Brief Web-Based Alcohol Reduction Intervention for Undergraduates

This study is currently recruiting participants.
Verified September 2013 by Yale University
Sponsor:
Collaborators:
Alcoholic Beverage Medical Research Foundation
Information provided by (Responsible Party):
Robert Leeman, Yale University
ClinicalTrials.gov Identifier:
NCT01694082
First received: September 20, 2012
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Alcohol Use
Heavy Drinking
Negative Consequences of Alcohol Use
Behavioral: THRIVE
Behavioral: Brief brochure and assessment control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Frequency of alcohol use [ Time Frame: 1-month post-intervention ] [ Designated as safety issue: No ]
  • Protective behavioral strategy use [ Time Frame: 1-month post-intervention ] [ Designated as safety issue: No ]
  • Overall Weekly Alcohol Consumption [ Time Frame: 1-month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of heavy drinking days [ Time Frame: 1-month post-intervention ] [ Designated as safety issue: No ]
  • Frequency of alcohol use [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
  • Overall weekly alcohol consumption [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 248
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THRIVE replication
Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption.
Behavioral: THRIVE
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.
Other Name: Tertiary Health Research Intervention Via Email
Experimental: THRIVE direct strategies
Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking.
Behavioral: THRIVE
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.
Other Name: Tertiary Health Research Intervention Via Email
Experimental: THRIVE indirect strategies
Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking.
Behavioral: THRIVE
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.
Other Name: Tertiary Health Research Intervention Via Email
Sham Comparator: 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.
Behavioral: Brief brochure and assessment control

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694082

Contacts
Contact: Robert F Leeman, Ph.D. 203-974-7373 robert.leeman@yale.edu
Contact: Christine Nogueira, B.A. 203-974-5765 christine.nogueira@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Robert F Leeman, Ph.D.         
Sponsors and Collaborators
Yale University
Alcoholic Beverage Medical Research Foundation
Investigators
Principal Investigator: Robert F Leeman, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Robert Leeman, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01694082     History of Changes
Other Study ID Numbers: 1207010596, K01AA019694
Study First Received: September 20, 2012
Last Updated: September 2, 2013
Health Authority: United States: Yale University Human Investigation Committee

Keywords provided by Yale University:
brief intervention
web-based interventions
computer-based interventions
harm reduction
young adult
college student

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Nicotine polacrilex
Nicotine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on April 15, 2014