Substance-Related DisordersPhase 2NCT03264872
Peer MI for Substance-using Emerging Adults
A Phase 2 study testing Peer-Enhanced Motivational Interviewing in people with Substance-Related Disorders, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Peer-Enhanced Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 31 Oct 2021
- 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.
United States1 site, 1 recruiting
- Recruiting
School of Social Work
Urbana, Illinois, 61801
Douglas C Smith, PhD, 217-333-5308, smithdc@illinois.edu
About this study
Official title: 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).
Read the 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).
- Conditions
- Substance-Related Disorders
- Being tested
- Peer-Enhanced 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
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.
Waitlist ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Enhanced Motivational Interviewing | Experimental | 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. Receives: Behavioral: Peer-Enhanced Motivational Interviewing |
| Waitlist Control | Other | Delayed Treatment. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and every 2 weeks during 12 week post-intervention period
Secondary outcomes (3)
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.
Measured: Baseline and every 2 weeks during 12 week post-intervention period
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.
Measured: Baseline and every 2 weeks during 12 week post-intervention period
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.
Measured: Baseline and every 2 weeks during 12 week 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 Aug 2017
- Study start8 Mar 2017
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Smith, University of Illinois at Urbana-Champaign
- Investigators
- Douglas C Smith, PhD, Principal investigator, University of Illinois Urbana Champaign School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264872
- Sponsor's protocol ID
- IRB17393
- Status last verified
- Oct 2018
- First submitted
- 23 Aug 2017
- Last updated
- 12 Oct 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 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-enhanced Motivational Interviewing for Emerging Adults With Risky Substance Use
- ClinicalTrials.gov ID
- NCT03264872
- Acronym / sponsor ID
- IRB17393
- Conditions
- Substance-Related Disorders
- Keywords
- Motivational Interviewing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 29 Aug 2017 (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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-Enhanced Motivational Interviewing | Experimental | Behavioral: Peer-Enhanced Motivational InterviewingBoth 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. |
| Waitlist Control | Other | Other: Waitlist ControlDelayed Treatment. |
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
- 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
Key exclusion criteria (11 listed)
- 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.
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 InterviewingTarget 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. | Behavioural | Peer-Enhanced Motivational Interviewing |
| Waitlist ControlAfter 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. | Other | Waitlist Control |
Primary outcome
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
3 secondary outcomes
GAIN Substance Frequency Scale (change)
Time frame: 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
Significant Other Behavior Questionnaire
Time frame: Baseline and every 2 weeks during 12 week 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 12 Oct 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 in people with Substance-Related 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 12 Oct 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. 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?
GAIN Substance Problem Scale (time frame: Baseline and every 2 weeks during 12 week 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 12 Oct 2018.