Ultra-brief Intervention for Problem Drinkers
1 other identifier
interventional
1,767
2 countries
4
Brief Summary
The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets. Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition. Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet. Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2008
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 9, 2013
April 1, 2013
2 years
May 30, 2008
April 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
frequency of alcohol consumption
measured at 3 and 6 months into the study
alcoholic drinks per occasion
measured at 3 and 6 months into the study
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATORNo intervention control
NO INTERVENTIONInterventions
participants in this condition will be mailed their respective pamphlets
The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.
Eligibility Criteria
You may qualify if:
- Age 19 years or more
- Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Washington
Seattle, Washington, 98105-6099, United States
University of Alberta
Edmonton, Alberta, T6G 2H1, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Publications (2)
Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.
PMID: 23110157DERIVEDCunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: research protocol. BMC Public Health. 2008 Aug 26;8:298. doi: 10.1186/1471-2458-8-298.
PMID: 18727823DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Cunningham, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
May 30, 2008
First Posted
June 3, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 9, 2013
Record last verified: 2013-04