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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03264872
Other study ID # IRB17393
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 8, 2017
Est. completion date October 31, 2021

Study information

Verified date October 2018
Source University of Illinois at Urbana-Champaign
Contact Douglas C Smith, PhD
Phone 217-333-5308
Email smithdc@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 31, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States School of Social Work Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 DSM-IV Baseline and every 2 weeks during 12 week post-intervention period
Secondary GAIN Substance Frequency Scale (change) 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
Secondary Rutgers Alcohol Problem Index (change) 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
Secondary Significant Other Behavior Questionnaire 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
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