Peer MI in FQHCs for Substance-using Emerging Adults

Substance Use Disorders Clinical Trial

Official title:

Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03758131
• Other study ID #: Smith17393FQHC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2019
• Est. completion date: February 2024

Study information

• Verified date: November 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
• Study type: Interventional

Clinical Trial 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.

Description:

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.)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• For the Target Client

1. 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,

2. Have a friend that they are willing to refer to the study to be their 'peer' (support) and that peer agrees to participate,

3. Are able to complete baseline and follow-up assessments and have a valid email,

4. Are willing to be video recorded, and

5. Are fluent in English

• For the Peer

1. Have weekly contact with the participating Target Client who referred them,

2. Are will to attend all study procedures (i.e. baseline assessment, intervention, follow up),

3. Are willing to be video record,

4. Are fluent in English

Exclusion Criteria:

• For the Target Client

1. Are current students in the lead Investigator's classes,

2. Are seeking residential treatment at the time of the screening call,

3. Are incarcerated or court-ordered to receive treatment at the time of the screening call,

4. Use drugs besides marijuana or alcohol over 45 of the past 90 days.

• For the Peer

1. Are current students in the lead Investigator's classes,

2. Are seeking residential treatment at the time of the screening call,

3. Are incarcerated or court-ordered to receive treatment at the time of the screening call,

4. Use drugs besides marijuana or alcohol over 45 of the past 90 days,

5. Are romantic partners of the Target Client

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Peer-enhanced Motivational Interviewing
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.
• Motivational Interviewing
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.

Other:
• Waitlist Control
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change: Marijuana Consequences Questionnaire (MACQ)	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.	Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary	Change: Days of Combined Cannabis and Alcohol Use	Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)	Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary	Change: Days of Cannabis and Binge Alcohol Use	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.	Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary	Change: Drinking Consequences	From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.	Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary	Change: Urine Testing	National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.	Baseline and at month 1, 2, 3, 6 and 9 post-intervention period