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Brief Alcohol E-Interventions Study

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ClinicalTrials.gov Identifier: NCT02952872
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Emily Grekin, Wayne State University

Brief Summary:
The project seeks to develop an effective computer-delivered brief intervention to reduce alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of the intervention will be tested with manipulation of common factors (empathy & positive regard), use of a voice, and use of an animated narrator. Participants will include 352 undergraduate students randomly assigned to one intervention condition; follow-up assessments will take place at one and 3 months. The main outcome will be means drink per day over the past 30 day.

Condition or disease Intervention/treatment Phase
Alcohol Drinking in College Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use Not Applicable

Detailed Description:
The proposed project seeks to develop a maximally effective computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. To accomplish this, we will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content, beginning with factorial designs evaluating main and interaction effects of specific intervention components. Our selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of non-specific factors, such as empathy and positive regard, to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. To accomplish these goals, we will examine outcomes of computer-delivered brief interventions in which common factors (empathy & positive regard), use of a voice, and use of an animated narrator are systematically manipulated using a factorial design. We will also systematically manipulate the presence vs. absence of motivational content in order to examine possible interactions between common factors and specific motivational techniques. Participants will be 352 undergraduates who are randomly assigned to 1 of 16 intervention conditions. Mean drinks per day over the past 30 days will be measured at 1 and 3-month follow-ups. Secondary analyses will also examine past month heavy drinking days, alcohol-related consequences, and intention to reduce alcohol use. We hypothesize that there will be significant main effects for (1) the factor consistent with Common Factors Theory (empathy and positive regard), (2) the two factors consistent with Media Equation Theory (voice and narrator), and (3) the presence of motivational content. We further hypothesize that mean drinks/day will be lower when (1) the common factors (empathy, positive regard) are combined with a voice and/or narrator or (2) motivational content is combined with common factors and/or a voice/narrator.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
Actual Study Start Date : December 23, 2016
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : January 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Arm 1
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 2
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 3
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 4
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 5
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 6
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 7
7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 8
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 9
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 10
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 11
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 12
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 13
13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 14
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 15
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Experimental: Arm 16
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.




Primary Outcome Measures :
  1. Mean Drinks Per Day [ Time Frame: 1 month and 3 months after baseline ]
    Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.


Secondary Outcome Measures :
  1. Number of Heavy Drinking Days Per Month [ Time Frame: 1 month and 3 months after baseline ]
    Number of days participant reports drinking 4/5 (male/female) alcoholic drinks in a 2-hour period during the past 30 days

  2. Report of Alcohol Related Consequences [ Time Frame: 1 month and 3 months after baseline ]
    Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire

  3. Intention to Reduce Alcohol Use [ Time Frame: 1 month and 3 months after baseline ]
    Participants self-report intentions to reduce drinking on the Drinking Intentions Questionnaire. On this questionnaire, participants rate how likely they are to reduce their drinking over the next week, month, and year on a scale ranging from '0 = Not at all likely' to '5 = Extremely likely.' Higher scores mean greater intentions to reduce drinking. In order to obtain more stable estimates and reduce type I error, responses to the week, month and year questions were summed to create a total drinking intentions score which could range from 0 to 15. More specifically, scores on each individual scale item (i.e. intentions to reduce drinking over the week, month and year) could range from 0 to 5. When summed together, these items created the total score (reported here) which could range from 0 to 15.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must be students at Wayne State University, aged 18 or older. Additionally, participants must report either (1) consuming 3 (women)/4 (men) drinks per day or 7 (women)/14 (men) drinks per week, (2) getting drunk at least once per week over the past 6 months or (3) binge drinking at least once per week over the past 6 months (i.e. more than 4 (women)/5 (men) drinks in a 2 hr. period).

Exclusion Criteria:

Individuals who are under the age of 18, or who do not meet the study's drinking criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952872


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Emily Grekin, PhD Wayne State University
  Study Documents (Full-Text)

Documents provided by Emily Grekin, Wayne State University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily Grekin, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT02952872    
Other Study ID Numbers: R21AA023660 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2016    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Emily Grekin, Wayne State University:
Computerized Brief Intervention
Additional relevant MeSH terms:
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Alcohol Drinking
Alcohol Drinking in College
Drinking Behavior