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

Primary Purpose

Suicide, Suicide Ideation, Suicidal Behavior

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Suicide

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

From Hardship to Hope: Financial Wellness Intervention

Arm Description

From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk Over the course of this study, the investigators will develop and pilot a financial wellness intervention to work in tandem with clinical treatment. 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 specialists, 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 29, 2021
Last Updated
August 7, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
American Foundation for Suicide Prevention, Baltic Street, AEH.
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1. Study Identification

Unique Protocol Identification Number
NCT04840134
Brief Title
From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
Official Title
From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
In response to QA/compliance concerns about specific studies, NYSPI is undertaking an Institute-wide safety review of research protocols. Studies will resume recruitment after the review has confirmed they are deploying adequate safety protections.
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
American Foundation for Suicide Prevention, Baltic Street, AEH.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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: 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. Assess the feasibility and acceptability/satisfaction of the novel intervention using qualitative and quantitative methods. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide Ideation, Suicidal Behavior, Hope, Financial Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
From Hardship to Hope: Financial Wellness Intervention
Arm Type
Experimental
Arm Description
From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk Over the course of this study, the investigators will develop and pilot a financial wellness intervention to work in tandem with clinical treatment. 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 specialists, 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).
Intervention Type
Behavioral
Intervention Name(s)
From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk
Intervention Description
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).
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale - Intensity of Ideation Sub-scale Change
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 9, Week 12 and Week 24
Title
Beck Scale for Suicidal Ideation Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Secondary Outcome Measure Information:
Title
Financial Threat Scale Change
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 9, Week 12, Week 24
Title
Financial Self-efficacy Scale Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Index of Personal Economic Distress Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Economic Hardship Questionnaire Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Satisfaction with Life Scale Change
Description
5-item self-report measure of global current life satisfaction. Values range from 5 to 35. Higher scores indicate greater levels of life satisfaction.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
State Hope Scale Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Medical Outcomes Survey Social Support Scale (MOS-SSS) Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Beck Hopelessness Scale Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Test of Self-Conscious Affect (TOSCA) Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
UCLA Loneliness Scale-8 (ULS-8) Change
Description
8-item measure of perceived social isolation. Values range from 8 to 32. Higher scores indicate higher levels of loneliness.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Kessler Psychological Distress Change (K-10) Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Title
Patient Health Questionnaire (PHQ-9) Change
Description
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.
Time Frame
Baseline, Week 6, Week 12, Week 24
Other Pre-specified Outcome Measures:
Title
Feasibility of Intervention Measure (FIM) Change
Description
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.
Time Frame
Week 1, Week 6, Week 12, Week 24
Title
Acceptability of Intervention Measure (AIM) Change
Description
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.
Time Frame
Week 1, Week 6, Week 12, Week 24
Title
Client Satisfaction Questionnaire-8 (CSQ-8) Change
Description
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.
Time Frame
Week 1, Week 6, Week 12, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar G Jimenez-Solomon, MPH
Organizational Affiliation
New York State Psychiatric Institute, Columbia University Irving Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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