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临床试验/NCT03132753
NCT03132753已完成不适用

Developing SUPPORT, a Community-Driven, Recovery-Oriented System of Care

Indiana University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of Participants Reporting Substance Use

研究概览

简要总结

The investigators seek to develop and assess the effectiveness of Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT), a community-driven recovery-oriented system of care for individuals recently released from prison. SUPPORT is modeled after Indiana Access to Recovery (ATR), a program that operated between October 2007 and December 2014. ATR, a national initiative funded by the Substance Abuse and Mental Health Services Administration (SAMHSA), provided comprehensive, flexible, recovery-oriented services for substance use disorder (SUD). The investigators' local evaluation of this program demonstrated significant improvement in a number of recovery-related outcomes (e.g., substance use, employment, income, involvement in the criminal justice system, and emotional well-being) for clients between intake and discharge. Additionally, qualitative findings from this evaluation demonstrated ATR was well liked among clients and providers. While Indiana ATR did serve a wider range of clients, the investigators have focused SUPPORT on returning inmates because (a) this was the largest group served by the program and (b) there is significant need for evidence-based SUD interventions for this population.

The investigators' primary long-term goal is to establish an effective and scalable recovery-oriented system of care for SUD within the reentry population. The investigators will conduct a pilot test comparing SUPPORT clients to clients receiving usual treatment. The investigators will collect quantitative data for both groups at multiple time points to understand the intervention's impact on recovery capital and outcomes and will collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences.

详细描述

The investigators will conduct the pilot at Public Advocates in Community Re-Entry (PACE), a nonprofit that provides services to individuals with felony convictions in Marion County Indiana. PACE has provided re-entry services in Marion County, IN for 55 years. PACE's services are divided into four distinct categories: transitional, employment, addiction, and pre-release services. It is the only former ATR agency in Marion County specializing in a re-entry population, and our evaluation of Indiana's program demonstrated they had significantly lower rates of recidivism than any other Marion County agency. In 2015, PACE served 1,703 new clients.

The investigators will recruit 100 clients for participation in the pilot, half (50) will be assigned to SUPPORT and half (50) to treatment as usual. SUPPORT clients will be offered 12 months of support service with a PACE recovery coach. The recovery coach will guide the SUPPORT client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The SUPPORT program will provide SUPPORT clients with $1,000 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover similar support services as the previous Access to Recovery (ATR) program, such as housing (permanent, transitional), employment services (training, placement, readiness), substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Clients will NOT be responsible for keeping track of their vouchers, but rather, his/her assigned recovery coach will track all voucher funding/spending. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion.

Clients in the treatment as usual group will have significantly reduced choices in services compared to SUPPORT clients. These clients will not receive vouchers to access support services such as transportation and housing and will only receive standard case management, which is more prescriptive and less intensive than the recovery consultant services provided through SUPPORT.

All PACE clients who are over the age of 18, have a SUD, are no longer incarcerated (in a prison, jail, or work release facility), are within 3 months from their release from prison, jail, or work release, and are unable to access the previously mentioned Recovery Works program, will be eligible for study participation. For both parolees and probationers the risk of recidivism is highest in the first year of release; therefore, the investigators will be connecting with clients during the initial months following releases. The investigators will also be excluding sex offenders from the pilot, as they face greater barriers to community integration and experience higher levels of supervision while on parole, which have the potential to confound results during a small-scale pilot. Once a potential client is released from incarceration and enrolled at PACE, if eligible, an intake worker will inform them of the opportunity to participate in the pilot study and describe the SUPPORT program services. If the client agrees to participate in the pilot, they will sign a consent form and be randomly assigned to either SUPPORT or a treatment as usual condition. If a participant in either the SUPPORT or treatment as usual group is re-incarcerated during the study period, the investigators will not engage them while under correctional supervision to collect data and the investigators will replace them with a new participant. However, if a participant is re-incarcerated but released back into the community during the study period, and reengages with PACE, they will continue to be a part of the study and the investigators will continue to collect data and offer them SUPPORT services. In short, for the purposes of this pilot, the investigators will not be collecting data from clients while incarcerated.

Quantitative:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All PACE clients who are over the age of 18, have a SUD, are no longer incarcerated (in a prison, jail, or work release facility), are within 3 months of release from prison, jail, or work release, and are unable to access the previously mentioned Recovery Works program will be eligible for study participation.

