Suicide Clinical Trial
Official title:
From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
NCT number | NCT04840134 |
Other study ID # | 8078 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2021 |
Est. completion date | September 30, 2025 |
Verified date | May 2024 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 80 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
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) |
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | American Foundation for Suicide Prevention, Baltic Street Wellness Solutions |
United States,
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 |
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