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Peer MI in FQHCs for Substance-using Emerging Adults

28. listopadu 2018 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.)

Typ studie

Intervenční

Zápis (Očekávaný)

150

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Illinois
      • Urbana, Illinois, Spojené státy, 61801
        • School of Social Work

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 29 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Ostatní jména:
  • PMI
Aktivní komparátor: 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.
Behaviorální: 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.
Ostatní jména:
  • MI
Komparátor placeba: 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.
Behaviorální: 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.
Ostatní jména:
  • PMI
Jiný: 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.
Ostatní jména:
  • Toaleta

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change: Marijuana Consequences Questionnaire (MACQ)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Illinois at Urbana-Champaign

Spolupracovníci

University of Washington

Vyšetřovatelé

  • Vrchní vyšetřovatel: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. srpna 2019

Primární dokončení (Očekávaný)

1. února 2024

Dokončení studie (Očekávaný)

1. února 2024

Termíny zápisu do studia

První předloženo

6. listopadu 2018

První předloženo, které splnilo kritéria kontroly kvality

28. listopadu 2018

První zveřejněno (Aktuální)

29. listopadu 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. listopadu 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. listopadu 2018

Naposledy ověřeno

1. listopadu 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Smith17393FQHC

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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