a single model of support that includes the components identified above - these are not separate interventions, but various components of one intervention designed in previous research by the study team.
In this clinical trial, the investigators will implement the P2C model for the first time. The study team will conduct a pilot study using an open randomized controlled trial, crossover design. A total of 20 participants will be assigned randomly to the intervention group, where they will receive P2C supports at baseline, and 20 participants will be assigned to a waitlist condition for six months, after which time, they will be offered the P2C intervention. Participants will be interviewed at baseline and every three months using mixed (qualitative and quantitative) interviews. Waitlisted participants will be interviewed during these same intervals using the same interview protocols, and while waiting, will receive care as usual.
详细描述
The investigators will conduct an open randomized controlled trial to pilot and evaluate the P2C model. The purpose of this pilot is to not only pilot the P2C intervention to determine the feasibility, acceptability, and initial effectiveness of the model, but also to pilot the study design to inform future, larger scale, implementation science research. While the study team will enter this pilot with the intention to complete a randomized controlled trial design, they will use a quasi-experimental design should the participants decline randomization. At the end of the trial, the study team will use the knowledge generated to inform refinements to the P2C model for future implementation science research.
Baseline data collection: Once all participants have been referred, research assistants will be provided with the names and contact information of potential participants. Research assistants will conduct interviews in person and read all interview components aloud to overcome threats to validity and reliability associated with illiteracy. These interviews will be composed of demographic elements (age, gender, sexual orientation, race, ethnicity, months housed/unhoused in the past year, health conditions, income), and a range of standardized measures that correspond with key constructs including community integration (primary outcome), meaningful activity engagement, mental well-being and substance use. Research assistants will use a visual stimulus when delivering these measures to reduce respondent fatigue. The team has used this strategy with a high degree of success in previous research when a large number of items is presented to individuals living with mental illness, substance use, or concurrent disorders and experiences of homelessness.
Qualitative interviews: In addition to demographic and quantitative items, the study team will deliver a baseline qualitative interview with participants in both UC and P2C groups to uncover participants' experiences of CI in the past and present. Interviews will be semi-structured, recorded on a digital recording device, and transcribed verbatim.
Recruitment, group assignment, and sample size estimation: The investigators will recruit participants through advertisements placed in the common areas of shelters, housing case management programs, and health care services in the recruitment city (Kingston, Ontario, Canada). The study team will also engage service providers in these organizations in our recruitment process by asking them to share information about this research with service users. Participants will be enrolled over a one-month period and will be included if they are: over the age of 16; have secured a tenancy within the last three months or are in the midst of moving into a tenancy; have experienced homelessness for at least one month in the past year; and acknowledge living with a mental illness and/or substance use disorder. The study team will assign participants to one of two groups: 1) usual care (UC); and 2) P2C. The UC group will receive typical services available in the community. The P2C group will be engaged in the P2C model in addition to any other supports available in their community. Participants will be assigned to groups that have been carefully matched based on gender, age, health condition, number of months of housed/unhoused in the past year, and income. The investigators will enroll 20 participants in each group (n=40 total). This sample size has been determined by modelling after sample sizes recommended for pilot research, with an attrition estimate of 15% [51].
Implementation: Once baseline interviews have been completed and participants have been assigned to P2C or UC groups, program staff will implement the P2C intervention with the P2C group. PSSs will be provided with the names and contact information for all participants in this group and will initiate the process of making contact with each within the first week to ensure that service for all participants begins at the same time. PSSs will initiate the development of relationships with each participant, while OT and SW at each site will ensure their availability for two days per week each for consultation. PSSs will meet with participants in the P2C group in community locations at least once per week. PSSs, OT and SW at each site will meet weekly for personal and professional support meetings as described in the overview of the P2C intervention in this proposal. The intervention and associated data collection will continue for a one-year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over the age of 16;
- •have secured a tenancy within the last three months or are in the midst of moving into a tenancy following homelessness
- •have experienced homelessness for at least one month in the past year
- •acknowledge living with a mental illness and/or substance use difficulty
排除标准
- •under the age of 16
- •have not experienced homelessness for at least one month in the past year
- •do not acknowledge living with a mental illness and/or substance use difficulty
- •do not have the cognitive capacity to participate in interviews or consent to participation
结局指标
主要结局
Change in Community Integration
时间窗: Participants will be interviewed at baseline, at three months, six months, nine months, and 12-months over the one year trial
Assessed using the following measures: UCLA Loneliness Scale; Interpersonal Support Evaluation List; Community Integration Scale. Participants will also be interviewed using a semi-structured interview protocol to identify experiences of community integration.
次要结局
- Change in mental well-being(Participants will be interviewed at baseline, at three months, six months, nine months, and 12-months over the one year trial)
- Change in meaningful activity engagement(Participants will be interviewed at baseline, at three months, six months, nine months, and 12-months over the one year trial)
- Change in substance use(Participants will be interviewed at baseline, at three months, six months, nine months, and 12-months over the one year trial)
