跳至主要内容
临床试验/NCT04840134
NCT04840134暂停不适用

From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
96
试验地点
1
主要终点
TFA: Theoretical Framework of Acceptability (TFA) Questionnaire Change

研究概览

简要总结

Financial hardship is an important risk factor for suicide. However, there are no evidence-based interventions to help individuals at risk for suicide to improve their financial situation. The intervention will support participants to address their financial difficulties (e.g., indebtedness, inability to meet basic needs) by coaching them to develop key financial management skills (e.g., budgeting, debt management), create a financial wellness action plan, map and activate their social networks, and connecting them with community-based financial supports (e.g., free financial counseling, publicly funded housing and food supports).

The intervention will be facilitated by trained peer coaches. The intervention will consist of three phases: (1) intensive; (2) intermediate; and (3) follow-up. The 6-week intensive phase will consist of 6 weekly group sessions and 4 one-on-one coaching sessions to navigate financial resources. The intermediate phase will consist of 3 biweekly group sessions, and either 3 biweekly or 2 monthly one-on-one coaching sessions, based on participant preference. The follow-up phase will offer 3 monthly group sessions, and either 3 monthly or 6 biweekly one-on-one coaching sessions based on participant preference. Group and one-on-one coaching sessions will be conducted remotely via a HIPAA-compliant videoconferencing platform.

This study will consist of five steps: (1) obtaining input from stakeholders to develop the intervention; (2) piloting it with a small sample of participants (n=10); (3) using this information to revise the intervention; (4) testing it in a randomized controlled trial with individuals experiencing financial hardship and suicide risk (n=96); and (5) finalizing the intervention manual.

详细描述

Decades of research have shown that financial hardship is a key risk factor for suicide. Studies have consistently found higher prevalence of suicidal ideation, suicide attempts, and suicide death among individuals experiencing financial hardship, such as unmanageable debts and difficulty paying for basic needs (e.g., housing, food). Stressful financial events (e.g., loss of income, evictions) are well-documented reasons for and precipitants of suicidal behavior. An increase in suicidal behavior is not only associated with objective aspects of financial hardship (e.g., number of debts, income level), but also with how hardship is experienced by individuals (e.g., financial threat, financial shame). In fact, growing evidence suggests that subjective financial hardship mediates the relationship between objective financial hardship and suicidal behavior.

Despite overwhelming evidence about the economic determinants of suicide, evidence-based interventions to reduce suicide risk and financial hardship are unavailable. Suicide prevention interventions at the individual level have largely focused on identifying or treating symptoms of psychiatric distress and other immediate clinical factors. Ecological-level interventions have mostly focused on increasing suicide awareness and reducing access to the means of suicide.

To address this gap, our project aims to develop a peer-led intervention that includes strategies and tools to reduce objective and subjective financial hardship, with the goal of decreasing hopelessness, shame, and depression (risk factors for suicide), increasing hope and life satisfaction (protective factors for suicide), and thereby reducing suicidal ideation and behaviors.

The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicidal ideation and behavior. If the findings of this study support its feasibility, acceptability, satisfaction, and initial efficacy, the investigators will formalize a peer coach training program, further develop an intervention fidelity measure, and pursue a randomized controlled trial to test intervention efficacy.

Specific aims and hypotheses are as follows:

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 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Working age (Self-reported age between 18-64).
  • •Provides informed consent (Self report: individual signs and dates Informed Consent Form).
  • •Stated willingness to comply with all study procedures and availability for the duration of the study (Self report).
  • •Lives or works in NYC (Self-report).
  • •Willing to receive referral to financial counseling (Self report).
  • •Objective financial hardship (Reports one or more types of financial hardship on the Financial Wellness Tool (FwTool), an 11-item assessment that measures overall financial hardship, food insecurity, housing hardship, difficulty paying for utilities, medical hardship, and indebtedness).
  • •Subjective financial hardship (Reports a Financial Threat score of 13 or higher [5-25] on the Financial Threat Scale (FTS), five-item scale that measures worry, fear, uncertainty, and preoccupation about one's financial situation).
  • •Moderate-to-high suicide risk as measured by the Columbia-Suicide Severity Rating Scale (C- SSRS) Screener administered by trained research staff (Endorses active suicidal ideation with or without a method or with some intent (items 2, 3, 4 on the C-SSRS) in the past 3 months, OR suicidal ideation with a plan or suicidal behavior (5 or 6 on the C-SSRS) in the past 3 months but NOT in the past month, confirmed by the study clinician during psychiatric evaluation).
  • •Receiving clinical treatment (Self-reports as currently enrolled in therapy or otherwise receiving treatment from a licensed mental health clinician; alternatively, willing to begin mental health treatment prior to the start of the intervention. Study participants will be asked to provide the name, phone number and email address for the treating clinician).
  • •Willing to participate in a financial wellness intervention via HIPAA-compliant videoconference platform (Self-report).
  • •Internet connection and video-capable device to participate in group sessions via HIPAA-compliant videoconference platform (Self-report).

