NCT04840134

Brief Summary

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jun 2021Mar 2027

First Submitted

Initial submission to the registry

March 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

March 29, 2021

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • TFA: Theoretical Framework of Acceptability (TFA) Questionnaire Change

    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.

    Week 1, Week 6, Week 12, Week 24

  • TEI-SF: Treatment Evaluation Inventory Change

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

    Week 1, Week 6, Week 12, Week 24

Secondary Outcomes (6)

  • 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

  • InCharge Financial Distress/Financial Well-Being Scale (IFDFW) Change

    Baseline, Week 6, Week 12, Week 18, Week 24

  • +1 more secondary outcomes

Other Outcomes (10)

  • Financial Satisfaction Scale

    Baseline, Week 6, Week 12, Week 18, Week 24

  • Financial Threat Scale Change

    Baseline, Week 6, Week 12, Week 18, Week 24

  • Satisfaction with Life Scale Change

    Baseline, Week 6, Week 12, Week 18, Week 24

  • +7 more other outcomes

Study Arms (2)

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).

Behavioral: From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk

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.

Other: Enhanced Treatment as Usual (eTAU)

Interventions

The intervention will be delivered in three consecutive phases: 1. Intensive Intervention Phase (weeks 1 to 6), consisting of 6 weekly group sessions and 4 one-on-one coaching sessions to navigate financial resources. 2. Intermediate Phase (weeks 7 to 12), consisting of 3 biweekly group sessions, and either 3 biweekly or 2 monthly one-on-one coaching sessions, based on participant preference. 3. Follow up Phase (weeks 13 to 24), consisting of 3 monthly group sessions, and either 3 monthly or 6 biweekly one-on-one coaching sessions based on participant preference. Key intervention components: 1. Peer-led group sessions 2. Individual peer coaching sessions to complement group sessions

From Hardship to Hope: Financial Wellness Intervention

Enhanced Treatment as Usual (eTAU) consists of ongoing clinical care with a licensed mental health clinician, representing the current standard of care, plus provision of financial wellness informational resources. These resources include a Financial Wellness Navigator (a curated directory of financial wellness services available to New Yorkers) and a handout describing free financial counseling services and how to access them. The control condition does not include peer-led group sessions, individualized peer coaching, or warm referrals that are part of the From Hardship to Hope intervention.

Control Arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 60. (MoCA score below 19)).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

SuicideFinancial Stress

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorStress, Psychological

Study Officials

  • Oscar G Jimenez-Solomon, PhD, MPH

    New York State Psychiatric Institute, Columbia University Irving Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study evaluates the feasibility, acceptability, and initial efficacy of From Hardship to Hope (FHH) using a randomized controlled trial (RCT). The intervention arm will receive a 24-week peer-led financial wellness program in addition to clinical care with a licensed mental health clinician. 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director, New York State Center of Excellence for Cultural Competence

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 9, 2021

Study Start

June 8, 2021

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations