- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01694082
Brief Web-Based Alcohol Reduction Intervention for Undergraduates
12. juni 2014 opdateret af: Robert Leeman, Yale University
Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates
Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet is very brief and has established efficacy.
This study aims to test versions of THRIVE tailored to American college students.
In addition to replicating original results with THRIVE, we will also test versions containing unique subsets of protective behavioral strategies to reduce alcohol consumption.
The primary hypothesis is that versions of THRIVE will be associated with lower overall alcohol consumption than an assessment and brief brochure control condition.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
207
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06519
- Yale University School Of Medicine
-
-
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:
- Must be a current student at Albertus Magnus College in New Haven, CT
Exclusion Criteria:
- Under 18 years of age
- 25 years of age or older
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: THRIVE replication
Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption.
|
THRIVE stands for (Tertiary Health Research Intervention Via Email).
Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
Andre navne:
|
|
Eksperimentel: THRIVE direct strategies
Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking.
|
THRIVE stands for (Tertiary Health Research Intervention Via Email).
Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
Andre navne:
|
|
Eksperimentel: THRIVE indirect strategies
Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking.
|
THRIVE stands for (Tertiary Health Research Intervention Via Email).
Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
Andre navne:
|
|
Sham-komparator: Brief brochure and assessment control
Participants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency of alcohol use
Tidsramme: 1-month post-intervention
|
1-month post-intervention
|
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Protective behavioral strategy use
Tidsramme: 1-month post-intervention
|
1-month post-intervention
|
|
Overall Weekly Alcohol Consumption
Tidsramme: 1-month post-intervention
|
1-month post-intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency of heavy drinking days
Tidsramme: 1-month post-intervention
|
1-month post-intervention
|
|
Frequency of alcohol use
Tidsramme: 6-months post-intervention
|
6-months post-intervention
|
|
Overall weekly alcohol consumption
Tidsramme: 6-months post-intervention
|
6-months post-intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert F Leeman, Ph.D., Yale University
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. oktober 2012
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
20. september 2012
Først indsendt, der opfyldte QC-kriterier
24. september 2012
Først opslået (Skøn)
26. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1207010596
- K01AA019694 (U.S. NIH-bevilling/kontrakt)
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 .