NCT03758131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

4.5 years

First QC Date

November 6, 2018

Last Update Submit

November 28, 2018

Conditions

Keywords

Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (5)

  • Change: Marijuana Consequences Questionnaire (MACQ)

    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: Urine Testing

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

Study Arms (3)

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.

Behavioral: Peer-enhanced Motivational Interviewing

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.

Behavioral: Motivational Interviewing

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.

Behavioral: Peer-enhanced Motivational InterviewingOther: Waitlist Control

Interventions

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.

Also known as: PMI
Peer-enhanced Motivational InterviewingWaitlist Control

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.

Also known as: MI
Motivational Interviewing

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.

Also known as: WC
Waitlist Control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Social Work

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Douglas C Smith, PhD

    University of Illinois Urbana Champaign School of Social Work

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas C Smith, PhD

CONTACT

Maggie A Helms, MBA

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 29, 2018

Study Start

August 1, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations