Brief Alcohol E-Interventions Study

NCT ID: NCT02952872

Last Updated: 2019-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-23

Study Completion Date

2018-01-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Drinking in College

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

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.

Group Type EXPERIMENTAL

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Intervention Type BEHAVIORAL

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Emily Grekin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Grekin, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Grekin ER, Beatty JR, McGoron L, Kugler KC, McClure JB, Pop DE, Ondersma SJ. Testing the efficacy of motivational strategies, empathic reflections, and lifelike features in a computerized intervention for alcohol use: A factorial trial. Psychol Addict Behav. 2019 Sep;33(6):511-519. doi: 10.1037/adb0000502. Epub 2019 Aug 22.

Reference Type DERIVED
PMID: 31436446 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R21AA023660

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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