Substance Use DisordersPhase 2NCT03758131
Peer MI in FQHCs for Substance-using Emerging Adults
A Phase 2 study testing Peer-enhanced Motivational Interviewing and Motivational Interviewing in people with Substance Use Disorders, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Peer-enhanced Motivational Interviewing and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
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.
Read the detailed 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.)
- Conditions
- Substance Use Disorders
- Being tested
- Peer-enhanced Motivational Interviewing, Motivational Interviewing, Waitlist Control
- Keywords
- Motivational Interviewing
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-enhanced Motivational InterviewingBehavioural
Also called PMI
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 InterviewingBehavioural
Also called MI
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.
Waitlist ControlOther
Also called WC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Peer-enhanced Motivational Interviewing; Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Secondary outcomes (5)
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.
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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)
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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.
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Drinking Consequences
From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Urine Testing
National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.
Measured: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study startAug 2019 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Douglas C Smith, PhD, Principal investigator, University of Illinois Urbana Champaign School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758131
- Sponsor's protocol ID
- Smith17393FQHC
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
- ClinicalTrials.gov ID
- NCT03758131
- Acronym / sponsor ID
- Smith17393FQHC
- Conditions
- Substance Use Disorders
- Keywords
- Motivational Interviewing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Aug 2019 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer-enhanced Motivational Interviewing | Experimental | Behavioral: Peer-enhanced Motivational InterviewingIn 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 | Active comparator | Behavioral: Motivational InterviewingIn 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. |
| Waitlist Control | Placebo comparator | Behavioral: Peer-enhanced Motivational Interviewing, Other: Waitlist ControlThose dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- For the Target Client
- For the Peer
Key exclusion criteria (11 listed)
- For the Target Client
- For the Peer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-enhanced Motivational InterviewingAlso: PMIIn 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. | Behavioural | Peer-enhanced Motivational Interviewing, Waitlist Control |
| Motivational InterviewingAlso: MIIn 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. | Behavioural | Motivational Interviewing |
| Waitlist ControlAlso: WCDyads 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. | Other | Waitlist Control |
Primary outcome
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Time frame: Baseline and at month 1, 2, 3, 6 and 9 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 Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV.
5 secondary outcomes
Change: Marijuana Consequences Questionnaire (MACQ)
Time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Days of Combined Cannabis and Alcohol Use
Time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Days of Cannabis and Binge Alcohol Use
Time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Drinking Consequences
Time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Urine Testing
Time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas C Smith, PhD principal investigator
University of Illinois Urbana Champaign School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peer-enhanced Motivational Interviewing and Motivational Interviewing in people with Substance Use Disorders, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas C Smith, PhD (217-333-5308, smithdc@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale (time frame: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.