Peer MI in FQHCs for Substance-using Emerging Adults
2018年11月28日 更新者：University of Illinois at Urbana-Champaign
Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
The main purpose of this study is to test whether a Peer-Enhanced Motivational Interviewing (PMI) intervention, which has been successful with college students, results in superior alcohol and marijuana use outcomes for emerging adults (EA), ages 18-29, who are clients of Federally-qualified Health Centers, and their peers.
In the first phase of the study, seventy-five peer dyads (total n = 150, ntarget client = 75, npeer = 75) will be randomized to receive either Peer-Enhanced Motivational Interviewing (PMI), Motivational Interviewing only (MI) or Waitlist Control (WC.)
In the second, expanded phase of the study, an additional 325 peer dyads (total n = 650, ntarget client = 325, npeer = 325) will be randomized to receive either Peer-Enhanced Motivational Interviewing, Motivational Interviewing only (MI) or Waitlist Control.
研究概览
地位
尚未招聘
条件
详细说明
This project randomizes peer dyads, consisting of one Emerging Adult (EA), 18-29 years old, who both has a substance use problem and attends a Federally-qualified Health Center (i.e. target client), and one peer, to one of three conditions. In the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will receive separate one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use. MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change. With the "peer" of each PMI dyad, the therapist presents peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication skills they can use to influence the target client's substance use. In the Motivational Interviewing only (MI) condition, the target client alone will receive the MI intervention with no peer participation. In the Waitlist (WC) condition, target clients and peers can receive the intervention at 2 months into the follow-up period for the PMI group.
The main purpose of this study is to test whether a Peer-Enhanced Motivational Interviewing (PMI) intervention, which has been successful with college students, results in superior alcohol and marijuana use outcomes for emerging adults (EA), ages 18-29, who are clients of Federally-qualified Health Centers, and their peers. Seventy-five peer dyads (total n = 150, ntarget client = 75, npeer = 75) will be randomized to receive either Peer-Enhanced Motivational Interviewing (PMI), Motivational Interviewing only (MI) or Waitlist Control (WC.)
研究类型
介入性
注册 (预期的)
150
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Douglas C Smith, PhD
- 电话号码：217-333-5308
- 邮箱：smithdc@illinois.edu
研究联系人备份
- 姓名：Maggie A Helms, MBA
- 电话号码：217-300-1159
- 邮箱：mhlms@illinois.edu
学习地点
-
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Illinois
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Urbana、Illinois、美国、61801
- School of Social Work
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 29年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
For the Target Client
- Score 5 or higher on the AUDIT-C measure and/or use alcohol or marijuana 13 days or more out of the past 90 days,
- Have a friend that they are willing to refer to the study to be their 'peer' (support) and that peer agrees to participate,
- Are able to complete baseline and follow-up assessments and have a valid email,
- Are willing to be video recorded, and
- Are fluent in English
For the Peer
- Have weekly contact with the participating Target Client who referred them,
- Are will to attend all study procedures (i.e. baseline assessment, intervention, follow up),
- Are willing to be video record,
- Are fluent in English
Exclusion Criteria:
For the Target Client
- Are current students in the lead Investigator's classes,
- Are seeking residential treatment at the time of the screening call,
- Are incarcerated or court-ordered to receive treatment at the time of the screening call,
- Use drugs besides marijuana or alcohol over 45 of the past 90 days.
For the Peer
- Are current students in the lead Investigator's classes,
- Are seeking residential treatment at the time of the screening call,
- Are incarcerated or court-ordered to receive treatment at the time of the screening call,
- Use drugs besides marijuana or alcohol over 45 of the past 90 days,
- Are romantic partners of the Target Client
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Peer-enhanced Motivational Interviewing
In the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will receive separate one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use.
Mi is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change.
With the "peer" of each PMI dyad, the therapist presents peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication skills they can use to influence the target client's substance use.
|
In the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will receive separate one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use.
MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change.
With the "peer" of each PMI dyad, the therapist presents peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication skills they can use to influence the target client's substance use.
其他名称：
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有源比较器：Motivational Interviewing
In the Motivational Interviewing (MI) condition, target clients only will receive one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use.
|
In the Motivational Interviewing (PMI) condition, target clients only will receive one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use.
MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change.
其他名称：
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安慰剂比较：Waitlist Control
Those dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm.
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In the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will receive separate one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use.
MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change.
With the "peer" of each PMI dyad, the therapist presents peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication skills they can use to influence the target client's substance use.
其他名称：
Dyads randomized to this intervention will have no contact with study personnel until 2 months after the PMI group has completed the PMI intervention.
Then those in the Waitlist Control condition will receive the full PMI protocol.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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A 16-item scale composed of lifetime symptoms of substance abuse, dependence, and substance-induced health and psychological disorders based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change: Marijuana Consequences Questionnaire (MACQ)
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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A 50-item self-report measure modeled after the Young Adult Alcohol Consequences Questionnaire (YAACQ) assessing marijuana problems over the past 6 months.
A 6-month time frame was chosen to adequately capture potential infrequent consequences among marijuana users.
Each item is rated dichotomously (yes/no) to indicate whether the marijuana-related problem occurred in the last 6 months.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Days of Combined Cannabis and Alcohol Use
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Days of Cannabis and Binge Alcohol Use
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Past month measure of days (out of past 30) of use of either substance.
Binge drinking calculated from Time-Line Follow-Back (TLFB) as number of days of consuming 4+ (females)/5+ (males) drinks.
Items drawn from GAIN's Substance Frequency Scale.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Drinking Consequences
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Urine Testing
大体时间：Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Douglas C Smith, PhD、University of Illinois Urbana Champaign School of Social Work
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年8月1日
初级完成 (预期的)
2024年2月1日
研究完成 (预期的)
2024年2月1日
研究注册日期
首次提交
2018年11月6日
首先提交符合 QC 标准的
2018年11月28日
首次发布 (实际的)
2018年11月29日
研究记录更新
最后更新发布 (实际的)
2018年11月29日
上次提交的符合 QC 标准的更新
2018年11月28日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.