跳至主要内容
临床试验/NCT06019247
NCT06019247Enrolling By Invitation不适用

Individual Placement and Support (IPS) for Serious Mental Illness in Jalisco, Mexico

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente6 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2024年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
120
试验地点
6
主要终点
Assessment of psychiatric symptoms

研究概览

简要总结

There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Hothe investigatorsver, not a single country in Latin America offers IPS services. In addition, services to support employment and education tend to be ad hoc, low-intensity, and not the investigatorsll evaluated because most clinicians are not trained in evidence-based practices.

Clinicians are not trained in evidence-based approaches and do not provide high-fidelity services. The overall goal of this project is to pilot the IPS for PSMI in the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco, Mexico. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere.

The investigators will use the Dynamic Adaptation Process model to first inform the adaptation of IPS in Mexico, using our previous experience adapting IPS and deep understanding of the local context (e.g., the nature of the labor market in Mexico) to inform the adaptations. The investigators will then evaluate the implementation and impact of the adapted IPS in a pilot RCT (N = 120).

This pilot RCT will Include quantitative and qualitative assessments at baseline, 6 months, and 12 months with clients, providers, and other key stakeholders. The investigators aim to refine implementation processes, understand outcomes and tools, and estimate pothe investigatorsr for a future regional trial in Latin America.

详细描述

The researchers propose to adapt, implement, and evaluate the Individual Placement and Support (IPS) model for people with serious mental illness (PSMI) in Jalisco, Mexico. Substantial data indicate that IPS can help PSMI succeed in competitive employment (i.e., 55% on average, but over 60% in credible studies). In addition, successful employment through IPS has been shown to improve quality of life, self-esteem, and community integration, and to reduce symptoms, hospitalizations, and mental health costs. With the partial exception of Chile, no country in Latin America offers IPS services. Previous regional research has reported that PSMI experience extreme poverty, exclusion from educational and employment opportunities, and multiple traumas, including violence and abuse. Evidence-based, locally adapted initiatives to improve the living conditions and social inclusion of this vulnerable population are warranted.

In Mexico, mental health care for PSMI is often fragmented and does not follow evidence-based practices (EBP). The Jalisco Mental Health System, a large network of mental health facilities throughout the state of Jalisco, is an exception. The researchers plan to implement IPS at the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). The usual care services are of lower intensity than IPS and lack most of its key components.

This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere. In addition, the regional government of Jalisco has committed to expanding the implementation of the adapted IPS program if the trial is successful.

Ricardo Saracco (National Institute of Psychiatry Ramón de la Fuente Muñiz, INPRF) and Alejandro Aldana (Jalisco Institute of Mental Health, IJSM) have brought together key stakeholders to collaborate with researchers in the US (Susser, Dixon, Bello, Mascayano). All have extensive expertise in psychosis research and in the implementation of evidence-based mental health practices in a variety of contexts, including Latin America. In addition, the INPRF and IJSM teams have a long-standing relationship in Mexico and have recently collaborated with the US team on a study of the impact of the COVID-19 pandemic on health care workers (e.g., the Health Care Workers HEROES study).

The investigators will initially use the Dynamic Adaptation Process model9 to inform the adaptation of IPS in Mexico. The investigators note that IPS has been adapted for successful implementation in more than 20 countries and for marginalized communities within the US (e.g., Latinxs). This prior experience and our deep understanding of the local context (e.g., the nature of the nature of the labor market in Mexico) will inform the adaptations. Second, the researchers will evaluate the implementation and impact of the revised intervention in a pilot RCT (N = 120). This pilot RCT will include quantitative and qualitative assessments at baseline, 6, and 12 months, conducted with clients (e.g., employment, financial well-being of the investigators), providers (e.g., attitudes toward the intervention), and providers (e.g., attitudes toward the intervention), (e.g., attitudes toward EBP), and other key stakeholders (e.g., potential employers). The researchers primary goals are to refine implementation processes, understand outcomes and tools, and assess investigators for a future, regional trial in Latin America.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (Potential participants will be deemed eligible if they)
  • Meet requirements for PSMI.
  • Are receiving services from CAISAME-EP for at least one month.
  • Are at least 18 years old.
  • Have expressed a goal of paid, competitive employment.
  • Have attended 2 informational sessions prior to recruitment.
  • Have no competitive employment during the past 3 months.
  • Are physically and cognitively able to participate in study for the planned year of follow-up.
  • Are willing to provide informed consent.
  • Agree not to seek usual vocational services.

排除标准

  • (Potential participants will not be eligible if they)
  • Don't meet requirements for PSMI.
  • Are not receiving services from CAISAME-EP for at least one month.
  • Are not at least 18 years old or older than 60 years old.
  • Have not expressed a goal of paid, competitive employment.
  • Have not attended 2 informational sessions prior to recruitment.
  • Have a competitive employment during the past 3 months.
  • Are not physically and cognitively able to participate in study for the planned year of follow-up.
  • Are not willing to provide informed consent.
  • Don't agree not to seek usual vocational services.

结局指标

主要结局

Assessment of psychiatric symptoms

时间窗: One year

Indicators of participants' mental well-being will be measured at baseline, six months and twelve months. Psychiatric symptoms will be measured using the Colorado Symptom Index.

Assessment of mental and physical functioning.

时间窗: One year

Outcomes of physical and mental functioning in daily life will be measured at baseline, six months and twelve months using the Study Short-Form 12-Item and physical and mental functioning at work using the Functional Assessment Battery.

IPS Employment impact measure

时间窗: One year

The aim of the evaluation is to measure the impact of the IPS programme on the employability of the participants. Outcome measures will be based on a baseline interview and quarterly interviews with participants. The impact of the intervention will be measured by changes from baseline in time in jobs held, hours worked and wages earned.

次要结局

  • Baseline customer demographics.(six months)
  • Quarterly client employment interviews(six months)
  • IPS Participation Measure(one year)
  • Participant employment report (weeks worked, hours worked per week, hourly wage, start and end dates of work) and feedback to IPS teams.(Eighteen months)
  • Follow-up interviews.(one year)
  • Employment specialist service log (time spent direct services, collaborating with mental health experts and job support).(six months)

研究者

发起方
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Arturo Saracco Alvarez

UNDER DIRECTOR OF CLINICAL RESEARCH

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

研究点 (6)

Loading locations...

相似试验

Individual Placement and Support Mexico | 临床试验