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临床试验/NCT03758131
NCT03758131Unknown2 期

Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年8月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
150
试验地点
2
主要终点
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale

研究概览

简要总结

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.

详细描述

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.)

研究设计

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

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Peer-enhanced Motivational Interviewing

Experimental

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.

干预措施: Peer-enhanced Motivational Interviewing (Behavioral)

Motivational Interviewing

Active Comparator

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.

干预措施: Motivational Interviewing (Behavioral)

Waitlist Control

Placebo Comparator

Those dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm.

干预措施: Peer-enhanced Motivational Interviewing (Behavioral)

Waitlist Control

Placebo Comparator

Those dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm.

干预措施: Waitlist Control (Other)

结局指标

主要结局

Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale

时间窗: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period

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.

次要结局

  • Change: Urine Testing(Baseline and at month 1, 2, 3, 6 and 9 post-intervention period)
  • Change: Days of Combined Cannabis and Alcohol Use(Baseline and at month 1, 2, 3, 6 and 9 post-intervention period)
  • Change: Days of Cannabis and Binge Alcohol Use(Baseline and at month 1, 2, 3, 6 and 9 post-intervention period)
  • Change: Drinking Consequences(Baseline and at month 1, 2, 3, 6 and 9 post-intervention period)
  • Change: Marijuana Consequences Questionnaire (MACQ)(Baseline and at month 1, 2, 3, 6 and 9 post-intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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