- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Elizabeth Lehinger, PhD
- Numéro de téléphone: 206-685-2638
- E-mail: bethl4@uw.edu
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98105
- Recrutement
- University of Washington School of Medicine
-
Contact:
- Elizabeth Lehinger, PhD
- Numéro de téléphone: 206-685-2638
- E-mail: bethl4@uw.edu
-
Chercheur principal:
- Elizabeth Lehinger, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Feasibility: Recruitment
Délai: 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
Délai: 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
Délai: 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
Délai: Post-intervention during Year 2
|
Measure of acceptability of the intervention |
Post-intervention during Year 2
|
|
Weiner's Intervention Appropriateness measure
Délai: Post-intervention during Year 2
|
Measure of appropriateness of the intervention |
Post-intervention during Year 2
|
|
Weiner's Feasibility measure
Délai: Post-intervention during Year 2
|
Measure of feasibility of the intervention |
Post-intervention during Year 2
|
|
Intervention Feasibility: Enjoyment Ratings
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heavy episodic drinking episodes
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Elizabeth Lehinger, PhD, University of Washington
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00020990
- K23AA032019 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage IPD
Beginning 1 year after publication of the main outcomes with no end date.
Critères d'accès au partage IPD
Qualified researchers
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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