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Peer MI in FQHCs for Substance-using Emerging Adults

Primary Purpose

Substance Use Disorders

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peer-enhanced Motivational Interviewing
Motivational Interviewing
Waitlist Control
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Motivational Interviewing

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For the Target Client

    1. 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,
    2. Have a friend that they are willing to refer to the study to be their 'peer' (support) and that peer agrees to participate,
    3. Are able to complete baseline and follow-up assessments and have a valid email,
    4. Are willing to be video recorded, and
    5. Are fluent in English
  • For the Peer

    1. Have weekly contact with the participating Target Client who referred them,
    2. Are will to attend all study procedures (i.e. baseline assessment, intervention, follow up),
    3. Are willing to be video record,
    4. Are fluent in English

Exclusion Criteria:

  • For the Target Client

    1. Are current students in the lead Investigator's classes,
    2. Are seeking residential treatment at the time of the screening call,
    3. Are incarcerated or court-ordered to receive treatment at the time of the screening call,
    4. Use drugs besides marijuana or alcohol over 45 of the past 90 days.
  • For the Peer

    1. Are current students in the lead Investigator's classes,
    2. Are seeking residential treatment at the time of the screening call,
    3. Are incarcerated or court-ordered to receive treatment at the time of the screening call,
    4. Use drugs besides marijuana or alcohol over 45 of the past 90 days,
    5. Are romantic partners of the Target Client

Sites / Locations

  • School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Peer-enhanced Motivational Interviewing

Motivational Interviewing

Waitlist Control

Arm Description

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 (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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change: Marijuana Consequences Questionnaire (MACQ)
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.
Change: Days of Combined Cannabis and Alcohol Use
Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)
Change: Days of Cannabis and Binge Alcohol Use
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.
Change: Drinking Consequences
From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
Change: Urine Testing
National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.

Full Information

First Posted
November 6, 2018
Last Updated
November 28, 2018
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03758131
Brief Title
Peer MI in FQHCs for Substance-using Emerging Adults
Official Title
Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Motivational Interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer-enhanced Motivational Interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Motivational Interviewing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Placebo Comparator
Arm Description
Those dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm.
Intervention Type
Behavioral
Intervention Name(s)
Peer-enhanced Motivational Interviewing
Other Intervention Name(s)
PMI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Other Intervention Name(s)
WC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Description
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.
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary Outcome Measure Information:
Title
Change: Marijuana Consequences Questionnaire (MACQ)
Description
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.
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Title
Change: Days of Combined Cannabis and Alcohol Use
Description
Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Title
Change: Days of Cannabis and Binge Alcohol Use
Description
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.
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Title
Change: Drinking Consequences
Description
From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Title
Change: Urine Testing
Description
National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.
Time Frame
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas C Smith, PhD
Phone
217-333-5308
Email
smithdc@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maggie A Helms, MBA
Phone
217-300-1159
Email
mhlms@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas C Smith, PhD
Organizational Affiliation
University of Illinois Urbana Champaign School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Social Work
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer MI in FQHCs for Substance-using Emerging Adults

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