Efficacy and Mechanisms of Technology-based Behavioral Interventions

College Student Drinking Clinical Trial

Official title:

Efficacy and Mechanisms of Technology-based Behavioral Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510728
• Other study ID #: OldDominionU
• Secondary ID: 5R01AA023197
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: May 2022

Study information

• Verified date: March 2021
• Source: Old Dominion University
• Contact: James M Henson, Ph.D.
• Phone: 757-683-5761
• Email: jhenson[@]odu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking in College
• College Student Drinking

Intervention

Behavioral:
• college drinker's check up
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.
• Protective Behavioral Strategies Intervention
This intervention component focuses on educating and promoting PBS activities in future college drinking situations
• Ecological Momentary Intervention
This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	California State University Dominguez Hills	Carson	California
United States	Colorado State University	Fort Collins	Colorado
United States	Old Dominion University	Norfolk	Virginia
United States	William and Mary	Williamsburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
James M. Henson	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mechanisms of behavior change (PBS use)	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
Other	Mechanisms of behavior change (PBS helpfulness)	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
Other	Mechanisms of behavior change (PBS motivation)	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
Other	Mechanisms of behavior change (PBS intentions)	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
Primary	Alcohol Consumption	Alcohol Use Disorders Identification Test (general consumption)	6-months
Primary	Alcohol Consumption	Modified version of the Daily Drinking Questionnaire (typical weekly consumption)	6-months
Secondary	Alcohol Consequences	Young Adult Alcohol Consequences Questionnaire	6-months