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- Essai clinique NCT02834949
Improving Brief Alcohol Interventions With a Behavioral Economic Supplement
24 octobre 2017 mis à jour par: James G Murphy, University of Memphis
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and alcohol-related consequences in college students.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
BMIs are associated with reductions in alcohol consumption and related problems, but effect sizes are generally small.
One BMI trial indicated that behavioral economic variables such as low levels of proportionate substance-free reinforcement and inelastic demand for alcohol predicted poor intervention response, and that participants who successfully reduced their drinking increased their participation in academic and other substance-free activities.
A subsequent NIAAA R21 developed a substance-free activity session (SFAS) supplement to traditional alcohol BMIs that attempted to increase engagement in constructive alternatives to drinking by enhancing the salience of delayed rewards (academic and career success) and the patterns of behavior (academic engagement) leading to these outcomes.
This study indicated that a two session (alcohol BMI + SFAS) preventive intervention resulted in significantly greater reductions in alcohol problems relative to a two session (alcohol BMI + Relaxation) active control condition.
The BMI+ SFAS was also associated with significantly greater reductions in heavy drinking for participants with lower levels of substance-free reinforcement at baseline.
This was the first controlled study to demonstrate that a supplement to traditional BMIs can improve outcomes.
The current study will extend these promising pilot results by (a) increasing the efficacy of the behavioral economic SFAS by including booster contact, (b) increasing power and generalizability by recruiting 425 students from two universities and including a no-treatment control group, (c) measuring drinking, as well as behavioral economic mechanisms as mediators and moderators of intervention outcomes (delay discounting, alcohol reinforcing efficacy, substance-free reinforcement) at 5 time points over a sixteen month period, and (d) evaluating the economic costs and benefits associated with the SFAS.
The goals of the SFAS - increasing student engagement in academic, campus, and career-related activities- are consistent with the priorities of most colleges.
Type d'étude
Interventionnel
Inscription (Réel)
393
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Missouri
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Columbia, Missouri, États-Unis, 65211
- University of Missouri
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Tennessee
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Memphis, Tennessee, États-Unis, 38152
- University of Memphis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 27 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male and female University of Memphis and University of Missouri
- College freshman or sophomore
- Full time student status
- Report 2 or more heavy drinking episodes (5/4 drinks for men/women) in the past month
Exclusion Criteria:
- Employed more than 20 hours per week
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: BMI + SFAS
Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use.
A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities.
The SFAS will be described to participants as the "College Adjustment Session" and the session will be conducted using an MI plus personalized feedback approach.
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This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting.
Elements included in the feedback are: (a) comparison of the student's perception of how much college students drink and actual student norms, (b) a comparison of the student's alcohol consumption vs. norms, (c) an estimate of the student's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol.
Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
The clinician initiates a discussion of the student's college and career goals.
Students discuss the values that motivate them as well as how alcohol use may interfere with their ability to accomplish these goals.
Students then receive information on graduation rates and income benefits for those who attend and excel in college.
They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
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Comparateur actif: BMI + Relaxation Session
Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use.
A week later, they will receive a relaxation training session.
In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes).
At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.
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This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting.
Elements included in the feedback are: (a) comparison of the student's perception of how much college students drink and actual student norms, (b) a comparison of the student's alcohol consumption vs. norms, (c) an estimate of the student's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol.
Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes).
At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.
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Aucune intervention: Assessment
Participants will fill out a battery of measures and receive no intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Alcohol Use from baseline to follow-up (4 timepoints)
Délai: Baseline, 1-month, 6-months, 12-months and 16-months
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Self-reported drinks consumed in a typical week
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Baseline, 1-month, 6-months, 12-months and 16-months
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Change in Alcohol-related Problems from baseline to follow-up (4 timepoints)
Délai: Baseline, 1-month, 6-months, 12-months and 16-months
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Self-reported alcohol-related consequences
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Baseline, 1-month, 6-months, 12-months and 16-months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: James G Murphy, Ph.D., University of Memphis
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2012
Achèvement primaire (Réel)
1 août 2017
Achèvement de l'étude (Réel)
1 août 2017
Dates d'inscription aux études
Première soumission
8 juillet 2016
Première soumission répondant aux critères de contrôle qualité
12 juillet 2016
Première publication (Estimation)
15 juillet 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5R01AA020829-03 (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) ?
Oui
Description du régime IPD
The investigators will maintain a de-identified database and after they publish the primary outcomes, they will make an individual level data available to researchers who are conducting integrated analyses.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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