Efficacy and Mechanisms of Technology-based Behavioral Interventions
2 other identifiers
interventional
600
1 country
5
Brief Summary
Large scale surveys indicate that approximately 68% of college students drink alcohol every month and 40% of college students engage in heavy episodic drinking. Despite prevention/intervention efforts, problematic alcohol consumption among college students continues to result in an estimated 1,800 deaths and 600,000 injuries annually, and epidemiological studies demonstrate no appreciable decrease in risk among college students. The purpose of the proposed research is to improve extant college-drinking interventions by advancing the dissemination methodology and the intervention content (Specific Aim 1). As a methodological improvement, rapid advances in mobile computing makes ecological momentary interventions (EMIs) increasingly feasible. EMIs refer to interventions that can be delivered multiple times and "in the moment". EMIs can optimize the timing and location of the intervention while also increasing the dose of the intervention. To improve the intervention content, the researchers will examine protective behavioral strategies (PBS) to reduce alcohol problems, not just alcohol use. PBS are behaviors that one can engage in immediately prior to, during, and immediately following alcohol use that limit alcohol use and/or alcohol-related harm. Research suggests that PBS use can protect individuals from alcohol problems above and beyond its effect on reducing alcohol use. The primary purpose of this research is to provide a more powerful test of a PBS intervention's effects on alcohol-related consequences by using a technology-based intervention methodology (i.e., EMI). Participants will be randomized into to a fully crossed, 3 (Standard BMI, BMI with a PBS component, control) X 2 (PBS-based EMI, Ecological Assessment Only) design. These 6 conditions will answer several critically important research questions (Specific Aim 2): a) does the addition of a PBS component improve the efficacy of a standard BMI, b) does a PBS-based EMI improve efficacy over the standard, single session BMI, c) does the combination of motivation-based intervention (BMI) with a skills-based intervention (EMI) yield even greater decreases in consequences (i.e., moderation). A final purpose of this research is to examine PBS norms, PBS perceived effectiveness, and motivation to change PBS use as novel mediators of the improved interventions. Results can be used to disseminate more effective college drinking interventions that are cheaper and more efficacious.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMarch 23, 2021
March 1, 2021
4.5 years
April 16, 2018
March 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Alcohol Consumption
Alcohol Use Disorders Identification Test (general consumption)
6-months
Alcohol Consumption
Modified version of the Daily Drinking Questionnaire (typical weekly consumption)
6-months
Secondary Outcomes (1)
Alcohol Consequences
6-months
Other Outcomes (4)
Mechanisms of behavior change (PBS use)
6-months
Mechanisms of behavior change (PBS helpfulness)
6-months
Mechanisms of behavior change (PBS motivation)
6-months
- +1 more other outcomes
Study Arms (6)
No single-session intervention-EMA
NO INTERVENTIONParticipants will be assessed both using a computer and using their phone. However, they will not receive an intervention at the start of the study and will only be using their phone for ecological assessment only data collection.
Standard single-session intervention-EMA
ACTIVE COMPARATORParticipants will take a computerized BMI with known efficacy, the college drinker's check up, and will be followed up. Participants in this condition will interact with their phone only for assessment purposes.
Augment single-session intervention-EMA
EXPERIMENTALParticipants will take a computerized BMI with known efficacy, the college drinker's check up, and will also take a computerized intervention developed to increase the use of protective behavioral strategies during drinking (Protective Behavioral Strategies Intervention). Participants in this condition will interact with their phone only for assessment purposes.
No single-session intervention-EMI
EXPERIMENTALParticipants in this group will not take a single-session intervention at baseline, but will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).
Standard single-session intervention-EMI
EXPERIMENTALParticipants will take a computerized BMI with known efficacy, the college drinker's check up, and will be followed up. Participants in this condition will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).
Augment single-session intervention-EMI
EXPERIMENTALParticipants will take a computerized BMI with known efficacy, the college drinker's check up, and will also take a computerized intervention developed to increase the use of protective behavioral strategies during drinking (Protective Behavioral Strategies Intervention). Participants in this condition will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).
Interventions
The College Drinker's Check-up (CDCU) is a single session, computer-based brief motivational intervention for heavy drinking college students. It takes a student about 45 minutes to go through it.
This intervention component focuses on educating and promoting PBS activities in future college drinking situations
This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.
Eligibility Criteria
You may qualify if:
- Current college students at the sponsor institution at the time of enrollment
- Between the ages of 18 and 25
- Consumed at least standard drink of alcohol in the past 4 weeks
You may not qualify if:
- Under age of 18 or older than 25
- Not a college student
- Did not drink alcohol in the past 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
California State University Dominguez Hills
Carson, California, 90747, United States
Colorado State University
Fort Collins, Colorado, 80523, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Old Dominion University
Norfolk, Virginia, 23529, United States
William and Mary
Williamsburg, Virginia, 23187, United States
Related Publications (4)
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
PMID: 8329970BACKGROUNDCollins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
PMID: 3998247BACKGROUNDRead JP, Kahler CW, Strong DR, Colder CR. Development and preliminary validation of the young adult alcohol consequences questionnaire. J Stud Alcohol. 2006 Jan;67(1):169-77. doi: 10.15288/jsa.2006.67.169.
PMID: 16536141BACKGROUNDMartens MP, Ferrier AG, Sheehy MJ, Corbett K, Anderson DA, Simmons A. Development of the Protective Behavioral Strategies Survey. J Stud Alcohol. 2005 Sep;66(5):698-705. doi: 10.15288/jsa.2005.66.698.
PMID: 16329461BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James M Henson, Ph.D.
Old Dominion University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Psychology
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 27, 2018
Study Start
November 15, 2017
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
March 23, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share