- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07839026
Greek Connections Study
Increasing Availability of and Engagement in Alcohol-Free Social Activities to Address Heavy Episodic Drinking and Alcohol Consequences Among Fraternity and Sorority College Students
The purpose of this study is to evaluate the feasibility and acceptability of an intervention aiming to reduce heavy episodic drinking and negative consequences from alcohol by increasing the availability of and engagement in alcohol-free social activities for college students who are affiliated with a fraternity or sorority organization.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The negative impact of heavy episodic drinking (HED) among college students continues to be a major public health issue, and students who are members of fraternities and sororities (Greek members) are at particularly greater risk for experiencing negative alcohol consequences due to frequent HED. This study integrates developmental and behavioral economic models of alcohol use to test an environmental approach to reducing alcohol-related harm among Greek members. Within the Greek community, chapters will plan and offer alcohol-free social activities for their chapter members to attend, providing alternatives to drinking events for building social connections. To increase usability and contextual fit, the program of alcohol-free social activities was developed and refined in collaboration with Greek members. The pilot trial is focused on evaluating the feasibility and acceptability of the intervention but will also evaluate changes in heavy episodic drinking and alcohol consequences using a pre-post design, with data collected across two consecutive academic years. Members of participating chapters will provide baseline data during Year 1 and receive the intervention during Year 2.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Elizabeth Lehinger, PhD
- Número de telefone: 206-685-2638
- E-mail: bethl4@uw.edu
Locais de estudo
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Recrutamento
- University of Washington School of Medicine
-
Contato:
- Elizabeth Lehinger, PhD
- Número de telefone: 206-685-2638
- E-mail: bethl4@uw.edu
-
Investigador principal:
- Elizabeth Lehinger, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Active membership in a sorority or fraternity organization at the University of Washington
- Age 18-29 years
Exclusion Criteria:
- None beyond failure to meet the inclusion criteria.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Alcohol-Free Social Activities Program
|
The Alcohol-Free Social Activities Program is a chapter-level behavioral intervention designed to increase the availability of and participation in rewarding social activities that do not involve alcohol among fraternity and sorority members. Participating chapters will receive a program toolkit containing guidance and procedures for planning and implementing alcohol-free social activities. Chapter leaders will select, plan, and implement activities for their members during the intervention period. The program is designed to increase opportunities for rewarding alcohol-free social experiences and strengthen social connection among chapter members. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intervention Feasibility: Recruitment
Prazo: From initiation of chapter recruitment through the end of Year 1 enrollment, approximately 18 months.
|
Number of chapters who agree to participate in the intervention |
From initiation of chapter recruitment through the end of Year 1 enrollment, approximately 18 months.
|
|
Intervention Feasibility: Retention
Prazo: From chapter enrollment through completion of the intervention period, approximately 14 months
|
The proportion of participating chapters that remain actively involved in the program through completion of the intervention period. |
From chapter enrollment through completion of the intervention period, approximately 14 months
|
|
Intervention Feasibility: Engagement
Prazo: The intervention delivery period (approximately 4 weeks) during year 2
|
Number of Greek members who attend the social activities |
The intervention delivery period (approximately 4 weeks) during year 2
|
|
Weiner's Acceptability measure
Prazo: Post-intervention during Year 2
|
Measure of acceptability of the intervention |
Post-intervention during Year 2
|
|
Weiner's Intervention Appropriateness measure
Prazo: Post-intervention during Year 2
|
Measure of appropriateness of the intervention |
Post-intervention during Year 2
|
|
Weiner's Feasibility measure
Prazo: Post-intervention during Year 2
|
Measure of feasibility of the intervention |
Post-intervention during Year 2
|
|
Intervention Feasibility: Enjoyment Ratings
Prazo: During the intervention period in Year 2
|
Ratings of enjoyment from Greek members who attend an alcohol-free social activity |
During the intervention period in Year 2
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Heavy episodic drinking episodes
Prazo: Assessment periods over two months of Year 1 and Year 2
|
Number of heavy episodic drinking episodes derived from the Daily Drinking Questionnaire |
Assessment periods over two months of Year 1 and Year 2
|
|
Alcohol consequences
Prazo: Assessment periods over two months of Year 1 and Year 2
|
Sum scores on the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) which assesses alcohol use consequences. Higher scores indicate worse outcome. |
Assessment periods over two months of Year 1 and Year 2
|
|
Intervention Feasibility: Practicality
Prazo: The intervention delivery period (approximately 4 weeks) during year 2
|
Time spent planning and facilitating alcohol-free social activities by chapters |
The intervention delivery period (approximately 4 weeks) during year 2
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elizabeth Lehinger, PhD, University of Washington
Publicações e links úteis
Publicações Gerais
- Murphy JG, Dennhardt AA. The behavioral economics of young adult substance abuse. Prev Med. 2016 Nov;92:24-30. doi: 10.1016/j.ypmed.2016.04.022. Epub 2016 May 3.
- Acuff SF, MacKillop J, Murphy JG. A contextualized reinforcer pathology approach to addiction. Nat Rev Psychol. 2023;2(5):309-323. doi: 10.1038/s44159-023-00167-y. Epub 2023 Mar 21.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00020990
- K23AA032019 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
This study will submit and share data with NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA). De-identified individual participant data underlying the results reported from this study will be made available to qualified researchers for secondary research purposes, consistent with participant consent, applicable institutional requirements, and the study's NIH-approved Data Management and Sharing Plan. Data will be de-identified prior to sharing. Data will be made available through NIAAADA and/or a controlled-access process. Researchers requesting access may be required to submit a research proposal and enter into a data use agreement that prohibits attempts to identify participants or participating organizations.
Prazo de Compartilhamento de IPD
Beginning 1 year after publication of the main outcomes with no end date.
Critérios de acesso de compartilhamento IPD
Qualified researchers
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .