Improving Brief Alcohol Interventions With a Behavioral Economic Supplement
24. října 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
393
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Missouri
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Columbia, Missouri, Spojené státy, 65211
- University of Missouri
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Tennessee
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Memphis, Tennessee, Spojené státy, 38152
- University of Memphis
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 27 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Žádný zásah: Assessment
Participants will fill out a battery of measures and receive no intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Alcohol Use from baseline to follow-up (4 timepoints)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: James G Murphy, Ph.D., University of Memphis
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. července 2012
Primární dokončení (Aktuální)
1. srpna 2017
Dokončení studie (Aktuální)
1. srpna 2017
Termíny zápisu do studia
První předloženo
8. července 2016
První předloženo, které splnilo kritéria kontroly kvality
12. července 2016
První zveřejněno (Odhad)
15. července 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. října 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. října 2017
Naposledy ověřeno
1. října 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 5R01AA020829-03 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu 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.
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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