- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06914856
회복 금융 : 수감 후 재정 건강 및 정신 건강
This proposal will address financial wellbeing, an often overlooked but important factor impacting reentry for justice-involved people with mental health challenges, who are disproportionately Black and Latine. The project will change community level determinants by integrating financial capability support (one-on-one coaching and access to financial tools and services) into existing services and training bank and credit union staff to reduce discrimination. It will also support collaborative community efforts working towards upstream policy and legal reforms to reduce the incidence of those financial challenges.
연구 개요
상태
상세 설명
This research project will use Community Based Participatory Research (CBPR) methods to achieve the following specific aim:
- Change community level determinants that impact financial well-being and health of the target group by training existing service provider including: i) community-based financial capability providers to be able to address financial difficulties of the target group; ii) service providers along the criminal justice pathway to be able to provide basic financial guidance to target group; iii) financial institution staff to reduce discrimination related to financial consequences of justice-involvement and mental illness. The investigator will also support community collaborations working for legal/policy reform that impacts finances of target group.
- Use mixed methods to assess impact on community determinants, measuring integration of financial capability support into existing services, ability of financial coaches to support target group, access to financial products, attitudes, knowledge and behavior of bank staff, strength of community collaborations, and progress towards changes in laws and policies.
- The investigator will assess impact on individuals by measuring target mechanisms (financial skills, self-efficacy and behavior) hypothesized to mediate the relationship between financial capability support and primary outcomes including financial well-being and other health determinants (employment, housing, social support, mental health supports, and belonging), secondary outcomes (health and recidivism) and mediators between primary and secondary outcomes (hope, empowerment, and mastery).
- Assess the value of integrating peer support into community-based financial capability support for the target group by randomizing participants into two groups, financial capability support only, or financial capability support plus peer support.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Connecticut
-
New Haven, Connecticut, 미국, 06513
- Yale University Program for Recovery and Community Health
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have been released from jail or prison 36 months ago or less
- Self-identify as having experiences with trauma, mental illness/mental distress, or substance use
- Living or using services in the greater New Haven area
- Interested in receiving financial guidance
Exclusion Criteria:
- Less than 18 years of age
- Not have been released from jail or prison 36 months ago or less
- Not self-identify as having experiences with trauma, mental illness/mental distress, or substance use
- Not living or using services in the greater New Haven area
- Not interested in receiving financial guidance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Financial Capability Support
The participants in this arm will receive one-on-one financial coaching, which entails monthly or more frequent meetings with a financial coach. The initial meetings will be held in person and subsequent meetings may be held via zoom, phone, or in person depending on the comfort and convenience of the participant. Participants will also receive access to safe and affordable financial services, which includes support with managing any existing bank accounts, or supporting a person to open a new overdraft-free account. Coaches can also help people to access other financial products such as free tax preparation (VITA), credit builder loans, online bank accounts, or other products recommended by our Justice Tech partner. |
|
|
실험적: Financial Capability Support with Peer Support
The participants randomized into this arm will receive services offered in the Financial Capability Support arm with the additional services of one-on-one peer support provided by a trained Recovery Support Specialist. Recovery Support Specialist, also referred to as Wellness coaches, will provide weekly meetings (30-60 minutes in duration) to the participants. |
The participants in this arm will receive one-on-one financial coaching, which entails monthly or more frequent meetings with a financial coach. Participants will also receive access to safe and affordable financial services, which includes support with managing any existing bank accounts, or supporting a person to open a new overdraft-free account. Coaches can also help people to access other financial products such as free tax preparation (VITA), credit builder loans, online bank accounts, or other products recommended by our Justice Tech partner. The participants will also receive will receive the additional services of one-on-one peer support provided by a trained Recovery Support Specialist. Recovery Support Specialist, also referred to as Wellness coaches, will provide weekly meetings (30-60 minutes in duration) to the participants. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Finances After Incarceration
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
57 questions (plus sub-questions) measuring financial health after incarceration. Outcomes include: use of safe and affordable financial products (no/yes averaged across multiple products, range 0-1), Savings (ordinal scale for amount of savings, range 1-8), Credit score (ordinal scale for range of credit scores, range 0-6). Measuring change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Money And Mental Health Scale
