Community Participation Navigators: Testing a Peer Intervention for Adults With Serious Mental Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Temple University Community Participation Scale (TUCP):
研究概览
简要总结
The Temple University Collaborative on Community Inclusion (TU Collaborative) is testing a community navigation intervention study based upon effective health navigation models by conducting a randomized controlled trial of the intervention to establish feasibility, efficacy, and outcomes among adults with serious mental illness (SMI).
详细描述
The study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to support and enhance community participation for adults with serious mental illness (SMI) receiving community mental health services. The intervention is based on two evidence-based strategies. The first is the patient navigation interventions, which are used to assist people with SMI to identify and overcome barriers to accessing care. The second is the Capability, Opportunity, Motivation model of behavior change (COM-B model) which evaluates how each of these factors influences behavior. Participants will be assigned to one of two groups, the Community Navigator condition, or a control group. Those in the intervention arm will develop a community support plan with a peer support specialist community navigator and those in the control arm will receive printed information on the importance, skills, and opportunities for participation. Over the course of the 6-month intervention, participants in the intervention arm, with support from the peer support specialist will develop an initial participation plan, and through weekly meetings online or in-person will monitor their progress and make changes as needed. Recruitment will occur only in Philadelphia in collaboration with residential treatment service providers including: Merakey, Horizon House, COMHAR, Inc, and potential others. Data collection for all participants will take occur at baseline and at the end of the 6-month intervention. We aim to recruit and enroll 96 participants for a 16-month period in a randomized control trial of a community navigation intervention. Participants will be randomly assigned to either the intervention or an informational control group. The intervention group will meet with a peer support specialist once a week for 60-90 minutes. Enrollment will occur over 16 months, with 6 participants joining each month from behavioral health residential service sites. Each participant will have two meetings with a research assistant - an intake interview and an exit interview after 6 months. The primary analyses are expected months after the study initiation.
The aim of the research study is to determine the efficacy of a peer-support intervention to navigate community opportunities and resource to increase participation among adults with SMI and to determine if participation in the intervention increases social connections and decreases loneliness. The existing navigation approaches in health care have employed peer-delivered services and demonstrated significant effects. The program theory of this intervention is based on existing models of peer-delivered health navigation approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Data analyst, research assistant conducting research interviews at baseline and post-treatment will be blind to participant allocation
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meet the criteria for an SMI diagnosis of schizophrenia, schizoaffective, bipolar, or major depression diagnosis based on the MINI,
- •are over the age of 18-years-old
- •are fluent in English: As current intervention materials and research and intervention personnel are only fluent in English, only participants who can communicate in written and spoken English are eligible for enrollment.
- •have a permanent residence without constraints on participation (free to come and go from residence without restrictions) 2
- •have the ability to provide informed consent.
排除标准
- •inability to provide consent (legal guardian)
- •unable to speak and understand English
结局指标
主要结局
Temple University Community Participation Scale (TUCP):
时间窗: baseline, and post-treatment after 6 months
self-reports of community participation in 22 different areas including going to a supermarket, participating in a community social group (like a book club or recreational sports team), going to a movie, or working for pay. Participants are asked to indicate the number of days in the past 30 days that they participated in each of the 22 areas, whether each participation area was important to them, and whether they felt they participated in each area enough, not enough, or too much. Recent research has found the measure to be reliable and valid. An updated version of this measure is included which adds questions related to relationships with intimate partners and children and digital participation.
WHO Disability Assessment Schedule
时间窗: baseline, and post-treatment after 6 months
measures each person's capability to participate. It assesses abilities in the areas of cognition, mobility, self-care, life activities, and participation. It contains 15-items.
次要结局
- Clinical Assessment Interview for Negative Symptoms(baseline, and post-treatment after 6 months)
- Assessment Opportunity(baseline, and post-treatment after 6 months)
- The Social Embeddedness Scale(baseline, and post-treatment after 6 months)
- Interpersonal Mattering Scale (Moschella & Baynard, 2021; Elliott et al., 2004):(baseline, and post-treatment after 6 months)
- 3-Item UCLA Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2004)(baseline, and post-treatment after 6 months)
- Lehman Quality of Life Interview (QLI)(baseline, and post-treatment after 6 months)
- Recovery Assessment Scale (RAS-20):(baseline, and post-treatment after 6 months)
- The MOS Social Support survey(baseline, and post-treatment after 6 months)