Peer MI in FQHCs for Substance-using Emerging Adults
28 de novembro de 2018 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Antecipado)
150
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Douglas C Smith, PhD
- Número de telefone: 217-333-5308
- E-mail: smithdc@illinois.edu
Estude backup de contato
- Nome: Maggie A Helms, MBA
- Número de telefone: 217-300-1159
- E-mail: mhlms@illinois.edu
Locais de estudo
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Illinois
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Urbana, Illinois, Estados Unidos, 61801
- School of Social Work
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 29 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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Comparador de 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.
Outros nomes:
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change: Global Appraisal of Individual Needs (GAIN) Substance Problem Scale
Prazo: 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.
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Baseline and at month 1, 2, 3, 6 and 9 post-intervention period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change: Marijuana Consequences Questionnaire (MACQ)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Douglas C Smith, PhD, University of Illinois Urbana Champaign School of Social Work
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de agosto de 2019
Conclusão Primária (Antecipado)
1 de fevereiro de 2024
Conclusão do estudo (Antecipado)
1 de fevereiro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
6 de novembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de novembro de 2018
Primeira postagem (Real)
29 de novembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de novembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de novembro de 2018
Última verificação
1 de novembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Smith17393FQHC
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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