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College Student DrinkingNCT03510728

Efficacy and Mechanisms of Technology-based Behavioral Interventions

A study testing college drinker's check up, Protective Behavioral Strategies Intervention and Ecological Momentary Intervention in people with College Student Drinking, run by James M. Henson at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
College Student Drinking
What is being tested?
college drinker's check up, Protective Behavioral Strategies Intervention and Ecological Momentary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
5 sitesUnited States
Study dates
15 Nov 2017to May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Under age of 18 or older than 25
  • Not a college student
  • Did not drink alcohol in the past 4 weeks

Trial locations and contacts

5 sites in 1 country.

James M Henson, Ph.D. contact

757-683-5761

jhenson@odu.edu

5 sites in 1 country

United States5 sites, 5 recruiting
  • University of New Mexico

    Albuquerque, New Mexico, 87131

    James M Henson, Ph.D.

    Recruiting
  • California State University Dominguez Hills

    Carson, California, 90747

    James M Henson, PHD, 757-683-5761, jhenson@odu.edu

    Recruiting
  • Colorado State University

    Fort Collins, Colorado, 80523

    James M Henson, PHD, 757-683-5761, jhenson@odu.edu

    Recruiting
  • Old Dominion University

    Norfolk, Virginia, 23529

    James M Henson, Ph.D.

    Recruiting
  • William and Mary

    Williamsburg, Virginia, 23187

    James M Henson, PHD, 757-683-5761, jhenson@odu.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
college drinker's check up, Protective Behavioral Strategies Intervention, Ecological Momentary Intervention
Keywords
Protective Behavioral Strategies
Medical subject headings
Alcohol Drinking in College

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • college drinker's check upBehavioural

    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 InterventionBehavioural

    This intervention component focuses on educating and promoting PBS activities in future college drinking situations

  • Ecological Momentary InterventionBehavioural

    This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.

Study groups in NCT03510728
Study groupRoleWhat they receive
No single-session intervention-EMANo 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-EMAActive 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.
Receives: Behavioral: college drinker's check up
Augment single-session intervention-EMAExperimentalParticipants 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.
Receives: Behavioral: college drinker's check up; Behavioral: Protective Behavioral Strategies Intervention
No single-session intervention-EMIExperimentalParticipants 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).
Receives: Behavioral: Ecological Momentary Intervention
Standard single-session intervention-EMIExperimentalParticipants 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).
Receives: Behavioral: college drinker's check up; Behavioral: Ecological Momentary Intervention
Augment single-session intervention-EMIExperimentalParticipants 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).
Receives: Behavioral: college drinker's check up; Behavioral: Protective Behavioral Strategies Intervention; Behavioral: Ecological Momentary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol Consumption

    Alcohol Use Disorders Identification Test (general consumption)

    Measured: 6-months

  2. Alcohol Consumption

    Modified version of the Daily Drinking Questionnaire (typical weekly consumption)

    Measured: 6-months

Secondary outcomes (1)
  1. Alcohol Consequences

    Young Adult Alcohol Consequences Questionnaire

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start15 Nov 2017
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
There are three conditions at the start of the study regarding assignment to a single-session intervention: none (control), standard BMI (CDCU), and the standard BMI plus a PBS-component. These are crossed with the type of application for their phone: an ecological momentary assessment-only or an ecological momentary intervention.
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510728
Sponsor's protocol ID
OldDominionU
Other IDs
5R01AA023197
Status last verified
Mar 2021
First submitted
16 Apr 2018
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 8329970
  • 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.

    PubMed 3998247
  • 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.

    PubMed 16536141
  • 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.

    PubMed 16329461

Questions about this trial

What is this clinical trial studying?

A study testing college drinker's check up, Protective Behavioral Strategies Intervention and Ecological Momentary Intervention in people with College Student Drinking, run by James M. Henson at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact James M Henson, Ph.D. (757-683-5761, jhenson@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Consumption (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510728, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021; AzTrials last refreshed its copy on 4 Nov 2026.

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