- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510728
Efficacy and Mechanisms of Technology-based Behavioral Interventions
Study Overview
Status
Conditions
Detailed Description
Hazardous alcohol use among college students is a significant public health concern that has resulted in the development of numerous interventions. Although motivational interviewing components are effective at reducing problematic alcohol consumption among college students via reductions in descriptive norms (i.e., the perceived drinking by peers), the effects of single-session brief motivational interventions (BMIs) on alcohol use and consequences are relatively short-lived (i.e., 3 months). Guided by a harm-reduction perspective, researchers have become increasingly interested in how protective behavioral strategies (PBS) can impact alcohol consequences beyond the effects of reduced alcohol consumption. PBS have been found to be a robust predictor of alcohol-related problems controlling for consumption, and multiple intervention studies have found that PBS mediates intervention effects. Few studies, however, have examined the efficacy of PBS-related intervention components.
Specific Aim 1a: The researchers will augment and improve extant college alcohol interventions by developing and rigorously evaluating an added PBS component to an existing BMI with demonstrated efficacy to further reduce alcohol-related consequences beyond what is explained by reduced consumption.
An additional goal of this research is to deliver PBS in a way that capitalizes on newer technologies that allow for the repeated in vivo delivery of alcohol interventions. Given the widespread use of handheld devices among the college population, ecological momentary intervention (EMI) shows great promise in producing lasting behavior for a modest cost.
Specific Aim 1b: The researchers will develop a technology-based, college-drinking ecological momentary intervention (EMI; a newer, less explored methodology) that is disseminated using mobile, hand-held devices, which can be used in vivo with every drinking episode.
Characterizing Intervention Efficacy. The researchers intend to demonstrate that adding a PBS-focused component can increase efficacy beyond standard single-session BMIs while keeping costs minimal. Although the researchers predict that the PBS-based EMI will effect greater and more lasting decreases in alcohol consequences beyond standard intervention, it is important to verify that cheaper, single-session alternatives are not as effective (i.e., PBS-based BMI). Therefore, the researchers intend to implement a 2 (EMI, Ecological Momentary Assessment only [EMA]) by 3 (no single-session intervention control, standard BMI, BMI plus PBS component) factorial design. The researchers will characterize the efficacy of the BMI+PBS and EMI over traditional, single-session BMIs in several ways:
Specific Aim 2a: The researchers will examine whether the EMI methodology effects greater and more lasting behavior change as compared to the EMA assessment conditions.
To accomplish Specific Aim 2a, the researchers will examine the main effect of assessment (EMI vs. EMA) to demonstrate that the EMI conditions yield better longitudinal outcomes regardless of the single-session intervention.
Specific Aim 2b: The researchers will examine whether the PBS intervention component leads to reduced alcohol related consequences as compared to a standard BMI, even with a single-session intervention.
To accomplish Specific Aim 2b, the researchers will examine the main effect of the single-session intervention to demonstrate that a single-session BMI that has been enhanced by the PBS component will yield superior longitudinal effects relative to a BMI without the PBS component regardless of assessment style (EMA or EMI); the researchers further expect both BMI groups to be superior to the no-intervention control.
Specific Aim 2c: The researchers expect the EMI to moderate the single-session intervention, such that the PBS-BMI coupled with EMI will yield superior longitudinal outcomes on drinking consequences.
The researchers expect the PBS intervention component to be most efficacious when delivered in vivo during high-risk, alcohol use situations (i.e., EMI), where student motivation and perceived norms about drinking are most challenged. By using a 2X3 design, the researchers will be able to verify the synergistic interaction and characterize the effect size of the relative superiority of the PBS single-session component coupled with the PBS-based EMI.
Mechanisms of Behavior Change. Unlike the BMI, which relies upon motivation and descriptive norm changes, the researchers expect the PBS intervention component to have different mechanisms of behavior change. Specifically, the PBS component is an intervention that emphasizes skill use rather than motivation. Further, when coupled with EMI, which is a direct behavioral intervention, the PBS component will effect change by targeting specific behaviors as opposed to drinking motivation.
Specific Aim 3: To characterize the differential mechanisms of behavior change across the single-session and EMI interventions.
The researchers expect key differences in the mediating variables across interventions conditions. The researchers will examine PBS norms, PBS perceived effectiveness, and motivation to change PBS to ascertain how the researchers can best effect increases in PBS use in college populations.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James M Henson, Ph.D.
- Phone Number: 757-683-5761
- Email: jhenson@odu.edu
Study Locations
-
-
California
-
Carson, California, United States, 90747
- Recruiting
- California State University Dominguez Hills
-
Contact:
- James M Henson, PHD
- Phone Number: 757-683-5761
- Email: jhenson@odu.edu
-
-
Colorado
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Fort Collins, Colorado, United States, 80523
- Recruiting
- Colorado State University
-
Contact:
- James M Henson, PHD
- Phone Number: 757-683-5761
- Email: jhenson@odu.edu
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87131
- Recruiting
- University of New Mexico
-
Contact:
- James M Henson, Ph.D.
-
-
Virginia
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Norfolk, Virginia, United States, 23529
- Recruiting
- Old Dominion University
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Contact:
- James M Henson, Ph.D.
-
Williamsburg, Virginia, United States, 23187
- Recruiting
- William and Mary
-
Contact:
- James M Henson, PHD
- Phone Number: 757-683-5761
- Email: jhenson@odu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under age of 18 or older than 25
- Not a college student
- Did not drink alcohol in the past 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No single-session intervention-EMA
Participants 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.
|
|
ACTIVE_COMPARATOR: Standard single-session intervention-EMA
Participants 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.
|
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.
|
EXPERIMENTAL: Augment single-session intervention-EMA
Participants 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.
|
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
|
EXPERIMENTAL: No single-session intervention-EMI
Participants 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).
|
This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.
|
EXPERIMENTAL: Standard single-session intervention-EMI
Participants 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).
|
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 EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.
|
EXPERIMENTAL: Augment single-session intervention-EMI
Participants 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Consumption
Time Frame: 6-months
|
Alcohol Use Disorders Identification Test (general consumption)
|
6-months
|
Alcohol Consumption
Time Frame: 6-months
|
Modified version of the Daily Drinking Questionnaire (typical weekly consumption)
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Consequences
Time Frame: 6-months
|
Young Adult Alcohol Consequences Questionnaire
|
6-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mechanisms of behavior change (PBS use)
Time Frame: 6-months
|
Revised Protective Behavioral Strategies Scale is used to measure the use of three types of protective behavioral strategies: Manner of Drinking, Limiting/Stopping Drinking, and Serious Harm Reduction.
Each scale is averaged (possible range 1 - 6, 1 = not at all, 6 = always/almost always), higher scores indicate more use of protective behavioral strategies.
|
6-months
|
Mechanisms of behavior change (PBS helpfulness)
Time Frame: 6-months
|
Perceived PBS Helpfulness scale assess the perceived helpfulness of using various PBS behaviors to moderate drinking.
Items are assessed on a 1 (Not helpful) to 5 (Extremely helpful) scale.
|
6-months
|
Mechanisms of behavior change (PBS motivation)
Time Frame: 6-months
|
The Motivation to use PBS scale assess the motivation of using various PBS behaviors to moderate drinking.
Items are assessed on a 1 (Not motivated) to 5 (Extremely motivated) scale.
|
6-months
|
Mechanisms of behavior change (PBS intentions)
Time Frame: 6-months
|
The Intentions to use PBS scale assess the future intentions of using various PBS behaviors to moderate drinking.
Items are assessed on a 1 (Never) to 5 (Always) scale.
|
6-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James M Henson, Ph.D., Old Dominion University
Publications and helpful links
General Publications
- 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.
- Collins 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.
- Read 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.
- Martens 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OldDominionU
- 5R01AA023197 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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