<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03758131</url>
  </required_header>
  <id_info>
    <org_study_id>Smith17393FQHC</org_study_id>
    <nct_id>NCT03758131</nct_id>
  </id_info>
  <brief_title>Peer MI in FQHCs for Substance-using Emerging Adults</brief_title>
  <official_title>Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to test whether a Peer-Enhanced Motivational Interviewing&#xD;
      (PMI) intervention, which has been successful with college students, results in superior&#xD;
      alcohol and marijuana use outcomes for emerging adults (EA), ages 18-29, who are clients of&#xD;
      Federally-qualified Health Centers, and their peers. In the first phase of the study,&#xD;
      seventy-five peer dyads (total n = 150, ntarget client = 75, npeer = 75) will be randomized&#xD;
      to receive either Peer-Enhanced Motivational Interviewing (PMI), Motivational Interviewing&#xD;
      only (MI) or Waitlist Control (WC.) In the second, expanded phase of the study, an additional&#xD;
      325 peer dyads (total n = 650, ntarget client = 325, npeer = 325) will be randomized to&#xD;
      receive either Peer-Enhanced Motivational Interviewing, Motivational Interviewing only (MI)&#xD;
      or Waitlist Control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project randomizes peer dyads, consisting of one Emerging Adult (EA), 18-29 years old,&#xD;
      who both has a substance use problem and attends a Federally-qualified Health Center (i.e.&#xD;
      target client), and one peer, to one of three conditions. In the Peer-Enhanced Motivational&#xD;
      Interviewing (PMI) condition, target clients and peers will receive separate one-hour&#xD;
      sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps&#xD;
      individuals work through ambivalence about making changes in substance use. MI is thought to&#xD;
      work because it is a non-confrontational intervention where a therapist empathetically&#xD;
      reviews substance use behaviors, listens empathetically, and reinforces any client statements&#xD;
      indicating a desire to change. With the &quot;peer&quot; of each PMI dyad, the therapist presents peer&#xD;
      with data about the extent of the target client's substance use, builds the peer's motivation&#xD;
      to help their friend, and teaches the peer communication skills they can use to influence the&#xD;
      target client's substance use. In the Motivational Interviewing only (MI) condition, the&#xD;
      target client alone will receive the MI intervention with no peer participation. In the&#xD;
      Waitlist (WC) condition, target clients and peers can receive the intervention at 2 months&#xD;
      into the follow-up period for the PMI group.&#xD;
&#xD;
      The main purpose of this study is to test whether a Peer-Enhanced Motivational Interviewing&#xD;
      (PMI) intervention, which has been successful with college students, results in superior&#xD;
      alcohol and marijuana use outcomes for emerging adults (EA), ages 18-29, who are clients of&#xD;
      Federally-qualified Health Centers, and their peers. Seventy-five peer dyads (total n = 150,&#xD;
      ntarget client = 75, npeer = 75) will be randomized to receive either Peer-Enhanced&#xD;
      Motivational Interviewing (PMI), Motivational Interviewing only (MI) or Waitlist Control&#xD;
      (WC.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2019</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change: Marijuana Consequences Questionnaire (MACQ)</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change: Days of Combined Cannabis and Alcohol Use</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <description>Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change: Days of Cannabis and Binge Alcohol Use</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change: Drinking Consequences</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <description>From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change: Urine Testing</measure>
    <time_frame>Baseline and at month 1, 2, 3, 6 and 9 post-intervention period</time_frame>
    <description>National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Peer-enhanced Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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 &quot;peer&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer-enhanced Motivational Interviewing</intervention_name>
    <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 &quot;peer&quot; 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.</description>
    <arm_group_label>Peer-enhanced Motivational Interviewing</arm_group_label>
    <arm_group_label>Waitlist Control</arm_group_label>
    <other_name>PMI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <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.</description>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <other_name>MI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist Control</intervention_name>
    <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.</description>
    <arm_group_label>Waitlist Control</arm_group_label>
    <other_name>WC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For the Target Client&#xD;
&#xD;
               1. Score 5 or higher on the AUDIT-C measure and/or use alcohol or marijuana 13 days&#xD;
                  or more out of the past 90 days,&#xD;
&#xD;
               2. Have a friend that they are willing to refer to the study to be their 'peer'&#xD;
                  (support) and that peer agrees to participate,&#xD;
&#xD;
               3. Are able to complete baseline and follow-up assessments and have a valid email,&#xD;
&#xD;
               4. Are willing to be video recorded, and&#xD;
&#xD;
               5. Are fluent in English&#xD;
&#xD;
          -  For the Peer&#xD;
&#xD;
               1. Have weekly contact with the participating Target Client who referred them,&#xD;
&#xD;
               2. Are will to attend all study procedures (i.e. baseline assessment, intervention,&#xD;
                  follow up),&#xD;
&#xD;
               3. Are willing to be video record,&#xD;
&#xD;
               4. Are fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For the Target Client&#xD;
&#xD;
               1. Are current students in the lead Investigator's classes,&#xD;
&#xD;
               2. Are seeking residential treatment at the time of the screening call,&#xD;
&#xD;
               3. Are incarcerated or court-ordered to receive treatment at the time of the&#xD;
                  screening call,&#xD;
&#xD;
               4. Use drugs besides marijuana or alcohol over 45 of the past 90 days.&#xD;
&#xD;
          -  For the Peer&#xD;
&#xD;
               1. Are current students in the lead Investigator's classes,&#xD;
&#xD;
               2. Are seeking residential treatment at the time of the screening call,&#xD;
&#xD;
               3. Are incarcerated or court-ordered to receive treatment at the time of the&#xD;
                  screening call,&#xD;
&#xD;
               4. Use drugs besides marijuana or alcohol over 45 of the past 90 days,&#xD;
&#xD;
               5. Are romantic partners of the Target Client&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas C Smith, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois Urbana Champaign School of Social Work</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Douglas C Smith, PhD</last_name>
    <phone>217-333-5308</phone>
    <email>smithdc@illinois.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maggie A Helms, MBA</last_name>
    <phone>217-300-1159</phone>
    <email>mhlms@illinois.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Social Work</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motivational Interviewing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03758131
org study id: Smith17393FQHC
nct id: NCT03758131
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
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.
measure: Change: Marijuana Consequences Questionnaire (MACQ)
time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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.
measure: Change: Days of Combined Cannabis and Alcohol Use
time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
description: Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)
measure: Change: Days of Cannabis and Binge Alcohol Use
time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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.
measure: Change: Drinking Consequences
time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
description: From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
measure: Change: Urine Testing
time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
description: National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.
arm group label: Peer-enhanced Motivational Interviewing
arm group type: Experimental
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 group label: Motivational Interviewing
arm group type: Active Comparator
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 group label: Waitlist Control
arm group type: Placebo Comparator
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: Peer-enhanced Motivational Interviewing
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 group label: Peer-enhanced Motivational Interviewing
arm group label: Waitlist Control
other name: PMI
intervention type: Behavioral
intervention name: Motivational Interviewing
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.
arm group label: Motivational Interviewing
other name: MI
intervention type: Other
intervention name: Waitlist Control
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.
arm group label: Waitlist Control
other name: WC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Douglas C Smith, PhD
role: Principal Investigator
affiliation: University of Illinois Urbana Champaign School of Social Work
last name: Douglas C Smith, PhD
phone: 217-333-5308
email: smithdc@illinois.edu
last name: Maggie A Helms, MBA
phone: 217-300-1159
email: mhlms@illinois.edu
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No