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
9-item survey used to measure money and mental health, including financial well-being. Total score range is 0-4, Higher scores indicate worse effect of money on mental health. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Housing & Employment - QOL
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
21-items selected from the Endicott Quality of Life measuring housing and employment. Subscales include satisfaction with living situation, satisfaction with safety, and satisfaction with work. Satisfaction rating scales range from 1-7 with higher scores indicating more satisfaction. An additional outcome is number of days worked in the last 90 days. For both satisfaction and number of days worked, measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Social Needs Screening Tool (CMS-AHC HRSN)
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
24-item screening tool assessing social determinants of health. Outcomes include financial strain (1-3), employment help needed (1-3), living situation (1-3). Higher scores indicate more social needs. Measuring change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Service Utilization
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
31-item survey used to measure utilization of health and mental health services. Outcomes are indicated by subscales measuring number of visits to medical care outpatient, medical emergency services, mental health outpatient, mental health emergency services, psychiatric rehabilitation services, self-help programs, and alcohol/drug counseling. Other subscales indicate number of nights in a facility for a medical/surgical problem, psychiatric problem, substance use problem, or staffed residential facility. Answer formats are number of visits or days. Higher scores indicate more service use. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Access To Health Services (from Phenx Toolkit)
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
10 questions measuring access to healthcare services. Outcomes include wellness visit in the past year (yes/no), delaying/missing medical care because of the cost (yes/no), number of urgent care visits, having a usual place to go for medical care (no, yes, multiple). Measuring change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Intersectional Discrimination Index
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
44-items (with branching logic) assessing discrimination, rating scales vary by question. Anticipated discrimination subscale ranges from 0-4, meaned across items. Lifetime day-to-day discrimination subscale ranges from 0-9, summed across items. Past year day-to-day discrimination subscale ranges from 0-18, summed across items. Lifetime major discrimination subscale ranges from 0-26, summed across items. Past year major discrimination subscale ranges from 0-13, summed across items. Higher scores indicate more discrimination. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recidivism
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
Number of days spent in jail/prison in last 6 months. The data are assessed through self-report and the public access criminal database called ctlookup.org. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Wellness in 8 Dimensions Inventory
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
67-item survey measuring wellness, rating scale 1-4, summary score meaned across items. Total score range is 1-4. Higher scores indicate higher wellness. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
SF-12v2 (Short Form Health Survey)
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
12-item survey measuring health, question format varies. Subscale range is 0-4 for Physical Component/Limitations Summary and Mental Component/Limitations Summary. Higher scores indicate more interference with daily living due to health problems. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Promis 1.0 - Anxiety for DSM-5
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
8-item survey measuring anxiety. Rating scale is 1-5, summary score is meaned across items. Total score range from 1-5. Higher scores indicate more anxiety. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Patient Health Questionnaire (PHQ-9)
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
10-item survey measuring depression, rating scale is 0-3, summary score meaned across items. Total score ranges from 0-3. Higher scores indicating more depression. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
PCL-5, (PTSD Checklist for DSM-5)
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
20-item survey measuring trauma. Rating scale is 0-4, summary score meaned across items. Total score range is 0-4. Higher scores indicate more traumatic symptoms. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
|
Addiction Severity Index (ASI) Limited Form
기간: Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
37-item survey measuring addiction with higher scores indicating more addiction, question format varies. Rating scale total score range from 0-4. Total scores range 0-1 for Alcohol Use Composite Score and Drug Use Composite Score. Higher scores indicate more alcohol or drug use/problems. Measuring mean change over time. |
Baseline Assessment, 6-Month Assessment, and 12-Month Assessment
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Chyrell Bellamy, Ph.D., Yale University
- 수석 연구원: Annie Harper, Ph.D., Yale University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2000033658
- 1R01MD018255-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data will be shared via the National Data Archive (NDA).
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .