Peer MI for Substance-using Emerging Adults

October 9, 2018 updated by: Douglas Smith, University of Illinois at Urbana-Champaign

Peer-enhanced Motivational Interviewing for Emerging Adults With Risky Substance Use

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • School of Social Work
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peer-Enhanced Motivational Interviewing
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.
Behavioral: Peer-Enhanced Motivational Interviewing
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.
Other: Waitlist Control
Delayed Treatment.
Other: Waitlist Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GAIN Substance Problem Scale
Time Frame: Baseline and every 2 weeks during 12 week 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 DSM-IV
Baseline and every 2 weeks during 12 week post-intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GAIN Substance Frequency Scale (change)
Time Frame: Baseline and every 2 weeks during 12 week post-intervention period
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.
Baseline and every 2 weeks during 12 week post-intervention period
Rutgers Alcohol Problem Index (change)
Time Frame: Baseline and every 2 weeks during 12 week post-intervention period
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.
Baseline and every 2 weeks during 12 week post-intervention period
Significant Other Behavior Questionnaire
Time Frame: Baseline and every 2 weeks during 12 week post-intervention period
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.
Baseline and every 2 weeks during 12 week post-intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB17393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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