- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01168726
Protective Behavioral Strategies and Brief Alcohol Interventions
15. juni 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
365
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Missouri
-
Columbia, Missouri, Forente stater, 65211
- University of Missouri
-
-
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 24 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Protective Behavioral Strategies
Personalized feedback on use of protective behavioral strategies.
|
Personalized feedback on use of protective behavioral strategies.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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).
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Matthew P Martens, PhD, University of Missouri-Columbia
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
1. januar 2010
Primær fullføring (Faktiske)
1. september 2010
Studiet fullført (Faktiske)
1. september 2010
Datoer for studieregistrering
Først innsendt
20. juli 2010
Først innsendt som oppfylte QC-kriteriene
21. juli 2010
Først lagt ut (Anslag)
23. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Protective Behaviors
- 1R21AA016779-01A2 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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. .