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Peer MI in FQHCs for Substance-using Emerging Adults

28 novembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.)

Tipo di studio

Interventistico

Iscrizione (Anticipato)

150

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Urbana, Illinois, Stati Uniti, 61801
        • School of Social Work

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 29 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • PMI
Comparatore attivo: 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.
Comportamentale: 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.
Altri nomi:
  • MI
Comparatore 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.
Comportamentale: 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.
Altri nomi:
  • PMI
Altro: 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.
Altri nomi:
  • Bagno

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change: Marijuana Consequences Questionnaire (MACQ)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Illinois at Urbana-Champaign

Collaboratori

University of Washington

Investigatori

  • Investigatore principale: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 agosto 2019

Completamento primario (Anticipato)

1 febbraio 2024

Completamento dello studio (Anticipato)

1 febbraio 2024

Date di iscrizione allo studio

Primo inviato

6 novembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

28 novembre 2018

Primo Inserito (Effettivo)

29 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 novembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 novembre 2018

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Smith17393FQHC

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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