search
Back to results

Efficacy and Mechanisms of Technology-based Behavioral Interventions

Primary Purpose

College Student Drinking

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
college drinker's check up
Protective Behavioral Strategies Intervention
Ecological Momentary Intervention
Sponsored by
James M. Henson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for College Student Drinking focused on measuring Protective Behavioral Strategies

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California State University Dominguez HillsRecruiting
  • Colorado State UniversityRecruiting
  • University of New MexicoRecruiting
  • Old Dominion UniversityRecruiting
  • William and MaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

No single-session intervention-EMA

Standard single-session intervention-EMA

Augment single-session intervention-EMA

No single-session intervention-EMI

Standard single-session intervention-EMI

Augment single-session intervention-EMI

Arm Description

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.

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.

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.

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).

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).

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).

Outcomes

Primary Outcome Measures

Alcohol Consumption
Alcohol Use Disorders Identification Test (general consumption)
Alcohol Consumption
Modified version of the Daily Drinking Questionnaire (typical weekly consumption)

Secondary Outcome Measures

Alcohol Consequences
Young Adult Alcohol Consequences Questionnaire

Full Information

First Posted
April 16, 2018
Last Updated
March 21, 2021
Sponsor
James M. Henson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03510728
Brief Title
Efficacy and Mechanisms of Technology-based Behavioral Interventions
Official Title
Efficacy and Mechanisms of Technology-based Behavioral Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James M. Henson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
College Student Drinking
Keywords
Protective Behavioral Strategies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No single-session intervention-EMA
Arm Type
No Intervention
Arm Description
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.
Arm Title
Standard single-session intervention-EMA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Augment single-session intervention-EMA
Arm Type
Experimental
Arm Description
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.
Arm Title
No single-session intervention-EMI
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard single-session intervention-EMI
Arm Type
Experimental
Arm Description
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).
Arm Title
Augment single-session intervention-EMI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
college drinker's check up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protective Behavioral Strategies Intervention
Intervention Description
This intervention component focuses on educating and promoting PBS activities in future college drinking situations
Intervention Type
Behavioral
Intervention Name(s)
Ecological Momentary Intervention
Intervention Description
This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.
Primary Outcome Measure Information:
Title
Alcohol Consumption
Description
Alcohol Use Disorders Identification Test (general consumption)
Time Frame
6-months
Title
Alcohol Consumption
Description
Modified version of the Daily Drinking Questionnaire (typical weekly consumption)
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Alcohol Consequences
Description
Young Adult Alcohol Consequences Questionnaire
Time Frame
6-months
Other Pre-specified Outcome Measures:
Title
Mechanisms of behavior change (PBS use)
Description
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.
Time Frame
6-months
Title
Mechanisms of behavior change (PBS helpfulness)
Description
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.
Time Frame
6-months
Title
Mechanisms of behavior change (PBS motivation)
Description
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.
Time Frame
6-months
Title
Mechanisms of behavior change (PBS intentions)
Description
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.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James M Henson, Ph.D.
Phone
757-683-5761
Email
jhenson@odu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Henson, Ph.D.
Organizational Affiliation
Old Dominion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
California State University Dominguez Hills
City
Carson
State/Province
California
ZIP/Postal Code
90747
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Henson, PHD
Phone
757-683-5761
Email
jhenson@odu.edu
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Henson, PHD
Phone
757-683-5761
Email
jhenson@odu.edu
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Henson, Ph.D.
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Henson, Ph.D.
Facility Name
William and Mary
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23187
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Henson, PHD
Phone
757-683-5761
Email
jhenson@odu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8329970
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. doi: 10.1111/j.1360-0443.1993.tb02093.x.
Results Reference
background
PubMed Identifier
3998247
Citation
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.
Results Reference
background
PubMed Identifier
16536141
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. doi: 10.15288/jsa.2006.67.169.
Results Reference
background
PubMed Identifier
16329461
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. doi: 10.15288/jsa.2005.66.698.
Results Reference
background

Learn more about this trial

Efficacy and Mechanisms of Technology-based Behavioral Interventions

We'll reach out to this number within 24 hrs