<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/NCT03264872</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17393</org_study_id>
    <nct_id>NCT03264872</nct_id>
  </id_info>
  <brief_title>Peer MI for Substance-using Emerging Adults</brief_title>
  <official_title>Peer-enhanced Motivational Interviewing for Emerging Adults With Risky Substance Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 project is to test whether Peer-Enhanced Motivational Interviewing&#xD;
      (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages&#xD;
      18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)&#xD;
      are randomized to receive either Peer-Enhanced Motivational Interviewing (PMI) or Waitlist&#xD;
      Control (WC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project randomized peer dyads, consisting of one EA (Emerging Adult; 18-29 years old)&#xD;
      with a substance use problem (i.e. target client) and one peer, to one of two conditions. In&#xD;
      the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will&#xD;
      receive separate one-hour sessions of Motivational Interviewing (MI) , an&#xD;
      empirically-supported treatment that helps individuals work through ambivalence about making&#xD;
      changes in substance use. MI is thought to work because it is a non-confrontational&#xD;
      intervention where a therapist empathetically reviews substance use behaviors, listens&#xD;
      empathetically, and reinforces any client statements indicating a desire to change. With the&#xD;
      'peer' of each PMI dyad, the therapist presents peers with data about the extent of the&#xD;
      target client's substance use, builds the peer's motivation to help their friend, and teaches&#xD;
      the peer communication skills they can use to influence the target client's substance use. In&#xD;
      the WC condition, target clients and peers can receive PMI after the study follow-up period.&#xD;
      Both target clients and their peers are followed for 12 weeks post-intervention.&#xD;
&#xD;
      The main purpose of this project is to test whether Peer-Enhanced Motivational Interviewing&#xD;
      (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages&#xD;
      18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)&#xD;
      are randomized to receive either Peer-Enhanced Motivational Intervie (PMI) or Waitlist&#xD;
      Control (WC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</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>GAIN Substance Problem Scale</measure>
    <time_frame>Baseline and every 2 weeks during 12 week 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 DSM-IV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GAIN Substance Frequency Scale (change)</measure>
    <time_frame>Baseline and every 2 weeks during 12 week post-intervention period</time_frame>
    <description>The GAIN substance frequency scale (SFS) measures the percent of days of substance use and percent of days of related problems from such substance use. This scale encompasses a large number of classes of substances, found to be ideal for measurement among poly- substance using individuals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgers Alcohol Problem Index (change)</measure>
    <time_frame>Baseline and every 2 weeks during 12 week post-intervention period</time_frame>
    <description>a 23-item self-administered screening tool (questionnaire) for assessing adolescent problem drinking. Respondents simply circle the number that corresponds to the number of times they have experienced each problem. Items can also be read aloud by an interviewer to clients with reading difficulties or it can be used as a springboard for a discussion of problems related to the client's alcohol use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant Other Behavior Questionnaire</measure>
    <time_frame>Baseline and every 2 weeks during 12 week post-intervention period</time_frame>
    <description>An instrument measuring the specific social support in terms of the patient's drinking. Assessments of the significant other's behavior in the presence of the patient drinking is provided by both the patient and significant other.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Peer-Enhanced Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both dyad members, the target client and their peer support person, in this Peer-Enhanced Motivational Interviewing arm will receive separate one-hour Motivational Interviewing (MI) sessions with a trained counselor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delayed Treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer-Enhanced Motivational Interviewing</intervention_name>
    <description>Target clients in this Peer-Enhanced Motivational Interviewing arm will receive separate one-hour Motivational Interviewing (MI) sessions, in which the therapist reviews the target clients substance use behaviors in a non-confrontational manner, listens empathetically, and reinforces any client statements indicating a desire the change. In this arm, the therapist also presents the target client's 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 sills they can use to influence the target client's substance use behaviors.</description>
    <arm_group_label>Peer-Enhanced Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist Control</intervention_name>
    <description>After the 12 week follow up period, if subjects in the Waitlist Control group desire to receive the Peer-Enhanced Motivational Interviewing intervention, that will be made available to them.</description>
    <arm_group_label>Waitlist Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the Target Client&#xD;
&#xD;
          -  Score 5 or higher on the AUDIT-C measure and/or use alcohol or marijuana 13 days or&#xD;
             more out of the past 90 days,&#xD;
&#xD;
          -  Have a friend that they are willing to refer to the study to be their 'peer' (support)&#xD;
             and that peer agrees to participate,&#xD;
&#xD;
          -  Are able to complete baseline and follow-up assessments and have a valid email,&#xD;
&#xD;
          -  Are willing to be video recorded, and&#xD;
&#xD;
          -  Are fluent in English&#xD;
&#xD;
        For the Peer&#xD;
&#xD;
          -  Have weekly contact with the participating Target Client who referred them,&#xD;
&#xD;
          -  Are will to attend all study procedures (i.e. baseline assessment, intervention,&#xD;
             follow up),&#xD;
&#xD;
          -  Are willing to be video record,&#xD;
&#xD;
          -  Are fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For the Target Client&#xD;
&#xD;
          -  Are current students in the lead Investigator's classes,&#xD;
&#xD;
          -  Are seeking residential treatment at the time of the screening call,&#xD;
&#xD;
          -  Are incarcerated or court-ordered to receive treatment at the time of the screening&#xD;
             call,&#xD;
&#xD;
          -  Use drugs besides marijuana or alcohol over 45 of the past 90 days.&#xD;
&#xD;
        For the Peer&#xD;
&#xD;
          -  Are current students in the lead Investigator's classes,&#xD;
&#xD;
          -  Are seeking residential treatment at the time of the screening call,&#xD;
&#xD;
          -  Are incarcerated or court-ordered to receive treatment at the time of the screening&#xD;
             call,&#xD;
&#xD;
          -  Use drugs besides marijuana or alcohol over 45 of the past 90 days,&#xD;
&#xD;
          -  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>Catharaine Fairbairn, PhD</last_name>
    <phone>(217) 333-0631</phone>
    <email>cfairbai@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>
    <status>Recruiting</status>
    <contact>
      <last_name>Douglas C Smith, PhD</last_name>
      <phone>217-333-5308</phone>
      <email>smithdc@illinois.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Urbana-Champaign</investigator_affiliation>
    <investigator_full_name>Douglas Smith</investigator_full_name>
    <investigator_title>Associate Professor, School of Social Work</investigator_title>
  </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/NCT03264872
org study id: IRB17393
nct id: NCT03264872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this project is to test whether Peer-Enhanced Motivational Interviewing
      (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages
      18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)
      are randomized to receive either Peer-Enhanced Motivational Interviewing (PMI) or Waitlist
      Control (WC).
This project randomized peer dyads, consisting of one EA (Emerging Adult; 18-29 years old)
      with a substance use problem (i.e. target client) and one peer, to one of two 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 peers 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 WC condition, target clients and peers can receive PMI after the study follow-up period.
      Both target clients and their peers are followed for 12 weeks post-intervention.

      The main purpose of this project is to test whether Peer-Enhanced Motivational Interviewing
      (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages
      18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)
      are randomized to receive either Peer-Enhanced Motivational Intervie (PMI) or Waitlist
      Control (WC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: GAIN Substance Problem Scale
time frame: Baseline and every 2 weeks during 12 week 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 DSM-IV
measure: GAIN Substance Frequency Scale (change)
time frame: Baseline and every 2 weeks during 12 week post-intervention period
description: The GAIN substance frequency scale (SFS) measures the percent of days of substance use and percent of days of related problems from such substance use. This scale encompasses a large number of classes of substances, found to be ideal for measurement among poly- substance using individuals.
measure: Rutgers Alcohol Problem Index (change)
time frame: Baseline and every 2 weeks during 12 week post-intervention period
description: a 23-item self-administered screening tool (questionnaire) for assessing adolescent problem drinking. Respondents simply circle the number that corresponds to the number of times they have experienced each problem. Items can also be read aloud by an interviewer to clients with reading difficulties or it can be used as a springboard for a discussion of problems related to the client's alcohol use.
measure: Significant Other Behavior Questionnaire
time frame: Baseline and every 2 weeks during 12 week post-intervention period
description: An instrument measuring the specific social support in terms of the patient's drinking. Assessments of the significant other's behavior in the presence of the patient drinking is provided by both the patient and significant other.
arm group label: Peer-Enhanced Motivational Interviewing
arm group type: Experimental
description: Both dyad members, the target client and their peer support person, in this Peer-Enhanced Motivational Interviewing arm will receive separate one-hour Motivational Interviewing (MI) sessions with a trained counselor.
arm group label: Waitlist Control
arm group type: Other
description: Delayed Treatment.
intervention type: Behavioral
intervention name: Peer-Enhanced Motivational Interviewing
description: Target clients in this Peer-Enhanced Motivational Interviewing arm will receive separate one-hour Motivational Interviewing (MI) sessions, in which the therapist reviews the target clients substance use behaviors in a non-confrontational manner, listens empathetically, and reinforces any client statements indicating a desire the change. In this arm, the therapist also presents the target client's 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 sills they can use to influence the target client's substance use behaviors.
arm group label: Peer-Enhanced Motivational Interviewing
intervention type: Other
intervention name: Waitlist Control
description: After the 12 week follow up period, if subjects in the Waitlist Control group desire to receive the Peer-Enhanced Motivational Interviewing intervention, that will be made available to them.
arm group label: Waitlist Control
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: Catharaine Fairbairn, PhD
phone: (217) 333-0631
email: cfairbai@illinois.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Urbana-Champaign
investigator full name: Douglas Smith
investigator title: Associate Professor, School of Social Work
mesh term: Substance-Related Disorders
sharing ipd: No