排除标准

  • Any individual that is not a PACE client, has not been released from prison, over the age of 18, or does not have a substance abuse disorder will not be included in the study.
  • Also, sex offenders will be excluded from this study because of the additional integration barriers faced by this population and their increased parole supervision, as these may confounding variables in such a small pilot.

研究组 & 干预措施

SUPPORT Group

Experimental

Subjects enrolled in the intervention.

干预措施: SUPPORT (Behavioral)

Treatment as Usual

No Intervention

Subjects enrolled in standard services.

结局指标

主要结局

Number of Participants Reporting Substance Use

时间窗: 12 months

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Difference in the Number of Days That Participants Reported Substance Use

时间窗: Baseline - 12 months

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Difference in Readiness to Change

时间窗: Baseline - 12 months

Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

Difference in Quality of Life: Perceived General Health

时间窗: Baseline - 12 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

时间窗: Baseline - 12 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

Frequency of Incarceration

时间窗: 12 months

Incarceration was measured through publicly available data on arrests, convictions, and periods of incarceration in Indiana. We searched each name in state prison and county jail records and identified them as incarcerated if their name appeared in the jail or prison data during the 12 month study window of their enrollment. Note: At baseline, we confirmed with our community partner that each participant had been in prison or jail, or on work release, within the past 3 months. However, this did not match the publicly available data, indicating that the available data is likely incomplete.

Number of Participants Reporting Substance Use

时间窗: Baseline

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Number of Participants Reporting Substance Use

时间窗: 6 months

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Difference in the Number of Days That Participants Reported Substance Use

时间窗: Baseline- 6 months

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Difference in the Number of Days That Participants Reported Substance Use

时间窗: 6 months - 12 months

Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

Difference in Readiness to Change

时间窗: Baseline - 6 months

Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

Difference in Readiness to Change

时间窗: 6 months - 12 months

Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

Difference in Quality of Life: Perceived General Health

时间窗: Baseline - 6 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

Difference in Quality of Life: Perceived General Health

时间窗: 6 months - 12 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

时间窗: Baseline - 6 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

时间窗: 6 months - 12 months

Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

Frequency of Incarceration

时间窗: 6 months

Incarceration was measured through publicly available data on arrests, convictions, and periods of incarceration in Indiana. We searched each name in state prison and county jail records and identified them as incarcerated if their name appeared in the jail or prison data during the 12 month study window of their enrollment. Note: At baseline, we confirmed with our community partner that each participant had been in prison or jail, or on work release, within the past 3 months. However, this did not match the publicly available data, indicating that the available data is likely incomplete.

次要结局

  • Difference in Self Determination(Baseline - 12 months)
  • Difference in Self Efficacy(Baseline - 12 months)
  • Difference in Number of Alters That Participants Identified in Their Social Network(Baseline - 12 months)
  • Difference in the Fraction of Network That Are Close to Subject(Baseline - 12 months)
  • Difference in the Network Closeness Sum(Baseline - 12 months)
  • Difference in the Network Closeness Average(Baseline - 12 months)
  • Difference in the Network Closeness Density(Baseline - 12 months)
  • Difference in the Fraction of Network Communicating With Subject(Baseline - 12 months)
  • Difference in the Fraction of Network Providing Support to the Subject(Baseline - 12 months)
  • Difference in the Fraction of Network Causing Subject Problems(Baseline - 12 months)
  • Difference in the Fraction of Network Using Substance(s)(Baseline - 12 months)
  • Difference in the Network Closeness Density(Baseline - 6 months)
  • Difference in the Fraction of Network Communicating With Subject(Baseline - 6 months)
  • Difference in Self Determination(Baseline - 6 months)
  • Difference in Self Determination(6 months - 12 months)
  • Difference in Self Efficacy(Baseline - 6 months)
  • Difference in Self Efficacy(6 months - 12 months)
  • Difference in Number of Alters That Participants Identified in Their Social Network(Baseline - 6 months)
  • Difference in the Fraction of Network That Are Close to Subject(Baseline - 6 months)
  • Difference in the Network Closeness Sum(Baseline - 6 months)
  • Difference in the Network Closeness Average(Baseline - 6 months)
  • Difference in the Fraction of Network Providing Support to the Subject(Baseline - 6 months)
  • Difference in the Fraction of Network Causing Subject Problems(Baseline - 6 months)
  • Difference in the Fraction of Network Using Substance(s)(Baseline - 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Salyers

Principal Investigator

Indiana University

研究点 (1)

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