排除标准

  • •Active SI with plan and intent in the past month (C-SSRS Screener administered by research staff and confirmed by study clinician (Yes to item 5, i.e., active suicidal ideation with plan and intent in the past month)).
  • •Recent suicidal behavior within the past month (C-SSRS Screener administered by research staff and confirmed by study clinician (Yes to item 6, i.e., has engaged in suicidal behaviors in the past month)).
  • •Florid psychosis or acute intoxication in need of detoxification (Clinical assessment by licensed study clinician during clinical evaluation).
  • •Cognitive impairment for those over age 60 (Montreal Cognitive Assessment - Blind Version (MoCA) conducted by research staff for those over age
  • •(MoCA score below 19)).

研究组 & 干预措施

From Hardship to Hope: Financial Wellness Intervention

Experimental

Experimental: Participants in the experimental arm will receive "From Hardship to Hope, A Peer-led intervention to reduce financial hardship and suicide risk." The intervention will support individuals experiencing financial hardship and suicide risk to address their financial difficulties (e.g., debt, inability to meet basic needs) by coaching them on financial management techniques, facilitating a financial wellness plan, and connecting them with community-based financial supports (e.g., free financial counseling). The intervention will be facilitated by trained peer coaches, who are individuals with lived experience of financial hardship and suicidal ideation or suicidal behaviors who are state certified peer specialists (having met formal training and experience requirements).

干预措施: From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk (Behavioral)

Control Arm

Active Comparator

The control arm will receive enhanced treatment as usual (eTAU), consisting of clinical care with a licensed mental health clinician plus information about financial wellness resources (a Financial Wellness Navigator and financial counseling handout). The Financial Wellness Navigator is a curated document providing information about financial wellness resources available to New Yorkers (e.g., brief description of the service, eligibility criteria, website for more information, contact information). This directory will be provided via email, online link, and/or post mail, depending on participant preference.

干预措施: Enhanced Treatment as Usual (eTAU) (Other)

结局指标

主要结局

TFA: Theoretical Framework of Acceptability (TFA) Questionnaire Change

时间窗: Week 1, Week 6, Week 12, Week 24

A questionnaire designed to assess the acceptability of healthcare interventions across design, evaluation, and implementation phases. It consists of seven domains: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. The measure includes items assessing both prospective and retrospective acceptability.

TEI-SF: Treatment Evaluation Inventory Change

时间窗: Week 1, Week 6, Week 12, Week 24

A 9-item version of the original 15-item Treatment Evaluation Inventory, assessing treatment acceptability and ethical concerns.

次要结局

  • InCharge Financial Distress/Financial Well-Being Scale (IFDFW) Change(Baseline, Week 6, Week 12, Week 18, Week 24)
  • Financial Hardship Screener(Baseline, Week 6, Week 12, Week 18, Week 24)
  • Columbia-Suicide Severity Rating Scale - Intensity of Ideation Sub-scale Change(Baseline, Week 6, Week 12, Week 18, Week 24)
  • Beck Scale for Suicidal Ideation Change(Baseline, Week 6, Week 12, Week 18, Week 24)
  • Economic Hardship Questionnaire Change(Baseline, Week 6, Week 12, Week 18, Week 24)
  • E-FwT: ENGAGE Financial Wellness Tool Change(Baseline, Week 6, Week 12, Week 18, Week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Jimenez-Solomon, PhD., MPH

Assistant Director, New York State Center of Excellence for Cultural Competence

New York State Psychiatric Institute

研究点 (1)

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