- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02834949
Improving Brief Alcohol Interventions With a Behavioral Economic Supplement
24. oktober 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
393
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Missouri
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Columbia, Missouri, Forente stater, 65211
- University of Missouri
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Tennessee
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Memphis, Tennessee, Forente stater, 38152
- University of Memphis
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 27 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv komparator: 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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Ingen inngripen: Assessment
Participants will fill out a battery of measures and receive no intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Alcohol Use from baseline to follow-up (4 timepoints)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: James G Murphy, Ph.D., University of Memphis
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2012
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. august 2017
Datoer for studieregistrering
Først innsendt
8. juli 2016
Først innsendt som oppfylte QC-kriteriene
12. juli 2016
Først lagt ut (Anslag)
15. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5R01AA020829-03 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
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.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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