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Peer MI in FQHCs for Substance-using Emerging Adults

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ClinicalTrials.gov Identifier: NCT03758131
Recruitment Status : Unknown
Verified November 2018 by University of Illinois at Urbana-Champaign.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Peer-enhanced Motivational Interviewing Behavioral: Motivational Interviewing Other: Waitlist Control Phase 2

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.)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: 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.
Other Name: PMI
Active Comparator: 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.
 Behavioral: Motivational Interviewing
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.
Other Name: MI
Placebo Comparator: 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.
 Behavioral: 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.
Other Name: PMI

Other: Waitlist Control
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.
Other Name: WC


Outcome Measures
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Primary Outcome Measures :
  1. Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change: Marijuana Consequences Questionnaire (MACQ) [ Time Frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period ]
    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.

  2. Change: Days of Combined Cannabis and Alcohol Use [ Time Frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period ]
    Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)

  3. Change: Days of Cannabis and Binge Alcohol Use [ Time Frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period ]
    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.

  4. Change: Drinking Consequences [ Time Frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period ]
    From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.

  5. Change: Urine Testing [ Time Frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period ]
    National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758131


Contacts
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Contact: Douglas C Smith, PhD 217-333-5308 smithdc@illinois.edu
Contact: Maggie A Helms, MBA 217-300-1159 mhlms@illinois.edu

Locations
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United States, Illinois
School of Social Work
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
University of Washington
Investigators
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Principal Investigator: Douglas C Smith, PhD University of Illinois Urbana Champaign School of Social Work
More Information
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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03758131    
Other Study ID Numbers: Smith17393FQHC
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Illinois at Urbana-Champaign:
Motivational Interviewing
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders