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Peer MI in FQHCs for Substance-using Emerging Adults

28 novembre 2018 mis à jour par: University of Illinois at Urbana-Champaign

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.

Aperçu de l'étude

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

Interventionnel

Inscription (Anticipé)

150

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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

    • Illinois
      • Urbana, Illinois, États-Unis, 61801
        • School of Social Work

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 29 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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:
  • AMP
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:
  • MI
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:
  • AMP
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:
  • Toilettes

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Délai: 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.
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
Change: Days of Combined Cannabis and Alcohol Use
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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
Change: Days of Cannabis and Binge Alcohol Use
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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
Change: Drinking Consequences
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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
Change: Urine Testing
Délai: Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 août 2019

Achèvement primaire (Anticipé)

1 février 2024

Achèvement de l'étude (Anticipé)

1 février 2024

Dates d'inscription aux études

Première soumission

6 novembre 2018

Première soumission répondant aux critères de contrôle qualité

28 novembre 2018

Première publication (Réel)

29 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Smith17393FQHC

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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