- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03758131
Peer MI in FQHCs for Substance-using Emerging Adults
Peer-enhanced Motivational Interviewing in Federally-Qualified Health Clinics for Substance-using Emerging Adults
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.)
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Douglas C Smith, PhD
- Numéro de téléphone: 217-333-5308
- E-mail: smithdc@illinois.edu
Sauvegarde des contacts de l'étude
- Nom: Maggie A Helms, MBA
- Numéro de téléphone: 217-300-1159
- E-mail: mhlms@illinois.edu
Lieux d'étude
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Illinois
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Urbana, Illinois, États-Unis, 61801
- School of Social Work
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
Autres noms:
|
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Comparateur actif: Motivational Interviewing
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.
|
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.
Autres noms:
|
|
Comparateur placebo: Waitlist Control
Those dyads randomized to the Waitlist Control (WC) condition willl be offered teh PMI intervention at month 2 post-intervention for the PMI arm.
|
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.
Autres noms:
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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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.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change: Marijuana Consequences Questionnaire (MACQ)
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
|
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.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Days of Combined Cannabis and Alcohol Use
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Past month measure of days (out of past 30) when participant used both marijuana and alcohol (based on Stein et al., 2018)
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Days of Cannabis and Binge Alcohol Use
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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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.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Drinking Consequences
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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From the Rutgers Alcohol Problems Index and used to indicate indicates the frequency of experiencing negative consequences due to alcohol use.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Change: Urine Testing
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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National Institute of Drub Abuse-approved urine test kit to determine presence of Marijuana metabolites in urine.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Smith17393FQHC
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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