- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01168726
Protective Behavioral Strategies and Brief Alcohol Interventions
15. juni 2017 opdateret af: Matthew P. Martens, University of Missouri-Columbia
Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact.
The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit.
Subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition.
It is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students.
Previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes.
One common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (PBS).
However, there are two important factors that limit our understanding of the effects of PBS on client outcomes.
First, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist.
Second, researchers have yet to conduct studies that dismantle the specific effects associated with the PBS component on client outcomes.
That is, studies have not tested interventions with and without assessment and feedback regarding a client's use of PBS.
Participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on PBS, a brief intervention that does not include this focus, and an education-only control condition.
Participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups.
Mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in PBS result in reductions in alcohol use/alcohol-related problems.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
365
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Missouri
-
Columbia, Missouri, Forenede Stater, 65211
- University of Missouri
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 24 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- At least one binge drinking episode in the preceding month
Exclusion Criteria:
- At-risk for alcohol dependence or major depressive disorder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Protective Behavioral Strategies
Personalized feedback on use of protective behavioral strategies.
|
Personalized feedback on use of protective behavioral strategies.
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Eksperimentel: Personalized Normative Feedback
Personalized feedback on how one's own drinking compares to relevant norms.
|
Personalized feedback on how one's own drinking compares to relevant norms.
|
Aktiv komparator: Alcohol Education
Educational information about harms associated with heavy drinking.
|
Educational information about harms associated with heavy drinking.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Drinks Per Week
Tidsramme: 6 Months
|
6 Months
|
|
Rutgers Alcohol Problems Index (RAPI)
Tidsramme: 6 months
|
Total scores on an alcohol problems scale.
Possible score range = 0-92.
Higher scores are indicative of more alcohol-related problems.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Drinking Norms Rating Form
Tidsramme: 6 months
|
Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form.
Higher values indicate that the individual perceives higher levels of drinking among other students.
Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.
|
6 months
|
Protective Behavioral Strategies Scale.
Tidsramme: 6 months
|
Use of protective behavioral strategies related to alcohol use.
Higher scores indicate more use of the strategies.
A total score was calculated by summing the three subscale scores on the measure (range = 3-18).
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6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Matthew P Martens, PhD, University of Missouri-Columbia
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Faktiske)
1. september 2010
Studieafslutning (Faktiske)
1. september 2010
Datoer for studieregistrering
Først indsendt
20. juli 2010
Først indsendt, der opfyldte QC-kriterier
21. juli 2010
Først opslået (Skøn)
23. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Protective Behaviors
- 1R21AA016779-01A2 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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