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Completed

NCT Number: NCT02952872

Brief Alcohol E-Interventions Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Tablet-based Intervention to Address Heavy Alcohol Use

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 2, 2016
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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