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Alcohol Drinking in CollegeNCT02952872

Brief Alcohol E-Interventions Study

A study testing Brief Tablet-based Intervention to Address Heavy Alcohol Use in people with Alcohol Drinking in College, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Drinking in College
What is being tested?
Brief Tablet-based Intervention to Address Heavy Alcohol Use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
23 Dec 2016to 13 Jan 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wayne State University

    Detroit, Michigan, 48202

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Brief Tablet-based Intervention to Address Heavy Alcohol Use
Keywords
Computerized Brief Intervention
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.

  • Brief Tablet-based Intervention to Address Heavy Alcohol UseBehavioural

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

Study groups in NCT02952872
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 2ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 3ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 4ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 5ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 6ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 7Experimental7. 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 8ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 9ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 10ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 11ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 12ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 13Experimental13. 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 14ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 15ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use
Arm 16ExperimentalParticipants 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.
Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

What is being measured

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

  1. Mean Drinks Per Day

    Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.

    Measured: 1 month and 3 months after baseline

Secondary outcomes (3)
  1. Number of Heavy Drinking Days Per Month

    Number of days participant reports drinking 4/5 (male/female) alcoholic drinks in a 2-hour period during the past 30 days

    Measured: 1 month and 3 months after baseline

  2. Report of Alcohol Related Consequences

    Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire

    Measured: 1 month and 3 months after baseline

  3. Intention to Reduce Alcohol Use

    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.

    Measured: 1 month and 3 months after baseline

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study start23 Dec 2016
  3. Primary completion25 Sep 2017
  4. Study completion13 Jan 2018

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
Masking
Single blind
Who is masked
Participant
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952872
Sponsor's protocol ID
R21AA023660
Status last verified
Jun 2019
First submitted
31 Oct 2016
Last updated
17 Jun 2019
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31436446

Questions about this trial

What is this clinical trial studying?

A study testing Brief Tablet-based Intervention to Address Heavy Alcohol Use in people with Alcohol Drinking in College, run by Wayne State University at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Drinks Per Day (time frame: 1 month and 3 months after baseline). 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 NCT02952872, which also lists 1 linked publication.

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 17 Jun 2019.

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