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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Alcohol Drinking in College
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 2 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 3 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 4 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 5 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 6 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 7 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 8 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 9 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 10 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 11 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 12 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 13 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 14 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 15 | Experimental | 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. Receives: Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use |
| Arm 16 | Experimental | 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. 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.
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)
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
Report of Alcohol Related Consequences
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
Measured: 1 month and 3 months after baseline
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.
- First posted2 Nov 2016 (estimated)
- Study start23 Dec 2016
- Primary completion25 Sep 2017
- Study completion13 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Drinking in CollegeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Grekin, Wayne State University
- Investigators
- Emily Grekin, PhD, Principal investigator, Wayne State University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
- ClinicalTrials.gov ID
- NCT02952872
- Acronym / sponsor ID
- R21AA023660
- Conditions
- Alcohol Drinking in College
- Keywords
- Computerized Brief Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 13 Jan 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 2 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 3 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 4 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 5 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 6 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 7 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use7. 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. |
| Arm 8 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 9 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 10 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 11 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 12 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 13 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use13. 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. |
| Arm 14 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 15 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
| Arm 16 | Experimental | Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol UseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Individuals who are under the age of 18, or who do not meet the study's drinking criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Tablet-based Intervention to Address Heavy Alcohol UseThe intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use. | Behavioural | Arm 1, Arm 10, Arm 11, Arm 12, Arm 13, Arm 14, Arm 15, Arm 16, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
Primary outcome
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.
3 secondary outcomes
Number of Heavy Drinking Days Per Month
Time frame: 1 month and 3 months after baseline
Report of Alcohol Related Consequences
Time frame: 1 month and 3 months after baseline
Intention to Reduce Alcohol Use
Time frame: 1 month and 3 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31436446Grekin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Grekin, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
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.