- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elizabeth Lehinger, PhD
- Número de teléfono: 206-685-2638
- Correo electrónico: bethl4@uw.edu
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Reclutamiento
- University of Washington School of Medicine
-
Contacto:
- Elizabeth Lehinger, PhD
- Número de teléfono: 206-685-2638
- Correo electrónico: bethl4@uw.edu
-
Investigador principal:
- Elizabeth Lehinger, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intervention Feasibility: Recruitment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Post-intervention during Year 2
|
Measure of acceptability of the intervention |
Post-intervention during Year 2
|
|
Weiner's Intervention Appropriateness measure
Periodo de tiempo: Post-intervention during Year 2
|
Measure of appropriateness of the intervention |
Post-intervention during Year 2
|
|
Weiner's Feasibility measure
Periodo de tiempo: Post-intervention during Year 2
|
Measure of feasibility of the intervention |
Post-intervention during Year 2
|
|
Intervention Feasibility: Enjoyment Ratings
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Heavy episodic drinking episodes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00020990
- K23AA032019 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 1 year after publication of the main outcomes with no end date.
Criterios de acceso compartido de IPD
Qualified researchers
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .