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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04840134
• Other study ID #: 8078
• Status: Suspended
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Financial hardship is an important risk factor for suicide. However, to date there are no evidence-based interventions to help individuals improve their financial situation and thus reduce suicide risk. The aim of our study is to develop a 24-week, peer-led intervention to reduce financial hardship for individuals experiencing financial difficulties and suicide risk, and to test whether it is feasible, acceptable to clients and achieves its desired effect. The intervention will support participants 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 specialists. The intervention consists of two phases: (1) a 9-week intensive phase will consist of weekly group sessions and one-on-one coaching sessions to navigate financial resources; (2) a 15-week follow-up phase will contain biweekly check-ins to achieve financial goals. This study will obtain input from stakeholders to develop the intervention (Step 1), pilot it with a small sample of participants (n=10; Step 2), use this information to revise the intervention (Step 3), test it in a larger sample of individuals with financial hardship and suicide risk (n=50; Step 4), and prepare a final version of the intervention manual (Step 5). The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicide.

Description:

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 not available. 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 provider training program, further develop an intervention fidelity measure, and pursue a randomized controlled trial to test intervention efficacy. Specific aims and hypothesis are as follows: 1. With multi-stakeholder input, develop and iteratively revise From Hardship to Hope, a peer-led financial empowerment intervention to reduce financial hardship and suicidal ideation and behaviors. 2. Assess the feasibility and acceptability/satisfaction of the novel intervention using qualitative and quantitative methods. 3. Examine the initial efficacy of the intervention on several outcomes. The investigators hypothesize that suicidal ideation intensity, hopelessness, and objective and subjective financial hardship will decrease after the intervention, while utilization of financial supports, financial self-efficacy, and hope will increase. 4. Explore the intervention's mechanisms of action (e.g., level of participation, change in subjective financial hardship). The investigators hypothesize that the amount of change in suicidal ideation intensity will be positively correlated with the change in subjective financial hardship, and both will be associated with the level of participation.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Working age (Self-reported age between 18-64)
• Lives of works in NYC (Self-report)
• Objective financial hardship (Financial Hardship Screening Tool (FHST) - endorses one or more financial hardship indicators, e.g., inability to repay debts, difficulty meeting basic needs, inability to pay bills on time)
• Moderate-to-high suicide risk (Self-report Columbia-Suicide Severity Rating Scale (C- SSRS) Screener (endorses active suicidal ideation, active suicidal ideation with method, active suicidal ideation with some intent in the past month, or passive suicidal ideation with suicidal behavior in past three months) (Yes to Items 2, 3 or 4, or Yes to 1 and 6).
• Receiving clinical treatment (Currently enrolled in therapy or otherwise receiving treatment; alternatively, willing to begin mental health treatment prior to the start of the intervention)
• Willing to participate in a financial wellness intervention (Self-report)

Exclusion Criteria:

• Active SI with plan and intent in the past month (Self-report C-SSRS Screener (Yes to item 5, i.e., active suicidal ideation with plan and intent in the past month)
• Recent suicidal behavior within the past two weeks (Self-report C-SSRS Screener (Yes to item 6, i.e., has engaged in suicidal behaviors in the past two weeks)
• Florid psychosis or acute intoxication in need of detoxification (Clinical assessment by Anxiety Disorders Clinic psychiatrist or psychologist)
• Require ER/hospitalization (Clinical assessment by Anxiety Disorders Clinic psychiatrist or psychologist)
• Cognitive impairment (Mini Mental Status Exam (MMSE) conducted by psychiatrist for those over age 60. MMSE score below 25)

Related Conditions & MeSH terms

• Financial Stress
• Hope
• Suicidal Behavior
• Suicide
• Suicide Ideation

Intervention

Behavioral:
• From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk
The intervention will be delivered in two consecutive phases: Intensive Intervention Phase (week 1-9), including 9 weekly peer-led group sessions (90min) and four one-on-one coaching sessions (60min); and Follow-up Intervention Phase (weeks 10-24),consisting of 3 monthly group sessions (90min) and bi-weekly phone check-ins to provide ongoing support (15-20min). Key intervention components: Peer-led group sessions include personal stories of financial empowerment; practical information about available financial supports; basic financial coaching and mutual support/ accountability (e.g., goal/action check-ins); One-on-one peer coaching sessions (throughout 24 weeks) to help participants identify their personal financial stressors and facilitate a personalized Financial Wellness Action Plan. Support to navigate and access financial supports in the community (e.g., financial counseling, free tax prep, housing eviction prevention, debt relief).

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	American Foundation for Suicide Prevention, Baltic Street, AEH.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of Intervention Measure (FIM) Change	4-item scale that measures the extent to which a participant believes the new intervention or treatment can be successfully used or carried out within a given agency or setting. Scores range from 4 to 20. Greater scores indicate greater perceived feasibility of the intervention.	Week 1, Week 6, Week 12, Week 24
Other	Acceptability of Intervention Measure (AIM) Change	4-item scale that measures the extent to which a participant believes the new intervention or treatment is acceptable, appealing, and meets his/her approval. Scores range from 4 to 20. Greater scores indicate greater acceptability of the intervention.	Week 1, Week 6, Week 12, Week 24
Other	Client Satisfaction Questionnaire-8 (CSQ-8) Change	8-item measure of participants' satisfaction with the service, intervention, or treatment received. Total scores range from 8 to 32, with higher values indicating higher satisfaction.	Week 1, Week 6, Week 12, Week 24
Primary	Columbia-Suicide Severity Rating Scale - Intensity of Ideation Sub-scale Change	Interview-based assessment of suicide ideation intensity. It consists of 5 items measuring frequency, duration, controllability, deterrents, and reasons for Ideation. Sub-scale values range from 2 to 25. Higher scores indicate greater suicidal ideation intensity.	Baseline, Week 3, Week 6, Week 9, Week 12 and Week 24
Primary	Beck Scale for Suicidal Ideation Change	21-item instrument for detecting and measuring the current intensity of specific attitudes, behaviors, and plans to die by suicide during the past week. The first 19 items assess the intensity of suicidality on a 3-point scale. Total score for these items ranges from 0 to 38, with greater scores indicating more severe suicidal ideation intensity. The final two items assess the number of previous suicide attempts and the severity of the intent to die associated with the last attempt.	Baseline, Week 6, Week 12, Week 24
Secondary	Financial Threat Scale Change	5-item self-report measure of current feelings of worry and preoccupation with current financial situation. Scores range from 5 to 25. Greater scores indicate higher perceived financial threat.	Baseline, Week 3, Week 6, Week 9, Week 12, Week 24
Secondary	Financial Self-efficacy Scale Change	3-item self-report measure of current perceived ability of improving financial situation. Scores range from 3 to 15. Higher scores indicate greater financial self-efficacy.	Baseline, Week 6, Week 12, Week 24
Secondary	Index of Personal Economic Distress Change	8-item self-report measure of difficulty in fulfilling daily household financial demands and meeting basic needs during the last 6 months. Scores range from 8 to 24. Higher scores indicate greater economic distress.	Baseline, Week 6, Week 12, Week 24
Secondary	Economic Hardship Questionnaire Change	12-item self-report scale measuring family economic hardship and changes in a household's style of living in the past 6 months (e.g., drop in income, ability meet basic needs). Values range from 0 to 36. Higher scores indicate greater recent economic hardship.	Baseline, Week 6, Week 12, Week 24
Secondary	Satisfaction with Life Scale Change	5-item self-report measure of global current life satisfaction. Values range from 5 to 35. Higher scores indicate greater levels of life satisfaction.	Baseline, Week 6, Week 12, Week 24
Secondary	State Hope Scale Change	6-item self-report scale of current level of hope. Measures hope via two factors: Hope Agency (i.e., perceived ability to achieve goals) and Hope Pathways (i.e., perceived pathways to achieve goals). Values range from 6 to 48. Higher scores indicate higher levels of hope.	Baseline, Week 6, Week 12, Week 24
Secondary	Medical Outcomes Survey Social Support Scale (MOS-SSS) Change	19-item measure of perceived current social support in emotional/informational, tangible, affectionate, and positive social interactions. Values range from 0 to 100. Higher scores indicate greater social support.	Baseline, Week 6, Week 12, Week 24
Secondary	Beck Hopelessness Scale Change	20-item self-report measure of hopelessness about the future, loss of motivation, and poor expectations in the past week. Values range from 0 to 20. Higher scores indicate higher levels of hopelessness.	Baseline, Week 6, Week 12, Week 24
Secondary	Test of Self-Conscious Affect (TOSCA) Change	Two-factor, 30-item self-report measure of current shame and guilt. Values range from 30 to 150. Higher scores indicate higher levels of shame/guilt.	Baseline, Week 6, Week 12, Week 24
Secondary	UCLA Loneliness Scale-8 (ULS-8) Change	8-item measure of perceived social isolation. Values range from 8 to 32. Higher scores indicate higher levels of loneliness.	Baseline, Week 6, Week 12, Week 24
Secondary	Kessler Psychological Distress Change (K-10) Change	10-item questionnaire that yields a global measure of psychological distress based on questions about anxiety and depressive symptoms experienced in the previous 4-week period. Total scores range from 10 to 50, with higher values indicating greater psychological distress.	Baseline, Week 6, Week 12, Week 24
Secondary	Patient Health Questionnaire (PHQ-9) Change	9-item measure of depressive symptoms and severity in the past two weeks. Values range from 0 to 27. Higher scores indicate greater depression severity.	Baseline, Week 6, Week 12, Week 24